SP60

( Reaffirmed 2004 )
LICENSED TO ESSAR STEEL LIMITED, HAZIRA FOR INTERNAL USE AT THIS LOCATION ONLY, SUPPLIED BY BOOK SUPPLY BUREAU.
CONTENTS
Chapter SECTION 1. General terms and their definitions (ISO/IEC Guide 2 :1991) SECTION 1. 2. 3. 2 COMPETENCE, 1 TERMINOLOGY concerning standardization and related activities .. . .. . .. . OF 3 Page No.
ACCEPTANCE LABORATORIES
AND ACCREDITATION
General requirements for the competence (ISO/IEC Guide 25 : 1990) Development and operation of laboratory
of calibration
and testing laboratories . .. .. . **.
19 27
proficiency
testing (ISO/IEC Guide 43 :1984) General requirements . .. . .. for . ..
Calibration and testing laboratory accreditation systems operation and recognition (ISO/IEC Guide 58 :1993) SECTION 3 PRODUCT AND QUAUTY
33
SYSTEM CERTIFICATION (ISO/IEC Guide 7 :1982) and related with standards .. . .. . .. . 41 45 47 51 55 71 77 91 101 115
1. 2. 3. 4. 5. 6. 7. 8. 9. 10.
Requirements
for standards
suitable for product certification certification systems
Code of principles on third-party (ISO/IEC Guide 16 : 1978)
Information on manufacturers declaration of conformity technical specifications (ISO/I EC Guide 22 : 1982) Methods of indicating conformity (ISO/IEC Guide 23 :1982) with standards
standards or other . .. ..a . .. certification .,, . .. systems .. . .. . . .. a*.
for third-party
General rules for a model third-party (ISO/IEC Guide 28 :1982) Guidelines for a step-by-step (ISO/IEC Guide 42 :1984)
certification
system for products certification system .*. . .. . .. .*. of a suppliers system schemes .*. for ...
approach
to an international third
General rules for IS0 or IEC international products (ISO/IEC Guide 44 : 1985) Guidelines for third party-assessment (ISO/IEC Guide 48 : 1986)
party certification
and registration quality
quality system .. . .. . .. .
An approach to the utilization of a suppliers certification (ISO/IEC Guide 53 : 1988) An approach to the review by a certification (ISO/IEC Guide 56 : 1989) SECTION 4 ACCEPTANCE
in third-party product . .. . .. . .. quality system .,, .. . .. .
body of its own internal
OF INSPECTION BODIES
BODIES AND CERTlFlCATlON body in the event of *,, . .. . ..
1. 2. 3.
Guidelines for corrective action to be taken by a certification misuse of its mark of conformity (ISO/IEC Guide 27 :1983) General requirements for the acceptance (ISO/IEC Guide 39 : 1988) 1983)
121 127 135
of inspection
bodies
.., . ,, ... . .. ... . ..
General requirements for the acceptance of certification bodies (ISO/lEC Guide 40 :
0)
ISBN 81-7061-045-l
As in the Original Standard, this Page is Intentionally Left Blank
INTRODUCTION
Assessment of conformity with standards may take a variety of forms and the situation in each country will vary depending on the prevailing techno-economic and social conditions and needs. The International Organization for Standardization (ISO) has identified 8 different certifications systems in use at present. However, ISO, by itself does not operate certification systems. Although individual claims of conformity with these standards are possible, any country wishing to introduce a certification system has, therefore, to evolve its own assessment procedures for the purpose. With a view to ensure that existing national certification systems would not tend to diverge and to establish converging trends that would pave the way to bilateral and multilateral arrangements and eventually to of general guideline documents at truly international certifications systems, the preparation international level were necessitated. The introduction of IS0 9000 series of standards and the subsequent work of ISOflC 176 in the application of standards on quality management have further confirmed the need for the development of these guides. In response to the above, and the demands, in particular from developing countries, CASCO (IS0 Council Committee for Conformity Assessment) has formulated 17 ISO/IEC guides (known as CASCO guides) on the above subjects. These guides relate to the testing, inspection and certification of products, processes and services, and to the assessment of quality systems, testing laboratories, inspection bodies, certification bodies and their operation and acceptance. While on this point, it may be mentioned that, in addition to the above guides, 7 European Standards, popularly known as EN 45000 series standards, on testing, certification and accreditation have also been published. On a comparative study, it has been observed that each CASCO Guide addresses an individual element of conformity assessment; whereas, EN 45000 series, in some cases, are combination of more than one element. The contents of EN 45001, EN 45002, EN 45003 and EN 45014 are similar to the corresponding CASCO Guides, whereas EN 45011, EN 45012 and EN 45013 are quite different from the CASCO Guides. MSD 2 (Quality Management) Sectional Committee of BIS scrutinized these CASCO guides and was of the opinion that these would provide useful guidance to our laboratories and certification bodies in harmonizing their procedures in line with the international practices. Therefore, MSD 2 Sectional Committee decided to adopt all these 17 guides. Further, it was decided that all these guides should be published together as one Special Publication so as to facilitate easy cross referencing to the other guides. It is hoped that this Special Publication will be of practical use to all those interested in assessment of conformity and related activities. As these guides are being impelmented by many IS0 member countries, it would promote mutual recognition and acceptance of national and regional conformity assessment systems.
(iii)
SECTION 1 TERMINOLOGY
FOREWORD The international Organization for Standardization (ISO) has published a number of guides on standardization policies and procedures, several of them in conjunction ,with International Electra-technical Commission (IEC). To guard against terminological inconsistencies, a clear understanding of basic concepts needed to be established, and unambiguous general terms and definitions provided. Therefore, a need was felt to prepare a guide which would contribute fundamentally towards mutual understanding amongst the members of IS0 and IEC and the various governmental and non-governmental agencies involved in standardization at international, regional and national levels. It should also provide a suitable source for teaching and referencing, briefly covering basic theoretical and practical principles of standardization, certification and laboratory accreditation. Keeping this in view, ISO/IEC Guide 2 General terms and their definitions concerning standardization and related activities was published. This section reproduces this guide.
CHAPTER
SP 60 : 1993
GENERAL TERMS AND THEIR DEFINITIONS CONCERNING STANDARDIZATION AND RELATED ACTIVITIES (lSO/IEC GUIDE 2 : 1991) Introduction
History
When the fifth edition of this Guide was issued for the first time as a joint ISO/IEC publication, in 1966, it superseded the fourth edition of IS0 Guide2 (1962). That edition had resuited from piecemeal extensions to the set of terms and definitions first published by IS0 in 1976 and prepared originally by the United Nations Economic Commission for Europe (ECE) in close consultation with ISO, primarily to facilitate the work of the ECE aimed at the removal of barriers to international trade arising from lack of harmonization of standards or inadequate international application of standards.
Readership
This Guide is intended to contribute fundamentally towards mutual understanding amongst the members of IS0 and IEC and the various governmental and non-governmental agencies involved in standardization at international, regional and national levels. It should also provide a suitable source for teaching and for reference, briefly covering basic theoretical and practical principles of standardization, certification and laboratory accreditation. Whilst IS0 and IEC jointly provide the international frfimework for standardization, covering a wide range of mainly technical matters, the general concept of standardization extends beyond their terms of reference. For IS0 and IEC purposes, the definition of standardization (1 .l 1 should accordingly be read in conjunction with the definitions of standard 13.2) and consensus (1.7).
Explanatory
notes
The use of parentheses (. . . 1 around words of some term means that these words may be omitted if it is unlikely that this will cause confusion. The definitions included in this Guide are directly equivalent in the English, French and Russian languages. They have been drawn up as concisely as practicable. Where they occur in other definitions, terms which have themselves been defined in this Guide are printed in italics. The notes appended to certain definitions offer clarification, explanation and examples to facilitate understanding of the concepts described. In certain cases the notes may differ in different languages for linguistic reasons (as in 7.1 and 14.2) or additional notes may be given. In science and technology, the English word standard is used with two different meanings: as a normative document as defined in 3.2 (in French norme, in Russian cTaHflapTl and also as a measurement standard (in French &alon, in Russian 3TanoH). This Guide is concerned solely with the first meaning. The second is the province of the International vocabulary of
basic and general I VIMI. terms in metrology
Reasons for the 1966 revision

Successive editions of IS0 Guide 2 added new terms and definitions in more or less isolated groups, within no overall planned framework. Work on a systematically structured revision was authorized by IS0 Council in 1981 as the principal task of a reconstituted working group within the IS0 Committee on standardization principles (ISO/STACO), including IEC and ECE spokesmen and in cooperation with the IS0 Committee on conformity assessment (ISO/CASCO) and the International Laboratory Accreditation Conference (ILAC).
General principles
The general terminological principles guiding the 1986 revision of Guide 2 were those established by ISO/TC 37,
Terminology nation). (principles and coordi-
It is not the aim of this Guide to duplicate definitions of terms adequately defined for general purposes in other authoritative international glossaries. From this point of view, particular attention is drawn to the International
vocabulary of basic and general terms in metrology WlMl jointly prepared by
Structure
of the Guide
A main reason for this activity was a request from ECE for complete and urgent revision of IS0 Guide 2 to take into account a number of specific problems raised by the ECE Government Officials Responsible for Standardization Policies as well as the proposed terminology being prepared in the ECE Working Party on Building. Also, IS0 was publishing an increasing number of Guides on standardization policies and procedures, several of them in conjunction with IEC. To guard against terminological inconsistencies, a clear understanding of basic concepts needed to be established, and unambiguous general terms and definitions provided.
ISO, IEC, the International Bureau of Weights and Measures IBIPM) and the International Organization of Legal Metrology (OIML) and published in 1984. Terms expressing more specific concepts may generally be constructed by combination of terms representing more general concepts. The latter terms thus form building blocks, and the selection of terms and construction of definitions within this Guide has been based on this approach in cases where equivalent English, French and Russian combined terms contain the same building blocks. In this way, additional terms can be readily constructed within the framework of the Guide. For example, the term safety standard can be defined as a standard (3.2) concerned with freedom from unacceptable risk of harm (definition of safety in 2.5). 3
In this Guide, related concepts are together sixteen under grouped headings, beginning with the more general and ending with the more specific aspects of standardization and related activities of certification and testing laboraton/ accredit&ion.
Equivalent terms in non-official languages

In addition to the terms given in the official languages of IS0 and IEC (English, French and Russian), equivalent terms provided by the relevant member bodies are given in the following languages: German Spanish Italian Dutch Swedish (de) (es) (it) .(nl) (sv)
SP 60 : IsSi
Standardization
1.1 standardization: Activity of establishing, with regard to actual or potential problems, provisions for common and repeated use, aimed at the achievement of the optimum degree of order in a given context.
NOTES 1 In particular, the activity consists of the processes of formulating, issuing and implementing standards.
2 Important benefits of standardization are improvement of the suitability of products, processes and services for their intended purposes, prevention of barriers to trade and facilitation of technological cooperation.
1.6.1 international standardization : Standardization in which involvement is open to relevant bodies from all countries.
1.6.2
regional
standardization
to relevant
: Standardization
bodies
in which
from countries from only one geographical, political or economic area of the world.
involvement is open
1.6.3 national standardization : Standardization place at the level of one specific country.
that takes
1.2 subject of standardization:

NOTES
Topic to be standardized.
1.6.4 provincial standardization : Standardization that takes place at the level of a territorial division of a country.
NOTE TO DEFINITIONS 1.6.3 and 1.6.4 - Within a country or a territorial division of a country, standardization may also take place on a branch or sectoral basis (e.g. ministries), at local levels, at association and company levels in industry and in individual factories, workshops and offices.
1 The expression product, process or service has been adopted throughout this Guide to encompass the subject ofstandardization in a broad sense, and should be understood equally to cover, for example, any material, component, equipment, system, interface, protocol, procedure, function, method or activity. 2 Standardization may be limited to particular aspects of any subject. For example, in the case of shoes, sizes and durability criteria could be standardized separately.
1.7 consensus: General agreement, characterized by the absence of sustained opposition to substantial issues by any important part of the concerned interests and by a process that involves seeking to take into account the views of all parties concerned and to reconcile any conflicting arguments.
NOTE Consensus
need not imply unanimity.
1.3 field of standardization (deprecated: domain of standardization) : Group of related subjects of standardization.
NOTE - Engineering, transport, agriculture, and quantities and units, for example, could be regarded as fields of stendardization.
Aims of standardization
1.4 state of the art : Developed stage of technical capability at a given time as regards products, processes and services, based on the relevant consolidated findings of science, technology and experience.
NOTE - The general aims of standardization follow from the definition in 1.1. Standardization may have one or more specific aims, to make a product, process or service fit for its purpose. Such aims can be, but are not restricted to, variety control, usability, compatibility, interchangeability, health, safety, protection of the environment, product protection, mutual understanding, economic performance, trade. They can be overlapping.
2.1 fitness for purpose: Ability of a product, process or service to serve a defined purpose under specific conditions.
1.5
acknowledged rule of technology: Technical provision acknowledged by a majority of representative experts as reflecting the state of the art. 2.2 compatibility: Suitability of products, processes or services for use together under specific conditions to fulfil relevant requirements without causing unacceptable interactions.
NOTE - A normative document on a technical subject, if prepared with the cooperation of concerned interests by consultation and consensus procedures, is presumed to constitute an acknowledged
rule of technology
at the time of its approval. 2.3 interchangeability: Ability of one product, process or service to be used in place of another to fulfil the same require-
1.6 level of standardization: Geographical, political or aconomic extant of involvement in standardization.
nn?nts. NOTE - The functional aspect of interchangeability is called functional interchangeability, and the dimensionalaspect dimensional interchangaabiliv' .
SP
60 :1993
2.4
variety control:
Selection of the optimum number of

processes or services to meet
Publicly available standards:
sizes or types of products, prevailing needs.
3.2.1 NOTE Variety corrtro/ k usually concerned with variety reduction. an
international international
standard:
Standard
that is adopted orgafrization
by
standardizing/standards to the public.
a nd
made available
3.2.2
ragional
regional
standard:
Standard
that is adopted by e
and made
standardizing/standards to the public.
organization
available
2.5
safe~:
Freedom
from unacceptable
risk of harm.
the safety of products, processes and serNOTE In standardization, vices is generally considered with a view to achieving the optimum
3.2.3
national standard:
Standard
that is adopted by a na-
balanceof a numberof factors,includingnon-technicalfactors suchas

human behaviour, thatvvill eliminate avoidable risks of harm to persons and gooda to an acceptable degree.
tionad standards
body and made available
to the public.
3.2.4 provincial
standard:
Sbndard
that is adopted
at the
2.6
protection of the environment: Presewation of the environment from unacceptable damage from the effects and operations of products, processes and services.
level of a territorial the public.
division of a country
and made available to
NOTETO DEFINITIONS3.2.1, 3.2.2, 3.2.3 and 3.2.4 By vittue of theirstatusas standards, their public availability and their arrrandrnent
or revision aa necesaay to keep pace with the state of the art, international, regional, national and provincial standards are presumed to constitute acknowledged rules of technology.
2.7
product protection (deprecated: environmental protection]: Protection of a product against climatic or other adverse conditions during its use, transport~r storage.
Othar
standards: branch may
Standards smndards
may aleo be adopted and company impact covering
on other Such several
3 3.1
Normative
documents
bases, e.g. standards countries.
standards.
have a geographical
normativa document: Document that provides rules, guidelines or characteristics for activities or their resulta. NOTES 1 The term normative
documents as standards,
document technical
32s)
is a generic term that covers such
specifications, codes of practice
prasterrdard: Document that is adopted provisionally by a standardizing body and made available to the public in
order that the necessary experience may be gained from its plication m which to base a standard.
ap-
and regulaeons.
2
A doctmwnt ia to be understood as any medium with information recorded on or in it.
3.3
technical specification: Docurrwnt
technical requirements 3 The terms for different kinds of normative documents are defined considering the document and its wntent as a single entity. service.
to
be fulfilled
that by a product,
prescribes process or
NOTES
1 A technical specification should indicate, whenever appropriate, the procedure(s) by means of which it maybe determined whether ths rsquimmanta given sre fulfilled. 2 A technical specflication may independent of a standard.
3.2
standard: Document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree
of order in a given context.
baastandard, a pert of a standani or
NOTE - Standards should be baaed on the consolidatedresultsof science, technologysnd experience,and aimed at the promotionof optimumcommunitybanefits.
SP 60 : 1993
3.4
code of practice:
Document
that recommends
prac-
4.4
standards
body:
Standardizing
body
recognized
at
tices or procedures for the design, manufacture, installation, maintenance or utilization of equipment, structures or products. NOTE - A code of practice may be a standard, independent of a standard.
a part of a standard or
national, regional or international level, that has as a principal function, by virtue of its statutes, the preparation, approval or adoption of sfandards that are made available to the public. NOTE A standards body may also have other principal functions.
3.5
regulation : Document
providing
binding
legislative
rules, that is adopted
by an authority.
4.4.1
national standards body: Standards body recognized
at the national level, that is eligible to be the national member of the corresponding international and regional standards organizations
.
3.5.1
technical
regulation : Regulation
of a standard,
nical requirements, porating the content code of practice.
that provides techeither directly or by referring to or incortechnical specification or 4.4.2
regional standards organization : Standards
organiz-
ation whose membership is open to the relevant national body political or from each country within one geographical, economic area only.
NOTE - A technical regulation may be supplemented by technical guidance that outlines some means of compliance with the requirements of the regulation, i.e. deemed-to-satisfy provision.
4.4.3
international
whose
standards
membership
organization : Standards
is open to the relevant
organization
national body from every country.
4 Bodies responsible and regulations 4.1
for standards
body (1) : Legal or administrative
entity that has specific
tasks and composition. NOTE - Examples of bodies are organizations, and foundations.
authorities,
4.5
companies
authority:
Body that has legal powers and rights.
NOTE -
An authority can be regional, national or local.
4.2
organization : Sody that is based on the membership
of
other bodies or individuals and has an established and its own administration.
constitution
4.5.1
regulatory authority : Authority

regulations.
that is responsible for
preparing or adopting
4.3
standardizing
body :
Body
that
has
recognized
activities in standardization.
4.5.2
enforcement
authority : Authority
that is responsible
for enforcing regulations. NOTE The enforcement

authority. authority may or may not be the same as
the regulatory
4.3.1
regional standardizing
organization:
Standardizing
organization whose national body from political or economic
membership each country area only.
is open to the relevant within one geographical,
Types
of standards
4.3.2 international standardizing organization : Standardizing organization whose membership is open to the relevant
national body from every country.
NOTE - The following terms and definitions are not intended to provide a systematic classification or comprehensive list of possible types of standards. They indicate some common types only. These are not mutually exclusive; for instance, a particular producf standard may alsc be regarded as a testing standard if it provides mefhods of test for characteristics of the product in question.
15.1 basic standard:
Standard that has a wide-ranging coverage or contains general provisions for one particular field. NOTE A basic standard may function as a standard for direct ap-
plication or as a basis for other standards.
SP 60
: 1993,
5.2
terminology
usually
standard:
Standard
that
is concerned and, etc. examples,
with terms,
accompanied
by their
definitions
Harmonization
terms and
of standards
can be harmonized are like standards. Corby replacing definitions obtained
sometimes, by explanatory
notes, illustrations,
NOTE -
Technical regulations
responding
standards by technical regulations in the definitions 6.1 to 6.9, and standardizjng bodies by authorities in definition 6.1.
5.3
testing standard : Standard

sometimes
that is concerned with other
with test provisions
methods,
supplemented
related to testing, such as sampling, sequence of tests.
use of statistical methods,
6.1
harmonized standards : Standards
on the same subject
approved by different standardizing
bodies, that establish inter-
changeability of products, processes and services, or mutual understanding of test results or information provided according
5.4
product
standard:
Standard
that
specifies
requireto
to these standards.
NOTES 1 Within this definition harmonized standards might have differences
ments to be fulfilled by a product establish its fitness for purpose. NOTES
or a group of products,
in presentation and even in substance, guidance on how to fulfil the requirements for alternatives and varieties.
e.g. in explanatory notes, of the standard, preferences
1 A producf standard may include in addition to the fitness for purpose requirements, directly or by reference, aspects such as terminology, sampling, testing, packaging and labelling and, sometimes, cessing requirements. pro-
2 The term equivalent standards is sometimes same concept as harmonized standards.
used to cover the
A product standard can be either complete or not, according to whether it specifies all or only a part of the necessary requirements. In this respect one may differentiate between standards such as dimendeliven/ standards.
sional, material, and technical
6.2
unified
standards:
identical in substance
Harmonized standards but not in presentation.
that
are
5.5
process
standard:
Standard
that
specifies
require-
6.3
identical
standards:
ments to be fulfilled ourpose.
by a process,
to establish
its fitness for
identical in both substance NOTES

1 Identification If in different
Harmonized standards and presentation.
that
are
of the standards languages,
may be different. are accurate translations.
5.6
service standard : Standard that specifies requirements
the standards
to be fulfilled by a service, to establish its fitness for purpose. NOTE - Service standards may be prepared in fields such as laundering, hotel keeping, transport, car servicing, telecommunications, in-
6.4
internationally
harmonized
standards : Standards
standard.
that are harmonized
with an international
surance, banking, trading.
5.7
interface
standard : Standard
with the compati&ility
ments concerned
that specifies requireof products or systems
6.5
regionally harmonized standards : Standards harmonized with a regional standard.
that are
at their points of interconnection.
6.6 5.8 rtandard on data to be provided: Standard that contains a list of characteristics for which values or other data are to be stated for specifying the product, process or service. 6.7
multilaterally
harmonized
that
are harmonized
between
more than two standardizing
bodies.
NOTE - Some standanls, typically, provide for data to be stated by ruppliN& others by purchasers.
bilaterally harmonized
between
bodies.
that are
harmonized
two standardizing
SP
60 :1993
6.8 unilaterally aligned standard : Standard that is aligned with another standard so that products, processes, services, rests and information provided according to the former standard meet the requirements of the latter standard but not vice versa. NOTE A unilefer8//y aligned stendard is not harmonized (or equivalent) with the sfenderd with which it is aligned.
7.5.2 optional requirement: Requirement of a normative document that must be fulfilled in order to comply with a particular option permitted by that document.
NOTE An optional requirement
may be either
:
or
a) one of two or more alternative
requirements;
b) an additional requirement that must be fulfilled only if applicable and that may otherwise be disregarded.
6.9 comparable standards: Standards on the same products, processes or services, approved by different standardizing bodies, in which different requirements are based on the same characteristics and assessed by the same methods, thus permitting unambiguous comparison of differences in the requirements.
NOTE standards. cOmfJ8f8b/8 standards
7.6 deemed-to-satisfy provision : Provision that indicates one or more means of compliance with a requirement of a normative document.
are not harmonized
(or equivalent)
7.7 descriptive provision : Provision for fitness for purpose that concerns the characteristics of a product, process or service.
Content of normative
documents
NOTE - A descriptive provision usually conveys design, constructional details, etc. with dimensions and material composition.
7.1 provision: Expression in the content of a normative document, that takes the form of a statement, an instruction, a recommendation or a requirement.
provision are distinguished by the form of wording they employ, e.g. insfructions are expressed in the imperative mood, recommendations by the use of the auxiliary should and requirements by the use of the auxiliary shall.
NOTE - These types of
7.8 performance provision: Provision for fitness for purpose that concerns the behaviour of a product, process or service in or related to use.
8
7.2
Structure
of normative
documents
stetement : Provision that conveys information.
8.1 body (21 (of a normative document) : Set of provisions that comprises the substance of a normative document.
NOTES 1 In the case of a sfanderd, the body comprises general elements relating to its Subjec? and definitions, and main elements conveying
pfovisions.
7.3 instruction : Provision that conveys an action to be performed.
2 Parts of the body of a nofmative document may take the form of annexes (normative annexes) for reasons of convenience, but other Iinformative) annexes may be eddition81 elements only.
1.4 recommendation: Juidance.
Provision that conveys advice or 8.2 additional element: Information that is included in a normarive document but has no effect on its substance.
7.5 requirement: fulfilled.
Provision that conveys criteria to be
NOTE - In the case of a St8nd8fd, additional elements may include, for example, details of publication, foreword and notes.
75.1 exclusive requirement (deprecated : mandatory requirement) : Requirement of a normative document that must necessarily be fulfilled in order to comply with that document. NOTE - The term mandatory requirement&ould be used to mean only a requirementmade compulsory by law or regulation.
Preparation
of normative
documents
9.1 stendards programme: Working schedule of a smnuhdizing body, that lists its current items of standardization woflc.
SP 60 : 1993
9.1.1 standards project: dards programme.
Specific work item within a stan-
9.9 new edition : New impression of a normative document that includes changes to the previous edition. NOTE - Even if only the content of existing correction or amendment sheets is incorporated into the text of a normativedocument,the new text constitutes a new edition.
9.2 draft standard: Proposed standard that is availablrgenerally for comment, voting 01 approval.
10
Implementation
of normative
documents
9.3 period of validity : Period of time for which a normative document is current, that lasts from the date on which it becomes effective (effective date), resulting from a decision of the body responsible for it, until it is withdrawn or replaced.
NOTE - A normative document can be said to be implemented in two different ways. It may be applied in production, trade, etc. and it may be taken over, wholly or in part, in another normative document. Through the medium of this second document, it may then be applied, or it may again be taken over in yet another normative document.
9.4 review: Activity of checking a normative document to determine whether it is to be reaffirmed, changed or withdrawn.
10.1 taking over an international standard (in a national

normative document): Publication of a national normative document based on a relevant international standard, or endorsement of the internationalstandard as having the same status as a national normative document, with any deviations from the international standard identified. NOTE - The term adoption is sometimes used to cover the same concept as taking over, e.g. adoption of an international standard in a national standard.
9.5 correction: Removal of printing, linguistic and other similar errors from the published text of a normative document. NOTE - The results of correction may be presented, as appropriate, by issuing a separate correction sheet or a new edition of the normative
document.
9.6 amendment: Modification, addition or deletion of specific parts of the content of a normative document. NOTE - The results of amendment are usually presented by issuing a separate amendment sheet to the normative document.
10.2 application of a normative document: mative document in production, trade, etc.
Use of a nor-
9.7 revision: Introduction of all necessary changes to the substance and presentation of a normative document.
NOTE - The results of revision are presented by issuing a new edition of the nommtive document.
10.2.1 direct application of an international standard: Application of an international standard irrespective of the taking over of that international standard in any other normative document.
9.8 reprint: New impression of a normative document without changes.
10.2.2 indirect application of an international standard : Application of an internationalstandard through the medium of another normative document in which it has been taken over.
SP 60 : 1993
11
11.1
References
to .standards in regulations
12
Testing
reference to standards (in regulations): Reference to one or more standards in place of detailed provisions within a
regulation.
NOTE - Definitions ot terms relevant to testing but relating to measurement standards can be found in the International vocabulary of basic and general terms in metrology (VIM).
NOTES
1 A reference fo sfandards is either dated, undated or general and at the same time either exclusive or indicative. 2 A reference fo standards may be linked to a more general legal provision referring to the stare of the art or acknowledged rules of technology. Such a provision may also stand alone.
12.1
test: Technical operation that consists of the determination of one or more characteristics of a given product, process or service according to a specified procedure.
12.1.1
testing:
Action of carrying out one or more tests.
11.2
11.2.1
Precision
of reference
(to standards) : Reference
to sran-
dated reference
in such a way that later revisions of the standard or standards are not to be applied unless the regulation is modified. NOTE - The standard is usually identified by its number and either date or edition. The title may also be given.
dards that identifies one or more specific standards
12.2
test method: forming a test.
Specified technical procedure for per-
12.3
11.2.2 undated reference (to standards): Reference to standards that identifies one or more specific standards in such a way that later revisions of the standard or standards are to be applied without the need to modify the regulation.
NOTE - The standard is usually identified only by its number. The title may also be given.
test report: Document that presents test results and other information relevant to a rest.
12.4
testing laboratory : Laboratory that performs rests.
NOTE - The term testing laboratory can be used in the sense of a legal entity, a technical entity or both. general reference (to standards): Reference to that designates all sfandards of a specified body and/or in a particular field without identifying them individually.
standards
11.2.3
interlaboratory test comparisons: Organization, performance and evaluation of rests on the same or similar items or materials by two or more laboratories in accordance with predetermined conditions.
12.5
11.3
11.3.1
Strength
of reference
exclusive reference (to standards): Reference to that states that the only way to meet the relevant requirements of a technical regulation is to comply with the standard(s) referred to.
sfandards
12.6
(!aboratory) proficiency testing : Determination of laboratory testing performance by means of interlaboratory test
comparisons.
11.3.2
indicative
reference
(to standards):
Reference
to
standards that states that one way to meet the relevant requirements of a technical regulation is to comply with the standard(s)
referred to.
NOTE - An indicative reference to standards is a form of deemed-tosatisfy provision.
13
Conformity
and related general concepts
11.4 mandatory standard : Standard the application of which is made compulsory by virtue of a general law or exclusive reference in a regulation.
13.1
conformity: Fulfilment by a product, process or ser. vice of specified requirements.
10
SP
60
: 1993
13.2
third
patty
: Person or body that is recognized as being

bs concerns the issue WI
13.6
registration
: Procedure by which a body indicates rele

of a product, or person, process or service, in an appropriate, or parpublicly
independent question.
NOTE
of the parties involved,
vant characteristics ticulars of a body available list.
Partles involved are usually supplier (first party) party) interests.
and pur
chaser (second
13.7 13.3 evaluation for conformity: a product, Systematic process examination fulfils
accreditation:
Procedure
by which
an authoritative
body gives formal recognition of the extent to which or service
that a body or person is compe-
tent to carry out specific tasks.
specified requirements.
14
13.3.1 inspection: Eva/u&ion for conformity by measuring,
Certification
activities : System that has its own rules of

for carrying out certification of
observing,
testing or gauging
the relevant characteristics.
14.1 certification system procedure and management conformity.

NOTES
13.3.2
conformity
testing:
Evaluation
for
conformity
by
1 Certification systems may be operated regional or international level.
at, for example,
national,
means of testing.
2 The central body that conducts and administers a certification system may decentralize its activities and rights to certify conformity.
13.3.3
type
evaluation:
evaluation
for conformity
on the of
14.2
certification
scheme
: Certification
system as related apply.
basis of one or more specimens the production.
of a product
representative
to specified products, particular standards

NOTE The term
processes or services to which the sarne
and rules, and the same procedure,

certification programme as certification is used
in some
countries to cover the same concept
scheme.
13.3.4 conformity surveillance: Evaluation for conformity to determine the continuing conformity with specified requirements. 14.3 certification conformity.
NOTE -
body
: Body that conducts certification of
13.4
verification
of
conformity: that a product,
Confirmation,
by
ex-
A certification body may operate its own testing and inspec-
amination
of evidence,
process or service fulfils
tion activities or oversee other bodies.
these activities carried out on its behalf by
specified requirements. 14.4

forms
inspection
inspection
body
services
(for
on behalf
certification]: Body that perof a certification body.
13.5 assurance of conformity: Procedure resulting in a statement giving confidence that a product, process or service
fulfils specified requirements.
NOTE ~~ For a product, the statement may be in the furm of a document, a label or other equivalent means. It may also be printed in or applied on a communication, a catalogue, tions manual, etc. relating to the product. an invoice, a user instruc-
14.5 licence (for certification) the rules of a certification svstem.
: Document, issued under by which a certification body

or marks
grants to a person or body the right to use certificates
of conformity for its products, processes or services in accordance with the rules of the relevant certification scheme.
13.5.1 suppliers declaration: Procedure by which a supplier gives written assurance that a product, process or service conforms
NOTE -
to specified requirements.
In order to avoid any confusion, the expression self-
14.6
applicant
(for
certification):
Person
or body
that
seeks to obtain a licence from a certification
body.
certification
should not be used.
13.5.2
certification
: Procedure by which a third party gives

process or service conforms
written assurance that a product, to specified requiwnents.
14.7 licensee (for certification) : Persc,l or body to which a certification body has granted a licence.
11
SP
60
: 1993
14.8 certificate of conformity: Document issued under the rules of a certification system, indicating that adequate confidence is provided that a duly identified product, process
or service is in conformity normative document. with a specific standard or other
multilateral arrangement : Recognition arrangement 15.4 that covers the acceptance of each others results by more than two parties.
14.9 mark,
mark of conformity (for certification): Protected applied or issued under the rules of a certification
15.5
reciprocity
: Bilateral relationship
where
both parties
have the same rights and obligations NOTES

1 Reciprocity
towards
each other.
system, indicating that adequate confidence is provided that the relevant product, process or service is in conformity with a specific standard or other normative document.
can exist within a multilateralarrangement reciprocal relationships.
comprising
network
of bilateral
14.10 access to a certification system: an applicant to obtain certification under system.
Opportunity for_ the rules of the
2 Though rights and obligations are the same, opportunities emanating from them may differ; this may lead to unequal relations
between parties.
i
14.11 body
participant that operates
in a certification system : Certification under the rules of the system without to take part in the management of the
Treatment accorded to products, 15.6 equal treatment: processes or services from one party that is no less favourable than that accorded to like products, processes or services from any other party, in a comparable situation.
having the opportunity system.
14.12 member of a certification system: Certification body that operates under the rules of the system and has the opportunity to take part in the management of the system.
national treatment: Treatment accorded to products, 15.7 processes or services originating in other countries that is no less favourable than that accorded to like products, processes or services of national origin, in a comparable situation.
15
Recognition
and approval
arrangements 15.8
national and equal treatment: Treatment accorded to products, processes or services originating in other countries that is no less favourable than that accorded to like products, in any
15.1
recognition
arrangement:
Agreement
that is based
on the acceptance by one party of results, presented by another party, from the implementation of one or more designated functional elements of a certification system. NOTES 1 Typical examples of recognition
inspection arrangements arrangements are testing arrangements. arrange-
processes or services of national origin or originating other country, in a comparable situation.
ments, 2
and certification
15.9 arrangements may be established at, for example, national, regional or international level.
Recognition
approval
: Permission for a product, process or service

or used for stated purposes or under stated
to be marketed conditions.
15.2
unilateral
arrangement:
Recognition
arrangement 15.9.1 type approval
that covers the acceptance
of one partys results by another
: Approval based on type evaluation.
Recognition arrangement that 15.3 bilateral arrangement: covers the acceptance of each others results by two parties.
12
SP 60 :1993
16 Accreditation
NOTE -
of testing laboratories
has been used for
16.5
(laboratory)
accreditation
criteria:
ments that is used by an accreditation

For eaSe of reading, the term laboratory
Set of requirebody, to be fulfilled by a
testing laboratory
in order to be accredited.
tesfing laboratory in the terms defined below.
16.1 (laboratory) accreditation

testing laboratory
: Formal recognition that a is competent to carry out specific rests or specific types of tests.
16.6
NOTE The term laboratory accreditation may cover the recognition of both the technical competence and the impartiality of a tasting laboratory or only its technical competence. Accreditation is
laboratory
assessment:
Examination of a testing
laboratory to evaluate its compliance with specific laboratory accreditation criteria.
normally awarded
following
successful
laboratory
assessment
and is
followed by appropriate
surveillance.
16.2 (laboratory) accreditation

laboratory accreditation.
system : System that has its own rules of procedure and management for carrying out
16.7 laboratory assessor : Person who carries out some or all functions related to laboratow assessment.
16.3 (laboratory) accreditation body: Body that conducts and administers a laboratory accreditation system and grants
accreditation.
NOTE - An accreditation body may wish to delegate fully or partially the assessment of a testing laboratory to another competent body (assessment agency). Whilst it is recognized that this may be a practical solution to extending recognition of testing laboratories, it is essential that such assessment be equivalent to that applied by the accreditation body and that the accreditation body take full responsibility for such extended
16.6
laboratory test report: Test report that by the testing laboratory that it is accredited for the test reported and that the fest has been performed in accordance with the conditions prescribed by the
includes a statement body.
accredited
accreditation
accreditation.
16.9 approved signatory (of an accredited

accredited laboratory: accreditation has been granted. 16.4
Testing laboratory to which
laboratory): Person who is recognized by an accreditation body as competent to sign accredited laboratory fesf reports.
13
SP 60
: 1993
INDEX
A
access to a certification system 14.10 accreditation 13.7 accreditation of testing laboratories 16 accredited laboratory 16.4 accredited laboratory test report 16.8 acknowledged rule of technology 1.5 additional element 8.2 amendment 9.6 applicant (for certification) 14.6 application of an international standard 10.2.1, 10.2.2 application of a normative document 10.2 approval 15.9 approved signatory (of an accredited laboratory) 16.9 assurance of conformity 13.5 authority 4.5 B basic standard 5.1 bilateral arrangement 15.3 bilaterally harmonized standards 6.7 body(l) 4.1 body(2) (of a normative document) 8.1 branch standard (3.2)
exclusive reference (to standards) 11.3.1 exclusive requirement 7.5.1
F
field of standardization 1.3 first party (13.2) fitness for purpose 2.1 functional interchangeability
(2.3)
G
general reference (to standards) 11.2.3
H
harmonized standards 6.1
I
identical standards 6.3 indicative reference (to standards) 11.3.2 indirect application of an international standard 10.2.2 inspection 13.3.1 inspection body (for certification) 14.4 interchangeability 2.3 interface standard 5.7 interlaboratory test comparisons 12.5 international standard 3.2.1 international standardization 1.6.1 international standardizing organization 4.3.2 international standards organization 4.4.3 internationally harmonized standards 6.4 instruction 7.3
C
certificate of conformity 14.8 certification 13.5.2 certification body 14.3 certification scheme 14.2 certification system 14.1 code of practice 3.4 company standard (3.2) comparable standards 6.9 compatibiilty 2.2 conformity 13.1 conformity surveillance 13.3.4 conformity testing 13.3.2 consensus 1.7 correction 9.5 D dated reference (to standards) 11.2.1 deemed-to-satisfy provision 7.6 descriptive provision 7.7 dimensional interchangeability (2.3) direct application of an international standard 10.2.1 draft standard 9.2
L
laboratory accreditation 16.1 laboratory accreditation body 16.3 laboratory accreditation criteria 16.5 laboratory accreditation system -16.2 laboratory assessment 16.6 laboratory assessor 16.7 laboratory proficiency testing 12.6 level of standardization 1.6 licence (for certification) 14.5 licensee (for certification) 14.7
M
mandatory requirement (deprecated) 7.5.1 mandatory standard 11.4 mark of conformity (for certification) 14.9
member of a certification multilateral arrangement multilaterally harmonized system 14.12 15.4 standards 6.6
E
enforcement authority 4.5.2 environmental protection (deprecated) 2.7 equal treatment 15.6 evaluation for conformity 13.3 14
N
national standard 3.2.3 national standardization 1.6.3
SP 60 : 1993
national standards body 4.4.1 national and equal treatment 15.8 national treatment 15.7 new edition 9.9 normative document 3.1.
S
safety 2.5 second party (13.2) self-certification (deprecated) 13.3 service standard 5.6 standard 3.2 standard on data to be provided 5.8 standardization 1.1 standardizing body 4.3 standards body 4.4 standards programme 9.1 standards project 9.1 .l state of the art 1.4 statement 7.2 subject of standardization 1.2 suppliers declaration 13.5.1
0
optional requirement 7.5.2 organization 4.2
P
participant in a certification system 14.11 performance provision 7.8 period of validity 9.3 process standard 5.5 product, process or service (1.2) product protection 2.7 product standard 5.4 proficiency testing (laboratory) 12.8 protection of the environment 2.8 provincial standard 3.2.4 provincial standardization 1.6.4 provision 7.1
T
taking over an international standard 10.1 technical regulation 3.51 technical specification 3.3 terminology standard 5.2 test 12.1 testing 12.1 .l test method 12.2 test report 12.3 testing laboratory 12.4 testing standard 5.3 third party 13.2 type approval 15.9.1 type evaluation 13.3.3
R
reciprocity 13.5 recognition arrangement 15.1 recommendation 7.4 reference to standards (in regulations) 11.l regional standard 3.2.2 regional standardization 1.6.2 regional standardizing organization 4.3.1 regional standards organization 4.4.2 regionally harmonized standards 6.5 registration 13.6 regulation 3.5 regulatory authority 4.5.1 reprint 9.8 requirement 7.5 review 9.4 revision 9.7
U
undated reference (to standards) 11.2.2 unified standards 6.2 unilateral arrangement 15.2 unilaterally aligned standard 6.8
V
variety control 2.4 verification of conformity 13.4
15
SECTION 2 COMPETENCE, ACCEPTANCE OF LABORATORIES

FOREWORD
AND ACCREDITATION
For promoting the confidence in calibration and testing laboratories that the test results given by them are reliable and reproducible, it is necessary to lay down general requirements which would help the laboratories in assessing whether they are competent or not. These requirements should include the implementation of quality systems. Standards and procedures should be development and harmonized with a view to: a) facilitate cooperation and experience. between laboratories and other bodies to assist in the exchange and testing laboratories of information
b) provide mechanism for promoting confidence in calibration that they operate in accordance with the stated requirements. c) facilitate removal of non-tariff operations
which can show
to trade between countries. for the competence for calibration and testing
Chapter 1 of this section provides general requirements laboratories.
Bodies assessing the technical competence of testing laboratories, such as accrediting bodies and certification bodies, use the results of proficiency testing in their assessment of technical competence of varying extents in their evaluation procedures. Proficiency testing is the use of results generated in inter-laboratory test comparison for the purpose of assessing the technical competence of testing laboratories. Chapter 2 of this section proficiency testing. gives the details about the development and operation of laboratory body, or down for
The assessment for acceptance of testing laboratory may be done by certification Therefore, harmonized standards and procedures must be laid accreditation body. laboratory accreditation, and should be recognized at a national or international level.
Chapter 3 of this section sets out the general requirements for operation of a system for accreditation of a calibration and/or testing laboratories so that accreditations granted and services covered by the accreditations may be recognized at a national or an international level and the body operating the accreditation system may be recognized as competent and reliable at a national or an international level. This section is based on the following ISO/IEC Guide 25 lSO/IEC Guide 43 ISO/IEC Guide 58 3 ISOAEC Guides. for the competence of calibration and testing laboratories,
General requirements 1990. Development
and operation of laboratory proficiency
testing, 1984. General requirements
Calibration and testing laboratory accreditation for operation and recognition, 1993
systems -
17
SP 60 : 1993
CHAPTER
GENERAL REQUIREMENTS FOR THE COMPETENCE CALIBRATION AND TESTING LABORATORIES (lSO/IEC GUIDE 25 :1990)
OF
Introduction
Since ISO/IEC Guide 25 was last revised in 1932 the use of quality systems in laboratories has greatly increased. Many countries have adopted their competence, ISO/IEC Guide 25 as the basis both for and for recognizing In recent years there it establishing quality systems in laboratories e.g. by accreditation. have been many developments was recognized that there
1.2
Additional
requirements
and information
which
have to
be disclosed for assessing competence or for determining compliance with other criteria may be specified by the organization
or authority granting the recognition

upon the specific character
for approval).
depending
of the task of the laboratory.
1.3
This Guide is for use by calibration and testing laboraand implementation of their qualitybodies, certifiof It may also be used by accreditation
in the field of quality assurance guides and standards; to revise ISO/IEC was a need
tories in the development

systems.
which have led to new and improved Guide 25 to reflect these changes.
cation bodies and others concerned laboratories.
with the Competence
ln this revision of the Guide attention is paid to the activities of both calibration and testing laboratories and account is taken of other requirements laid down for laboratory Code competence such as those Practice in the OECD of Good Laboratory
References : 1936, Quality Vocabulary. and quality
(GLP) and the IS0 !NOO series of quality assurance standards. This Guide should that they operate provide a mechanism and testing in accordance for promoting con-
IS0 8402 IS0 WOO standards
fidence in calibration
laboratories
that can show
: 1987, Quality management

-
assurance
with its requirements.
Guidelines for selection and use.
Acceptance of calibration and test results between countries

will facilitate the removal of non-tariff barriers to trade. The use of this Guide will facilitate cooperation between laboratories and other bodies to assist in the exchange of information and experience, and procedures. This Guide is specific laboratories. Laboratories meeting for calibration and to calibration laboratories and testing and in the harmonization of standards
ISO 9001 syslems Mode/ for quality assurance in design/development, production, installation and servicing. ISO 9002 assurance ISO 9003 assurance
I 1987,Qdb
: 1987,
Quality systems in production and installation.
Model
for
quality
: 1987,
Quality systems in final inspection and test. management
Model
for
quality
the requirements of this Guide comply, testing activities, with the relevant
ISO 9004 : 1987, Quality elements - Guidelines. lSO/lEC Guide 2
and
quality
system
requirements of the IS0 gOO0 series of standards, including those of the model described in IS0 9002 when they are acting as suppliers producing calibration and test results.
: 1986, General terms and their definitions

and related activities. of basic and general terms in
concerning international
standardization vocabulary (VIM)
For laboratories engaged in specific fields of testing such as the chemical field (see for example the OECD Code of Good Laboratory Practice) or the information technology field, the requirements of this Guide will need amplification and interpretation, as referred to in clause 4.2 of ISO/IEC Guide 55.
metrology
: 1984, issued by BIPM, IEC, IS0 and OIML.
Definitions
from ISO/IEC Guide 2, IS0 8402 and general terms in
The relevant definitions
Scope
in accordhas to demonstrate that it as competent to carry out
the International
vocabulary
of basic and
1.1 This Guide sets out the general requirements

ance with which a laboratory or tests. operates, if it is to be recognized
matro~ogy (VIM) are applicable, the most relevant being quoted below together with further definitions applicable for the purposes of this Guide.
specific calibrations
3.1
laboratory:
Body that calibrates
and/or
tests.
19
SP 60 :1993
NOTES
1
In cases where a laboratory forms part of an organization other activities besides calibration and testing, refers only to those parts of that organization that carthe term
NOTE ment,
In connection
with the management
of measuring
equip-
verification
provides a means for checking
that the deviations and correspondsmaller than regulation or
between
values indicated by a measuring allowable error defined
instrument
ries out
ing known values of a measured quantity are consistently the maximum specification in a standard, peculiar to the management
laboratory
that are in-
vofved in the calibration and testing process. 2 As used herein, the term laboratorv out calibration or testing at or trom a permanent at or from a temporary location, facilitv, Or refers to a body that carries
of the measuring equipment.
The result of verification leads to a decision either to restore to service, or to perform adjustments, or to repair, or to downgrade, or to declare obsolete. In all cases it is required that a written trace of the verification performed be kept on the measuring instruments individual record.
in or from a mobile facilitv.
3.2 testing laboratory:

[ISO/IEC Guide 2 12.41
Laboratory that performs tests.
3.9 quality system: The organizational structure, responsibilities, procedures, processes and resources for implementing quality management. [ISO 8402 3.8, without the notes]
3.3 calibration calibration.
laboratory:
Laboratory
that
performs
3.10 quality manual : A document stating the quality policy, quality system and quality practices of an organization.
NOTE The quality manual may call up other documentation quality arrangements. relating
3.4 calibration:
The set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material measure, and the corresponding known values of a measurand. NOTES
1 The result of a calibration permits the estimation of errors of indication of the measuring instrument, measuring system or material
measure, 2 or the assignment of values to marks on arbitrary scales. other metrological properties.
to the laboratorys
3.11 reference standard: A standard, generally of the highest metrological quality available at a given location, from which measurements made at that location are derived. [VIM 6.081
A calibration
may also determine
3 The result of a calibration may be recorded in a document,

sometimes called a calibration certificate or a calibration report. 4 The result of a calibration is sometimes expressed as a calibration factor, or as a series of calibration factors in the form of a calibration
CUNO.
3.12 reference material: A material or substance one or more properties of which are sufficiently well established to be used for the calibration of an apparatus, the assessment of a measurement method, or for assigning values to materials. [ISO Guide 30 2.11
3.13 certified
[VIM - 6.131 3.5 test: A technical operation that consists of the determination of one or more characteristics or performance of a given product, material, equipment, organism, physical phenomenon, process or service according to a specified procedure. NOTE The result of a test is normally recorded in a document
reference material (CRM): A reference material one or more of whose property values are certified by a technically valid procedure, accompanied by or traceable to a certificate or other documentation which is issued by a certifying body. [ISO Guide 30 2.21
sometimes called
a test report or a test certificate. 12.1, amended1
3.14 traceability: The property of a result of a measurement whereby it can be related to appropriate standards, generally international or national standards, through an unbroken chain of comparisons. [VIM 6.121
[ISO/IEC Guide 2 -
3.6 calibration method: performing a calibration.
Defined technical procedure for
[A note given in the VIM to this definition applies to the French text only.1
3.7 test method: Defined technical procedure for performing a test.
3.15 proficiency
3.8 verification:
testing : Determination of the laboratory calibration or testing performance by means of interlaboratory comparisons. IISO/IEC Guide 2 12.6, amended]
Confirmation by examination and provision of evidence that specified requirements have been met.
SP
60
: 1993
3.16 requirement:
individual quantified
A translation or
of the needs into a set of specifications for the
shall define and document
its policies and objectives for, and its
descriptive
characteristics of an entity in order to enable its realization and examination.
commitment to, good laboratory practice and quality of calibration or testing services. The laboratory management shall ensure that these policies and objectives are documented in a quality manual and communicated to, understood, and implemented by all laboratory personnel concerned. The quality manual shall be maintained current under the responsibility of
4
4.1
Organization
The laboratory
and management
shall be legally identifiable. It shall be
the quality manager.
organized and shall operate in such a way that its permanent, temporary and mobile facilities meet the requirements of this Guide.
5.2
The quality manual,
and related quality documentation,
shall state the laboratorys policies and operational procedures established in order to meet the requirements of this Guide. the quality contain manual and related quality documentation shall also
4.2 a)
The laboratory
shall staff with the authority their duties; and resources at a quality commitments, b) the policy statement, including by top management; and management objectives and
have managerial
needed to discharge b)
have arrangements
to ensure that its personnel are free financial and other pressures which
organization charts;
structure
of the
from any commercial,
laboratory,
its place in any parent organization
and relevant
might adversely affect the quality of their work; c) be organized in such a way that confidence in its at all
organizational c) the
relations
between
management,
technical
oper-
independence times; dl
of judgement
and integrity is maintained
ations, support services and the quality system; d) procedures for control and maintenance
of documen-
specify and document
the responsibility,
authority
and
tation: e) job descriptions of key staff and reference
interrelation
of all personnel who manage, the quality of calibrations
perform or verify and tests; with the calif) identification of the laboratorys is appropriate); procedures approved (where this concept g) named) who has h) the laboratorys scope of calibrations and/or tests; the laboratorys descriptions of other staff;
work affecting e)
to the job
provide supervision
by persons familiar
bration or test methods and procedures, calibration or test and the assessment to non-supervisory supervision; (however ratio of supervisory
the objective of the of the results. The personnel shall be
signatories
such as to ensure adequate f) have a technical
for achieving traceability of
measurements; manager overall responsibility for the technical operations;
g) have a quality manager (however named) who has responsibility for the quality system and its implementation. The quality manager level of management policy In some or laboratory manager. shall have direct access to the highest at which resources, decisions and to the quality are taken the manager on technical may
i) arrangements for ensuring that the laboratory reviews all new work to ensure that it has the appropriate facilities and resources before commencing j) reference to the calibration, such work; verification and/or
test pro-
laboratories,
cedures used; k) procedures reference for handling calibration to the major used; verification and test items; and
also be the technical manager or deputy technical manager; h) nominate deputies in case of absence of the technical I) have documented rights; in interlaboratory compolicy and prom) referenceto procedures for calibration, maintenance of equipment; equipment measurement i) where relevant, to ensure cedures the protection of clients confidential standards
or quality manager;
reference
and
information j) where
and proprietary appropriate,
participate
parisons and proficiency
testing programmes.
n) reference to verification practices including interlaboratory comparisons, proficiency testing programmes, use of reference materials and internal quality control schemes;
Quality system, audit and review
o) procedures to be followed for feedback and corrective action whenever testing discrepancies are detected, or departures from documented policies and procedures occur; p) the laboratory tionally permitting and procedures management arrangements for excepdepartures from documented policies specifications;
5.1 The laboratory shall establish and maintain a quality system appropriate to the type, range and volume of calibration and testing activities it undertakes. shall be documented. The available for use by the laboratory The elements of this system documentation personnel. shall be The laboratory quality
or from standard
21
SP 60 : 1993
q) r)
procedures
for dealing with complaints; confidentiality and proprietary
7 7.1
Accommodation
Laboratory
and environment
calibration and test areas, shall be such or tests.
procedures for protecting
accommodation, lighting,
rights; s) procedures for audit and review.
energy sources, as to facilitate 7.2
heating and ventilation of calibrations
proper performance
The environment
in which these activities are undertaken affect the required Particular care shall be taken when
5.3
The laboratory with
shall arrange for audits of its activities at continue to of the quality of the system. activity Such to be
shall not invalidate accuracy laboratory
the results or adversely
appropriate comply are,
intervals to verify that its operations the requirements possible,
of measurement. premises.
such activities are undertaken
at sites other than the permanent
audits shall be carried out by trained and qualified wherever independent
staff who
audited. Where the audit findings cast doubt on the correctness or validity of the laboratorys calibration or test results, the laboratory mediately shall take immediate notify, in writing, corrective action and shall imany client whose work may have
7.3 The laboratory shall provide facilities for the effective monitoring, control and recording of environmental conditions as appropriate. biological midity, Due attention dust, shall be paid, for example, interference, to husterility, electromagnetic
been affected.
mains voltage,
temperature,
and sound and vibration or tests concerned.
levels, as appropriate 5.4 The quality system adopted to satisfy the requirements suitability and effectiveness of and
to the calibrations
this Guide shall be reviewed at least once a year by the management to ensure its continuing to introduce any necessary changes or improvements.
7.4 There shall be effective separation between neighbouring areas when the activities therein are incompatible. 7.5 Access to and use of all areas affecting these activities shall be defined and controlled. the quality of
5.5
All audit and review findings and any corrective
actions 7.6 Adequate measures shall be taken to ensure good housekeeping in the laboratory.
that arise from them shall be documented. within the agreed timescale.
The person respon-
sible for quality shall ensure that these actions are discharged
NOTE - It is the laboratorys responsibility to comply with the relevant health and safety requirements. This aspect, however, is outside the
5.6
the
In addition quality
to periodic audits the laboratory provided to clients
shall ensure as
scope of this Guide.
of results
by implementing
checks. These checks shall be reviewed appropriate, but not be limited to:
and shall include,
8
poss-
Equipment
The laboratory (including
and reference
shall be furnished materials)
materials
with all items of equiprequired for the correct
a) internal quality control schemes using whenever ible statistical techniques; b) participation in proficiency testing or other
8.1
ment
reference
performance interlaboratory c) comparisons; reference materials reference and/or in-
of calibrations
and tests. In those cases where the
laboratory needs to use equipment outside its permanent control it shall ensure that the relevant requirements of this Guide are met. 8.2 All equipment shall be properly maintained. Maintenance
regular use of certified
house quality control using secondary d) e)
materials; methods; procedures shall be documented. Any item of the equipment which has been subjected to overloading or mishandling, or which gives suspect results, or has been shown by verification or otherwise to be defective, and wherever shall be taken possible stored The out of service, at a specified verifishall or laboratory calibrations
replicate testings using the same or different re-testing of retained items; of results for different
f) correlation item.
characteristics
of an
clearly identified cation
place until it has been repaired and shown by calibration, or test to perform the effect satisfactorily. examine tests. personnel, knowledge 8.3 of this defect on previous
6
6.1
Personnel
The testing laboratory shall have sufficient having the necessary education, training, technical and experience for their assigned functions.
Each item
of equipment
including
reference
materials
shall, when appropriate, be labelled, marked identified to indicate its calibration status.
or otherwise
6.2
The testing laboratory shall ensure that the training of its
8.4
personnel is kept up-to-date.
Records shall be maintained of each item of equipment and all reference materials significant to the calibrations or tests performed. The records shall include
6.3
eXPeriH-03
Records on the relevant qualifications, training, skills and of the technical personnel shall be maintained by the laboratory.
a)
the name of the item of equipment; and serial
b) the manufacturers name, type identification, number or other unique identification;
SP 60 : 1995
cl
dl
date received and date placed in service; current location, condition when where appropriate; received (e.g. new, used, recon-
10 10.1
Calibration
The laboratory
and test
methods
instructions on
shall have documented of all relevant equipment,
e)
f)
the use and operation ling and preparation where the absence
on the handand or testing, the manuals and shall be
ditioned ); copy of the manufacturers instructions, where
of items and for calibration of such instructions standards,
could jeopardize
calibrations reference maintained
or tests. All instructions, up-to-date
available; g) dates and results of calibrations and/or verifications and date of next calibration and/or verification; h) details of maintenance carried out to date and planned
data relevant to the work of the laboratory
and be readily available to the staff.
10.2 The laboratory shall use appropriate methods and procedures for all calibrations and tests and related activities within its responsrbrlrty (including sampling, handling, transport and of storage, preparation of items, estimation of uncertainty and/or required,
for the future; i) history of any damage, malfunction, modification or
repair.
measurement
and analysis
of calibration
test data). and with or tests
They shall be consistent concerned.
with the accuracy
any standard specifications
relevant to the calibrations
9
9.1
Measurement
traceability
and calibration
10.3 Where methods or are not specified, standards, the laboratory those published shall, by having an effect on or tests shall be The wherever possible, select methods that have been published in national organizations or in relevant scientific texts
All measuring and testing equipment or validity verified of calibrations and/or before
the accuracy calibrated
international
being put into service. programme
laboratory. shall have an established bration and verification
for the cali-
reputable technical or journals.
of its measuring
and test equipment. 10.4 Where it is necessary to employ methods that have not
9.2
The overall programme
of calibration
and/or
verification
and validation of equipment shall be designed and operated so as to ensure that, wherever applicable, measurements made by the laboratory are traceable to national standards of measurement where available. Calibration certificates shall wherever applicable indicate the traceability to national standards of measurement and shall provide the measurement results and of
been established as standard, these shall be subject to agreement with the client, be fully documented and validated, and be available reports. to the client and other recipients of the relevant
10.5 method,
Where
sampling
is carried
out
as part
of the
test and
associated uncertainty of measurement and/or a statement compliance with an identified metrological specification.
the laboratory
shall use documented
procedures
appropriate
statistical techniques
to select samples.
9.3
Where
traceability the
to national standards of measurement laboratory shall provide satisfactory or proof results, for example by participation of interlaboratory comparisons
10.6
is not
applicable,
Calculations appropriate checks.
and
data
transfers
shall
be subject
to
evidence of correlation in a suitable programme ficiency testing.
10.7 Where computers or automated equipment are used for the capture, processing, manipulation, recording, reporting, storage or retrieval of calibration or test data, the laboratory shall ensure that: a) bl use; the requirements computer of this Guide are complied with; is documented and adequate for
9.4
Reference
standards
of
measurement
held
by
the
laboratory purpose,
shall be used for calibration unless it can be demonstrated standards
only and for no other that their performance
as reference
has not been invalidated.
software
9.5 Reference standards of measurement shall be calibrated by a body that can provide traceability to a national standard of measurement. There shall be a programme of calibration and verification for reference standards.
c) procedures protecting the
are established integrity of data;
and implemented such procedures
for shall
include, but not be limited to, integrity of data entry or capture, data storage, d) computer data transmission and data processing; is maintained to
and automated
equipment
9.5 tween
Where
relevant,
reference
standards and measuring
and
testing equipment calibrations
shall be subjected and verifications.
to in-service checks be-
ensure proper functioning and provided with the environmental and operating conditions necessary to maintain the integrity of calibration e) for and test data; appropriate procedures of data including the
9.7 Reference materials shall, where possible, be traceable to national or international standards of measurement, or to national or international standard reference materials.
it establishes and implements the maintenance of security of, computer records.
prevention of unauthorized amendment
access to, and the unauthorized
23
SP 99 :1993
10.9 Documented procedures shall exist for the purchase, reception and storage of consumable materials used for the technical operations of the laboratory.
13
Certificates
and reports
11
Handling of calibration
and test items
11.1 The laboratory shall have a documented system for

uniquely identifying the items to be calibrated or tested, to ensure that there can be no confusion regarding the identity of such items at any time. 11.2 Upon receipt, the condition of the calibration or test item, including any abnormalities or departures from standard condition as prescribed in the relevant calibration or test method, shall be recorded. Where there is any doubt as to the items suitability for calibration or test, where the item does not conform to the description provided, or where the calibration or test required is not fully specified, the laboratory shall consult the client for further instruction before proceeding. The laboratory shall establish whether the item has received all necessary preparation, or whether the client requires preparation to be undertaken or arranged by the laboratory.
13.1 The results of each calibration, test, or series of calibrations or tests carried out by the laboratory shall be reported accurately, clearly, unambiguously and objectively, in accordance with any instructions in the calibration or test methods. The results should normally be reported in a calibration certificate, test report or test certificate and should include all the information necessary for the interpretation of the calibration or test results and all information required by the method used.
13.2 Each certificate or report shall include at least the following information : a) a title, e.g. Calibration Certificate, Test Report or Test Certificate; b) name and address of laboratory, and location where the calibration or test was carried out if different from the address of the laboratory;
cl unique identification of the certificate or report (such as serial number) and of each page, and the total number of pages; d) name and address of client, where appropriate;
11.3 The laboratory shall have documented procedures and appropriate facilities to avoid deterioration or damage to the calibration or test item, during storage, handling, preparation, and calibration or test; any relevant instructions provided with the item shall be followed. Where items have to be stored or conditioned under specific environmental conditions, these conditions shall be maintained, monitored and recorded where necessary. Where a calibration or test item or portion of an item is to be held secure (for example, for reasons of record, safety or value, or to enable check calibrations or tests to be performed later), the laboratory shall have storage and security arrangements that protect the condition and integrity of the secured items or portions concerned. 11.4 The laboratory shall have documented procedures for
the receipt, retention or safe disposal of calibration or test items, including all provisions necessary to protect the integrity of the laboraton/.
e) description and unambiguous identification of the item calibrated or tested;
f) characterization and condition of the calibration or test item; g) date of receipt of calibration or test item and date(s) of performance of calibration or test, where appropriate;
h) identification of the calibration or test method used, or unambiguous description of any non-standard method used; i) reference to sampling procedure, where relevant;
j) any deviations from, additions to or exclusions from the calibration or test method, and any other information relevant to a specific calibration or test, such as environmental conditions;
k) measurements, examinations and derived results, supported by tables, graphs, sketches and photographs as appropriate, and any failures identified; I) a statement of the estimated uncertainty of the calibration or test result (where relevant); m) a signature and title, or an equivalent identification of the person(s) accepting responsibility for the content of the certificate or report (however produced), and date of issue; nl where relevant, a statement to the effect that the results relate only to the items calibrated or tested; 01 a statement that the certificate or report shall not be reproduced except in full, without the written approval of the laboratory.
12
Records
12.1 The laboratory shall maintain a record system to suit its particular circumstances and comply with any applicable regulations. It shall retain on record all original observations, calculations and derived data, calibration records and a copy of the calibration certificate, test certificate or test report for an appropriate period. The records for each calibration and test shall contain sufficient information to permit their repetition. The records shall include the identity of personnel involved in sampling, preparation, calibration or testing.
12.2 All records (including those listed in 8.4 pertaining to calibration and test equipment), certificates and reports shall be safely stored, held secure and in confidence to the client.
13.3 Where the certificate or report contains results of calibrations or tests performed by sub-contractors, these results shall be clearly identified.
24
SP 60 :1993
13.4 Particular
care
and attention
shall
be paid
to the ar-
14.2
The laboratory
shall record
and retain
details
of its in-
rangement of the certificate or report, especially with regard to presentation of the calibration or test data and ease of assimilation by the reader. The format shall be carefully and specifically designed for each type of calibration shall be standardized or test carried
vestigation contractors
of the competence and compliance of its suband maintain a register of all sub-contracting.
out, but the headings
as far as possible.
15
Outside
support
services
and supplies
services and in support of to
13.5 Material
report form
amendments after
to a calibration
certificate,
test in the the Test
15.1 Where the laboratory procures outside supplies, other than those referred to this Guide,
calibrations support sustain or tests, the laboratory
or test certificate
issue shall be made only or data transfer including Calibration Certificate [or serial number...
shall use only those outside
of a further document, Supplement to statement Report or Test Certificate], relevant or equivalent all the
services and supplies that are of adequate quality confidence in the laboratorys calibrations or tests.
[or as otherwise Such amendments 12 of this 15.2 Where no independent assurance of the quality of outside support services or supplies is available, the laboratory shall have procedures to ensure comply that purchased equipment, The materials and services with specified possible, materials specifications requirements.
identified/, shall meet Guide.
form of wording. requirements
of clause
13.6
The laboratory that
shall notify casts
clients
promptly,
in writing, measuring of results
of any event
such as the identification doubt certificate,
of defective on the validity
laboratory equipment plying brations 15.3 with
should, wherever and consumable any standard
ensure that purchased are not used until they verified as comrelevant to the cali-
or test equipment or amendment
have been inspected,
calibrated
or otherwise
given in any calibration
test report
or test certificate
to a report
or certificate.
or tests concerned. The laboratory it obtains or tests. shall support maintain services records of all suppliers required for
13.7 The laboratory shall ensure that, where clients require transmission of calibration or test results by telephone, telex,
facsimile will follow quirements preserved. or other electronic or electromagnetic means, staff documented procedures that ensure that the reof this Guide are met and that confidentiality is
from whom calibrations
or supplies
16 16.1
Complaints
The laboratory shall have documented policy and profor the resolution of complaints received from clients about the laboratorys activities. A record shall taken by the of all complaints and of the actions
cedures
14
Sub-contracting
a laboratory testing, this with
of calibration
sub-contracts work shall these requirements. in question
or testing
any part of with the a
or other parties be maintained laboratory.
14.1 Where
calibration laboratory is competent or
be
placed
complying
The laboratory and complies
16.2 Where a complaint,

doubt concerning policies the laboratorys this Guide laboratorys that those promptly
shall ensure and be able to demonstrate to perform the activities with the same criteria of competence respect of the work being sub-contracted. advise portion the client in writing of its intention party. of the testing to another
that its sub-contractor as the laboratory in The laboratory shall to sub-contract any
or any other circumstance, raises laboratorys compliance with the or with the requirements of
or procedures,
or otherwise concerning the quality of the calibrations or tests, the laboratory shall ensure areas of activity and responsibility involved are in accordance with 5.3 of this Guide.
audited
25
SP 60 : 1993
CHAPTER
DEVELOPMENT PROFICIENCY
AND OPERATION OF LABORATORY TESTING (ISO/IEC GUIDE 43 :1984)
Preamble
Proficiency testing is the use of results generated petence of participating reproducibility testing laboratories. mination of the precision of test methods by inter-laboratory in interlaboratory testcomparisons for the purpose of assessing the technical comtest comparisons, Determination such as the deterof repeatibility and
Other purposes may be served by interlaboratory described in IS0 5725, Precision of test methods
rests, but these are outside the scope of this Guide. of testing laboratories, of technical competence such as accrediting bodies and certification bodies, use the results depending on based solely on pro; Guide 25, Genera/ retesting
Bodies assessing the technical competence of proficiency testing in their assessment against
to varying extents in their evaluation such as those specified
procedures
their particular policies. The Guide draws the important distinction between assessment of technical competence ficicency testing and assessment alone. Attention is drawn to the need to distinguish between use proficiency bodies assessing the technical competence although factors to be taken into account of some pertinent references pre-determined requirements in ISO/IEC quirements for the technical competence of testing laboratories, noting the limitations of assessments
based on proficiency
of testing laboratories,
which may test com-
organize and/or comparisons
testing among other assessment criteria and bodies which merely organize interlaboratory in the organization to the Guide. is annexed
parisons. This Guide is directed towards the former,
of interlaboratory
generally are indicated and a bibliography
0
9.1
introduction
Interlaboratory test comparisons on presumably identical materials do not, in general, yield identical results, due to many dif-
ferent factors referred to in IS0 5725.
9.2
The purposes for which interlaboratory checking overall laboratory checking
test comparisons
are undertaken
may include
testing performance; of laboratory staff;
individual testing performance the effectiveness
establishing determining Proficiency testing
of a test method; of a material or product to a particular degree of accuracy. test comparisons for purpose (a) only.
one or more characteristics
is the use of interlaboratory
9.3
Most bodies assessing the technical
competence
of testing
laboratories
require or expect
satisfactory
participation
in protesting
ficiency testing as significant evidence of a testing laboratorys is inappropriate. However, a) it is emphasised that a major distinction
ability to produce reliable test results except where proficiency
exists between
:
of its total operation against pre-determined re-
the evaluation and
of the competence
of a testing laboratory
by the assessment
quirements, b)
the examination
of the results of a testing laboratorys
participation
in proficiency
testing which may only be considered
as
giving information about the technical competence of the testing laboratory specific conditions of the test (or tests) involved in the proficiency testing.
at the particular point (or points) in time under the
27
SP 60 : 1993
Scope
and field
of application
The object of this Guide is a) b) c) to assist in the selection and organization of interlaboratory test comparisons in proficiency for proficiency testing;
to describe the factors which should be taken into account to describe how bodies assessing the technical for use by governmental competence competence
testing; may use proficiency testing. bodies, but
This Guide is intended assessing the technical fidence between
or non-governmental
bodies such as accrediting which can contribute
bodies and certification
of testing laboratories.
It may also be useful to assist testing laboratories
in self-evaluation,
recognizes that proficiency different
testing is only one of a number of mechanisms testing laboratories. details for interlaboratory
to the establishment
of mutual con-
The Guide does not give operational
test comparisons.
A bibliography
of some pertinent
references
is an-
nexed to the Guide but is not exhaustive.
References
Determination of repeatability and reproduclblllty certification by inter-laboratory tests. accreditation.
IS0 5725, Precision of test methods IS0
Guide 2, General terms and their definitions Guide 25, General requirements
concerning
standardization,
and testing laboratory
ISOIIEC
for the technical competence
Definitions
definitions, taken from IS0 Guide 2, are applicable
The following
3.1
testing
laboratory
: A laboratory which measures, examines, tests, calibrates or otherwise determines the characteristics
oi
performance
of materials or products.
3.2
test
method
: A defined technical procedure to determine one or more specified characteristics

testing
of a material or product.
3.3
proficiency
: Methods of checking laboratory testing performance

(RM)
by means of interlaboratory
tests.
3.4
reference
material
: A material or substance one or more properties of which are sufficiently well established to be used
the assessment of a measurement method, or for assigning values to materials.
for the calibration In addition,
of an apparatus, definition
the following
applies for the purpose of the present Guide
3.5
interlaboratory test comparisons : Organization, performance and evaluation of tests on the same or similar items or materials by two or more different laboratories in accordance with pre-determined conditions.
4 4.1
Proficiency
Confidence
testing
and laboratory
performance
obtains reliable results is of the utmost importance their own evaluation to users of laboratory serof other bodies.
that a testing laboratory
consistently
vices. Users seeking such an assurance
can undertake
or can take note of the evaluation
4.2
The extent to which proficiency
testing is used by bodies assessing the technical competence are matters of policy for the bodies themselves.
and the use
which is made of the information
generated
4.3 Where the outcome of the participation by a testing laboratory in proficiency testing may affect its status in relation to a body assessing the technical competence of testing laboratories, the body should provide documented procedures clearly defining beforehand its response to different possible outcomes.
28
SP 60 : 1993
4.4
Where
appropriate, sources
participation
in proficiency
testing
may provide
testing
laboratories
with information
which
may be useful in
detecting
possible
of error where
these exist.
5
5.1
Types
of proficiency
testing with methods
testing
vary depending They on the nature possess of the material feature laboratories. or product under test, the test method of test results in use and the by ones laboratories
Proficiency of testing laboratory
number testing
laboratories function.
participating.
the common
of the comparison
obtained
those obtained
by one or more other testing
In some cases, one of the participating
may have a controlling The following are types
of proficiency
testing
programmes
5.2
Where
Type A
the item or material to be tested is circulated successively being from one participating laboratory laboratory laboratory to the next. for the purpose in order of the proficiency whether any
The item or material test, for testing changes Examples have taken
may be returned being passed
to a central
laboratory
used as a reference testing
before
on to the next successive
participating
to determine
place to the item or material. used in thts type of proficiency testing include audit devices, products, certified reference materials.
of items or materials
5.3
Where
Type 6
randomly testing selected sub-samples from a source of a suitable degree of homogeneity are distributed simultaneously to par-
ticipating
laboratories.
5.4
Type C
or a matenal are divided into two or more parts with each participating laboratory testing testing one part of each in 5.3, in par-
Where samples of a product
sample. This is frequently referred to as split sample testing and differs ticular when no control is possible over the homogeneity of the sample
from the type of proficiency being divided.
described
Development
of proficiency
testing
General
principles
Therefore, the contents of this clause
6.1 The methods of operation within different organizations are not expected to be identical. are intended only as a guide to be modified appropriately to cater for particular situations. 6.2
a) Bodies assessing the technical competence of testing involving or time to time in response laboratories may organize
proficiency
testing
programmes and all the laboratories for
as on-going
interlaboratory
test comparisons testing
as many as possible
of the test methods
which b) c)
they wish to use proficiency interlaboratory
information; from
as particular
test comparisons a) and b).
to particular
perceived
needs;
or
on a basis intermediate
between
6.3
Bodies
assessing
the technical instead
competence
of testing
laboratories
may take advantage as described
of suitable
interlaboratory
test com-
parisons
organized
by others,
of or in addition
to proficiency include
testing
in 6.2.
In such cases. factors a) b) c) the technical
to be taken and statistical
into consideration soundness
of the test comparison;
access to the results; participation by laboratories not currently involved in the interlaboratory test comparisons but which are subject to technical
assessment d) cost.
by the body;
29
SP 60 : 1993
6.4
cerning
Bodies
assessing
the technical persons
competence with expertise
of testing
laboratories
which
use proficiency
testing
should
establish
one or more matters con-
specialist
groups proficiency
comprising testing
in the test methods of interlaboratory
and interlaboratory
testing
to advise on general
and the interpretation
test comparisons.
6.5
a)
The functions providing
of the specialist
group(s)
may include the technical procedure,
:
competence including of testing laboratories on the use of proficiency testing testing as an ob-
advice
to a body assessing laboratory evaluation
element jectives; b)
of its testing
the selection
of types of proficiency
to suit particular
the development
and review
of procedures
for the planning,
execution,
analysis
and reporting
of interlaboratory
test com-
parisons; c) the identification and evaluation of interlaboratory group reports; may reflect the performance of participating laboratories. test comparisons organized by other bodies with a view to their possible
use by the body d) the evaluation
to which
the specialist
of proficiency
test results as they
6.6
The following proficiency
matters testing policy
should
be taken
into account
by a body
assessing
the technical
competence
of testing
laboratories
in
adopting a) b)
as part of its assessment of the body; test comparisons laboratories.
procedure
the established the feasibility
of interlaboratory competence
in relation Such factors
to the various
tests for which
the body undertakes of suitable
an assessment
of the technical will be important; c) d) e) f) g) h) the specific
of testing
as cost and the availability
test item(s) and material(s)
tests which
may be most significant; are to be examined; laboratories other and the frequency being of their participation; is to be permitted;
the measurement the number whether
ranges which
of participating
testing
participation
by laboratories materials: against
than those
assessed
the use of reference the establishment
of criteria
which
the performance
of participating
laboratories
is to be assessed.
.6.7
In general,
the results generated analysis at the design stage.
in proficiency
testing
require statistical
analysis
which
can be accomplished test comparison
at different and should
levels. be taken
The level of statistical into consideration
possible will depend
on the design of the particular
interlaboratory
6.8
others.
The level of understanding should therefore The use of histograms
of statistical be analyzed and charts
analysis
among
participating
laboratories
will vary. The results of proficiency laboratory clearly in relation
testing,
at
least initially,
so as to show the results of each participating may assist.
to those of the
7
7.1
Inter-laboratory
The operation persons
test comparisons
of particular interlaboratory separate groups test involved. comparisons will require the guidance group of persons with detailed technical
knowledge propriate
and experience
of the test methods
To this end the specialist particular
(see 6.4) may need to enlist one or more aptest comparisons.
or may establish
to supervise
interlaboratory
7.2
Appropriate matters the inherent the smallest the number the number
statistical
design of an interlaboratory
test comparison
is essential
and careful
consideration
should
be given to the
following a) b) c) d)
and their interaction repeatability differences
:
of the test(s) involved; laboratories at a desired confidence level;
and reproducibility to be detected laboratories;
between
participating
of participating of samples
to be tested
and the number
of repeat tests to be carried
out on each sample.
30
SP
60
: 1993
In the absence of reliable information it.
concerning
a), it may be necessary to organize a pilot interlaboratory
test comparison
to obtain
7.3
Other matters which will need to be taken into account
in the organization
of an interlaboratory
test comparison
include the
following a) b)
:
to be used by participating laboratories; relating to the samples which may affect the integrity in transit and effects of ambient conditions; of the test
the test method(s) the availability
of suitable test samples and any conditions shelf life, possible damage
comparison
such as homogeneity,
cl the provision of detailed instructions covering all aspects of the interlaboratory test comparison which must be adhered to by the participating laboratories including details of the procedure to be followed in reporting results to the organizing body; d) the preservation of anonymity amongst participating laboratories.
31
SP 60 : 1993 CHAPTER 3
CALIBRATION AND TESTING LABORATORY ACCREDITATION SYSTEMS -GENERAL REQUIREMENTS FOR OPERATION AND RECOGNITION (lSO/IEC GUIDE 58 :1993)
1 Scope
This document
3 Definitions
The ielevant
applicable.
for the operation of a system for accreditation of calibration and/ or testing laboratories so that the accreditations granted and the services covered by the accreditations may be recognized at a national or an international level and the body operating the accreditation system may be recognized at national or international level as competent and reliable.
sets out the general requirements
definitions
contained
in ISO/IEC apply and/or
Guide
2 are
In addition, the following poses of this document:
definitions
for the pur-
3.1 laboratory: Body that calibrates

13.1 of ISO/IEC Guide 25:19901
tests.
3.2 accreditation: Procedure

Users of the services of an accreditation body, other than the laboratories accredited by that accreditation body, may require compliance with requirements additional to those specified in this document. The object of this document is to provide guidance for the setting up and operation of an accreditation body and to facilitate agreements on mutual recognition of accreditation of laboratories between such bodies. NOTE -It is recognized that agreements on mutual recognition of
accreditations aiming at the removal of barriers to across-border trade may have to cover other aspects not explicitly specified in these general requirements, such as proficiency testing or other interlaboratory comparisons, exchange of staff or training programmes. In particular, with a view to creating confidence and harmonizing the interpretation and implementation of standards, each accreditation body should encourage technical cooperation and exchange of experience among laboratories accredited by it, and it should be prepared to exchange information on accreditation procedures and practices with other accreditation bodies.
by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks.
NOTE -Accreditation does not of itself qualify the laboratory to approve any particular product. However, accreditation may be relevant to approval and certification authorities when they decide whether or not to accept data produced by a given laboratory in connection with their own activities. 113.7 of ISO/IEC Guide 2:1991, with the addition of a note1
For the purposes of this document the term client refers to any organization or person that engages the services of a calibration or testing laboratory.
4 Accreditation
body
4.1 General provisions 4.1.1 The procedures

operates manner. shall underwhich the accreditation body be administered in a non-discriminatory
References
ISO/IEC Guide 21991, General terms and their definitions concerning standardization and related activities. ISO/IEC Guide 25:1990, General requirements for the competence of calibration and testing laboratories. ISO/IEC Guide 43:1984, Development laboratory proficiency testing.
IS0
Access to an accreditation system operated by an accreditation body shall not be conditional upon the size of the laboratory or membership of any association or group, nor shall there be undue financial conditions to restrict participation. 4.1.2 The competence of an applicant laboratdry shall be assessed by the accreditation body against all of the requirements of ISO/IEC Guide 25. 4.1.3 The requirements of ISO/IEC Guide 25 may have to be interpreted for a specific calibration, test, or type of calibration or test by the accreditation body. These interpratations shall be formulated by relevant and impartial committees or persons possessing the necessary technical competence. They shall be published by the accreditation body. 4.1.4 The accreditation body shall require accredited oratories to maintain impartiality and integrity. lab-
and operation
of
8402, Quality Vocabulary.
management
and quality
assurance
IS0
1001 l-1: 1990, Guidelines Part 7: Auditing.
for auditing
quality
systems
IS0 1001 l-2:1991, Guidelines - Part 2: Qualification criteria
for auditing quality systems for quality systems auditors.
33
SP
60
: 1993
4.1.5 The accreditation body shall confine its requirements, assessment and decision on accreditation to those matters specifically related to the scope of the accreditation being considered. 4.2 4.2.1
m) have arrangements that are consistent with applicable laws, to safeguard, at all levels of its organization (including committees), confidentiality of the information obtained relating to applications, assessment and accreditation of laboratories. 4.2.2 The accreditation body shall have arrangements for either controlling the ownership, use and display of the accreditation documents or controlling the manner in which an accredited laboratory may refer to its accredited status, or both. 4.3
Organization
of the accreditation
body shall
body
The accreditation
a) be a legally identifiable,
public or private entity; relevant to its accredi-
b) have rights and responsibilities tation activities;
Quality system
c) have adequate arrangements to cover liabilities arising from its operations and/or activities; d) have the financial stability and resources required for the operation of an accreditation system; e) have and make available on request a description of the means by which it receives its financial support; f) employ a sufficient number of personnel having the necessary education, training, technical knowledge and experience for handling the type, range and volume of work performed, under a senior executive who is responsible to the organization, body or board to which it reports;
4.3.1 The accreditation body shall operate a quality system appropriate to the type, range and volume of work performed. This system shall be documented and the documentation shall be available for use by the accreditation body staff. The accreditation body shall designate a person having direct access to its highest executive level, to take responsibility for the quality system and the maintenance of the quality documentation. 4.3.2 The quality system shall be documented in a quality manual and associated quality procedures, and the quality manual shall contain or refer to at least the following: a) a quality policy statement; b) the organizational
Cl
9) have a quality system, including an organizational structure, that enables it to give confidence in its ability to operate a laboratory accreditation system satisfactorily; h) have documented policies and procedures for the operation of the quality system that include
structure of the accreditation
body;
the operational and functional duties and services pertaining to quality, so that each person concerned will know the extent and the limits of their responsibility; procedures including document
policies and decision-making procedures that distinguish between laboratory accreditation and any other activities in which the body is engaged; policies and procedures for the resolution of complaints and appeals received from laboratories about the handling of accreditation matters, or from users of services about accredited laborator!es or any other matters;
d) administrative trol;
con-
e) policies and procedures tation process; f)
to implement
the accredi-
arrangements for feedback and corrective whenever discrepancies are detected;
actions
i)
together with its senior executive, and staff, be free from any commercial, financial and other pressures which might influence the results of the accreditation process; have formal rules and structures for the,appointment and operation of committees involved in the accreditation process; such committees shall be free from any commercial, financial and other pressures that might influence decisions or shall have a structure where members are chosen to provide impartiality through a balance of interests where no single interest predominates;
9) the policy and procedures complaints and disputes; h) the policy audits; i) and procedures
for dealing with appeals,
for conducting
internal
j)
the policy and the procedures system reviews;
for conducting
quality
j)
the policy and the procedures for the recruitment and training of assessors and monitoring their performance.
k) establish one or more technical committees, each responsible, within its scope, for advising the accreditation body on the technical matters relating to the operation of its accreditation system; I) not offer consultancies or other services which may compromise the objectivity of its accreditation process and decisions;
4.3.3 The accreditation body shall audit its activities to verify that they comply with the requirements of the quality system. The quality system shall also be reviewed to ensure its continued effectiveness. Audits and reviews shall be carried out systematically and periodically and recorded together with details of any corrective actions taken. 4.3.4 The accreditation body shall maintain records to demonstrate that accreditation procedures have been ef-
34
SP 60 : 1993
fectively fulfilled, particularly with respect to application forms, assessment reports, and reports relating to granting, maintaining, extending, suspending or withdrawing accreditation. These accreditation documents shall form part of the record. 4.3.5 The accreditation body shall have a policy and procedures for retaining records for a period consistent with its contractual and legal obligations. The accreditation body shall have a policy and procedures concerning access to these records consistent with 4.2.1 m) of this document. 4.4 Granting,
Laboratory
assessors
for assessors
team appointed to assess a
5.1 Requirements
The assessor or assessment laboratory shall
a) be familiar
tation
with the relevant legal regulations, accrediprocedures and accreditation requirements; of the relevant documents; assess-
knowledge b) have a thorough ment method and assessment
maintaining, extending, and withdrawing accreditation
suspending,
technical knowledge of the specific c) have appropriate calibrations, tests or types of calibrations or tests for which accreditation is sought and, where relevant, with the associated sampling procedures;
4.4.1 The accreditation body shall specify the conditions for granting, maintaining and extending accreditation and the conditions under which accreditation may be suspended or withdrawn, partially or in total for all or part of the laboratorys scope of accreditation. 4.4.2 The accreditation body shall have arrangements to grant, maintain, suspend or withdraw accreditation, increase or reduce the scope of accreditation or require reassessment, in the event of changes affecting the laboratorys activity and operation, such as changes in personnel or equipment, or if analysis of a complaint or any other information indicates that the laboratory no longer complies with the requirements of the accreditation body. 4.4.3 The accreditation relating to the transfer status (e.g. ownership) changes. 4.5
The
d) be able to communicate orally;
effectively,
both in writing
and
e) be free of any commercial,
financial or other pressures or conflicts of interest that might cause assessor(s) to act in other than an impartial or non-discriminatory manner; not have offered consultancies to laboratories which might compromise their impartiality in the accreditation process and decisions.
attributes of assessors from IS0 10011-21991, clause 7. may be
f)
NOTE - Guidance on personal

obtained
body shall have arrangements of accreditation when the legal of the accredited laboratory
5.2 Qualification
The accreditation for
procedures
body shall
for assessors
procedure
have an adequate
Documentation
publiat ad-
accreditation body shall provide (through cations, electronic media or other means), update equate intervals, and make available on request
a) qualifying assessors, comprising an assessment of their competence and training, and attendance at one or more actual assessments with a qualified assessor, and b) monitoring the performance of assessors.
about the authority under which accredia) information tation systems operated by the accreditation body were established and specifying whether they are mandatory or voluntary; containing its requirements for accredib) a document tation in accordance with the present document; c) a document maintaining, accreditation; d) information process; stating the arrangements for granting, extending, suspending and withdrawing
5.3 Contracting
of assessors
The accreditation body shall require the assessors to sign a contract or other document by which they commit themselves to comply with the rules defined by the accreditation body, including those relating to confidentiality and those relating to independence from commercial and other interests, and any prior association with laboratories to be assessed. 5.4
about
the assessment
and accreditation
Assessor records
up-to-
on the fees charged e) general information and accredited laboratories; f)
to applicant
The accreditation body shall possess and maintain date records on assessors consisting of
a) name and address; b) organization c) educational

affiliation qualification and position held; status;
a description of the rights and duties of accredited laboratories as specified in 7.1, 7.2 and 7.3 of this document, including requirements, restrictions or limitations on the use of the accrediting bodys logo and on the ways of referring to the accreditation granted.
and professional
d) work experience;
35
SP
60
: 1993
e) training
f)
in quality assurance, bration and testing;
assessment
and cali-
The information gathered shall be used for the preparation of on-site assessment and shall be treated with appropriate confidentialitv.
experience in laboratory field of competence;
assessment,
together
with
6.2 Assessment
9) date of most recent updating of record. 5.5 6.2.1 The accreditation body shall appoint qualified assessor(s) to evaluate all material collected from the applicant and to conduct the assessment on its behalf at the laboratory and any other sites where activities to be covered by the accreditation are performed. 6.2.2 To ensure that a comprehensive and correct assessment is carried out, each assessor shall be provided with the appropriate working documents. 6.2.3 The date of assessment shall be mutually agreed with the applicant laboratory. The latter shall be informed of the name(s) of the qualified assessor(s) nominated to carry out the assessment, with sufficient notice so that the laboratory is given an opportunity to appeal against the appointment of any particular assessor. 6.2.4 The assessor(s) shall be formally appointed. A lead assessor shall be appointed, if relevant. The mandate given to the assessor(s) shall be clearly defined and made known to the applicant laboratory. NOTE-Guidance on procedures for assessment may be obtained in IS0 lOOll-1:1990, clause 5. 6.3
Procedures for assessors
Assessors shall be provided with an up-to-date set of procedures giving .assessment instructions and all relevant information on accreditation arrangements.
6 Accreditation
6.1
process
for accreditation
Application
6.1.1 A detailed description of the assessment and accreditation procedure, the documents containing the requirements for accreditation and documents describing the rights and duties of accredited laboratories (including fees to be paid by applicant and accredited laboratories) shall be maintained up-to-date and given to applicant laboratories. 6.12 Additional relevant information to applicant laboratories on request. shall be provided
6.1.3 A duly authorized representative of the applicant laboratory shall be required to sign an official application form, in which or attached to which a) the scope of the desired accreditation fined; is clearly de-
Sub-contracting
of assessment
b) the applicants representative agrees to fulfil the accreditation procedure, especially to receive the assessment team, to pay the fees charged to the applicant laboratory whatever the result of the assessment may be, and to accept the charges of subsequent maintenance of the accreditation of the laboratory; c) the applicant agrees to comply with the requirements for accreditation and to supply any information needed for the evaluation of the laboratory. 6.1.4 The following minimum information shall be provided by the applicant laboratory prior to the on-site assessment: a) the general features of the applicant laboratory (corporate entity: name, address, legal status, human and technical resources); b) general information concerning the laboratory covered by the application, such as primary function, relationship in a larger corporate entity and, if applicable, physical location of laboratories involved; c) a definition, for the calibrations concerned, of the type of measurement performed, the measurement range and best measurement capability, and for tests, of the materials or products tested, the methods used and the tests performed; d) a copy of the laboratorys quality manual and, where required, the associated documentation.
6.3.1 If an accreditation body decides to delegate fully or partially the assessment of a laboratory to another body, then the accreditation body shall takefull responsibility for such an assessment made on its behalf. 6.3.2 The accreditation body shall ensure that any body to which assessment has been delegated is competent and complies with the applicable provisions of this document.
6.4 Assessment
report
6.4.1 The accreditation body may adopt reporting procedures that suit its needs but as a minimum these procedures shall ensure that: a) a meeting takes place between the assessor or assessment team and the laboratory management prior to leaving the laboratory, at which the assessment team provides a written or oral report on the compliance of the applicant laboratory with the accreditation requirements; b) the assessor or assessment team provides the accreditation body with a detailed assessment report containing all relevant information concerning the ability of the applicant laboratory to comply with all of the accreditation requirements, including any which may come about from the results of proficiency testing; c) a report on the outcome of the assessment is promptly brought to the applicant laboratorys notice by the accreditation body, identifying any non-compliances that have to be discharged in order to comply with all of
36
SP
60
: 1993
the accreditation requirements. The laboratory shall be invited to present its comments on this report and to describe the specific actions taken, or planned to be taken within a defined time, to remedy any noncompliances with the accreditation requirements identified during the assessment. 64.2 The final report authorized by the accreditation body and submitted to the laboratory, if it is different, shall include as a minimum: a) date(s) of assessment(s); b) the name(s) of the person(s) responsible for the report; c) the names and addresses assessed; of all the laboratory sites
2) for calibrations,
the type of measurement performed, the measurement range and best measurement capability; the
3) for tests, the materials or products tested, methods used and the tests performed;
4) for specific calibrations and tests for which accreditation has been granted, the methods used defined by written standards or reference documents that have been accepted by the accreditation body; c) where appropriate, the persons recognized by the accreditation body as being responsible for the calibration certificates, test certificates or test reports; d) the effective date of accreditation, accreditation if applicable; and the term of the
d) the assessed scope of accreditation or reference thereto; e) comments of the assessor(s) or assessment team on the compliance of the applicant laboratory with the accreditation requirements. 6.4.3 The reports should take into consideration:
e) the accredited laboratory by a unique number.
6.7 Surveillance laboratories
and reassessment
of accredited
a) the technical qualification, experience and authority of the staff encountered, especially the persons responsible for the technical validity of calibration certificates, test reports or test certificates; b) the adequacy of the internal organization and procedures adopted by the applicant laboratory to give confidence in the quality of its services, and of the physical facilities, i.e. the environment and the calibration/test equipment of the laboratory, including maintenance and calibration, having regard to the volume of work undertaken; c) any proficiency testing or other interlaboratory comparison performed by the applicant laboratory, the results of this proficiency testing, and the use of these results by the laboratory; d) the actions taken to correct any noncompliances ified at previous assessments. ident-
6.7.1 The accreditation body shall have an established documented programme consistent with the accreditation granted for carrying out periodic surveillance and reassessment at sufficiently close intervals to ensure that its accredited laboratories continue to comply with the accreditation requirements. 6.7.2 Surveillance and reassessment procedures shall be consistent with those concerning the assessment of laboratories as described in this document.
6.8 Proficiency testing

6.8.1 Laboratories shall be encouraged by the accreditation body to participate in proficiency testing or other interlaboratory comparisons. 6.8.2 Proficiency testing or other interlaboratory comparisons may be organized by the accreditation body itself or by any other body judged competent. Proficiency testing should be consistent with the provisions contained in ISO/IEC Guide 43. 6.8.3 Accredited laboratories shall participate in proficiency testing or other interlaboratory comparisons as required by the accreditation body. Their performance in such tests shall meet the requirements of the accreditation body.
6.5 Decision on accreditation

6.5.1 The decision whether or not to accredit a laboratory shall be taken by the accreditation body on the basis of the information gathered during the accreditation process according to 4.2.1. 6.5.2 The accreditation body shall not delegate its responsibility for granting, maintaining, extending, suspending or withdrawing accreditation.
6.6 Granting accreditation

6.6.1 The accreditation body shall transmit to each accredited laboratory formal accreditation documents such as a letter or a certificate signed by an officer who has been assigned such responsibility. These formal accreditation documents shall permit identification of the name and address of the laboratory that has been
6.9 Certificates laboratories
or reports issued by accredited
6.9.1 An accreditation body shall normally allow an accredited laboratory to refer to its accreditation in calibration certificates, test reports and test certificates that contain only the results of calibrations or tests, or types of calibration or test, for which accreditation is held. 6.9.2 The accreditation body shall have a policy that defines the circumstances in which accredited laboratories are permitted to include, in calibration certificates, test reports ortest certificates, the results of calibrations or
accredited; b) the scope of the accreditation, including: 1) the calibrations or tests, or types of calibration or test, for which accreditation has been granted;
SP 60 : 1993
tests for which accreditation is not held and the results of sub-contracted calibrations or tests.
h) in making reference to its accreditation status in communication media such as advertising, brochures or other documents, complies with the requirements of the accreditation body. 7.3
7 Relationship and laboratory
between
accreditation
body
Notification of change
7.1 The accreditation body shall have arrangements to ensure that the laboratory and its representatives afford such accommodation and cooperation as is necessary to enable the accreditation body to verify compliance with the requirements for accreditation. These arrangements shall include provision for examination of documentation and access to all calibration and testing areas, records and personnel for the purposes of assessment, surveillance, reassessment and resolution of complaints. 7.2 The accreditation credited laboratory body shall require that an ac-
7.3.1 The accreditation body shall have arrangements to ensure that an accredited laboratory informs it without delay of changes in any aspect of the laboratorys status or operation that affects the laboratorys a) legal, commercial b) organization staff; or organizational status;
and management,
e.g. key managerial
c) policies or procedures, where appropriate; d) premises; e) personnel, equipment, facilities, working environment or other resources, where significant; f) authorized signatories;
a) at all times complies with the relevant provisions of this document; b) claims that it is accredited only in respect of services for which it has been granted accreditation and which are carried out in accordance with these conditions: c) pays such fees as shall be determined tation body; by the accredi-
d) does not use its accreditation in such a manner as to bring the accreditation body into disrepute and does not make any statement relevant to its accreditation which the accreditation body may consider misleading or unauthorized; e) upon suspension or withdrawal of its accreditation (however determined) forthwith discontinues its use of all advertising matter that contains any reference thereto and returns any certificates of accreditation to the accreditation body; f) does not use its accreditation to imply product approval by the accreditation body;
or other such matters that may affect the laboratorys capability, or scope of accredited activities, or compliance with the requirements in this document or any other relevant criteria of competence specified by the accreditation body. 7.3.2 Upon receipt of due notice of any intended changes relating to the requirements of this document, the relevant criteria of competence and any other requirements prescribed by the accreditation body, the accreditation body shall ensure that the laboraton/ carries out the necessary adjustments to its procedures within such time as, in the opinion of the body, is reasonable. The laboratory shall notify the body when such adjustments have been made. 7.4
Directory of accredited
laboratories
g) endeavours to ensure that no certificate or report nor any part thereof is used in a misleading manner;
The accreditation body shall produce periodically a directory of accredited laboratories describing the accreditation granted.
SECTION 3 PRODUCT AND QUALITY SYSTEMS CERTIFICATION

FOREWORD
Quality Systems is gaining increased series of standards. Coupled to this, not only in developing countries but harmonization and transparency of organization. interest world the European the developed approach in over and it is currently directed at the IS0 9000 Market 1992 provides a challenge to the industry countries as well due to persistence of EEC on the manufacture and service provided by any
The internal market is generally achieved through certification of products according to detailed In the international sphere, the technical barriers to trade appear when the national standards. national regulations concerning one product are more stringent in the country of destination than in the country of origin.
Therefore, the documented procedure should be laid down for competence of an organization and further procedures should be laid down for harmonization of standards and procedures world over. This would facilitate mutual acceptance of products or systems between countries thereby facilitating the removal of non-tariff barriers to trade. The various chapters under this section give the guidelines introduction to each of the chapters covered is given below: covering the above aspects. An
A product is said to conform to a standard if it fulfils all the requirements defined therein. All parties which make use of a standard for the purpose of conformity certification or declaration of conformity must be able to derive from the contents of the standard a common understanding of their meaning and intent. The standards must be written so as to be clear and precise, and result in accurate and uniform interpretation. Chapter 1 of this section will assist the technical committees in drafting standards in such a way that they are suitable for certification purposes. The activities of International Organization for Standardization (ISO) and International Electra-technical Commission (IEC) members in making standards and operating third-party certification systems are based on the fact that standards are essential tools of economic activity; standards improve productivity, trade and facilitate transfer of technology. Therefore, IS0 and IEC Councils have established principles for consideration and adoption by its members, which are given in Chapter 2 of this section. There are cases where it is useful, and even necessary, and other technical specifications be indicated, either on way. But, the manufacturer may also declare under his conformity with standards or other technical specifications. followed are given in Chapter 3 of this section. that conformity of products with standards the products themselves or in some other sole responsibility that his products are in In such a case, the various principles to be
With the increased development of international trade and the increased demands by government authorities, customers and others to establish whether a product conforms with standards, it is becoming more and more important that the methods of indicating such conformity should be clearly understood. Chapter 4 of this section lays down methods for indicating conformity with standards. Most of the national standards bodies operate a third-party certification system for determining conformity with product standards. For this purpose, certification body operating the system at a national level shall, as a minimum, have suitable organizational structure and utilize personnel, Chapter 5 of this section gives the general rules for a model equipment and operating procedures. third-party certification systems for products, One of the major obstacles to wide spread participation in international certification systems is the lack of confidence which certification bodies have in their across-border counterparts and the fear of large scale commitment to a system with which they have had no previous experience. The chapter 6 of this section guides those parties who wish to gain some experience in the operation of acceptance arrangements in the international area, but who may not be prepared currently to participate fully in an international certification system.
International certification schemes have an inherent possibility of reducing time and expense as opposed to complete retesting and reappraisal in each country. Chapter 7 of this section applies to international certification schemes for determining conformity with product standards through initial testing and assessment of a manufacturers quality system and its acceptance followed by surveillance that takes into account the manufacturers quality system and the testing of samples from the factory and the open market. This chapter outlines general rules which parties interested in establishing IS0 or IEC certification scheme should use in developing such schemes. The objective of third party system of assessing and registering a suppliers quality system is to provide adequate level of confidence that the suppliers quality system conforms to the identified requirements for that system. This third party system involves only the assessment of the suppliers quality system and is not concerned with the certification of products, processes pr services. Chapter 8 of this section sets forth criteria, the observance of which is intended to ensure that assessment bodies operate third party assessment systems in a consistent and reliable manner, thereby facilitating their acceptance and recognition on a national or international basis. Certification programmes utilizing elements of suppliers quality assurance system can be effective for both the supplier and the certification body in achieving certification in a timely cost-effective manner and in assuring that products continuously conform to standards. Chapter this section outlines a general approach by which certification bodies wishing to do so can develop apply product certification programmes utilizing elements of a suppliers quality system. very and 9 of and
One of the most essential elements for the operation of an international certification system or for mutual recognition of national certification systems is confidence in the competence of the certification bodies participating in the system or engaged in mutual recognition. Chapter 10 of this section provides a framework for use by a certification body in assessing itself, its procedures, and its operations. Using this framework, a certification body should be able to compile a documentary record of its internal quality system review procedure. This section is based on the following ISO/IEC Guide 7 ISO/IEC Guide 16 ISO/IEC Guide 22 ISO/IEC Guide 23 ISO/IEC Guide 28 ISO/IEC Guide 42 ISO/IEC Guide 44 ISO/IEC Guide 48 lSO/IEC Guide 53 lSO/IEC Guide 56 Requirements 10 ISO/IEC Guides: 1982 1978
for standards suitable for product certification, certification
Code of principles on third-party
systems and related standards,
Information on manufacturers declaration technical specifications, 1982 Methods of indicating systems, 1982
of conformity with standards or other certification 1982 system, 1984
conformity with standards for third-party certification
General rules for a model third-party Guidelines for a step-by-step
system for products, certification
approach to an international third-party
General rules for IS0 or IEC international products, 1985 Guidelines for third-party system, 1986 assessment
certification
schemes for quality product
and registration
of a suppliers
An approach to the utilization certification, 1988
of a suppliers quality system in third-party
An approach to the review by a certification system, 1989.
body of its own internal quality
40
SP 60 : 1993
CHAPTER
REQUIREMENTS FOR STANDARDS SUITABLE FOR PRODUCT CERTIFICATION (ISO/IEC GUIDE 7 :1982)
introduction
is said to conform to a standard if it fulfils all the requiremerlts of conformity defined tllCr?ln
A product
All parties which make use of a standard for the purposes
organizations, testing and inspection bodies that are used by certification tion, must be able to derive from the contents of the standard a common must be written so as to be clear and precise and result in accurate
certlftcar:n:t w decldation of conformity e.g. certiflcatiorl bodieq; InClrlufnc:turers and users of the products in quesundcrstoncflrq of their meaning and intent. The standards
and uniform rnit?rpleiatlor;. pur-
The aim of this Guide is to assist technical committees documents between buyer and seller and the like.
in drafting standards in such a way that they are suitable for certification
poses. It must be borne in mind that such standards could also be used for pcrrposes other than certification
such as in contractual
If a standard is intended to be used for certification should, in addition to including representatives
or if it is apparent
that it couitl be used for certification, inciude persons with certification
the technical committee experience.
of all interests concerned,
Definitions
contained in IS0 Guide 2, General terms and their defirutwts conceriwg s;::irrdardiatron and certification, are appli-
The definitions cable.
General
purposes a number of aspects with which standards should normally ccmply (such as those covered by the Directives work of ISO, part 2, Methodology and its annexes), require emphasis. These relate to the specific inclusion or so as to ensure its suitability for certification in such a manner that easy reference purposes.
For certification for the technical
exclusion of items in the standard The standard should be prepared
to or use of it cart be made
4
4.1
Requirements
purposes and which complies with
Each standard which the appropriate technical committee considers suitable for certification this guide, should contain a clear statement to this effect in its scope.
4.2
Standards should always be prepared in such a way that they facilitate and do not retard the development of technology. Usually this is accomplished by specifying product performance requirements rather than product design requirements.
4.3
Standards should specify all those and only those characteristics and requirements that are necessary to define the properties of the product or its performance, to meet the aim or objective of the standard. If it is not practicable to include all characteristics and re-
quirements in one standard, reference can be made to other relevant standards. These requirements should be specified together with the required limiting values and tolerances where applicable, and the test methods to measure the characteristics specified.
4.4
4.5
Only such characteristics
which can be objectively
verified should generally be included in the standard.
The characteristics and requirements should be clearly stated and be precise, valid and specific. They should be free from subjective elements, and the use of such phrases as sufficiently strong to or of adequate strength, etc. should be avoided. 41
SP
60
1993
4.6
It is often necessary to allow for more than one category, if necessary). Designers, users and consumers should therefore
type or grade of a product within the same standard
(or in separate reasons.
standards Standards
often need such variations for specific purposes or for economic
be prepared in such a way that these needs can be met. that such variations are so clearly defined that a clear identification the product. that this approach may not be appropriate to standards covering of the one chosen for certification can
In such cases it is important
be made either as a part of the marking or on a label accompanying When considering the matter of variations it should be remembered safety, health or environment.
4.7
Requirements
for manufacturing
processes should not be included in standards,
unless it is impossible to adequately
specify the
product without
doing so.
NOTE - Where it is necessary in a third-party certification scheme that controls for manufacturing processes are specified, such requirements should be inciuded in the specific rules for the certification scheme, based on the standard.
5
5.1
Test methods
Test methcds
should be consistent with the purpose of the standard,
be objective,
concise, accurate and produce consistent,
highly reproducible
results; they should be clearly identified and appear preferably
in separate sections of the standard.
To the extent practicable and consistent with the objective of the test, the method employed should be based on the use of readily available equipment and conduct of the test within reasonably short periods of time, thus avoiding to the highest practicable degree, the calling up of highly specialized equipment and the conduct of unduly lengthy and expensive tests, the certification testing.
If the standard specifies expensive or time consuming the purpose of further surveillance simple identification same as the originally approved In such cases the identification rules of the certification product.
body may decide that, after a successful initial test, for products are still the
tests may be carried out to ensure that the manufactured
tests may be incorporated
in the standard but their recognition
will be at the discretion of the specific
scheme.
5.2
Ideally, a test method specified in a standard should be described in sufficient
detail that qualified personnel
in any laboratory
would achieve the same results as far as it is technically possible, when using the equipment in the standard.
and applying the test methods specified
5.3
When
it is considered
technically
necessary,
each test method should incorporate
a statement
as to its limit or reproducibility
and repeatability.
5.4
Limiting values of requirements
associated with each method may be given in such way as to specify a permissible tolerance or or a minimum or maximum value as appropriate.
an average value with an upper or lower limit as appropriate,
5.5
The standard
should specify the sequence
of tests when this sequence
can influence
the results.
5.6
When
chasing test methods, in other standards.
account
should be taken of standards for general test methods
and of related tests for similar
characteristics
5.7
Equipment
and facilities required for the test methods specified should be readily available. Where such equipment then the standard should include such specifications testing can be conducted by all involved parties.
is not comas
mercially available and has to be individually manufactured, to ensure that comparable
for the equipment
5.8
Non-destructive
test methods should be preferred, whenever
they can replace, within the samelevel
of confidence,
the destruc-
tive methods.
5.9
Where
two or more methods
are given for a single test, one of these methods should be designated
as the referee method.
42
SP 60 : 1993
6.10
Where the standard does not indicate performance and how the values obtained
criteria to specific limits, the standard should specify the test method to be
employed
in the testing are to be communicated.
5.11
Where
type testing requires the testing of a number of items to determine
compliance
with specific paragraphs
in the stan-
dard, the number of items should be specified in the standard.
Control
of quality
during
production
is exercised by the manufacturer body. should not be defined in the standard, nor
The method by which control of quality during production the means by which that control is independently
checked by a certification
NOTE - The rules relating to this cnntrol in a third-party certification system is the responsibility of the certification body and should be included in a separate document.
7
7.1
Packaging, Packaging
marking
and labelling
requirements
The standard should, when relevant, specify requirements vent hazards, contamination
for the packaging packaging.
of the product,
either to protect the product,
or to pre-
or pollution arising from inadequate
7.2
Marking
and
labelling specifying the information to be given on the product or on a label accompanying the pro-
The standard should contain requirements duct, such as a)
:
or marking traceable to the manufacturer, requirements the date of manufacture or a code in lieu
the name and address of the manufacturer
thereof, b)
the size, rating, or capacity where the standard delineates
on such basis; which are necessary to ensure about the delivery, maintenance,
the product or packaging should be marked and if necessary labelled according to requirements or to avoid misuse of the product, authorities, or its means of protection; for potential to the user, buyer or regulatory expiry date, etc.; such as warnings hazards,
the correct use of the product, p:oduct transportation,
or to convey information storage,
c) when specific marking such as hazard warnings are required (e.g. symbols which indicate keep away from fire), the markings called for should preferably be universally recognized. Symbols should preferably be used, words may be added; d) each item of the product or if this is not possible then its packaging, can be related; service, the standard should include should be marked or durably labelled with an identifica-
tion to which the certification e)
when necessary for correct installation or mounting of the product for its later satisfactory for such an instruction to accompany the product;
a requirement f)
the marking specified should be clearly legible and durable for the environnement
and other conditions
of exposure
of the pro-
duct; g) marking which is limited to the identification of a code, classificatior? or rating rnay be included in the standard.
7.3
Limitations
7.3.1
Indications
of conformity certificates of conformity or manufacturers declaration of conformity should not be included
Matters relating to marks of conformity, in the standard.
7.3.2
Effective
dates
and users
responsibilities dates or allocate responsibilities to various parties who make use of the standard.
The standard should not include effective
NOTE - Establishing effective dates for standards is the responsibility of certification bodies and their clients operating under a particular certification scheme. 43
SP 60 : 1993
Assessment
requirements
of conformity
relating to assessment of conformity could, in certain cases, appear in a separate document. Such a sampling
Sampling
schedule may, for the selection of samples for inspection and testing before acceptance in an annex, contain a specified statistically calculated sampling and compliance the number of allowable with the standard during manufacture Careful consideration that, where conforming
NOTE -
or rejection of single lots, and only as a guide
schedule stating the number of samples to be drawn, of the product or testing
defectives
and the compliance
level (AQL),
to be established through testing, which the parties concerned and is a way of assessing the conformity of control of quality during production
consider to be satisfactory.
It can be used independently
of the manufacturer
in those cases where no information is available,
about the implementation
or this is required by the user/client. is required. In particular, knowingly permit it must be borne in mind to non-
of possible adverse effects of the use of statistical techniques certification is concerned, a certification body cannot
third-party products.
its mark to be applied
For certificarion
of conformity
based on statistical methods, there are at present particular cases where the above restriction may not be aprequirements are contained in the standard itself.
plied and both the sampling schedule and product
SP 60 : 1993
CHAPTER
CODE OF PRINCIPLES ON THIRD-PARTY CERTIFICATION SYSTEMSAND RELATED STANDARDS (lSO/IEC GUIDE 16 :1978)
The
activities
of
IS0
and
IEC
members activity;
in making standards
standards promote
and in operating systems) the improvement
third
party
certification
systems based on fact that standards
standards applying
(subsequently the experience
referred
to in this code as certification
are based on the recognized of production
are an essential tool
of economic
and the increase of trade by
of science and technology. on foreign trade are to be regarded production. members on standards They exclude and certification therefore are designed moreover to as part of their overall effect, although standards should
The repercussions
of standards
not be such as to provide The agreements worked
protection out by IS0
to domestic and
IEC and their transfer
improve cation. The IS0
international
trade
and facilitate
of technology.
any idea of discriminatory
appli-
and
IEC
members
recognize
moreover
the major
role of manufacturers
assurance of conformity
through
normal
manufacturer/customer
relationships. the IS0 and IEC Councils members, have established for consideration the following and adoption principles which presuppose
In the light of these considerations, degree of reciprocity in mutual organizations
relations
between
by the members
of the two
:
systems established by IS0 and IEC members or in which they participate, period of time. up for implementation giving particular in certification shall take to attention whether national, regional
1 Certification
worldwide, in appropriate 2 Where
or
shall be based directly
or indirectly
on IS0
or IEC international
standards as far as possible, each time they exist
form and suitable precision or IEC international
or can be drawn up in a reasonable standard has been or is likely for the functioning to requirements
an IS0 the IS0
to be taken
systems, particular a) b) c)
and IEC members
responsible is adapted
of the systems, and IS0 of conformity certification,
and IEC themselves,
care to see that this standard of the specified methods with
clear definition
characteristics; of measurements and test; of guidance on the requirements for systems of ensuring con-
exact and reproducible provision, in parallel
the technical
specification,
formity d) 3 Any
with the specification; the development of technology. conformity certification of products without discrimination
the need to allow for and promote certification
system based on standards should permit
as
to their origin. 4 Any
The details of any such system should be fully described system based on standards precision, the internal the development
in publicly
available
documents. where they exist in appropriare being certified,
certification and suitable
should utilise to the maximum control procedures
possible extent,
ate form
quality
of manufacturers
whose products
and should encourage 5 Any certification
of those procedures. should include inquiry procedures for the settlement of appeals concerned
system based on standards
with operation 6 Any
of the system. system based on standards should be organized with the functioning in such a way that an independent authority representing of
certification
the interests
of all parties concerned
of the system ensures, with full impartiality,
that the principles
this code are respected. 7 Where two or more IS0 or IEC members for the same product-or If a suitable IS0 group for of rights and obligations resulting or groups of members they and aimed have developed seek suitable at eliminating or are developing arrangements discrimination two or more certification one another to disparity based on between If of a
systems equality
of products,
should
with related
each of them
standards.
or IEC international from such arrangements standard.
standard
exists, it should form the technical
basis for such arrangements.
not, any standard corresponding
shall be made available to IS0 or IEC with a view to the develdpment
IS0 or IEC international
45
SP
60
: 1993
8
tries
IS0
and 1EC members

fully from
shall provide
the provisions
one another
of this code.
with.all
possible assistance so that the nationals
of their respective coun-
can benefit
Any member
of IS0 or IEC having a complaint member
to make regarding member a solution.
non-application participates,
of this code in relation
to a certification
system which IEC Council, 10 IS0
another
operates or in which another
may request the good offices of the IS0 or
as the case may be, with a view to finding
and IEC shall continue of reference desirable
to offer their services to national to standards
and international acceptance
governmental of certification
organizations
for implemenIt
tation
of the policy
and for international
systems and arrangements.
is therefore
that the principles
of this code should be brought with conformity certification.
to the attention
of all authorities
other than IS0 and
IEC members,
NOTE
who are in general concerned
- The definition of conformity
of some terms used in this code is agreed as follows (see IS0 Guide 2)
:
specifications.
certificate
A document
attesting that a product that a product
or a service is in conformity
with specific standards or technical specifications.
mark of conformity
:A
mark attesting
or a service is in conformity
with specific standards or technical or mark of conformity
conformity certification : The action of certifying by means of a certificate in conformity with specific standards or technical specifications. certification certification certification system
of conformity
that a product or service is
A system having its own rules of procedure
and management,
for carrying out conformity
certification.
body : An impartial body, governmental or non-governmental, possessing the necessary competence and reliability system, and in which the interests of all parties concerned with the functioning of the system are represented. system
to operate a
third party certification certification arrangement facilitate trade.
:A
certification
system managed by a certification
body or under its surveillance. of certification
An arrangement
which establishes the mutual acceptability
systems or related procedures in order to
SP 60 : 1993
CHAPTER
INFORMATION ON MANUFACTURERS DECLARATION OF CONFORMITYWITH STANDARDS OR OTHER TECHNICAL SPECIFICATIONS (lSO/IEC GUIDE 22 :1982)
Information on manufacturers declaration of conformity with standards or other technical specifications
Introduction
it is useful, and even necessary, themselves that conformity way. of products with standards and other technical specifications
There are cases where be indicated, either
on the products
or in some other
Third-party conformity certification evidenced by a certificate or a mark of conformity is a solution offering valuable assurance to the user, due to its very principles and modes of implementation. But, subject to the restrictions or prohibitions of the national laws in the countries where the products are marketed, the manufacturer may also declare under his sole responsibility that his products are in conformity with standards or other technical specifications. This presupposes his order with that the manufacturer ambiguity is conscious or oversight. of the responsibility he undertakes, and that the customer is able to prepare the least possible
Scope
and field
of application
the recommended that a product procedures when the manufacturer with specific standards offers or is requested technical to declare under his sole specifications.
1.1 This document

responsibility
sets forth
to the purchaser
is in conformity
or other
1.2
Where
used, a manufacturers is directed with
declaration towards
should
be based on the entire with International
contents Standards
of a standard. (IS0 or IEC), but it may also be used for
1.3
This document conformity
primarily
conformity technical
declaring
NOTE -
national
standards
or other
specifications.
Whenever the
In the followrng text, whenever declaration expression manufacturers
the term standard is used, it is meant to cover standard or other technical specification. is used, it is meant to cover manufacturers declaration of conformity.t)
1)
The term self-certification
is not used in this document
in order to avoid possible confusion with certification
procedures
in general which imply
the involvement of a third party.
47
SP 60 : 6993
Definitions
the following definitions apply
For the purposes of this document,
2.1
manufacturer
: The party that is responsible for the production and is able to ensure that quality assurance is exercised over
of the standard (or standards) are met. As an extension of the above the definition for the manufacturer described importers, assemblers, etc. provided that they meet the prerequisites
the products to the degree that all requirements may also apply to distributors, under clause 5.
2.2
manufacturers
declaration
of conformity
of a third-party
: The action by which a manufacturer

is in conformity system. certification
declares under his sole responsibility, by or other technical specification,
means of a declaration without
of conformity,
that the product
with a specific standard
being under the procedures
Form of manufacturers
declaration
declaration
may be evidenced by a declaration in a statement, catalogue, pamphlet, invoice,
The manufacturers label, etc.
delivery note,
Objective
of the manufacturers
declaration refers.
declaration
is to indicate that the product concerned is in conformity
The objective of the manufacturers standards to which the declaration
with the provisions of the
Prerequisites
for the manufacturer
to declare
conformity
The manufacturer opinion,
should have the direct or indirect capability of the standard(s)
to exercise quality assurance over the product to a degree that, in his the manufacturer should have at his disposal all necessary process, assembly, finished products, pack-
the requirements etc.).
are met. For this purpose,
means for carrying out this assurance at all levels (raw materials, supplies, manufacturing ing, marking, He should make information
on the control and the results of tests exercised available when appropriate.
6 6.1
Declaration
The declaration a) b)
of conformity
should as a minimum provide the following information
the name and address of the manufacturer the identification of the product
issuing the declaration; information, such as lot, batch or serial
: name, type or model number, and all supplementary
number,
Cl
sources and number of samples: standardk) in a precise, complete information and clearly defined way (title, number and date of issue); etc.;
the reference if relevant,
d) et f) g)
all supplementary
that may be required such as grade, category,
the date of issue of the declaration; signature and title of authorized the statement officer, unless this is not possible (telex, for example); of the manufacturer.
that the declaration
is issued under the sole responsibility
6.2
based.
The information
supplied shall be such that there is a capability
of relating the declaration
to the test results on which it was
6.3
The declaration
shall not imply or suggest endorsement
by a standards body or other authority
or by any thiid party in general.
SP
60
:1993
6.4 An example of declaration of conformity is given below : We . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..lmenuracturer.s.name................... .............................
..................................................................................................................
(address)
declare under our sole responsibility that the product
. ..................................................................................................................
(name, type or model, lot, batch or serial number, possibly sources and numbers of items)
to which this declaration relates is in conformity with the technical requirements of the following standard(s) :
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .._........................
(title)
.......................
(No. /
. ................
(year)
. . . . . . . . . . . . . . . . . . . . . . ..__..............._._..................
(grade)
. .............................................
(category) (if applicable)
........................................................
(name of authorized officer)
. ........................................................
(title of authorized officer)
........................................................
(date of issue)
. ........................................................
(signature)
Limitations
on reference to manufacturers
declaration
of conformity
in standards
Matters relating to manufacturers declarations of conformity or any reference thereto should not be included as a requirement in a standard.
8
8.1
Marking
on a product (excluding marks of conformity)
For the purpose of this document, marking is defined as follows :
marking11 : Application of indications on a product or on a package primarily for the purpose of identifying the product and/or certain features of the product. NOTES 1 Markingdoes not includemethodsof indicatingconformity. 2 The indications may include : indication of origin, identification labels or items, characteristics of the product, safety warnings, etc., user
information.
8.2
It is understandable that if the name of the standards body or its abbreviation appears on a product, it can be interpreted in the public mind as connoting some approval of the product by the standards body. Extreme caution should be exercised in this respect to avoid a confusing or misleading situation. Marking in which reference is made to the standards body should not be encouraged, especially on any items sold direct to the general public. If, however, there are cases where it is desirable for a manufacturer, under his sole responsibility, to indicate on a product the standards number and the letters designating the standards body (and generally IS0 or IEC), such marking should be limited to the identification of a code, classification or rating (for example, power of motorcars, speed of films, etc.).
1)
Definition1.1.13 IS0 Guide2-1980, amended. 49
SP
60
: 1993
8.3
Although
marking,
by definition
(see 8.11, is not considered
an accepted
method
of indicating
conformity,
it is recognized
that
in the present situation as it exists in practice, for example because of the legal situation in some countries, there are cases where a manufacturer uses a marking for other purposes than the identification of a code, a classification or a rating. This is why it was felt necessary to specify in 8.4 a number of minimum criteria which should apply in cases where marking references a standards body or its standards.
8.4
Such marking
shall not be ambiguous criteria apply
or in any way lead to misinterpretation
The following a) marking
minimum
: : it shall include the identification

body, followed of the manufacturer, and refer to the appropriate
shall be as specific by the letters
as possible
standard(s) b) c) d)
indicating
the standards
by the number
and the date of issue of the standard; body; body;
it shall in no way suggest it shall in no way include in cases where provisions
or lead to the belief that it has been endorsed any reference to or be associated of figures with
by the standards
recognized
marks of the standards are made,
for the indication
or of classes
of characteristics
these
shall appear
in the
marking; e) it should make clear, even for a technically referred to cover(s) uninformed purchaser, which characteristics are covered by the given reference,
in
particular
if the standard(s)
only some of the characteristics
of the product.
8.5
Reference case of marking
to marking as a means of indicating conformity should not be included referring only to a designation code, classification or rating.
as a requirement
in a standard
except
in the
SP 60 : 1993
CHAPTER
METHODS OF INDICATING CONFORMITY THIRD-PARTY CERTIFICATION SYSTEMS
WITH STANDARDS FOR (ISO/IEC GUIDE 23 :1982)
Introduction .
of international a product trade and the increased demands by government with standards, it is becoming authorities, purchasers, consumers that the
With the increased development and others to establish whether methods of indicating
or service conforms
more and more important
such conformity
should be clearly understood. this need would include
The questions which arise in considering what is being certified? by whom is it certified?
_
-
who requires the certification? why is evidence of conformity how best is information required? transmitted to the buyer, user (consumer) or government authorities?
on conformity
Scope
and field
of application
of indicating conformity with standards and reference thereto in standards. to conformity Whilst it is directed
This Guide lays down specifically specifications. for International
methods
to conformity Standards
with standards,
it is recognized
that it may be equally
applicable
with other technical
It applies to indications of conformity
made under the authority of a certification or other purposes.
body. This Guide is primarily intended
but may be used for national standards
2
IS0
Reference
Guide 2-1980, General terms and their definitions concerning standardization and certification
Definitions
which appear in IS0 Guide 2 are applicable, except that, for the purpose of this document, the following
The relevant definitions definitions apply
: : A legally registered certification

mark applied by or issued under the procedures with specific standards or other technical of a third-party cer-
3.1
mark
of conformity
tification
system for a product or service which is in conformity
specifications.
3.2
certificate
of conformity
: A document issued under the procedures of a third-party certification system and attesting that a
with specific standards or other technical specifications.1)
product or a service is in conformity
1)
It is recognized that certificates of conformity may have different meanings and applications in different countries.
51
SP 60 : 1993
4 4.1 4.2
Who
requires
information
manufacturer
on conformity
with
standards?
with the relevant standard.
The responsible
may require that it be known that his product is in conformity
The purchaser
may need to know that the product
he has purchased
meets the requirements
which have been specified. For instance, he may
The word purchaser purchase
does not necessarily imply that he is the ultimate user of the complete finished product. into, for example, fasteners.
steel bars for machining
4.3
Inspection organizations,
insurance companies,
etc. may need to have information
on conformity
in order to have con-
fidence
in the product for which they are taking a risk.
4.4
Regulatory
bodies, such as governments,
etc. may need evidence
that products
covered
by legislation
meet the required
standards.
Categcries
of purchasers
as follows
Purchasers
listed in 4.2 can be categorized
5.1
Consumer (i.e. the individual member of the general public)

is assumed to have little or no technical knowledge and seldom has access to the standard
The consumer
5.2
Informed
purchaser
to be able to understand standards within his field of work.
The informed purchaser is assumed to have sufficient knowledge
6 6.1
Categories General
of standards
to which
conformity
can be certified
Conformity
may be demanded
for various categories
(types) of standards.
The question which is to be faced is what method of in-
dicating conformity could be applied in order to convey to the user, purchaser, inspection organizations, regulatory bodies, etc., the information on conformity with the standard and on whose authority this is stated. The categories in which product standards fall (for the range of products from raw materials and component items through to end-items) can usually be grouped into two main types
6.1.1
Comprehensive
product standards
the essential characteristics, requirements, test methods, etc. necessary to enable
Such standards
have the objective of specifying purpose.
the product to serve its intended
6.1.2
Standards for specific properties
These standards cover specific properties and are not necessarily comprehensive product standards. They may specify one specific property, such as the colour fastness to light of textiles, or they may specify more than one property. This type of standard is frs
quently used for regulatory purposes, for example where only the safety aspect of a product is specified.
7 7.1
Methods
of indicating
conformity
with
standards
Mark of conformity
system to indicate that compliance with the standard is under the
A mark of conformity is limited for use in a third-party certification supervision of such a system.
In implementing the mark of conformity method,
it is necessary to exercise care to indicate clearly the coverage
intended.
52
SP 60 : 1993
In cases where only certain components assuming that the entire product
of a product bear a certification
mark, care should be taken not to mislead the consumer into
is certified. it relates to all the requirements of a standard and not to selected sections or
A mark of conformity characteristics
is to be used only where body.
and should be operated under specific rules applicable thereto.
A permit or licence for the use of a mark of conformity
is issued by a certification
7.2
Certificate
of conformity
as to the standards covered by the certificate. or standards covering specific properties. only. Certificates The method may be used Certificates of conformity are issued of conformity
The aim of this method is to provide, for the user, information to indicate conformity under the procedures at least the following a) b) c) with comprehensive product standards may relate to all the requirements information
of a standard or to selected sections or characteristics
of a third party certification
system and may be either of a voluntary or mandatory
nature. They should contain
:
body;
name and address of the certification name and address of the manufacturer; identification of the product certified
and the lot, batch,
serial number,
model or type number
to which the certification
applies; d) reference to the appropriate standard (title, number, and year of issue); when the certification applies to only a portion of a
standard, e) f)
the applicable
portion(s)
should be clearly identified;
date of issue of certificate; signature and title of authorized officer. of relating the certificate information to the test results on which it was based.
The information
supplied shall be such that there is a capability certification
The rules of a third-party
system may also specify additional
to be included.
Limitations
on reference
to marks
of conformity
and certificates
relationship
of conformity
in standards
regulations. It
The primary uses of standards
are as technical
documents
in a buyer-seller
or as the basis of technical of conformity),
follows that the inclusion in the standard of requirements dard which stipulates a requirement table by all IS0 and IEC member
indicating conformity
requires careful consideration. certificates
An International
Stan-
to indicate conformity
(marks of conformity,
may not be implemen-
bodies because of national,
legal or other provisions. should not appear in standards but in separate documents or certificates of conformity. certification system, which
Matters relating to marks of conformity should relate to all aspects connected In the case of marks of conformity such documents
or certificates of conformity with the implementation of conformity bodies.
of marks of conformity
or certificates
issued by or under the procedure of a third-party
should be established
by certification
Markings limited to indicate a designation, in the standard.
code or classification are not considered to be marks of conformity
and may be included
9 9.1
Types of mark Recommended
of conformity marks of conformity

marks of conformity to distinguish the difference between a mark of conformity for Dif-
Whilst it may be desirable to have differing products complying with a comprehensive dard dealing only with specific properties, ferentiation
product standard from a mark of conformity it will not be easily understood
indicating that a product complies with a stanand could lead to misinterpretation.
by the consumer
would require a legend below each mark. level, where the relevant marks of conformity are intended to be internationally acceptable, the problem is further
At the international complicated wits
by the question of languages.
Whilst the international
languages of IS0 and IEC are English, French and Russian, the
of the products are not necessarily sufficiently versed in other than their native tongue to be able to read a legend in English,
French or Russian.
53
SP
60
: 1993
It is suggested
that the mark of conformity
be preferably
used for products
complying
with the requirements
of a comprehensive
product standard. Example
0
ABC
In cases where the standard understandable contains different should appear in close proximity If the grade or value has not been stipulated or value. in the standard,
ABC B-1974*
grades or types, descriptive
words
but preferably
symbols which are universally
to the mark of conformity
to indicate which grade or type is being certified.
but left open for any grade or value to be stated by the manufacturer, and its stated grade
then such grades or values should appear in close proximity to the mark, indicating the property or characteristic
9.2
Further considerations
essential reasons still make it desirable to apply a mark of conformity to a product com-
If, after all the factors have been considered,
plying with a standard which only covers specific properties of the product, it is suggested that the mark of conformity together with the reference to the standard as well as a short indication of the aspects covered by the standard, may be applied to the product. It is preferable to use symbols which are universally understandable rather than descriptive words. Example :
ABC However, it is recommended that consideration
224-1979
0
ABC
Colour
fastness
only* to the use of certificates of conformity
should rather be given in such circumstances
which would be more precise in their information,
10 Indication using a mark

Any international
of the certifying authority in the case where of conformity is in operation

certification system which utilizes a mark of conformity
an international
certification
system
should be administered
by the certification
bodies which
participate in the system. It is therefore necessary to determine the need to indicate on the product the identity of the certification body administering the mark. Care should be taken that such a designation, when used, is not confused with national or other marks of conformity.
11
Information
for consumers
certificates of conformity and marking to indicate designations must be understandable to the
The concepts of marks of conformity, consumer. Extensive information
effort will be required to ensure that the consumer
is aware of the meaning
of these concepts.
This is only an example. The inclusion or not of the date of the standard or other forms of traceability to the standard, or the identification of the
by the certification system.
property being certified is a matter to be determined
SP 60
: 1993
CHAPTER
PRFNFRAI G,,~..L-..-L
Rlll .,-II-.
FS FT)R _.. .A. MnOFl .I.---_
THIRD-PARTY . . . . . .. - --..
CERT!F!C_AT!ON
SYSTEM FOR PRODUCTS (lSO/IEC GUIDE 28 :1982)

0 Introduction
type of certification system
These model general rules are valid for the following A third party certification quality management system of determinrng
conformity followed
with product standards through initial testing and assessment of a factory by surveillance that takes into account the factory quality management
system and its acceptance
system and the testing of samples from the factory

NOTE This model system corresponds because it was the most
and the open market.

Publication,
to system No. 5 as described in ISOilTC and could thus offer
Certification -
Principles andpractice. of other
This system
was chosen
comprehensive
the best basis for the eventual
development
systems.
The identification A certification sonnei, edition). Any certification ISO/IEC
of conformity
may be in the form of a certificate
of conformity
or a mark of conformity.
(See ISO/IEC structuret) I3u/ltL
Guide 23.)
body operating
and
the system at national level shall as a minimum

procedures that compiy with the criteria
have a suitable organizational

given in iS0 Guide 24 ana
and utilize perUurae Lo \raresr
equipment,
operating
scheme
under the system
requires as a prerequisite
a standard
that is suitable for certification
purposes.
(See
Guide 7.)
References
concerning standardization and certification.
IS0 Guide 2, General terms and their definitions ISOIIEC ISOIIEC Guide 7, Requirements Guide 23, Methods for standards
suitable for product
certification. for third-party xrtification systems. bodies.
of indicating
conformity
with standards
IS0 Guide 24, Guidelines ISOIIEC
for the acceptance
of testing and inspection competence
agencies by certification of testing laboratories.
Guide 25, General requirements
for the technical
Definitions
of IS0 Guide 2-1980 and its Addendum 1-1981 are applicable.
The relevant definitions
Basic conditions
for obtaining and retaining the licencez) to issue a certificate of conformity or to use a mark of conformity are
The basic conditions
that the applicant/licensee tification of conformity
follows these General Rules and the Specific
Rulesa) of the relevant scheme and that he applies the idenwith the relevant standard(s).
only to products that are within the scope of his licence and are in conformity
Application
for licence
from the certification body. An example of such a form is given in annex B. by the certification scheme and specified in the
The application shall be made on a special form obtainable The appiication reiates to the specific product
or group of products
determined
Specific Rules. It should normally
cover products
coming from one factory only.
11 Guidelines on this subject are in preparation within ISOICERTICO. 2)

For the purpose of this document the words licence and licensee are used although the granting of a licence is only one of several means of in&eating that the applicant concerned has been accepted by the certification body.
3)
For Specific Rules, see annex A. 55
SP 60 : 1993
A certification
body on acceptance
of a completed
application
form and receipt of the deposit, if required, will confirm this to the apof the application.
plicant and provide him with any further information
necessary for the processing
5
5.1
Initial
inspection
of factory
and quality
management
system,
and initial
testing
General
with the appli-
After confirmation of the acceptance of the application, the certification body shall make the necessary arrangements cant for the initial inspection in accordance with the rules of the scheme. The certification management body is responsible for all actions of certification, surveillance of the product from initial testing and inspection,
assessment of the factory quality
system through
produced. and testing.
The certification If the certification
body shall inform the applicant
of the results of the initial inspection
body is not satisfied that all the requirements has failed.
for licensing are being met, it will inform the applicant of those aspects
in which his application
If a-r&-ant pan ...,__ chnw that rcn-wx%l artinn bar moot all the r~na~irwnontc R -r cnorifinri limit . . ... ... . _ __...I_ time ... ,,_ . .. ..... the cpr. . the . .. ..vlr...,.... .. . ... . _....,-.... w.._.. . ..._ heon --_.. taken .. ..._. . hv -, him . ... .. tn .., . ..__. _.. ...- .vy-.. ..._..._ within
tification cancelled.
body will repeat only the necessary parts of the initial inspection
procedure
and testing.
Otherwise
the application
will be
Where a cost limit is specified by a certification sion of the cost limit may be required.
body as part of its application
procedure,
the filing of a new application
or an exten-
_-.
nernspection
may not be needed for subsequent
submittais
of the same product.
5.2
Assessment
of factory quality management
system
forms part of the initial inspection. This may be done according
Assessment
of the applicants specified
system of factory quality management Rules of the scheme. of the quality management
to requirements
in the Specific
All records produced tification
from implementation
system related to certification
shall be readily available for cer-
body inspection. shall ensure that the question a designated is concerned of responsibility to the certification body for the quality management management system is clearly perfor-
The applicant defined,
e.g. by appointing
person who is independent
from production
as far as the technical
mance of his function
and who is qualified to maintain the contact with the certification
body, to ensure that the above
provisions have been observed.
5.3
53.1
Initial testing2) Selection of samples

of samples for tests and examination shall be based on the rules of the scheme. to be certified, and be made from production tools and
The selection Samples assembled Where
should be representative using methods
of the entire line or group of production for the production samples, run.
established
testing
is based on prototype
confirmation
tests or examination,
as appropriate,
should be made on production
samples.
5.3.2
Conduct of initial testing

with the applicable standard(s) and the Specific Rules of the scheme.
The initial testing is carried out in accordance
1)
This term is still under consideration by ISOlTC
176, Q~a/ity 8SSUf8fW19.
2) As used herein, initial testing refers to the process by which the certification body before granting or extending a licence, determines that a product complies with the requirements of the applicable standard(s). It is often called type testing.
SP 60 : 1993
5.3.3
Use of test
data
produced
by other
than
the certification
body
Where the certification body chooses to use test data produced by others, thebody, or its designafed test agency,shall ensurerhar
the party condurting the testing complies with at least the criteria of IS0 Guide 24 and ISO/IEC Guide 25.
Licensing
body, when complete fulfilment of the requirements has been established, informs the applicant issues a licence. accordingly, sub-
The certification agreement
mits a licensing agreeementl)
for his signature
(unless already done) and, on conclusion,
(An example of such an
and a licence is included in annec C.)
Extending
a licence
of identification of conformity to additional types or models of pro-
A licensee wishing to extend his licence to allow the application tion body, using the usual application are successful, additional
ducts, made in the same factory to the same standard as the products for which a licence is already held, shall apply to the certificaform (annex B). The certification body in such cases may decide not to carry out a factory inthat they comply with the standard. If the tests spection but to require test samples of the additional licences will be granted. to additional types of products made at the same factory, but to different standards, or types of products to determine
If the licensee wishes to apply the certification if the licensee wishes to apply for certification of the original application procedure
to be used in an additional factory that is not covered by the earlier license, those parts will have to be carried out.
which do not cover the new circumstances
Surveillance
body exercises the surveillance of the products on the basis of the requirements Rules of the scheme.2) exercised under agreed for adequate of the relevant standard and of the
The certification
quality management The certification conditions. surveillance.
system on the basis of the Specific
body may appoint an agent to carry out the surveillance under its authority and responsibility, appointed by the certification body shall have all the facilities and qualified
Any agent
staff necessary
The licensee shall be informed
about the results of the surveillance. body about any intended of the product, modification in the product, manufacturing process or quality whether the
The licensee shall inform the certification management announced
system which may affect the compliance products
and it is up to the certification
body to determine
changes require another initial testing and inspection or other further investigations. resulting from such changes until the certification
In such cases the licensee will not be
allowed to release certified
body has notified the licensee accordingly.
The licensee should keep a record of all complaints tification body on request.
relative to the products covered by the licence and make these available to the cer-
9 9.1
Use of a mark
of conformity
and marking
Mark of conformity
the principles of ISO/IEC Guide 23 should be followed. Such a mark of
In cases where the system utilizes a mark of conformity, conformity shall be distinctive in nature and shall, inter alia. with legal protection
be proprietary
as regards composition, of counterfeiting
control of use; or other forms of misuse;
be so coded or otherwise
designed as to aid in detection
1) If a certification scheme falls under a law that specifies in detail the scheme in question and if such a scheme is administered by a governmental body or body acting on its behalf, such an agreement may not be necessary. 2) In some cases it may be unnecessary to base surveillance on a repetition of all the elements of initial testing; this could be the case with custombuilt products and be applied to cases where the initial testing is very complicated or where the samples are very expensive. In such cases the surveillance may be based on examination only or combined with more simple identification tests which ensure that the product is in conformity with the tested sample. Such identification tests should be described in the Specific Rules of the scheme. 57
SP 60 : 1993
be non-transferable
from one product to another; except where the physical size of the unit or the type of product does not permit, in which the unit is marketed.
be directly applied to each unit of production
in which case the mark may be applied to the smallest package
9.2
Marking
it may be appropriate of certification to use other marking in association with the mark of conformity, from the mark of conformity such as used;
In certaincircumstances
name or trademark name of product identification
body where such cannot be determined obvious;
classification
where suchis not completely
of the relevant standard(s). with the Specific Rules of the scheme. scheme has been based it is important that the marking clearly indicates
Such marking shaii be in accordance
In the event of revision of a standard on which a certification the appropriate the requirements laid down for the product.
edition of the standard in question or a date code marking where applicable,
so that the user is informed correctly of
10
Publicity
by licensees
to issue a certificate of conformity or apply a mark of conformity for
A licensee has the right to publish that he has been authorized products to which the license applies.
In every case the licensee shall take sufficient care of his publications non-certified products. If the manufacturer agreement
and advertizing
that no confusion
arises between
certified and
wishes to publish parts of a test report which relates to the certification body. claim or the like in user information,
of his products
he shall have a written
of the certification
The licensee shall not specify function, accompanying Specific the product
that could mislead purchasers by the certification
to believe that perfor-
mances of the product or its use are covered by the certification and related to the certification Rules of the scheme.
when in fact they are not. Instruction
books or other user information body if so required by the
scheme shall be approved
11
Confidentiality
The certification body is responsible for ensuring that secrecy is maintained by its employees and those of its agent (see clause 8, second paragraph) concerning all confidential information with which they become acquainted as a result of their contacts with the licensee.
12
Misuse
of a certificate
or mark
of conformity
as a part of its programme of proper control on the use of its certificates or
The certification body shall operate a checking programme mark of conformity. Incorrect references to the certification
system or misleading use of certificates or the mark found in advertisements, action or publication
catalogues,
etc.,
should be dealt with by suitable actions which could include legal or corrective In cases of misuse of certificates or the mark of conformity
of the transgression.
by licensees corrective
action shall be taken.
13
Suspension
of a licence
for a product
may be suspended for a limited period, for example in the following withdrawal cases
The licence applicable
to a specific product
if the surveillance shows non-compliance if a case of improper use of the certificate
of such a nature that immediate
is not necessary;
or the mark, e.g. misleading prints or advertisement
is not solved by suitable retrac-
tions and appropriate
remedial measures by the licensee;
58
SP
60
: 1993
if there has been any other contravention
to the rules of the scheme or the procedures under a suspended
of the certification licence applicable
body. to that product.
The licensee shall not identify as certified any product that has been produced A licence may be also be suspended non-production An official equivalent or for other reasons. of a licence will be confirmed by the certification after mutual agreement between
the certification
body and the licensee for a limited period of
suspension means).
body in a registered
letter to the manufacturer
(or by
The certification
body shall indicate under which conditions with clause 15.
the suspension
will be removed,
such as for example
corrective
action
taken in accordance
On fulfilment
of these conditions the suspension shall be removed by notifying the manufacturer are not fulfilled the certification body shall withdraw the licence
that the licence has been reinstated.
If the conditions
14
14.1
Withdrawal/Cancellation
Apart from the suspension if the surveillance of a licence, a licence may be withdrawn rn the following cases
shows that the non-compliance
is of a serious nature; of his financial obligation;
_
-
if the licensee fails to comply with the due settlement if there is any other contravention
ii inadequate
of the licensing agreement;
measures are taken by the iicensee in the case of suspension. body has the right to withdraw the licence by informing the licensee by registered (annex Cl. depending on the letter (or
In the above cases the certification equivalent means). Concerning
specification
of time limit, see article 10 of specimen body when considering
licensing agreement
The licensee may give notice of appeal, and the certification nature of the case -
the appeal may or may not -
decide to proceed with its decision to withdraw
or cancel the licence.
Prior to withdrawal of a iicence the certification body shall decide upon the consequences in relation to products certified under the licence, whether the mark of conformity shall be removed from all products in stock and perhaps even if practicable from products already sold, or whether tions are required. a clearance of the stock of marked products should be allowed within a short period of time, and if other ac-
14.2 -
Furthermore,
the licence may be cancelled
in the following
cases
if the licensee does not wish to prolong the licence; if the standard or rules are changed and the licensee either will not or cannot ensure compliance with the new requirements,
cf. clause 16;
if the product
is no longer made or the licensee goes out of business; in the licensing agreement.
or on the ground of other provisions certified
14.3
Withdrawal
or cancellation
of a licence may be published
body.
15
Corrective
action
or a mark of conformity corrective action should be taken to safeguard their use.
In cases of misuse of a certificate
59
SP
60 :1993
16
Implementation
of modifications
of a standard (see also article 11 of annex C)
There are a number of factors that need to be considered when establishing the date on which product requirements in a revised standard will come into force (effective date), where the previous edition of the standard has formed the basis of the certification. Tha &nr+i\ra I Il.2 cII-3ll.r
-be
Arrtn
nf I
mnr(ificr+inn IIIvuIIIcI.III
+n 3 r+~nrl~rrl . a .z~III
ml IP+ ha nmmhlieher( hw tha oortifircdinn IIIU.3, .a )IYI1~II Y, .Il.z VI Llll..eLllI
hlvltr vu,
c.nA 41 lioancanr Iic+aA m,nAar thn rnhaII cl,, llrllG7wwa II3%W llurl LII.2 auIm3II~
in question by the certification The factors to be considered -
body are to be notified to provide adequate when choosing the effective date include,
time for resubmittal.
but are not necessarily restricted to requirements; a product complying with the revised requirements;
the urgency of complying
with revised health, safety,
or environmental
the length of time and financial costs for retooling the extent of stock on hand and whether% avoidance operational of unintentional problems commercial
and manufacturing
can be reworked
to meet the revised requirements;
advantage body.
given to a particular
manufacture
or design;
Where
questions
of product
liability are involved,
they must be dealt with on the basis of the relevant legal system(s).
18
Dispute
of the certification body can be brought into action.
In cases of disputes the appeal procedure
19
Fees
of a certification scheme are to be decided by the certification body for each scheme.
The fees for the operation
SP
60 :1993
Annex Checklist
A of Specific Rules
for basic content
For each scheme,
a set of Specific Rules should be established,
taking into account the production
methods and the kind of product checklist
or group of products to be covered by the scheme (see clause 4). In establishing may be utilizated to indicate items which should be considered among others. a) b) Full identification Requirements of the products and related standard(s) such as
Specific Rules for a scheme, the following
to which the scheme applies.
for initial testing and inspection
:
selection of items to be inspected sampling procedure;
and tested;
initial product evaluation
testing and test methods;
of the test results; of the factoryl); result;
initial inspection evaluation
of the inspection
evaluation evaluation marking
of competence of measuring
of staff of the factory; and testing equipment used by the manufacturer including calibration;
of product
(related to mark of conformity); (e.g. for mounting or use);
checklist for possible instructions
c) d)
Requirements
for surveillance
procedure
such as of the factory;
check product evaluation frequency
testing and check inspection
of the results of the checks; (minimum) of check testing and check inspection.
Fee and cost structure Details of the contract If applicable, format
of the scheme. to be established between the certification body and the licensee.
e) f)
of test report.
1)
Including inspection upon receipt of incoming supplies to verify if they comply with contract requirements
parts and end products.
and storage and internal transport
cf
raw materials,
61
SP
60 :1993
Annex
Specimen of form for for CONFORMITY CERTIFICATION OF CONFORMITY OR MARK
APPLICATION
BY USE OF CERTIFICATES
Tobesentto
. . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(Ceflificationbody)
Address
Information
regarding
the applicant
:
office
The applicants
name and address of registered
Phone and telex numbers
manufacturing
.a~
piace of the product
Name and title of person responsible for the quality management system :
Business address
Phone and telex numbers
Relevant standard(s)
Relevant Specific Rules Number Title :
.-
Description of products : (seefirst two columns of specimen licence - appendix 1 to annex Ci
Number Title :
: :
: :
Date of issue
Date of issue
Statement Statement
: *
We herewith We herewith
declare that we will settle the costs related to this application. declare to be willing, on a positive result of the initial testing and inspection, related to the certification of the products mentioned to conclude above.
within a specified time an agreement
Dateofapplication............................................................................ Name and title of person authorized to sign on behalf of the applicant
. . . .._..........._..._...._...................................
(In block letters) Signature ................. .................................................................
(Examples)
62
SP
60
: 1993
Appendix Specimen)
1 to annex
B assessment
for initial questionnaire
for factory
Annex to application
.. . .. . ....
. . __ . . . . . . . . . . . . .
This questionnaire
should be filled in and returned together with the application and his capability to control the quality and continuing
form. It is intended to provide preliminary conformance
information of
relative to the applicant relevant specifications. This document
of his products to the requirements
will be used by the certification
bodys inspection staff during preliminary visits to the factory or factories involved as a
part of the initial inspection. Supplements may be included where it is necessary to expand any statements. should be completed for each factory involved, or variations between factories clearly indicated.
A separate document The statements The information Information
should relate to the facilities available as the date of completion given in this document will be treated in the strictest confidence. facilitate the treatment
of this form.
on the following
subjects will furthermore
of the application.
Date sample is available for evaluation Will this be production If protoype, Has product or prototype
sample?
when is production
scheduled? (if so please attach report)
been tested to the standard?
Urgency of application. INDEX P-_r:-_ 3ecLIll , .._---:--.:-I - II,...*-_., rcK;rury lyalnLarlll Materials, components and services
Section 2 Section 3 Section 4 Section Section 5 6 -
Manufacture Quality control and testing Records and documentation Application of indications of conformity
Section
1.1 Procedures/paperwork
information on basic system
1 -
Factory
organization
Please give following
1.1.1
Do you produce against orders or for stock?
1.1.2
Do you issue a Works
Order or equivalent?
1) This specimen was selected from a current national practice; no attempt was made to harmonize the wording with the main part of this Guide. The specimen can be adapted in accordance with the actual situation for a given scheme.
63
SP
60
: 1993
1.1.3
If so does this identify
a batch
as a separate
entity?
1.1.4
Do products
arid/or
container
s carry Works
Order identification
in manufacture?
1.1.5
If not how does system
allow
for products
to be isolated
in case of doubtful
quality?
1.1.6
Please give any other
relevant
information
on basic system
1.2
Quality
control/inspection
information
staff
on factory QC staff organization
Please give following
1.2.1
Head of Quality
Assurance
1.2.2
Reporting
to?
1.2.3
Is there a separate
X/Inspection
Dept?
1.2.4 1.2.4.1 1.2.4.2
If so indicate Chief If staff Inspector are aware if different from 1.2.1 standard(s)
of the tests in the relevant
1.2.5 1.2.5.1 1.2.5.2 1.2.5.3
Are storemanlproduction Materials? In process operations?
operators
responsible
for inspection
and test on
Final product?
1.2.6
If so are they
monitored
by QC staff?
1.2.7
Are Quality
Audit
checks
carried
out and by whom?
1.2.8
Please give any other
information
on QC staff
organization
Section
2.1 Purchase
2 -
Materials,
quality
components
and services
specifications/materials
purchased,
assurance
involved. or services, indicating action taken on re-
Please detail
main materials
specification adopted
used and major suppliers on receipt of materials,
Please also give quality jects.
assurance
methods
components,
Section
3.1 System
various steps in manufacture -
3 -
Manufacture
Please detail advantageous.
a production
schedule
and/or
supplement
in chart
form
showing
stages
may be
3.2
What
Maintenance
maintenance
system
system
plant
and equipment
is in operation?
64
SP 60 : 1993
Section
4.1 System
4 -
Quality
control
and testing
Please detail Quality Control system, including sampling system followed,

dard. A QC schedule or supplement cross-referenced
with particular reference
to the tests in the relevant stan-
to chart required in 3.1 is advantageous.
Please attach any QC manual or instructions
on Quality Control issued to staff.
4.2
Test equipment/instruments,
gauges
and tools
and indicate system and frequency of checking and if certificates
Please detail test equipment are available.
used, makers names and references,
Section
5.1
5.1.1
5 -
Records
and documentation
General
Please indicate form of master specification, i.e. drawings, product/parts schedule, reference sample, etc. Also indicate other
general records available.
5.1.2
Please indicate system used to amend design/specification.
5.2
5.2.1
Compliance
Specification
found in past six months. If tests in accordance with the relevant standard(s) have already
Please indicate level of defectives
been carried out, attach copies of summary
of test results if available.
5.2.2 output.
Please indicate the level of claims/complaints
made under warranty
and/or
otherwise
and give also as a percentage
of total
5.2.3
Have independent
tests been made on products
against the standard?
By whom?
Please attach copies if available.
Section
6.1 Mark of conformity
6 -
Application
of indications
of conformity
Please attach an illustration conformity.
if available and indicate method,
e.g. special label, embossing, the mark of conformity
etc., which wi!l be used to show mark of
Please indicate at which stage of manufacture
will be applied.
6.2
Certificate
of conformity
or shipment the certificate is issued. A
Please attach an illustration of the proposed format and indicate at which stage of manufacture specimen certificate is reproduced in appendix 2 by way of an example.
65
SP
60
: 1993
Appendix Specimen
..
l
2 to annex
of a certificate
of conformity
Certificate
Certificate
of conformity
No.
The
. . . . . . . . . .._......._..............._....__..._ [name of Certification Body1
herebycertifiesthat
.._...._..........,__.._...._._...............
(hereinafter tification
scheme for the manufacture
called the Firm) has complied with the published General and Specific Rules Number of . . . . . . shown in the attached schedule. (name of product)
. in respect of a cer-
These Rules have infer aha necessitated Certification a) b) Body to the standards
the submission
of samples of the scheduled Additionally
product(s)
for examination
and testing by the
referred to in the schedule.
the scheme
requires the Firm to
permit their factory(ies)
situated at
to be periodically inspected by the Certification to be selected from production, is being maintained. Committee of the or from the market, for independent
Body and testing and
allow samples of the scheduled product(s) for assurance that continuity
examination This certificate document No.
of conformity
is granted with the authority of the Certification
. .
whose terms of reference are defined in
..
. . of . . . .
. ..
. . . 19
. [Date1
Body to duly observe and comply with the requirements for the scheme which the Certification
The Firm hereby covenants with the Certification the General and Specific
of the scheduled standards.
Rules and with any Regulations
Body may establish.
Signed for the Certification
Body
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .._..._.......__.._...._.................................................
Director Date Signed for the Firm ._..._...__.___.____..._..._...__.._.,..... 19..
:
Date . . . .._..._......._._..._...__...__._....._. 19..
......................................................
Name of the Certification Body The rules of a third-party certification system may also specify additional information to be included.1
INOTE -
66
SP
60
: 1993
Annex Specimen of a licensing
C or
agreement for the use of a certificate mark of conformity
The
. . . Certification
this matter by . . . . . . (name), licensee,
Body, having its registered offices at . . . . ., hereinafter referred to as the certification body and represented in . . . . . . (title) . . . . . . hereby grants to . . . . . . . having its registered off ices at . . . . . . , hereinafter referred to as the covered by the appended licence, as approved by the certification body for such products
licence to certify the products
specified in the first column of the valid licence which are controlled by the licensee in accordance with the standards referred to in the second column and the Specific Rules referred to in the third column of the valid licence and on the conditions of the following general agreement.
Article
1 : Regulations
for certification
and inspection
system (in question) apply to this agreement as well as the standard(s) and
The stipulations the Specific
of the General Rules for the certification in the attached licence.
Rules, specified
Article
2.1
2 : Rights
and obligations
products manufactured and supplied by him as specified covered in the licence based on and atRules specified in the as stated in the by the licence,
The licensee agrees that the certified the certification
tached to this agreement licence. Accordingly,
will comply with the requirements body authorizes
stated in the standards
and General and Specific
the licensee to certify the products
Specific Rules of the scheme.
2.2
The licensee agrees that the persons representing
the certification
body will have unobstructed
access without involved.
prior notification
to the premises of the factory
covered by the license during the normal working
hours of the factory
2.3
The licensee agrees that the products for which the licence is granted will be produced to the same specifications body found by the initial testing to be in compliance with the standard.
as the sample
that the certification
Article
3.1
3 : Surveillance
body carries out a continuing surveillance on the licensees compliance with his obligations, in accordance with
The certification
the conditions stated in the Genera/Rules
for the cerrifcation
system and the Specific Rules for the scheme as specified in the licence.
3.2 body.
This surveillance
is carried out by the certification
body employees
or by employees
of agencies on behalf of the certification
Article
4 : Information
on modifications
in production
modification in the product, the manufacturing process or the quality
The licensee shall inform the certification management system.
body of any intended
Article
5 : Complaints
body keep records and report to the certification body any complaints regarding
The licensee shall upon request of the certification those aspects of the products
covered by the licence.
Article 6.1 6.2
6 : Publicity
The licensee has the right to publish that he has been authorized to certify the products to which the license applies.
Among other methods the certification body gives publicity to the authorization of certifying compliance with a standard in the p&Kc journal . . . . . . and to cancellation of this agreement with the licensee, as appropriate.
67
SP
60 : 1993
Article
7 : Confidentiality
body is responsible for seeing that confidentiality acquainted is maintained by its employees concerning all confidential informa-
The certification
tion with which they become
as a result of their contacts
with the licensee.
Article
8.1
8 : Payment
body all expenses in relation to the surveillance, including test, inspection and ad-
The licensee shall pay to the certification ministration costs.
Article
9 : Agreement
period
unless withdrawn for justified reasons or cancelled by either
This agreement
comes into force on . . . . and remains in force until
party upon due notice given to the other party.
Article
10 : Withdrawal/cancellation
of licence
the necessary time of notice prior to the withdrawal/cancellation will
If withdrawal/cancellation differ due to the situation Depending Situation
of the licence comes into question, that causes it.
on the reason for the withdrawal/cancellation requiring the dispatch of notice
the following
schedule of notice will be followed Days of notice prior to
that can lead to withdrawal/cancellation Manufacturers The certification dous : Violation wish to cancel
withdrawal/cancellation to be specified by the certification body
:
that the product is hazar-
body determines
none for other reasons than safety body
of an existing standard,
max. 60 days max. 30 days
Non-payment
of charges to certification
: :
Failure to meet other provisions of the licensing agreement Mandatory compliance with new requirements
max. 60 days
in relation to reNegotiable
vision of a standard Advice of cancellation termination
:
shall be sent by registered letter (or equivalent
means) to the other party, stating the reasons and the date of
of the agreement.
Article
11.1
11 : Modification
If the requirements
of product
requirements
are modified, the certification requirements body shall immediately will become effective,
applying to the products covered by this agreement letter for equivalent means), examination
inform the licensee by registered
stating at what date the modified
and advising him of any need for a supplementary
of the products which are subject to this agreement.
11.2
Within
a specified period of time after receipt of the advice described in paragraplr means) whether period of his acceptance of the modification
11.1, the licensee shall inform the certificaIf the licensee gives confirmaexamination is
tion body by registered letter for equivalent tion within the specified favourable, a supplementary
he is prepared to accept the modifications. of the certification
and provided the result of any supplementary bodys records.
licence will be issued or other modifications
11.3
If the licensee advises the certification
body that he is not prepared to accept the modification
within the time specified in acexamination is not become
cordance favourable, effective
with 11.2 or if he allows the terms for acceptance to the certification body, unless otherwise
to lapse, or if the result of any supplementary body.
the licence covering the particular product shall cease to be valid on the date on which the modified specifications decided by the certification
68
SP
60
: 1993
Article
12 : Liability
in connection with the relevant legal systems.1
[To be specified
Article
13 : Appeal/dispute
arise in connection with this agreement are to be settled in accordance with the appeal procedures of the cer-
All disputes that my

tification bodv.
issued in duplicate
and signed by authorized body
representatives
body and the applicant.
For the certification
For the applicant Date ._ _...
:
__ .._.. _.....
Date ,.,__...__._____.___..........
__ . .._
_.__.__._.,_...._.................
(Signature) (title)
.,.,.__,._.._..__._._.............
(Signature) (title)
69
SF
60
: 1993
Appendix Specimen of form for
1 to annex
C certificates or mark
a licence for the use of the of conformity
IAn illustration of the certificate attached
or mark of conformity
is to be
to this form or may be inserted here1
Licence No.
..
.......................................
to Agreement
No.
............................................
(certification body)
lssuedby . . . . . . .................................................................................
To
............
.........................................................................................
................................................................................................... ...................................................................................................
(licensee)
.............. ..............
Products for which the licence is granted
Cat. no., type or other descriptive identifiers
Standard(s)
Specific
rules
Dateofissue....................................................................................................,... SignedforCertificationBody............................................................................,............ (signature) (title)
70
SP 60 : 1993
CHAPTER
GUIDELINES FOR A STEP-BY-STEP APPROACH TO AN INTERNATIONAL CERTIFICATION SYSTEM (lSO/IEC GUIDE 42 :1984)
Introduction
performed by a product certification system involving third-party certification bodies include evaluation of the
The basic functions
product by testing to designated standard(s), inspection and approval of the manufacturing facility and quality system, subsequent monitoring of the production and quality system, and controlling the methods by which conformity is indicated. Obviously, all these functions accessible When must be performed within the laws of the country where the certification and executed in a completely non-discriminatory is granted, manner. it is obvious that they are likely to in accordance with agreed and readily rules and procedures,
the methods for implementing drawback
these functions
on an international certification
basis are contemplated,
become complex to administer and co-ordinate. significant
Yet, as difficult as these problems may appear to be, they still may not pose the most system.
to the initiation of a full-fledged
One of the major obstacles to widespread participation in international certification systems is the lack of confidence which certification bodies have in their across-border counterparts and the fear of large scale commitment to a system with which they have had no previous experience. This paper suggests that, through a progressively expanding set of acceptance arrangements, confidence among certification bodies at the international level can be fostered and certification bodies can gain experience and thereby have their fear of participation allayed as they move towards In addition participation in a truly international certification certification system. approach to an international certification
to building confidence
in across-border
bodies, the step-by-step
system enables the parties to develop bilateral or multilateral arrangements adjust readily to different legal systems. This approach will, where the parties so desire, also permit the continued ported product, countries. thereby avoiding the problems of educating
which provide advantages
to all the parties and which can
use of the importing countrys certification of new and unfamiliar
mark on the immarks of other
the public to the significance
Under this approach, the need for duplicate testing or inspection is obviously reduced, especially if the parties agree upon the use of a common standard. The use of international standards together with the implementation of the other items discussed herein will greatly enhance this feature. There
bodies,
have existed for many years a number of various forms of acceptance arrangements invoking across-border certification which have operated successfully without benefit of a formalized international certification system. These arrangements or acceptance by one party of the work of another party in dealing with one or more of the elements certification system (see clause 5).
generally involve the recognition
of a comprehensive
The approach suggested herein is predicated upon the use of recognized national, regional or, preferably, international standards if
available, where the technical requirements on which the certification is based are available to the general public.
Scope
and object
of acceptance arrangements certification system. in
This paper is prepared as a guide to those parties who wish to gain some experience in the operation the international area, but who may not be prepared currently to participate fully in an international
References
covering standardization, certification and testing laboratory accreditation.
IS0 Guide 2, General terms and their definitions ISOIIEC Guide 7, Requirements for standards
certification.
71
SP
60
: 1993
ISO/IEC
Guide 16, Code of principles
on third party certification conformity
systems and related standards. for third-party certification systems.
IS01 IEC Guide 23, Methods

ISOIIEC Guide 25,
of indicating
with standards competence
General requirements
for the technical
of testing laboratories. body in the event of misuse of its mark of conformity.
IS0
Guide 27, Guidelines for corrective

Guide 28,
action to be taken by a certification certification
ISOIIEC
General rules for a model third-party General requirements General requirements General requirements
system for products.
ISO/IEC
Guide
38,
for the acceptance for the acceptance for the acceptance
of testing laboratories. of inspection of certification bodies. bodies.
ISOIIEC
Guide
39,
ISOIIEC
Guide
40,
NOTE
Because of the development
of further related documents
(in particular a guide on general rules for IS0 or IEC international third-party cer-
tification schemes for products,
in preparation),
the reader is advised to inquire about and consult such documents, in addition to those referenced.
3
3.1
Explanation
acceptance
of terms
arrangement
: A procedure which establishes recognition by involved parties of results from the implementation
elements of a certification system.
surveillance and other related items. In this document,
of one or more designated

NOTE -
functional
Functional elements refer to such items as testing, inspection, elements is described as the partys work.
the performance of the
functional
3.2
3.3
unilateral
arrangement
: Acceptance : Acceptance
of a partys work in one country
by a party in a second country.
bilateral
arrangement
of a partys work in one country by a party in a second country and, reciprocally, by the party in the first country.
the ac-
ceptance
of the work of the party in the second country
3.4
multilateral
arrangement
: Acceptance
of each others work by parties in more than two countries.
Step-by-step
approach
4.1 An arrangement normally commences with acceptance of one partys work by another, or by execution of a formalized bilateral agreement in which one or both parties recognize the others work. At a later date, such an arrangement may be expanded to include still other parties. When this multilateral arrangement covers all essential elements and is provided with a form of co-ordination, certification bodies, a truly international cluding a set of operating rules and procedures, and is open to all qualified certification
in-
system has evolved. In assessing the proposed expansion of a multilateral acceptance arrangement into a true international certification system, reference should be made to ISO/IEC Guide 28 and other applicable documents identified in clause 5 or in preparation. Parties wishing to formulate bilateral or multilateral agreements to cover some major aspect of certification, such as acceptance of test results or inspection services involving across-border certification bodies, should use the information in clause 5 in identifying features necessary to support the acceptance arrangement arrangements. covering the understood conditions under which the parties will arrangements and
Parties to an acceptance operate. provides information
should draw up an agreement
Clause 6 covers various provisions to be considered for inclusion in the agreement which will be useful in connection the qualification with the implementation
establishing acceptance
of these and other provisions identified in clause 5. arrangements, reference should
For assistance in evaluating be made to ISO/IEC
of parties proposing to establish bilateral or multilateral
Guides 25, 38, 39 and 40.
72
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4.2
The following
illustrates how an initial acceptance
arrangement
can be subsequently
expanded into an international
certification
system with the result that the needed experience
and confidence
to accept the work of others is acquired
Step 1
Acceptance functional
by a party in an importing country (ICI of the work of a party in an exporting country (EC) involving a single element and covering one or more product categories.
Step 2
Acceptance
by a party in the IC of the work of a party in the EC involving two or more functional elements and covering
one or more product categories.
Step 3
Acceptance
by a party in the IC of certification
by a party in the EC covering one or more product categories.
Step 4
Conversion
of any of the above unilateral arrangements
(steps
1 to 3) to a bilateral arrangement.
of arrangements noted in any of the
Step 5
Inclusion of other countries in a multilateral above steps.
arrangement
based on the acceptance
Step 6
Agreement
of the parties to participate in an international
certification
system for the product categories covered by the
various agreements.
4.3
In moving to a comprehensive
certification
system, the step-by-step
approach
may be started at any of the steps described in
the example
of 4.2 or progress to any of these steps.
4.4
Another
illustration of a step-by-step system
method is the process by which a regional or multinational
agreement
moves to an inter-
national certification
:
agreement on mutual recognition of test results, based on the ICs standards. Subsequent-
Step 1
A regional or multinational ly, the agreement
is opened to other countries.
Step 2
A regional or multinational dards. Subsequently,
agreement
on mutual recognition
of test results, based on regional or international
stan-
the agreement
is opened to other countries.
Step 3
The agreement of conformity.
on recognition
of test results is replaced by an agreement
on mutual recognition
of certificates or marks
Elements to be addressed in a comprehensive (See clause 2 for complete identification of references. ) Initial assessment and testing
certification
system
5.1
References
Guide 28, annex B Guide 28, sub-clause Guide 25, clause 10 Guide 38, sub-clause 5.3.1 8.6 b) 5.3.2
Contract to test (application) Selection of samples
Initial testing Assessment of factory (test equipment, personnel, systems facilities)
Guide 28, sub-clause Guide 25
Assessment of factory quality management
Guide 28, sub-clause 5.2 and appendix 1 to annex 6 Guide 25, clause 12
Test reports Use of data produced Acceptance by other than the certification body
Guide 28, sub-clause Guide 38
5.3.3
73
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60
1993.
5.2
Follow-up
inspection
References
Guide 28, clause 8 Guide 28, clauses 6, 7, 13 and 14 Guide 28, clause 8 and annex C testing where required Guide 28, clause 8 Guide 39
Factory surveillance Licensing
Frequency schedules
Selection
of sample for re-examination of inspection bodies
Acceptance
5.3
Mark
Indication
of conformity
Guide 28, sub-clause Guide 23 Guide 28, sub-clause Guide 23 Guide 28, clause 10 9.1
Certificate
9.1
Publicity Contract to control use
Guide 28, clause 7
5.4
General and administrative

Guide 28, clause 3 Guides 2, 25 and 39 between parties
Basic conditions Definitions to apply)
Details of the agreement a) bl Special provisions Standards -
:
insurance) Guide 28, clause 17 Guide 7 Guide 25 Guide 28, clause 16 and annex B
liability, indemnification, effective dates
test methods
cl d)
e)
f) 9)
Financial arrangements Handling disputesl Corrective action
Guide 28, clause 19 Guide 28, clause 18 Guide 27 Guide 28, clause 15
Reciprocity2 Confidentiality and security
Guide 16 Guide 39, clause 10 Guide 28, clause 11 Guide 40. clause 9 Guide 25, clause 11 Guide 40, clause 7
h)
Retention
of records and documents
j)
Personnel training of the parties)
6 6.1
Provisions
of an Agreement
Parties to the Agreement

should be identified by their corporate names and addresses or other legal identification. If part of a larger
Parties to the Agreement
organization, such relationship should be declared. should be identified. Other types of communication
The name of the person or persons authorized identifiers should be disclosed.
to speak or act for each party
1) 2)
Identifies items that are further discussed in clause 6. A reference paper on this subject, document KSO/CERTICO 107 Rev. 31, is available from the IS0 Central Secretariat.
74
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60
6.2.
Scope
of coverage
It is essential that there is a clear understanding by both parties to the Agreement of the product categories, functional elements and standards to be covered. The details should be spelled out with sufficient wording to eliminate any misunderstanding and ambiguity. If the Agreement same meaning. If there is any likelihood that the scope might be revised from time to time, it should be included in the Agreement which is referred to in the main body of the Agreement. This will facilitate updating of the Agreement revised appendix should be signed by the authorized signatories of both parties and dated. as an appendix The must be in two languages, care shall be taken to ensure that the words selected in both languages have exactly the
when the scope is changed.
If the scope is to be changed from time to time this should be clear from the wording of the main text of the Agreement. after mentioning mutually that the scope of products is listed in the appendix, in parenthesis could be added Subject agreed between both parties from time to time.
For example,
to change as may be
6.3
Definitions
of terms
not covered
by ISO/IEC
Guides
or documents
It is quite possible that the Agreement of the parties will rely on the use of words or terms having specific meanings not covered by the referenced ISO/IEC Guides or documents. Where such is the case these terms should be clearly and unambiguously defined in the Agreement.
6.4
Legal system
and court
of jurisdiction
When laws of one or more parties to an Agreement mandate the standards to be applied, the parties to the Agreement choose and acknowledge which governments substantive and procedural law shall govern the interpretation of the Agreement and any legal proceedings which may arise out of the Agreement. the Agreement. It is therefore essential that there be a clear documentation of laws which will govern
6.5
Personnel
training
of the parties
In order to have a mutual confidence and acceptance of test results and reports between parties, and identical interpretation of the requirements of the standard(s) involved, it will be necessary to institute a training programme for selected personnel of the parties. Such training is likely best achieved through each partys representatives In addition, party. Not only technical training of personnel is necessary but also training in administrative the programme covered by the Agreement. matters pertinent to the successful pperation of being trained in the technical operations of the other party. and testing techniques and procedures of the other a special audit team of each party should evaluate the laboratories
The Agreement should specify sufficient details about training of personnel, e.g. location, timing, travel arrangements, retraining when staff changes occur, costs and payments to the degree necessary to permit harmonious relations in the implementation of the Agreement.
6.6
Special
provisions
Liability,
indemnification,
insurance
Any Agreement should document details concerning features such as insurance, liability, loss, costs, damages, reasonable legal fees and expenses of whatever kind or nature which one party may sustain or incur by reason or in consequence of any acts or any omissions of the other party in respect to duties specified in the Agreement.
6.7
Assessment
of parties
to perform
under
the Agreement
and continuing
surveillance
It is important that the Agreement

facilities, equipment,
specify how and when one party will assess the other as to possession of necessary facilities, Clarification of what might constitute only minor changes as opposed to major
equipment and capable staff. The need for additional assessments should also be specified to cover occasions when changes occur in staff or scope of the Agreement. changes and the more expeditious and less costly way of handling minor changes should also be stated. as the programme covered by the Agreement progresses, should also be spelled out. These
Procedures for continuing surveillance, would include such things as
aI
b)
the method for achieving corrective action if any incompetence

the timing and nature of reinspections
or inadequacies
are discovered equipment,
b/ either party; staff, testing practices;
by either party of the other parties facilities,
SP
60
: 1993
cl d) e)
6.6
proficiency
testing; of one partys findings by the other party on an on-going practices. basis;
conditions covering the acceptance
the manner of sharing costs of surveillance
Administrative
procedures
Communications,
exchanges
of documentation,
languages
to be used
These pro-
The Agreement
shall clearly reference
any administrative
procedures
that may be required to carry out the Agreement.
cedures might include methods of communication, and how and by what means documentation shall be exchanged, as well as the format of the documentation. Another important consideration in the event that two countries have different languages is to spell out in the Agreement which language is to be used in each form of communication. If for any reason both languages are to be used, it will be necessary to spell out what language is to be used in the event of a dispute on interpretation.
6.9
Verification
procedures
Where a party wishes to exercise the right to verification out in the Agreement. If the verification details of such procedures
of any aspect of the others work, such provision should be clearly spelled of samples, factory visitation, testing, or the like, full
involves financial expense, procurement
should be included in the Agreement. information as they may require in order to fully
It should be clearly stated that both parties have the right to request such additional accept the work of the other party.
6.10
Resolution
of disputes
The parties to an arrangement should recognize the possibility of disagreements arising which cannot be satisfactorily resolved solely by the parties. A mechanism having good probability of resolving such disagreements, short of legal action, should be considered and referenced in the Agreement if agreeable to the parties.
6.il
Length
of term
of the Agreement
Method
of termination
must be specified.
The length of term of the Agreement
and the conditions
for renewal or termination
76
SP 60 : 1993
CHAPTER
GENERAL RULES FOR IS0 OR IEC INTERNATIONAL THIRD-PARTY CERTIFICATION SCHEMES FOR PRODUCTS (lSO/IEC GUIDE 44 :1985)
0 0.1
Introduction
International certification schemes have an inherent possibility of reducing time and expense as opposed to complete retesting
and reappraisal
in each country.
0.2
Although
this Guide addresses IS0 or IEC certification
schemes, it may also serve as a model for other international
certification
schemes.
0.3 -
An IS0
or IEC certification
scheme
(hereafter
called the scheme)
can take different
forms depending
on
the product in question; the practical needs for certification; the existing legal, financial, trade or other conditions in the countries interested in the scheme in question.
0.4
The question of whether the establishment (See ISO/IEC
of a scheme or whether Guide 42.)
a solution based on bi- or multilateral
arrangements
is more
suitable should also be considered.
0.5
It is up to those considering
the establishment
of a scheme to judge the merits of establishing
such a,scheme.
0.6
a) b)
The following
elements form the basis of the certification approved by IS0 or IEC;
schemes for products
use of suitable standards, operation
of such schemes through the national member bodies of IS0 or IEC, or rhe bodies they have
designatedto act on
their behalf; c) a degree of co-ordination and monitoring of the certification activities under the authority of the IS0
Councilor IEC Council.

ISO/IEC Guide 28
0.7
For each scheme a set of Specific Rules, which can vary from scheme to scheme,
must be prepared.
gives
general rules for a model system. In addition, further elements must be added to the rules of ISO/IEC suitable for international purposes.
Guide 28 if the scheme is to be
0.8
0.9
There are essential principles which have to be followed
if a scheme is to be established.
These are outlined in clause 4.
In establishing
a scheme,
there are certain procedures
which should be followed
and these are outlined
in clause 5.
Scope
and field
of application
certification schemes for determining conformity with product standards through initial testing and
This Guide applies to international assessment of a manufacturers
quality system and its acceptance
followed by surveillance that takes into account the manufacturers
quality system and the testing of samples from the factory and the open market). They are operated in accordance with ISO/IEC Guide 28 and placed under the authority of IS0 or IEC. This Guide outlines general rules which parties interested in establishing an IS0 or IEC certification scheme should use in developing such schemes.
1)
The certification
system described in clause 1 is identified in ISO/ITC
booklet, Certification
Principles andpract/ce,
as System No. 5. This type
of certification
system was chosen because it is the most comprehensive
and includes information
on elements that may be found in other systems.
This Guide may thus serve as a basis for the development
of other systems.
77
SP
60
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2
IS0
References
Guide 2, General terms and their definitions Guide 7, Requirements for standards concerning standardization, certification and testing laboratory accreditation.
ISO/IEC ISO/IEC ISO/IEC ISO/IEC ISO/IEC ISO/IEC ISO/lEC ISO/IEC ISO/IEC ISO/IEC
certification.
Guide 16, Code of principles Guide 23, Methods
on third party certification conformity
systems and related standards. for third-party certification systems.
of indicating
with standards competence
Guide 25, General requirements
for the technical
Guide 28, General ruies for a model third-party Guide 38, General requirements Guide 39, General requirements . Guide 40, General requirements
certification
for the acceptance for the acceptance for the acceptance approach
of inspection of certification
bodies. bodies. certification system.
Guide 42, Guidelines for a step-by-step Guide 43, Development and operation
to an international proficiency
of laboratory
testing.
Definitions
of IS0 Guide 2 are applicable. In addition, for the purpose of the present Guide, the following definition
The relevant definitions applies
: : National member of IS0 or IEC which has been admitted into the relevant certification
requirements. scheme through
member organization
having met the membership
NOTE - This term includes all categories of membership in an IS0 or IEC certification scheme, with or without national certification activity, by the IS0 or IEC member body or the body it has designated to act on its behalf.
4
40
Essential
principles
for the establishment

only after authorization
of IS0
schemes
A scheme may be established
by the IS0 Council or IEC Council.
4.1
The rules of the scheme and approved
shall adhere to the general principles Council or IEC Council.
and rules for IS0
schemes developed
by
ISO/CASCO
by the IS0
4.2
4.3
The creation of the rules for the scheme shall be the responsibility
of a Provisional Certification
Committee
(PCC)
see 5.4.
The administration
of the scheme shall be the responsibility the certification function.
of a Certification
Committee
(see 5.5) and the certification
activity of the
including granting, designated
revoking and withdrawal
of licences in accordance
with the rules of the scheme shall be the responsibility
national body performing
4.4
Only certification schemes based on approval or validation and surveillance
by third parties can form the basis of the scheme.
4.5
IS0
or IEC standards
suitable for certification other standards complying
purposes complying with ISO/IEC
with ISO/IEC
Guide 7 shall be used, except Committee
that in the
absence of such standards Council or IEC Council.
Guide 7 may be considered
for provisional use, in consultation (see 5.5) and by the IS0
with any relevant ISG or IEC technical committee,
subject to prior approval by the Certification
1) See also document ISO/CERTICO 283 (Rev.) CERTICO statement on general approach to IS0 international certification systems, available on request from the IS0 Central Secretariat,
78
SP 60 : 1993
4.6
The rules of the scheme shall require provisions for addressing between member organizations themselves and between
liability issues. This is normally accomplished member organizations
through
signed
agreements
and IS0 or IEC as appropriate.
4.7
Each scheme shall be financially
self-supporting.
4.8
The opportunity
to obtain
certification
under the rules of the scheme
shall be open to all interested
parties,
regardless
of
whether
or not there is a national member
of IS0 or IEC in their countries.
4.9
The rules of the scheme shall require infer alia that evaluation inspection bodies and certification
be conducted
to determine
that all member organizations, in ISO/IEC
testing
laboratories, appropriate.
bodies in the scheme meet the requirements
Guides 25, 36, 39 and 40, as
4.10
Membership
in the scheme presupposes
a degree of reciprocity 1). The nature of the reciprocity
shall be addressed when the
detailed procedures
of each scheme are developed.
4.11
tion.
The specific
rules of the scheme
shall not detract
from the basic responsibility
of the manufacturer
that only products certifica-
complying
of the relevant standard and applicable rules are indicated as being covered by conformity
4.12
4.13
There shall not be more than one scheme for a given product standard.
The rules of the scheme
shall require that each member
organization
shall make available to its licensees a procedure
for
appealing against the decisions of the organization. address each of the following a) Confidentiality -
The appeal procedure
shall include as a minimum,
provisions which adequately
:
of a proprietary nature shall be so identified and, if agreed to by the body responsible for adminis-
Matters
tering the appeal procedure b) Due notice Adequate
(see annex AI, shall be so handled. notice of any and all hearings held in connection with an appeal shall be given to all concerned
parties. cl Right to be heard The procedures shall not deny any of the involved parties the right to be fully heard and shall offer each present and participating.
side equal opportunity d) Published
to make its case, such as by time allotted or by number of representatives Procedures under which an appeal is hea,rd shall be in writing
procedures
and available to parties having a
primary interest in the subject of the appeal. e) f) g) Judgement Records Judgement on the appeal shall be rendered record of any appeal.shall by impartial and non-involved parties.
A full and complete -
be made and shall be made available to the involved parties. time limits shall be established in the rules.
Time restraints
For each step in the processing
of an appeal, appropriate
4.14
The rules of the scheme shall, in addition to the elements Annex
addressed in 4.13 &s appropriate,
include provisions for settling disthe provi-
putes between member organizations. of an Appeal Procedure.
A illustrates an example of an Appeal Procedure that is judged to incorporate
sions of 4.13 except item g, which may vary from scheme to scheme. This example does not necessarily include all the required details
4.16
The rules of the scheme shall specify the methods for achieving, and inspection
on a continuous
basis, technical
coordination
among all cer-
tification bodies, testing laboratories
bodies in the scheme.
6 6.1
Procedures initiation
for setting
up an tS0
scheme
popoSals to establish a scheme
may emanate
in the IS0
or IEC Technical
Committee
(TC) which establishes
a working
group to
investigate the proposal and proceed in accordance
with this Guide.
1) A reference paper on this subject, document ISO/CERTICO
107 (Rev. 3). is available on request from the IS0 Central Secretariat.
79
SP 60 : 1993
Proposals received from other sources must be directed to the IS0 Council or IEC Council which may decide either to refer the request to the relevant TC, which then proceeds as above, or to entrust a designated group to process the request.
5.2
Identification
of need and support
Before starting a scheme, it is necessary to ascertain : al b) whether there is a need that justifies the establishment of such a scheme;
whether there is sufficient interest for ensuring that the scheme will be viable. that may be used to establish (a) and (b). Such a questionnaire may be used at two
Annex 6 gives an example of a questionnaire stages :
5.2.1 It may be used, in a first stage, as a basis for the initial investigation mentioned in 5.1. It is then forwarded by the Secretariat of the relevant TC or designated group to the IS0 Central Secretariat or IEC Central Office, together with relevant information concerning the characteristics of the product(s) to be covered, the applicable standard(s), trade figures and any other available information which the Secretariat of the relevant TC or other designated group would consider useful to submit in support of the proposal. 5.2.2
After consultation between the relevant IS0 Council or IEC Council advisory committee on certification, the IS0 Central Secretariat or IEC Central Office and the Secretariat of the relevant TC or designated group, the questionnaire is then distributed by the IS0 Central Secretariat or IEC Central Office to all IS0 or IEC member bodies to establish whether there is sufficient support from such member bodies to establish a scheme. The replies are evaluated by the IS0 Central Secretariat or IEC Central Office together with the Secretariat of the relevant TC or designated group and the relevant Council advisory committee on certification. If the questionnaire reveals adequate support and there is no well-founded opposition against the suggestion, a recommendation to take steps for the establishment of such a scheme is submitted to the IS0 Council or IEC Council for approval. After approval, a Provisional Certification Committee is established, to prepare the Specific Rules of the scheme.
5.3
Membership
of the Provisional
Certification
Committee
(PCC)
The PCC shall be open to representatives of all parties interested in the scheme, including persons involved in the work of the TC or sub-committee (SC) which prepared the standard. It shall include persons with adequate certification experience and other interested parties who could use the scheme, for example certification bodies, governmental bodies, etc., from countries which indicated interest. The secretariat service of the PCC can be supplied either by one of the members or by the IS0 Central Secretariat or IEC Central Office, on an agreed cost reimbursement basis. Persons wishing to serve on the PCC shall so inform the IS0 Central Secretariat or IEC Central Office, giving their names, addresses, employers and interests which they would represent on the committee.
5.4
Preparation
of Specific
Rules
The Specific Rules of the scheme shall contain the rules which are necessary as a supplement to the standard in question for running the scheme in a uniform way in spite of the fact that the certification activity is decentralized. Annex A to ISO/IEC Guide 28 gives an indication of the necessary content of the Specific Rules of an IS0 or IEC certification scheme. In preparing the Specific Rules, 5.4.1 and 5.4.2. ISO/IEC Guide another questionnaire using the mulating a questionnaire suited In submitting members. 5.4.1
the PCC will have to make basic choices on a number of essential points, such as those covered in 42 may also be consulted in this respect. To this effect, it may consider it appropriate to circulate example given in Annex C and possibly certain questions taken from Annex 6, as a basis for forto the particular purpose.
the Specific Rules to IS0 or IEC, the PCC shall submit a record of voting on the approvai of the Specific Rules by its
Method
of indicating
conformity and shall specify the related rules. The following methods may be con-
The PCC shall establish the method of indicating conformity sidered : a) b) use of an international use of an international certificate of conformity; mark of conformity;
80
SP
60
: 1993
c) d) e)
use of a national certificate
of conformity
within the scheme;
use of a national mark of conformity a possible combination of the above.
within the scheme;
The PCC shall specify the manner in which the relevant standard and certification Reference should be made to ISO/IEC Guide 23.
body are identified in the indication of conformity.
5.4.2
Standards
to be used to ensure that it is suitable for certification purposes in accordance with ISO/IEC Guide 7.
The PCC shall examine the standard
5.4.3
Approval
of the Specific
Rules
When the draft Specific Rules are prepared and approved by the PCC they are sent to the relevant Council advisory committee tification to ensure that they follow the essential principles in clause 4 and adhere to other principles or rules established IEC. If agreed by the relevant Council advisory committee IEC Council or a body appointed tification Committee appointed quirements given in 5.5. on certification,
on cer-
by IS0 and
the draft Specific Rules will be sent to the IS0 Council or based on meeting the qualification re-
by IS0 Council or IEC Council for final approval. The PCC is then disbanded and replaced by a Cerfor the particular scheme by the IS0 Council or IEC Council,
5.5
Membership
of the Committee
Certification
Committee
(CC) by member organizations which are
The Certification
(CC) shall be open to membership of a membership
:
with the rules of the scheme; certification scheme;
ready to take the responsibility prepared to implement
of the CC and willing to act in accordance
the standard(s)
in question as the standard(s)
to be used in the international
prepared to share the responsibilities in the case of a certitying member, Only one body may be designated scheme. The Secretariat
and financial costs of the scheme; for certification bodies as specified in ISO/IEC Guide 40.
complying with the requirements
to act on behalf of an IS0 or IEC member which does not choose to participate
itself in a given
service of the CC can be supplied either by one of the members or by the IS0 Central Secretariat basis.
or IEC Central Office,
on an agreed cost reimbursement
5.6
Duties
and
powers
of the Certification
Committee
The duties and powers of the CC are a) b) to examine the qualification to ensure that the testing
:
for compliance with the rules of the scheme; bodies used within the scheme comply with
of members and applicants laboratories, inspection
bodies and certification
ISO/IEC c) d)
Guides 25, 38, 39 and 40; of the Specific Rules by the member organizations of the scheme; the requirements of the standard, if
to supervise the implementation to co-operate
with the TC or SC responsible for the standard in question in interpreting
necessary; e) to draft amendments by the IS0 to the Specific Rules, subject to agreement by the relevant Council advisory committees acquired; on the application of these on certification
/and approval f)
Council or IEC Council in the light of experience of the Specific
to provide interpretation
Rules and to advise in cases of doubt or disagreement
rules; g) h) to allocate costs to the member to supervise and encourage organizations, in accordance with agreed rules;
the schemes for which it is responsible;
81
SP
60
: 1993
il j)
to appoint a Chairman of the ad hoc Appeal Committee, where appropriate; to determine the information it requires from the member organizations;
k) to maintain an up-to-date register of the officers and members, including names and addresses and affiliations, to be submitted to IS0 or IEC; I) to provide IS0 or IEC with a copy of the minutes of its meetings.
The CC shall meet when convened by the Chairman, or upon request either of the Chairman of the relevant Council advisory committee on certification, or of one-third of the CC members. 5.7 5.8 The CC may, if necessary, appoint other committees to undertake specific tasks assigned to them and report to the CC. The CC is responsible to the IS0 Council or IEC Council.
82
SP.60
:1993
Annex Appeal
procedurell
There shall be created an ad hoc Appeal Committee 7, 8 and 9.
to handle disputes. The Committee
shall be established
in accordance
with
paragraphs
Before a formal appeal can be made to the ad hoc Appeal of the member organization.
Committee
the appellant shall have exhausted
all the internal appeal
procedures
A formal appeal is initiated when an appellant files a formal complaint with the IS0 Central Secretariat with the Certification Committee in the Appeal or the party designated Procedure in the Appeal Procedure, of the Appeal of the Appeal Committee. Committee The Secretary
or IEC Central Office and, The Secretariat The Chairman is followed. will apCom-
in addition,
as appropriate. Committee. Appeal
point a member of staff as Secretary mittee or the party designated responsible
is responsible for ensuring that the Certification Procedure
selects the Chairman
in turn is
for seeing that the full Appeal
is established
and that the formalized
The rules of the Certification
Committee
shall specify a procedure
for handling formally filed appeals; they shall require that the and that the facts in dispute must be stated in writing prior At the Hearing the parties may ask questions Committee. Following the formal of each the Hearing,
involved parties are given adequate to the Hearing ad hoc Appeal Committee other, make unsolicited statements
notice when Hearings are scheduled,
and that the parties must agree on the issue being disputed. Committee
and respond to questions of the ad hoc Appeal Session and together with a written
will notify the parties when a decision will be made available to them. The decision of the ad hoc Appeal record of the Hearing and the decision of the ad hoc to the parties and to the Secretariat.
shall be made in Executive be transmitted
Appeal Committee
The rules of the Certification developed
Committee
covering appeals shall provide that the Hearing be conducted to the IS0
in such a manner that the Appeal Com-
information
at the Hearing is recorded and made available to both parties and that the decision of the adhoc
mittee shall have the effect of an official rule of the scheme unless it is not acceptable
Council or IEC Council.
Disputes may be handled solely by correspondence
when agreeable to the principals. herein for a formal hearing.
The information
to be developed
and the
procedures followed
shall be the same as those prescribed
When the matter in dispute involves the interpretation Committee composed
or applicability designated Committee
of an IS0 or IEC standard, as follows
the appeal shall be heard by an
ad hoc Appeal 1)
of individual members
a member who takes part in the work of the Technical organization,
(TC) responsible for the standard in question, chosen by the
involved member 2) 3) a member a member
from that TC, chosen by the disputant appointed by the Certification
licensee; who shall serve as Chairman of the ad hoc Appeal Committee.
Committee
When the matter in dispute involves a decision covering compliance Committee composed
or non-compliance of
of a product with a designated
standard,
the appeal shall be heard by an ad hoc Appeal 1) a member of the Certification certification, Committee
:
This member shall have experience in
chosen by the involved member organization. with the member organizations
performing, third-party involved in the dispute, 2) 3)
shall be affiliated with a member organization
of the particular scheme covering the product involved in the dispute;
and shall not be affiliated Committee
a member of the Certification a member appointed
chosen by the licensee, other than himself; Committee who shall serve as Chairman of the ad hoc Appeal Com-
by the Chairman of the Certification
mittee. II The use of this Procedure bv concerned parties is entirely voluntary (see however paragraph 5).
83
SP 60 : 1993
9 When the matter in dispute involves the application of the Rules of a scheme, the appeal shall be heard by an ad hoc Appeal Committee composed of : 1) a member of the Certification Committee chosen by the involved member organization. This member shall not be affiliated with the involved member organization; 2) a member of the Certification Committee chosen by the licensee, other than himself;
31 a member appointed by the Chairman of the Certification Committee who shall serve as Chairman of the adhoc Appeal Committee.
10 A representative of the Secretariat shall serve as a non-voting secretary of the ad hoc Appeal Committee. In this capacity, he shall receive and process the requests for initiating a formal appeal.
SP
60
:1993
Annex
ISO/IECMemberBody Date
............................
............................................
QUESTIONNAIRE ON MEMBERS AlTITUDES TOWARDS SOME FORM OF INTERNATIONAL THIRD-PARTY CERTIFICATION FOR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...*
(to be completed and returned to the IS0 Central Secretariat or IEC Central Office
by the date shown on the covering letter.) Yes
NO
1
1.1
Assessment
of need
certification based on ISO/IEC stanci 0
Does there appear to be a need for some form of international
dards? If yes state reasons; If no, state on what grounds (for example opposition in principle, cost, un-
necessary, not required) . . . . . . . . . . . . ..__..._......_.......................___...___...._............................
1.2
Is there effective
support by manufacturers state on what grounds
for international
third-party
certification
If the answer is no,
opposition cost
in principle not required no manufacturers)
unnecessary,
other (for example
1.3
Is there
effective
support by users for international state on what grounds
third-party
certification !
If the answer is no,
opposition cost
in principle not required
unnecessary,
other (for example no manufacturers)
I.4
Is there effective
support
by national authorities
and other bodies for international
third-party
cerG
tification? If the answer is no, state on what grounds
r! LJ
:
certification
opposition opposition
CQSt
in principle to accepting other countries
unnecessary, other
not required
1.5
Is there interest by consumer
organizations
where a consumer
product is involved?
El
cl
Production
produced in your country?
Is the product
cl
IName
or description
ot productlsll
85
St 60 : 1993
Yes 3 Tradition of pre-purchase check
No
Is there a tradition of pre-purchase check on the manufacturer or product?

If the answer is yes :
ill
3.1
By purchasers?
cl
If so, state briefly the procedures applicable, for example by private purchasing bodies by governmental purchasing bodies others By third-party certifiers?
3.2
If so, state briefly the procedures applicable, for example by governmental bodies (agencies) by non-governmental bodies
Regulations
Is certification required by legislation?
cl
For . . . . . . . . . . . . . . . . . . . . . . . . .(ISO/IEC Member)
Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Date..........................................
SP 60 : 1993
Annex C
QUESTIONNAIRE CONCERNING A PROPOSED THIRD-PARTY PRODUCT CERTIFICATION SCHEME

It is urged that the questionnaire be first read from beginning to end before answering any of the questions. To reduce the time spent, most of the questions can be answered by placing a tick in the appropriate box.
References
and scope of the proposed Scheme1
...................................................................................... 1.1 Titleofdraft/standard .................................................................................................................... 1.2 1.3 Reference................................................................................................. TC/SC.. .............. ...... . . . .......... ......... ... ... . ....................................
...................................................................................... 1.4 Scopeofthestandard ................................................................................................................... ................................................................................................................... ................................................................................................................... ................................................................................................................... ...................................................................................................................
2
2.1
Type of standard
Yes
No
Is the standard
2.1.1 2.1.2 2.1.3 2.1.4
A method of test only? A glossary or set of definitions only? Concerned only with dimensions? A code of practice?
c!
cl
0
cl
cl
cl
cl q cl
with :
cl q cl
2.1.5 A specification, i.e. containing requirements of a product and the method of measuring those requirements? 2.1.6 In conformity with ISO/IEC Guide 7?
2.2
2.2.1 2.2.2 2.2.3 2.2.4
Is the scope of the standard concerned

Personal safety equipment? Safety considerations? Health ? Protection of the environment?
cl
cl cl cl
cl
cl
cl cl
1)
In some instances the scheme may cover more than one standard.
87
SP
60
: 1993
No
22.5 Performance (fitness for purpose)?
0 cl
2.2.6
A matter which is, or is likely to be, the subject of legislation?
2.2.7
A matter which is of interest to the ordinary shopper
the consumer?
Cl
cl 0
2.2.6
A matter which is of interest to large-scale
purchasers?
2.2.9
A matter which is of interest to manufacturers?
2.3
Purpose
of the
standard
(Why
was the standard
prepared?
What
need was it designed
to
meet ?I
2.3.1
Variety
reduction
2.3.2
Elimination
of differing
requirements
2.3.3
Identification
of unsatisfactory
products/practice
2.3.4
Safety or health
2.3.5
Protection
of the environment
2.3.6
New technology
2.3.7
Facilitation
of trade
2.3.6
Legislation
2.3.9
Other(specify)................................,,....................................... . . . . . . .._._......._............__......_..._..,,.._._.................................
..
. . . . . . . . ..___.........___........__.._......_............._.........................
3
3.1
Characteristics
of the product
covered
by the standard
Is the product mass (or serially) produced?
3.2
Are the consequences specify why
of failure due to non-compliance
with standards
likely to be serious?
If yes,
3.2.1
32.2
Health, safety
Protection of the environment
3.2.3
High remedial cost (for example
pipeline or costly construction)
3.2.4
Other socio-economic
consequences
(Specify)
.................................................................................... ............................................................................................ ............................................................................................ ............................................................................................
88
SP
60
: 1993
No 3.3 Can the important assessed : 3.3.1

3.32
characteristics
of the product
be easily,
and cheaply,
By a visual examination
By an inexpensive
by the purchaser?
test prior to purchase?
3.3.3
Are any of the tests necessary likely to require specialized
equipment?
3.4 -
Is the product
in question
:
and different ways? products are made?
a material from which numerous a component a complete
used in many different end product?
If no to all above, how would you describe it?.
.. . .... .... .. .. . . ..... ..... ... . . . .. . . .... ....... .... ... .. .. .. .. .. .. .. .. ..
. .. . ....... ... ..... ..... . . . .. ...... ... ......... ........
4 4.1
Trade
Can you assess the approximate total value of world production of the product?
If yes, estimated annual value
.
region of the world?
4.2
4.3
Is production
confined
to any particular
Is there a detectable here
pattern of world trade in the product?
If so, give indication
:
From .... .. ..... . .. .. .._.. .. ...... ........ To ... ... ..... ........... .. ........
4.4
Does more than 50 % of the world production
come from less than 10 countries?
Ifso,which?................................................................................, .._,._._,_................._.............................................................
4.5
Is more than
50 % of the international
trade
limited
to less than
10 countries
as exporters
or
importers?
4.6
Are there any known for example
trade barriers?
If yes,
:
requirements for product
4.6.1
Varying
(climatic)
4.6.2
Lack of harmonized
requirements
(standard)
4.6.3
Divergent
legislative requirements
for product
4.6.4
Divergent
acceptance
requirements
(assessment,
testing,
approval,
certification!
89
SP 60 : 1993
CHAPTER
GUIDELINES FOR THIRD-PARTY ASSESSMENT AND REGISTRATION OF A SUPPLIERS QUALITY SYSTEM (lSO/lEC GUIDE 48 :1986)
0 0.1
Introduction
These guidelines and are valid for a third-party a suppliers Quality system of
References
Vocabulary.
IS0 8402, Quality
assessing wherein
registering
System, IS0 !3000, Quality management and quality dards - Guidelines for selection and use. 1) assurance stan-
:
this third-party to the system is designed processes primarily for use on and is being or services
an industry sector basis or by individual companies, related suppiied; products,
IS0 9001, Quality systems - Model for quality assurance in design development, production, installation and servicing.21 IS0 9002, Quality systems production and installation.21 Model for quality assurance in
the
supplier (e.g.
is capable
of
providing relevant
such
quality System IS0 9003. Quality systems final inspection and test, 2) IS0 9004, Quality management Guidelines. 2) Model for quality assurance in
assurance Standard
as specified IS0 9001,
in the
Quality
IS0 9002 or IS0 9003) together as required.
with supplementary
documentation
and quality system elements
0.2 means quate
The objective
of this third-party and subsequent requirements
system is to provide, surveillance, Quality
by IS01 IEC Guide 2, General terms and their definitions ing Standardization and related activities. ISOIIEC Guide 39, General requirements inspection bodies. ISOIIEC Guide 40, Generalrequirements certification bodies. concern-
of assessment
an adeSystem
level of confidence to the identified
that the suppliers
conforms
for that system. for the acceptance of
0.3
This third-party Quality
system involves only the assessment System and is not concerned processes or services.
of
the suppliers certification
with the
of products,
for the acceptance
of
0.4
The
identification
of conformance
to the
appropriate
Quality System Standard and any supplementary documentation will be in the form of a registration document.
3
The
Definitions
relevant definitions of IS0 Guide 2 and definitions IS0 8402 are
0.5 A body operating the system shall conform applicable requirements of ISO/IEC Guide 40.
to
the
applicable.
In addition,
the following
apply for the
purpose of this guide.
3.1
supplier
: The party that is responsible for the product,
Scope
and field
of application
of which is intendassessthereby or manner,
process or service and is able to ensure that quality assurance is exercised. The definition may apply to manufacturers, distributors, importers, assemblers, service organizations, etc.
This guide sets forth criteria, the observance ment systems in a consistent and reliable
ed to ensure that assessment bodies operate third-patty facilitating international While many their acceptance basis. has been produced third-patty contained and recognition
on a national
3.2
assessment
body
: Third-party
Standards.
body which
assesses
and registers the Quality Systems published Quality System
of suppliers with respect to
this document
with a view to proassessment systems, be useful in 3.3 field registration of assessed
viding a basis for harmonizing of the provisions assessment second-party
: Inclusion of the suppliers particulars and

capability by the assessment body in an
herein might
procedures.
approprjate
register or list.
__.
1) 2)
..__
At present at the stage of draft. To be published shortly.
91
SP
60 :1993
3.4 registration document : Document indicating that a suppliers Quality System conforms to specified Quality System Standards and any under the system. supplementary documentation required
The assessment
body may, with the agreement
of the supplier, fin and
appoint an agent to undertake full or in part) or surveillance responsibility, and expertise performed
either the initial assessment or both under its.authority
under agreed conditions.
The assessGuide 39.)
ment body shall satisfy itself that the agent has all the facilities 3.5 assessment system
: System having its own rules of

for carrying out the assessment and its subdocument
necessary for the task. (See ISO/IEC
procedure leading sequent
and management
to the issue of a registration maintenance.
5.4
The supplier which
is required
to have a documented Quality System
Quality StanSupvisit is
System
conforms
to applicable
dards (e.g. IS0 9001, IS0 9002 or IS0 9003) as supplemented, 3.6 assessment scheme
: Application
System
of an assessment proQuality System
if necessary, plement arranged,
by the relevant Quality System (see annex A). for conformance by the assessment
Assessment
system
to a suppliers
Quality
for the products,
(QSAS)
Before an assessment
cesses or services to which the same particular Standards and rules apply.
programme
a detailed appraisal of the applicants body.
Quality System is then the
documentation is undertaken notified
with the above requirements The supplier or deviations from
NOTE -- The term assessment as assessment scheme.
covers the same concept
of any significant
omissions
requirements
in order that suitable amendments visit.
can be made
prior to the assessment
Application
for assessment
should application form available
5.5 a)
The supplier shall ensure that all documentation registration relating to the Quality System for
The application -
which be made on an appropriate from the assessment -be completed body fan example is given in annex B); b) in a language body; ci cover a suppliers Qualrty System at specified locations; relate to the Quality System for the products. prospecified by or acceptable to the assessment
is sought,
including
the Quality
Manual body; of the body; and
or its equivalent, all pertrnent
is made available to the assessment records relating to implementation
Quality System are made available to the assessment the assessment bodys assessors are permitted
assisted to undertake d) responsibility is clearly
assessment
of the Quality System; body for the Quality by appointing a
to the assessment defined,
cesses or services supplied. On receipt of an application the assessment _ body should 5.6 advise the supplier of acceptance of the application or, if applicable, provide of the reasons for rejection further information about of the application; the scheme if and any agreed financi;al payment,
System
for example
designated
person responsible
for ensuring that the system
rules are observed.
The assessment
team should have at least.one coordinator conflict
membor One
experienced member team objection arise.
as an assessor in the technology The supplier
concerned.
will act as the assessment to named
(also known as has the right of of interest may
leader or lead assessor).
assessors where
necessary; -identify further information required frorn the supplier
to support
the application.
5.7
When
the
assessment
team
arrives
at the
suppliers manage-
premises, activities. a)
a meeting
of the team and the suppliers of the meeting are
ment takes place prior to the start of the physical assessment
5
5.1
Assessment
procedure
has been accepted, arrangements in accordance the assessment with the supplier
The objectives
After the application
to arrive at a clear understanding
of the assessment
body shall make the necessary for the initial assessment scheme.
procedure; b) to establish an official channel of communication be-
with the rules of the
tween the team and the manayement; informal visit is often useful prior to the forhis readiness on the c) to clarify any points not thoroughly understood or to
5.2
A preliminary
mal assessment for assessment assessment
process. This visit is used to gain an impression and the type of expertise required
answer questions
dealing with specific or sensitive matters of processes/procedures
of the suppliers size, the nature of his operation, team.
and to reinforce confidentiality observed during assessment.
5.8 5.3 The assessment body is responsible for all the phases of surveillance assessment. assessment. This includes the initial and follow-on
The
assessment procedures
involves for
an in-depth
appraisal to the
of the relevant
suppliers
conformance
requirements.
The supplier is required to demonstrate of the documented procedures.
the prac-
tical application
The assess-
92
SP
60 :I993
.nent body shall have procedures are identified and which require correct.
by which nonconformances action by the supplier to
7 Modifying registration
the scope of a suppliers
A supplier holding a valid registration 5.5 At the conclusion of its work, the assessment team conthe registration at its discretion, a new application to be modified, decide whether required. venes to discuss its findings.
document
may apply for body will, is necessary or
and the assessment re-assessment
5.10
The team will then present its findings to the suppliers or management representatives. The co-ordinator
management
will make a verbal summary, including a statement regarding their observations. At the meeting, the supplier should be given the opportunity to question the team on their findings.
8
The
Surveillance
assessment body shall perform with surveillance of the
suppliers 5.11 Subsquently the assessment body will inform the for
Quality System
on the basis of the system rules, to the relevant requirements.
verify continuing The frequency the assessment ity System
conformity
supplier in writing any corrections
of its decisions and the time limit by which document.
and extent of visits should be at the discretion of body, in such a way as to ensure that the Qual-
should be made to meet the requirements
the issue of a registration
is maintained.
5.12
The
supplier
should
show
that
corrective
action
has a full that
been taken to meet all of the relevant requirements specified time limit. The assessment or partial corrective assessment re-assessment action or accept taken, has been written visit.
within the
Changes to the Quality
System
body may undertake declaration to be confirmed
The supplier shall
by the
body during a surveillance
inform
the assessment
body
promptly
about
any inchanges
tended
changes
to the Quality
System
or other
5.13
which may affect conformance When the assessment body is satisfied team, with the recommendation of the assessment document registra-
to the requirements;
favourable
tion is granted,
and a registration
is issued to the
supplier (see annex C as an example).
accept the assessment bodys decision as to whether the intended changes require re-assessment or further investigation.
5.14 visits.
Granting
of
registration
is followed
by surveillance
The assessment
body shall reply promptly to any notification
of
change to the Quality System. An organization that, directly or through the agency of
5.15 System
sub-contractors, assessment is achieved
advises a company
how to set up its Quality should not provide of interest. unless strict separation
or writes its quality documentation services to that company,
IO Use of the assessment logo

If the assessment body is proprietor
bodys symbol or
to ensure that there is no conflict
of a symbol or logo intendthe supplier may use the by the assessment or in product conformity.
ed for use under the relevant scheme,
Issue of a registration
body shall
document
specified symbol or logo only as authorized a way that may be interpreted as denoting
body. This symbol or logo shall not be used on a product,
The assessment a) b)
inform the supplier that registration provide the supplier with
has been granted;
11
a registration document, The which may be used subject to the provisions of clause 11; c) register the supplier as having a Quality System in for
Publicity
assessment body shall make its register of assessed
suppliers available for public inspection dated at least annually. or a publication It may distribute information accordance with the schemes assessment requirements containing
and this should be upcopies of the register, from the register.
the products,
processes or services supplied; The supplier may
d) authorise the supplier to use the assessment bodys specified symbol or logo subject to the provisions of clause 10.
inform authorities,
potential customers, purchasers or purchasing of the full and exact details of the registration;
93
SP 60
: 1993
display the registration
document; bodys symbol or logo as
suspension
will be removed
(such as corrective
action
under of
clause 15). The assessment make use of the assessment authorized the suspension. Upon fulfilment A supplier whose Quality System is registered under this period, system shall not claim or imply that a product, vice has been assessed, certified or approved a recognized product certification scheme. process or serby the assessspecifically (see clause 10).
body may publish notification
of the indicated conditions within the specified body will remove the suspension and will
the assessment
notify the supplier accordingly; otherwise, the registration be cancelled and the registration document withdrawn.
ment body unless such supplier has the product certified under
15 12 Confidentiality
body is responsible for ensuring that confidenby its employees and those of its appointed
Corrective
action
is responsible notifying for taking prompt and
A registered adequate corrective
supplier
action
to correct
any contravention or taken.
of the system body of the
The assessment
rules, and for formally
the assessment
tiality is maintained
action proposed
agents concerning all confidential information with which they become acquainted as a result of their contact with the applicant or supplier, except where otherwise required by law. This may include a formal non-disclosure agreement.
16
Withdrawal/Cancellation
body should cancel a registration, withdraw
The assessment
13
Misuse
of a registration
a registration document shall cease to use the registration document (and, if bodys symbol or logo) as soon as
the registration document and cancel any agreement for the use of the bodys symbol or logo in the following cases : a) under the relevant provisions of clause 14; indicates that non-conformance is of a serious nature; to rele-
A supplier awarded display or otherwise applicable, practicable after
the assessment
b) if surveillance vant requirements c)
at the formal request of the supplier; if the system rules are changed (see clause 17) and the to the
at a lapse of registration, clauses 14 and 16); b)
suspension
or cancellation
(see d)
supplier either will not or cannot ensure conformance the supplier has made a change to his Quality System by the assessment body (see to affect e) if the supplier ceases to supply the product, period of time; new requirements; which has not been accepted
clause 9) and which could reasonably be expected the suppliers qualification for registration; c) the supplier has failed to implement
process or
service for an extended to the f) if the registered
a change
supplier fails to meet financial body; specifically provided
obliga-
system rules issued by the assessment body (see clause 17); d) any other circumstances to affect arising adversely Jvhich could
tions to the assessment g)
on any other grounds
for under
reasonably
be expected
the suppliers
the system rules or formally agreed between the assessment body and the supplier. This will be exercised by informing the supplier accordingly The assessment
Quality System.
by
14
Suspension
of registration
for a limited period at the
registered
letter or equivalent
means.
body
may publish notification Registration assessment may be suspended bodys discretion, indicates for example non-conformance withdrawal to the releis not con-
of the cancellation. body against a deci(see clause 18).
A supplier may appeal to the assessment sion not to award or to withdraw
registration
if surveillance
vant requirements sidered necessary;
but immediate
17 Implementation rules
registration docuto the assessment
of changes
to the system
if improper symbol
use of the registration, or logo is not remedied
ment,
In the event of changes being required to the system rules, the assessment body shall for suppliers affected by a proposed change(s); the effective time for
bodys satisfaction;
if there has been any other contravention
of the rules of body.
a)
afford opportunity
the scheme or the procedures An official suspension body in a registered and will means,
of the assessment
change to submit comments b) date
on the proposed
shall be confirmed letter to the supplier the conditions
by the assessment or by equivalent under which the
specify an effective date for the change(s); shall be by agreement to allow
sufficient
indicate
suppliers to amend their Quality System;
94
SP 60 : 1993
c)
formally
notifiy
all
suppliers
affected concerned.
by
the
new
18
Appeal/Dispute
and disputes are subject to the appeals procedures body (see ISO/IEC Guide 40). of
requirements
of the effective
date of the change
and the Appeals date may the assessment
action required of the supplier(s) Failure to take the required under clause 16. action
by the effective
laad to suspension under clause 14 or withdrawal/cancellation
SP
60
: 1993
Anne3 :A Guidelines for drafting Quality System Assessment Supplements (QSAS)
A.1
Introduction
Supplement System there (QSAS) is a basic and for a par-
A.3 A.3.1
Essential elements
The following of a QSAS aspects although should be considered in the
The Quality System Assessment document registration ticular for suppliers Where schemes.
Quality required,
assessment
preparation
it is possible that not all of
It details specific requirements
these aspects need be covered in each case.
scheme.
shall be a separate A.3.1.1 exclusions. A description of the products, processes or services with reference to any specific
QSAS for each scheme. Each QSAS is prepared by the assessment body in cooperation with interested parfies, including but not limited to suppliers and purchasers.
covered by the specific scheme,
A.3.1.2
An
indication
of the tvpes of specifications
to kt
A.2 Content of a Quality System Assessment Supplement (QSAS) A.2.1

The aim of a QSAS is to incorporate specific Stan-
covered by the scheme, which may be one or a combination of the following a)
:
or international standards and codes
national
of
requirements
consistent
with applicable
Quality System
practice; b) industry-based standards and codes of practice;
dards related to the products, the supplier from developing process to satisfy the scheme
processes or services supplied. his own systems of controlling requirements. his
The document shall be prepared in such a way as not to restrict
CC) the suppliers own standards and codes of practice; d) customers specifications; requirements.
A.22 defines means
The QSAS what by which
shall be prepared shall achieve the requirements inspections
as a document without The
which the of raw
e)
any statutory
the supplier at which
detailing stages the
are met. are
manufacture
performed,
A.3.1.3 dard (e.g.
Reference
to the appropriate
Qualit y System Stan-
material tests which are undertaken, to be tested or inspected, tion commensurate with
or the sample size which is contract requirements. establish his
IS0 9001, IS0 9002 or IS0 9003).
shall be left to the suppliers discrethe supply A.3.1.4 tion of these standards,
Reference to any additional clarification or interpretaas required for a particular scheme.
These details may vary from one supplier to another since each supplier is organized own procedures differently and will therefore which are suitable for his particular situation.
A.3.2
Any words and phrases for which an accepted meanwith IS0 8402.
ing is required shall be definedand in accordance
shall, where appropriate, be
SP
60
: 1993
Annex System for the assessment Quality
B of suppliers
and registration Systems
Application
for registration
Nameofsupplier Address .......................................................
............................................................... ...............................................................
Contact Position
............................................................... ...............................................................
. . .._........_...................._..._........._............_. Contact Position . . . . . . . . . . . . . . . . . . . . . . . . . . .._...._..................._......._. ~..~~.~......~.....~~......~~......~.~..~..~.....~.~~.~..~....~
Description registration
of category is sought
of products,
,............,_......... ... . ., ,..._......,_._., ., . . . . . . . . . . . . . .
processes or services
for which
Quality
System
Assessment
Supplement
(QSAS)
Details
of assessment already held
and
. . . . . . . . . . . . .._......_....._...............
registration
Details System
of any Quality documentation
.
The company a) b) hereby with undertakes the Rules for the System connected with of assessment the registration and registration process of suppliers Quality Systems; granting of registration.
to comply
to pay all fees and costs
irrespective
of the eventual
Signed
:
(title)
Date
:
to Body1
Please return [address
of Assessment
Include d s.eDardte sheet If necessarv.
97
Annex Registration of a Quality
C Assessed Supplier
System
RegistrationNo.
. . . . . . . . . . . . . . . . . . . . . . . . .._....._.............__...................
TheAssessmentBodyherebygrantsto
................................................................................ ................................................................................ ................................................................................
(hereinafter called the Supplier) the right and licence to be listed in the Assessment Bodys Register of Quality System Assessed Suppliers in respect of the products, processes or services particularly described in the Schedule hereto, bearing the same number as this Registration. Such products shall be manufactured by the Supplier at, or such processes or services shall be offered at or from, only the address given above, and under a Quality System in accordance with (e.g. IS0 9001, IS0 9002 or IS0 9003 and QSAS No. . ..I.
The Registration is granted subject to the system rules governing the Registration referred to above, and the Supplier hereby covenants with the Assessment Body duly to observe and comply with the said rules.
lssuedby
. . . . . . . ..~.................................................................. (name of Assessment Body)
SignedfortheAssessmentBody
._._...__.._.._.__..__.._..___.__,_......_..___,..,..,_.. (title)
Date :
Signedforthesupplier
. . . . . . . . . . . . . . . . . . . . .._.._.........._..__._..__.._......._....
(title)
Date :
98
SP 60 : 1993
Schedule to Registration
No.
lssuedto:
............................................................................ ............................................................................
Products
(processes)
(services)
with
respect
to which
the Suppliers
Quality
System
is registered
. . . . . . . . . . . . . . . . . . . . . . . . . . . . .._...._._.._........................................... . . . . . . . . .._...._...._...........................................................
IThis schedule should clearly define the limits of the registration coverage.
Signed
for the Assessment
Body
(title)
Date
99
SP 60 : 1993
CHAPTER
AN APPROACH TO THE UTILIZATION OF A SUPPLIERS QUALITY SYSTEM IN THIRD-PARTY PRODUCT CERTIFICATION (lSO/IEC GUIDE 53 :1988)
1
1.1
Scope
This Guide outlines a general approach programmes by which certifi-
IS0 9000 standards
: 1987, Quality management

Guidelines
and quality
assurance
for selection and use.
cation bodies wishing to do so can develop and apply product certification systems. utilizing elements of suppliers quality
IS0 9001 servicing.
: 1987,
Quality
systems
Model
for
quality and
assurance in design/development,
production,
installation
1.2
The forms of programmes certification as principles
espoused by this Guide are for
conformity
of products only and in all cases involve
IS0 9902 assurance
: 1987.
Quality systems in production and installation.
Model
for
quality
the following
:
capability to to manufacture the relevant IS0 9004 : 1987, Quality elements - Gurdelines. management and quality system IS0 9003 assurance
: 1987,
a)
assessment a
of a suppliers product
Quality systems in final inspection and test.
Model
for
quality
consistently standard(s); b)
conforming
testing or comparable of the
evaluation body
of the product to determine
to the com-
satisfaction
certification
pliance with the requirements c) application of a suitable
of the standard; follow-up service to assure by the supThe relevant definitions of ISOIIEC Guide 2 apply. In addition, applies. for the purposes of this Guide, the followrng definition
Definitions
ongoing plier; r.h
conformity
of products
manufactured
control
of the mark and/or
name
of the certification supplier
body.
: The party that is responsible for the product,

The definition may apply to manufacturers,
prois dis-
1.5
cess or service and is able to ensure that quality assurance Within certification programmes it is possible for third a variety of certification exercised. tributors, bodies to develop importers, assemblers, service organizations, etc.
party certification procedures
to meet the needs of suppliers having a wide range
of quality assurance capabilities. Those suppliers with the least demonstrated capabilities in this regard could be involved in certification procedures where the greatest number of steps in the total certification programme would be carried out by the certification body. Those suppliers programme with highly developed 4.1 Deciding on the form of programme body to meet level pracquality systems going auditing programme could process a large number by the certification of the steps rethe form of
Steps
in developing
a programme
quired by the certification
under a system of onThe programme is developed by the certification body reserves the needs of individual suppliers, in their knowledge tices. The elements within which of the quality system practices commonly and those certifiprogramme a certain sector of industry or of quality assurance
body. Whatever
that is developed,
the certification
the authority to certify or not to certify any product manufactured by the supplier. A certification body may at its discretion specify herein. programme criteria in addition to those described
several industry sectors which have reached an acceptable and application
employed
the industry can be applied are
sector are examined to achieve into the
References
elements
the needed
ISO/IEC Guide 2 : 1986, General terms and their definitions concerning standardization and related activities. ISO/IEC Guide 28 : 1982, General rules for a model third-party certification system for products.
cation programme criteria.

NOTE in the Information
incorporated
on the elements or in similar
of quality systems can be found national documents of some
IS0 9C&0 series
countries.
101
SP 60
: 1993
4.2 The three phases in the implementation certification programme
of a
All forms of product certification programmes within the scope of this Guide consist of the following three phases : a) b) c) qualification; certification; follow-up.
b) check .to ensure that the supplier has the necessary equipment, staff and facilities for carrying out the tasks assigned to him for his <participation in the certification programme, cJ have the supplier demonstrate his capability to test samples so as to assure conformity with the-specific product standard(s) used in the programme; this may involve verification of test results by the certification body; d) ensure that those quality elements that must be carried out by the supplier as part of the certification programme are being properly performed; also, that the necessary safeguards to ensure that they will continue to be properly performed are in place.
5
5.1
The qualification
phase
In this phase the supplier is assessed to see if he qualifies in meeting all parts of the certification process which he is re. quired to fulfil under the particular certification programme.
5.7
5.2 To facilitate the assessment, a programme data form is developed which contains pertinent information needed to be acquired from the applicant. Two examples of such forms, one fairly simple and one more complex, with regard to the number of quality system elements involved in the programme, are shown in annexes A and B. 5.3 Depending upon the nature of the programme being developed and the degree to which the programme will utilize a suppliers quality system, the certification body may require a supplier to have a minimum level of successfully demonstrated experience with the certification body in the production of conforming products before the supplier is permitted to apply for product certification under the programme.
Following the visit. to the factory by the certification bodys assessment team, a report on the teams findings is prepared and submitted together with the completed application to the responsible persons or group in the certification body to determine whether and under what conditions the applicant may be qualified. If the information is found to be complete and acceptable, the applicant is so informed in writing.
5.8
A supplier can be qualified for additional product categories only after another assessment specifically directed to the new product category has been successfully completed.
5.9 All the facilities involved in the process of developing a product covered under a certification programme, whether part of the suppliers organization or not, must be evaluated by representatives of the certification body.
5.4
An applicant completes the form and returns it to the certification body. An evaluation of the responses provides an excellent indication of whether or not the applicant is likely to qualify as a programme participant. Clarifications required by either party are obtained by the quickest available form of communication.
5
6.1
The certification
phase
5.5 Following clarifications, a date is arranged for a visit to the applicants plant. The certification bodys assessement team should contain persons knowledgeable in a) b) cl the applicable product standard(s); appropriate laboratory procedures and techniques;
The action to be taken for certification will depend upon the type of programme developed. Following the qualification phase, the supplier may, for example, need to apply for certification each time he desires a new product to be certified. The certification process will then be implemented as described in the programme and the prescribed elements of the suppliers quality system will be included in that process. See also clause 7~).
8.2
assessment procedures; system elements included in the pro-
d) the quality gramme.
5.6
The matters to be investigated by the assessment team at the suppliers plant will vary widely depending upon the degree to which the supplier is to be involved in the certification process. Normally, however, the assessment team shall take the following actions : a) in general, ascertain that all. information provided in the
As ? first example, a simple procedure may be based only upon acceptance of test data generated by the suppliers laboratory, i.e. only those elements required for assessment of the suppliers testing facilities and practices are involved in the qualification (see annex A). In such a case, after its qualification the laboratory would be visited by a representative of the certification body to a) b) cl witness all types of tests; or witness some types of tests: or review the suppliers test results;
programme data form is correct;

102
and if found to be in order, to accept them.
SP 60
1993
6.3 Asa second example (see annex 6). following a qualification phase the elements requirements permitted to categories of which involves assessment of a large number of of a suppliers quality system and of all the other of the certification programme, the supplier is apply the certification bodys mark to certain products under an ongoing follow-up phase.
being adhered tb and, in general, satisfies himself that the product covered by the programme continues to conform to the product standard. Normally this would also indude witnessing some selected tests, examination of quality assurance records and examination of products ta determine compliance with requirements. b) During a follow-up inspection, discussion shall take place concerning the test programme as it relates to new products within the authorized product category to be evaluated prior to the next inspection visit. When such discussion pertains to authorization to apply the mark or other evidence of certification of the certifcation body to new or revised products; the inspection team shall be composed of individclals who normally make such decisions within the certification body. cl Labels or other evidence of certification shall not be applied to a design or construction which, in the opinion of the inspection team, could produce non-conformance until the evidence of compliance has been accepted by the certification body. d) The minimum frequency of follow-up visits is prescribed in the programme. Follow-up will take place at all locations covered by the programme. For example, if products are manufactured at a different location from that at which the products are designed, tested and evaluated, and all these elements are part of the programme, follow-up will cover all relevant locations. e) Records shall be kept by the certification body of al models of products certified.
6.4 The examples given in annexes A and B are illustrative of

programmes which utilize (A) very few elements, and (6) many elements of the suppliers quality system. In addition to these examples, there are many different combinations of elements possible which a certification body may decide to employ in order to meet different needs.
The follow-up phase
This phase is designed to provide a means for assuring those who rely on the certification mark that products, once certified, and for the subsequent period of time that the supplier applies the certification bodys mark to the products, continue to meet the requirements of the applicable product standards. Involved in this phase is an ongoing, in plant, working relationship between staff of the certification body and staff of the supplier. Details of the follow-up inspection will vary with the needs of the type of programme being developed. However the following general principles always apply. a) In carrying out follow-up inspection at the suppliers plant, a-representative of the certification body ensures that all quality system elements prescribed in the programme are
103
SP
60
: 1993
Annex Example
A very few elements
of a programme data form in a case involving of a suppliers quality system
introductory note (not part of the programme data form) This is an example of a certification bodys programme data form for a supplier who requests certification under a programme which has been developed to make use of the suppliers testing laboratory for generating some or all of the test data required to indicate compliance with the tests called for by the applicable standard(s). The suppliers quality system elements to be assessed by the certification body under this programme are measuring and testing equipment; product testing and measurement.
the availability of appropriate instrumentation and testing equipment;

adequacy of energy supplies to perform required testing; the suppliers equipment calibration programme;
demonstration of ability to conduct tests in accordance with prescribed standards and the practices of the certification body. During the qualification phase, other matters of concern to the certification body include a) establishing the designated person and deputy to be responsible for all dealings with the certification body; b) ascertaining the suppliers knowledge of the applicable standards and how this knowledge is maintained on an ongoing basis; c) the experience and qualification of all personnel testing products, including their capability to perform tests in accordance with the techniques and procedures prescribed and/or used by the certification body. Information pertaining to all of the above items is sought via the programme data form (see example on the following page).
The assessment by the certification body of the suppliers quality system involves such items as the Quality Manual for the laboratory operations;
limits of accuracy of all measuring and test equipment involved; the environment in which the calibrations are performed; the environment in which the testing is performed; the methods of measurement and test;
104
SP 60 : 1993
Programme data form (Specimen)
1
1.1
Introduction
This form
and instructions
is intended about programme for assuring bodys that all the to provide the certification body
Location
and responsible
persons
with information a) the
1.8
Test facility
(address
in full)
suppliers which
....................................................... ....................................................... ....................................................... ....................................................... .......................................................
products conformity b)
bear the certification
mark are in
with the applicable
requirements; of the suppliers
the qualifications
and responsibilities
staff responsible
for implementing
the programme. a) Person at test facility with responsibility for handling
1.2
For each of the following documentation body.
questions the certification the answer wherever
body ap-
requires propriate.
to confirm
A copy of the documentation
will be kept on file by
matters pertaining to products evaluated under this programme, including responsibility for checking product compliance with all reievant standards.
the certification
Name: 1.3 This form is to be completed by the supplier and returned documentation prior of the certification control Position to the certification body with supporting by representatives
................................................
: ..............................................
to a visit to the facility
File : .................................................. Supplier: Location: ............................................. .............................................
body to review the implementation
of the compliance
programme. A form shall be completed tional facility location.
for each new or addi-
.......................................................
1.4 The completed form, documentation, and the suppliers laboratory compliance control programme will be used as the basis of the assessment.
: ............................................ : ................................................. Telefax : ...............................................

Telephone Telex
In order to retain certification under this programme, the supplier shall advise the certification body pkomptly in writing of any changes in organization, personnel, information or other detail reported in this form. The information contained in this form will be reviewed periodically by the certification bodys personnel during subsequent visits to the facility to determine and record any changes that may have occurred.
1.5
This person must have the written supplier, enforce the certification make necessary changes
authority bodys
to represent requirements bodys
the and
in production
test facilities and prostandards
cedures when required and related documents.
Yes Does this authority exist? Cl
No cl
1.6
Where
there is not enoughspace
on the form for the in-
To whom
does this person report? (name and position)
formation
requested a note should be made in the appropriate ., dated .I. The required space : e.g. See Appendix material should be identified, dated and attached.
....................................................... ....................................................... .......................................................
1.7 When confidential body.
completed, this form and its contents become and will be handled as such by the certification
b)
Name of alternate : .................................. .......................................................
105
SP
60
: 1993
1.9
Manufacturing
(supply
facility
3.5
tained
Are for
permanent each
calibration
records and
maintest
yes 0
No 0
relevant
measuring
_........_.............. : ................ ........................ .............................. ........................ Address (in full) : .............. __............... .. .. .............................. . . .._.............._...................__..........._.. _.....__.............._...._.........___......,......_. ,.....__....,............_._..........__..._......._. Name (in full) Person at manufacturing manufacturing Name: Position Telex: Telefax (supply) facility with responsibility under this programme for
device? If yes, in what form? Provide relevant examples.
3.6
What
standard
instruments
and
devices
are used for
calibration?
products evaluated
3.7
Are written
calibration
procedures 0 for issue? 0
available? Who assumes responsibility
...............................................
: ..............................................
: ............................................ ................................................ : ...............................................
Telephone
3.8
Describe how the standard instruments and devices are traced to international or national metrological standards.
Personnel
4
4.1
Test procedures
Do written procedures exist for all protostandards cl body?
Append job descriptions and indicate the experience of all personnel responsible for testing products to the certification bodys requirements and for writing product reports.
type testing
required
by the relevant
and bulletins of the certification
cl
3
3.1
Measuring
and testing
equipment
Who assumes responsibility
for issue?
criteria : A calibration
deficiencies
control system which detects and provides timely and positive corrective action
4.2
Are the procedures
available to all test percl
sonnel?
shall be established for all measuring and testing equipment used to verify the conformity of products to requirements of the certification body. 4.3 Are the personnel competent to understand 0 the procedure Measuring and testing equipment shall be calibrated to applicable reference standards which in turn are certified as being traceable to internationally or nationally recognized standards. and to perform all required testing? personnel who are competent
List names of relevant duct the tests.
to con-
3.2 What measuring and test equipment is used to carry out tests to the certification bodys requirements? List with serial numbers, make and model as applicable and provide accuracies for each item.
4.4
Is there a written programme for revising test methods in accordance with revisions to the certification bodys requirements? 0
Provide details.
3.3
How
frequently
are
measuring
and
test
devices
calibrated?
List for each item.
4.5
tests
Are the records available and investigations
of the results of evaluated 0 Cl
of products
3.4 How is the calibration status of measuring and test equipment identified?
under this programme? If not, why? Provide details.
106
SP
60
: 1993
Annex Example
B many elements
of a programme data form in a case involving of a suppliers quality system
Introductory
note
(not part of the programme of a certification
data form) data
quality system.
The elements
involved in this programme
in-
This is an example
bodys programme
clude the following : measuring and testing equipment, records, nonconformances, customer-supplied items,
quality inspec-
form for a supplier (electrical supplier in this case) who requests certification under a programme which has been developed to make use of a large number of the elements of a suppliers
tion and test, document control, identification and traceability, purchasing, manufacturing and construction, corrective action, design assurance.
SP
60
: 1993
Programme data form (Specimen)
File:
.................................................. ............................................. .............................................
Suppsier: Location:
1 1.1
Introduction
This form
and instructions
to provide the certification body
1.8
The supplier must agree to establish procedures that control the design of products to ensure that the certification bodys requirements are translated correctly into specifications, drawings, procedures and instructions for purchasing, testing, manufacturing and construction.
is intended about
with information
a) the suppliers programme for assuring that the products which bear the certification bodys mark are in conformity with the applicable b) requirements; and responsibilities of the suppliers 2.1 At least two persons shall be appointed of this programme to be responsible at a manuOnly these certification for the operation implemented
2
the programme.
Organizing
for the programme
the qualifications
staff responsible
for implementing
facturing facility, i.e. a person with primary responsibility and at
1.2
For each of the following
questions the certification
body
least one alternate persons may bodys mark.
person to act in his absence. the application of the
requires documentation such as procedures, charts, drawings, test data, job descriptions, etc., as proof of capability to implement the programme. A copy of this documentation will be kept on file by the certification body.
authorize
2.1.1 Person at the manufacturing (supply) facility responsible for handling matters pertaining to products under this programme Name:................................................ Telephone:............................................
1.3 This form is to be completed by the supplier and returned to the certification body with supporting documentation as required by the certification body prior to a visit to the facility by the certification body to review the implementation of the compliance control programme. A form shall be completed new or additional facility location. for each
1.4 The completed form, documentation, and the suppliers compliance control programme will be used as the basis of the assessment.
( : ........ ... . .. . .. .. .. . .. .......... Position in organization : . .. .... .. ... . .. .. .. .... .. ........ . .. . To whom does this person report? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .._..
Physically located at
.. ..
1.5
In order to retain certification under this programme, the supplier shall advise the certification body promptly in writing of any changes in organization, personnel, information or other detail reported in this form. The information contained in this form will be reviewed periodically by the certification bodys personnel during subsequent visits to the facility to evaluate their acceptability and determine and record any changes that may have occurred.
2.1.2 Name:
Alternate
person responsible
................................................
Telephone
1.6 Where there is not enough space on the form for the information requested, a note should be made in the appropriate space; e.g. See Appendix . . ., dated . .I. The required
material should be identified, dated, signed and attached.
: ........................................... : ................................... ....................................................... Position in organization : ................................. ....................................................... To whom does this person report? : ........................ . . . . . . . . . . . .._......._._.._............................
Physically located at Provide an organization chart showing the relationship
2.1.3
of these persons to the organization. NOTE - If this application is for a facility depending on another location within the supp!iers organization for design and prototype verification control, provide the information required in 2.1 for location of control.
1.7 When confidential body.
completed, this form and its contents become and will be handled as such by the certification
108
SP 60 : 1993
2.2
Independence
and authority
2.5
Compliance
management
The individuals identified in 2.1 shall be independent of management directly responsible for production and have written responsibilin/ and authority to take the following actions. a) require correction of deviations from the requirements before the application of the certification mark. Yes Do they have this authority? Do they exercise this authority? No 0 0
A compliance management programme shall be in existence and operating at the facili*/. 2.51 Is there a compliance management programme? 2.5.2 How is the documented? compliance management Yes 0 No 0
programme
q
n
Provide a copy of the compliance management procedures as applicable. 2.5.3 Are the documents that describe the compliance management procedures approved by management? 2.5.4 Are these documents periodically reviewed and updated?
b) require changes pertaining to the certifiers requirements in design, drawings, procurement, etc. Do they have this authority? cl cl
cl
cl
c) arrange for and verify the removal of the certification mark from products which do not comply with the certifiers requirements or from products which have not been covered by the programme. Do they have this authority? Do theY exercise this authority? 0 0 0 0
cl
Cl
Bywhom? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Position:.............................................. At what intervals? .. . . . . ... . .. 2.5.5 The compliance management documents shall contain
2.3 Criteria concerning experience training and responsibility
and/or
a). organization, structure and assignment of responsibilities within the compliance management programme; bj c) inspection and test plans; procedures for each element.
The individuals identified in 2.1 shall be experienced and/or have been trained for performing their duties. What experience and related on-the-job formal training do they have?
2.4 The individuals identified in 2.1 shall have the authority and responsibility for ensuring that a) the certification mark is applied only to those products for which authorization has been given by the certification body in writing. Do they have this authority and responsibility?
Do the compliance management documents provide this information?
3
3.1
Design
control
and prototype
verification
cl
b) the latest documents of the certification body pertaining to the applicable requirements are available at the facility and are being worked to. Do they have this authority and responsibility? 0 ,o
The supplier shall establish procedures that control the design of products to ensure that the certification bodys requirements are translated correctly into specifications, drawings and procedures. Have such procedures been developed? III
Describe these procedures briefly in general terms and attach applicable supporting documents. 3.2 Is a design review made by personnel who are fully conversant with the certification bodys requirements?
c) the products which bear the certification mark comply with the applicable requirements before shipment. Do they have this authority and responsibility? 0 0
Cl
cl
dl the applicable requirements of the following sections are implemented and being followed at the facility. Do theY have this authority and responsibility? 0 0
What are their names? ....................................................... ....................................................... ....................................................... ....................................................... NOTE - If these persons are the sameas those identifiedin 2.1, state the fact above and go to 3.3.
Provide position descriptions, signed by a responsible executive, in which the authority and responsibility of 2.2 and 2.4 are given.
SP
60
: 1993
What qualifications, experience and related formal training do these persons have?
on-the-job
or
verify the conformance tification body.
of products to requirements
of the cer-
3.3
inspections
and tests shall be performed
by the supplier
on representative samples of each prototype product and whenever an engineering change is made to a product to verify conformance to the certification bodys requirements. Yes Are such inspections and tests performed? and tests? No a c
Measuring and testing equipment shall be calibrated to applicable reference standards which in turn are certified as being traceable to internationally or nationally recognized standards.
4.2
What
measuring
and test equipment i.e. make,
is used? List each model and serial
q
0
relevant numbers.
type by full description,
Are records kept of these inspections
4.3
At
what
intervals
is each
critical
measuring
and test
device calibrated?
3.4
Give the names of the persons who have the responsibility for carrying out these tests and inspections.
4.4
Names
Are written
calibration
procedures
available equip-
: ..................... . ........
for each type
of measuring
and testing
Yes 0
No cl
....
.... ... ......
ment?
4.5 . . . . . . . . . . . . . . . . . . . . ..___._........._..................
What qualifications, experience and related on-the-job formal training do each of these persons have? or
How
is the calibration identified?
status of critical measuring
and
test equipment
4.6
of
Are permanent calibration records maintained for each measuring and test device?
3.5
these
Provide an organization persons to other
chart showing the relationship administrative
executive,
and super-
4.7
visory positions.
Is each measuring instrument show when it was last calibrated?
marked
to 0 0
3.8
The persons responsible for the management programme at the manufacturing
of the cer-
4.8
What
standard
instruments
and
devices
are used for
tification
location shall have
calibration? Itemize by make, model and serial number; calibrated and when next due for calibration.
the authority to participate in design review and to review and approve all engineering changes. Do they have this authority? cl U
indicate when last
3.7
Where
is the
design
control
and
product
verification
4.9
Describe how the standard
instruments
and devices are
carried out?
traced to international
or national standards.
3.8
There shall be evidence requirements
that prototype
products
comply
4.10
Describe
how required
environmental
conditions
that
with all relevant
body before
are specified for testing are produced
and controlled.
they are released for production. There shall be a statement on file at the manufacturing location which is available to the certification body.
5
Do the procedures evidence? at the facilities provide for this 0 0
Production
inspection
and test
plan
5.1
Criteria. A written
which describes
inspection
and test
plan shall be inspections
developed 3.8.1 A detailed record of all tests and test results shall be on file at the location of design control and prototype verification. This shall be accessible by personnel at the manufacturing (supply) location. Do the procedures evidence? at the facilities provide for this 0 0
all of the production
and tests necessary to ensure that each product under this certification programme complies with the requirements of the certification body before shipment. This details of its implementation as follows. a) Details of inspection and components, controls plan shall include
as applied
to incoming
materials
production
lines, final inspec-
tion and packaging.
4 4.1
Measuring
and testing
equipment
If non-certified to ensure original that
components shipments
are
used,
the
above
infor-
mation shall include a description
of the procedure followed are the same
Criteria. A calibration control system which detects defifor all measuring and testing equipment used to
received
as the
ciencies and provides timely and positive corrective action shall be established
component
evaluated
and found
to be in combody.
pliance with the requirements
110
SP 60 : 1993
b) Details of instrumentation, records of calibration dates.
calibration facilities and
6.4 All nonconformances shall be investigated to determine the cause. Yes No Is this done? cl cl
cl A system for recording the results of production-line tests as required by the certification body. dl Details of the methods used for segregation and disposition. of nonconforming products. el Details of all required factory production tests as provided by the certification body in writing. Has such an inspection and test plan been developed? Has such an inspection and test plan been implemented? Does this plan include details of the certification bodys required factory tests? Yes cl No 0
6.5 After the cause of a nonconformance has been determined, appropriate action shall be taken to prevent repetition. Is this done? Provide an example of documentation. cl cl
Purchasing
cl
cl
7.1 Criteria. The supplier shall ensure that purchased components (for his products) under the certification programme comply with the applicable requirements of the certification body and that only certified components are used when required by the certification body. Has this practice been implemented? Cl Cl
Provide the certification body with a copy of this plan.
5.2 A list of the characteristics to be inspected and/or tested and the related acceptance criteria shall be available at each location where an inspection and/or tests are performed to verify conformance requirements of the certification body. Is such information available at these locations? 0 0
Describe the procedure used to identify incoming components that are required tc be certified and to ensure they are certified. 7.2 Non-certified components such as switches, circuitbreakers, transformers, motors, etc., may be used. If a noncertified component is used, however, it shall be evaluated and tested to determine compliance with relevant requirements of the certification body. Describe the procedure used to identify incoming components evaluated in the above manner that ensures they comply fully with relevant requirements of the certification body. 7.2.1 The examination and testing of representative samples of non-certified components may be carried out either by the certification body or by the supplier. Suppliers may carry out the examination and testing only if they have personnel thoroughly familiar with the latest testing practices and with requirements of the standards relevant to the components and are properly equipped to carry out required testing, and only if specifically authorized by the certification body. Who is the person responsible for ensuring that all non-certified components are in compliance with requirements of the certification body? Name:................................................ Does this person have the requisite qualifications? 0 0
Corrective
action
6.1 Criteria. A system for controlling components and final products which do not comply with the requirements of the certification body shall be developed to ensure that such components and final products are not released for use before appropriate corrective action has been taken. Has such a system been developed? Has such a system been implemented? 0 cl cl 0
Provide a copy of the document describing the system.
6.2 Components and final products that have been reworked or repaired to comply with the certification bodys requirements shall be reinspected and/or retested. Is this done? cl 0
Provide an organization chart showing the relationship of this person to other executive, administrative and supervisory positions. 7.2.2 A record of all certified components containing the following information shall be maintained : a) b) a description of the component, e.g. switch, relaY. etc.: the name of the supplier;
6.3 Products which bear the certification bodys certification mark and which do not comply with the certification bodys requirements or have not been covered by the certification programme shall have the certification mark removed before they are shipped from the factory. Is this done?
111
SP
60 :1993
c) the catalogue or model designation sufficient to provide specific identification; dl the electrical .rating;
b) environmental conditions and results of inspections and tests performed on the prototype product to verify conformance to the requirements of the certification body; c) photographs showing external and internal views of the product and its components along with sufficient description, such as drawings and/or text, to provide a record of the initially evaluated designs found to comply with the applicable product standard; d) schematic drawings of primary and secondary circuits;
e) a record of the standards, bulletins, notices and other requirements of the certification body used to determine compliance; f) whether the prototype examination and testing was carried out by the certification body or the supplier of the end product; g) the results of the tests.
Yes No
Is this record maintained? Inwhatform?
cl
e) list of primary circuit components and whether or not they are certified; if they are not certified, a description or drawingof the component and relevant test data to demonstrate conformance to the applicable requirements of the certification body; f) list of secondary circuit components that are in safety circuits; or not in Class 2 circuits; or
. . . . . . . . . . . . . . . . . . . . . . . . . . . .._......__....
Forhowlong? .......................................... Where is it available? .................................... -
8. Programme
8.1 Criteria
and product
records
records
in critical circuits (such as interlock circuits, patient circuits in electro-medical equipment, etc.). Yes Are such records kept? 0 0 No 0 0
concerning
programme
Production line inspection and test records that demonstrate the conformance of the final product to the certification bodys requirements shall include as a minimum
Do they contain the information described?
identification of the product; inspection and tests performed; inspection and test results; basis of acceptance; nonconformances; corrective action taken; measures taken to prevent recurrence; date of inspection and/or test; inspectors identification.
Who has the authority and responsibility to maintain these records? Name:................................................ Where are they located?
..
..
..........
8.3 Criteria ccncerning programme and product
filing and storage records
of
Are such records kept? Do they contain the information described? Wherearetheykept?.................................... 8.2 Criteria concerning product records
q cl
El
Programme and product records shall be filed for easy retrieval and availability to the certification bodys representative. Also, they shall be stored in a proper environment to minimize deterioration or damage and to prevent loss. The product records referred to in 8.2 shall be kept as long as the product is in use. The period of use will be mutually agreed upon by the certification body and the supplier, with due consideration to requirements under applicable warranties and laws. Agreed? 0 cl
Summary
of general details
The following records shall be kept for each product under this certification programme : al a copy of the nameplate, nameplate drawing or marker which shows the certification mark, identification number of the product and the electrical rating;
9.1 File: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date:.................................................
9.2
Suppliers name (in full) : ........................... .......................................................
112
SP 60 : 1993
Address (in full) : .......................................
....................................................... ............................................... .......................................................
9.5 Category of products manufactured at manufacturing location
. .......
....................................................... ................................................ ......
9.3 Manufacturing bxrpply) location name (in full) : ....................................................... Address fin full) : ....................................... .......................................................
9.6
Application
Completed by suppliers representative : Name:................................................
9.3.1
Design, test and evaluation facility (if applicable)
(Print)
Name (in full) : ......................................... Address (in full) : .......................................
Signature: ................................ Date : .....................................
.......................................................
For certification
bodys use only
Reviewed by Head of certification bodys assessment team
9.4
Name of representative responsible for handling matters relating to the certification body Representatives name : ................................. Position : .............................................. Physicallocation : ......................................
Name:................................................
IPrint)
Signature: ................................ Date : .....................................
SP 60 : 1993
CHAPTER
10
AN APPROACH TO THE REVIEW BY A CERTIFICATION BODY OF ITS OWN INTERNAL QUALITY SYSTEM (lSO/IEC GUIDE 56 :1989)
0
0.1
Introduction
One of the most essential elements for the operation of
2)
use
of
procedures and
which
provide
for
appropriate comparable surveillance
organizational testing an international certification system or for mutual recognition of national certificetion systems is confidence in the competence of the certification engaged 6.2 bodies participating in the system or in mutual recognition. can be built through a progressively arrangements, expandin cer-
administrative and methods,
structure, comparable
equipment
procedures, comparable legal protection and other features which assure that none of the participants is at undue risk in accepting other participants work.
Confidence
6.7 Agreements between systems in different countries covering a number
parties operating certification will generally include provisions in-
ing set of acceptance
bilateral or multilateral,
of items not dealt with in this Guide,
the process of a step-by-step approach to an international tification system, as described in ISO/IEC Guide 42. 6.3 The aim of the procedure recommended
cluding such items as exchanges of personnel, comparison of surueillance, testing and inspection techniques, the legal system to be utilized in case of dispute, etc.
in this Guide is
to facilitate and accelerate the initiation of such a process, by providing certification bodies with a means of maintaining and improving 0.4 their competence. 1) in the conformity cer-
1
body will be based
Scope
for use by a certification body
It is recognized
that confidence
This Guide provides a framework
tification system operated both -
by a certification
in assessing itself, its procedures, and its operations. The framework incorporates requirements and recommendations to be found in all relevant fSO/IEC reference documents. Using this framework, documentary cedure. a certification body should be able to compile a record
on the organizational
structure
and documented
pro-
cedures of the certification
body, and are applied and to enhance the
record of its internal quality system review prodistribution to all parties concerned. elements and
how
It will also be possible to use this documentary
on the manner in which the procedures the organizational structure serves of the certification
for subsequent
effectiveness
bodys operation.
0.5 Confidence should be based on identical fundamental elements and criteria to be met by certification bodies, which necessitates structure, cluded), functions 0.6 the appropriate surveillance being specified organization and and administrative facilities system. (if inof all facilities testing
Certification bodies may include other specific criteria depending on specific needs.
and legal and fees structure
the performance
References
booklet, Certification Principles and practice
ISO/ITC
The following certification
factors contribute bodies or involved
to increased confidence in an mutual international certification ISO/IEC Guide 2, General terms and their definitions and related activities concernin ing standardization
among
participating
certification arrangements: 1)
system,
use of equivalent
standards;
ISOIIEC Guide 7, Requirements duct certification
for standards
suitable for pro-
1 I Most of the points addressed in this Guide are covered in more detail in other ISO/IEC guides (see clause 2). The purpose of this Guide is only to facilitate the approach to the first steps recommended, for example, in ISOllEC Guide 42. In no way is it implied, however, that a certification body that has used this Guide to review its internal quality procedures will automatically be recognized by other certification bodies. Agreements between certifying bodies (reciprocity) require some form of assessment of each others arrangements regarding procedures, experience, organizational structure, legal framework, rules, auditing, testing, etc. A system of assessment involving examination teams may be required for a valid implementation of mutual recognition, as is the case, for example, in the IEC Quality assessment system for electronic components (IECQ).
115
-SF 60 :1993
ISO/IEC
Guide
16, Code of principles
on third-party
certifi-
6 6.1
Documentation
Before self-assessment can commence,, the system
cation systems and related standards ISO/IEC Guide 23, Methods of indicating systems 6.2 ISOllEC petence IS0 mity ISO/lEC Guide 28, General rules for a model third-party certifi6.4 In addition to the operational documentation the certification body should have a manual to cover ISOIIEC Guide 38, General requirements for the acceptance of a) b) c) ISO/IEC Guide 46, General requirements bodies approach to an e) list of names, qualifications and experience for the acceptance of d) organizational structure; chart which depicts responsibilities reporting ISOIIEC Guide 42, Guidelines for a step-by-step international certification system ISOIIEC third-party ISOIIEC bodies Guide 44, General rules for IS0 certification legal identification the administrative terms of reference of the certification structure body; Guide 25, General requirements of testing laboratories for corrective for the technical comThe elements booklet, to be documented are covered in the in ISO/ITC Certification Principles and practice, conformity with stanunder operation should be fully documented.
dards for third-party
certification
which eight typical systems are identified action to be taken by 6.3 tice. The main types of documentation booklet, Certification
(systems 1 to 8).
Guide 27, Guidelines
a certification
body in the event of misuse of its mark of confor-
are outlined in Chapter Principles and pkac-
5 of the ISO/ITC
cation system for products
testing laboratories ISOIIEC inspection Guide 39, General requirements bodies for the acceptance of
of the certification board;
body;
of the governing
certification
and
of each
or IEC international
member of the staff engaged in the actual certification process, including details regarding availability of staff in places other than headquarters; f) information including on any certification training
schemes for products accreditation systems -
Guide 54, Testing laboratory
training received by the
General recommendations
for the acceptance
of accreditation
staff,
in the principles
and practice of
quality assurance: g) staff instructions; documentation records, and change control; system used for their maintenance,
Definitions
in ISO/IEC Guide 2:1986, or any later
h) i)
The relevant definitions edition, are applicable.
including
and blank copies of report forms used;
Credibility
importance to any certification scheme, whether
jl
procedures
covering the control of marks of conformity
and actions to be taken in cases of misuse; k) procedure for investigating complaints action; to ensure confidentialreceived
Of prime
intended for internal, bilateral or multilateral use, will be its credibility and therefore acceptability. This aspect must be kept foremost becomes during any self-assessment programme, and critical to any international scheme.
and
taking any necessary corrective I) procedures ity; m) nl
and staff instructions
Elements to be addressed
internal qual-
publications; appeals (see ISO/ITC Chapter booklet, 5.11). to these elements are Certification Princi-
The elements to be addressed in a comprehensive ity system review procedure are the following : documentation (clause 6); (clause 7);
ples and practice,
The general requirements pertaining given in ISO/IEC Guide 40.
testing laboratories inspection certification
services (clause 8); staff (clause 9); (clause 10).
7 7.1
Testing laboratories
The testing laboratory may be an integral part of the
checklist for assessment
certification
body or it may be a separate entity.
116
SP 60 : 1993
7.2
It is not intended
that this Guide cover the work of testing
10.2
Procedures
by which the system is operated include provision
laboratories. Procedures
7.3
formed testing 7.4
It is of for
critical
importance purposes
that
the
testing
work
per-
for a) competent and responsible management and ap-
certification
be done
by a competent propriately trained staff; on a non-discriminatory validation basis; activities; testing and inspec-
laboratory. Testing work performed laboratory for certification purposes specific is to be in ap-
done by a testing ISO/IEC propriate 7.5 Guides
that meets the criteria involved. have a system
specified criteria
b) cl d)
participation both
25 and 38 and additional
for the type of product body should points.
initial and continuing and retention
The certification
of laboratory
selection
of qualified
selection
based on these
tion services; e) dispute resolution through an impartial appeals
7.5 A laboratory suitably accredited for the purpose be capable of satisfying the above requirements.
should
mechanism;
f)
notification
to licensees
of changes
in standards
and
8
8.1
Inspection
services
body may be an integral part of the cer-
procedures; g) confidentiality maintenance safeguarding revocation monitoring of proprietary of records; use of mark, of authorization procedures including legal support; information;
The inspection
tification
body or it may be a separate entity. purposes is to the criteria of for
h) i) j) k) etc;
8.2 Inspection work performed for certification be done by an inspection body that meets ISO/IEC Guide 39 and additional involved. specific the type of product
criteria appropriate
to use mark; regarding periodic inspections,
9
9.1
take
Certification
Staff and should should knowledge
staff
I) be competent have the for the functions necessary education, they undertraining, training programme on certification for the benefit work. of industries and staff engaged in certification
technical 9.2
and experience. on the academic body. Records or other of training qualifications and
10.3
should be maintained and experience
Requirements
for
for licensing
include (see clause 6 of ISO/IEC
Information
experience should 5.3
of each member
of the staff
Requirements Guide 28)
licensing
be kept up-to-date. Staff should pertaining should work body ensure have available be maintained to them clear documented and responsibilities. up-to-date. b) technically spection; c) d) complaint provisions appropriate resources for testing and inina) suppliers quality management system. and documentation (only for Systems 5 and 6 described in the ISO/ITC booklet, Certification Principles and practice);
structions instructions
to their duties
These
5.4 When certification and should
is sub-contracted to an outside body, the is responsible for the sub-contracted work that the party performing body the work meets for a testing laboratory referred referred to in 7.4, and to in 8.2. more than
records against
system; non-conforming products to which
the requirements the requirements 9.5
for an inspection
the mark is applied; In small organizations, one person may fulfil one function. e) f) provision practices for notification relating to the of product changes; body
use of the certification
10
Checklist
for assessment
name or mark of conformity.
NOTE - The following checklist for assessing a certification bodys operation of third-party certification systems is based on ISO/IEC Guides 7, 23, 25, 27, 28, 38, 39 and 40.
10.4
Indication
of conformity
by a certificate or mark which body; supplier Guide 23);
Conformity
is indicated
10.1
Standards
a) reflects includes the registered information where mark of the certification on product, applicable standards, b)
Standards upon which the system is based, covering products, processes and services, shall be suitable for use as a basis for certification.
and other parties,
(see ISO/IEC
SP 60 : 1993
cl presents clearly the extent of the certification, where applicable.
10.6
Fee structure
and financial
aspects
10.5
Documentation
Documentation required by the system includes a) availability of a published programme directory listing products, processes and services which may be certified, standards, licensees, and other parties; b) c) d) file of legally binding agreements with licensees; availability of statement covering operating procedures; availability of annual review or report.
The certification body should have well laid out guidelines from the financial point of view for granting licences and for operating the certification system (see clause 19 of ISO/IEC Guide 29).
NOTE - When complete, the checklist will be accompanied bv a document which will key each item to relevant sections of the ISOliEC reference documents.
11
Appeal
The certification body should provide for an independent line of appeal available to its licensees.
118
SECTION 4 ACCEPTANCE
FOREWORD
OF INSPECTION AND CERTIFICATION BODIES
In the international sphere, the technical barriers to trade appear when the national regulations concerning one product are more stringent in the country of destination than in the country of origin. Therefore, the documented procedure, harmonized world over, should be laid down for the inspection/accreditation bodies. This would facilitate mutual acceptance of products or systems between countnes thereby facilitating the removal of non-tariff barriers to trade. Chapter 3 of this section sets forth criteria, the observance of which is intended to ensure that certification bodies possess the necessary competence and reliablity to operate a third party certification system and thereby facilitate their acceptance or recognition on a national or international basis.
Inspection is an important component, associated with other activities, including certification, that assists in national and international trade. Considerations of competence, impartiality and integrity are Chapter 2 of this section sets out fundamental to the acceptability of the inspection processes. general criteria, the observance of which is intended to provide that the services of the inspection bodies are conducted with technical competence, impartiality, confidentiality and thoroughness, careful observation and accurate reporting by competent staff, and to serve the needs of all its customers. In the event of misuse of its mark of conformity, a certification body has to take corrective actions. Chapter 1 of this section identifies series of procedures which a national certification body should consider in deciding how it should respond to: a) A reported misuse of its registered mark of conformity, or to be hazardous
b) A situation in which a certified product is subsequentlyfound This section is based on the following ISO/IEC Guide 27 ISO/IEC Guide 39 ISO/IEC Guide 40 3 ISO/IEC Guides:
Guidelines for corrective action to be taken by a certification event of misuse of its mark of conformity, 1983 General requirements General requirements for the acceptance for the acceptance of inspection of certification
body in the
bodies, 1988 bodies, 1983
119
SP 60 : 1993
CHAPTER
GUIDELINES FOR CORRECTIVE ACTION TO BE TAKEN BY A CERTIFICATION BODY IN THE EVENT OF MISUSE OF ITS MARK OF CONFORMITY (lSO/IEC GUIDE 27 :1983)
1 1.1
Introduction
The purpose in deciding
a reported a situation
of this paper is to identify how to respond to
a series of procedures
which
a national
certification
body
(tron governmental)
shoLild
consider
a) b)
:
mark of conformity, is subsequently will depend or found to be hazardous* of factors such as
misusel) in which
of its registered a certified body
product chooses
The action
that a certification
upon a number
: the laws of the country
in which the mark;
the the
misuse occurs; the nature of the contract or agreement between the certification body and the party misusing seriousness of the misuse; whether the misuse was inadvertent or deliberate; whether the product is hazardoussj. It is recognized as a producer that a manufacturer or distributor or distributor product of a product which can be involved in two distinctly different ways, namely,
as a misuser or
of a marked
subsequently
is found
to be a hazardous
product. develop and which might of in
It is also recognized
that the ability
to foresee
all potential
forms of misuse or other forms of use that might
result in a marked product misuse. While the hazards each situation In deciding requires
becoming hazardous is exceedingly more difficult than to safeguard the obvious and common forms arising from these different situations both require corrective actions the assessment of responsibility different is might considerations. take, the certification body will be motivated by a desire to protect the integrity
quite
upon what action
of its mark, to
assist persons who may be misled by the misuse of the mark and to provide equity to competitive users of the mark, while being cognizant of the problem of mass production and distribution. The corrective action described herein is based on the premise that, in general, the following conditions exist
:
the use of a mark of conformity which is applied to each certified product.
1.1.1 The certification 1.1.2 The certification

law of the country
system
involves
body
has its mark of conformity it is headquartered.
registered
or in other ways the use of its mark protected
under at least the
in which
11
Misuse may take a variety of forms such as al misapplication of mark or non-conforming
:
products, e.g. a non-conforming product may result from a violation of a contract, inadequate by a certification on non-certified body or laboratory; products.
quality control, or error in assessment b+ 21 unauthorized
of conformity
use of the mark, e:g. mark appearing
Some reasons for which product al b) c) inadequate standards;
may be found to be subsequently
hazardous are
unanticipated
end-use of a product; defect.
a manufacturing
31 This document is limited to corrective action applying to a mark of conformity; the case of certificates of conformity might be considered at a later stage il a demand exists. The document is directed at non-governmental certification bodies, although it could also be used by governmental certification bodies operating similar types of certification systems.
121
SP 60 : 1993
1.1.3
A contractual
arrangement
or legal agreement
concerning
the use or misuse of the mark of conformity
exists between
the cer-
tification
body and the party authorized
to use the mark.
1.1.4
The party authorized
to use the mark is capable of exercising continuous
control over the certified product(s)
to ensure that all
terms of the contract
are met.
1.1.5
The mark of conformity
cannot be applied to a product except upon authorization
and control of the certification
body which
owns the mark.
1.2
Certification
bodies will normally take strong corrective action when their mark is counterfeited The action that can be taken depends in part upon the laws of the country
and applied without any form of in which the counterfeiting and
contract
or agreement.
misuse occurred.
2
2.1
Definitions
recall
: The action by which the misuser or the producer of a subsequently

the products from users, the marketplace action.
recall must be effected
hazardous product or other party responsible for or distribution sites and returns them to the factory
making the product available withdraws or other acceptable

NOTE -
location for corrective
Because of legal problems of ownership,
by the manufacturer
or other party responsible for products
distribution
2.2
misuser
: Any person, organization or other corporate body that has misused the mark of conformity whether or not the pro-
duct is eligible to bear the mark.
2.3
producer
of a subsequently
hazardous
product
(POSHP)
: Any person, organization or other corporate body that has been

of that body to the product(s)
complying
with all requirements
body, has properly applied the mark of conformity
involved but has learned that the product(s)
has (have) been found to be hazardous.
2.4
hazardous
: With respect to a manufactured

and there is either or
product,
means exposing
life, limb or property
to dangerous
or imminently an unac-
dangerous conditions. ceptable a) b) percentage,
A hazardous product is considered to exist if the quantity of products involved is such as to constitute
an unsafe construction,
the product is gaining widespread
use in applications and
not foreseen when the standard was written,
such applications
in turn
being ones for which the product was not certified,
no specific scope of applications no limiting scope of applications
has been provided in the standard,
and in written material accompanying the product at
has been provided by the manufacturer
point of sale.
NOTE Where an inherent hazard is necessary for the product to perform its intended function, hazardous as used in the context of this definition. e.g. rotating beaters of a food mixer, such a hazard
shall not be considered
2.5
corrective
action
: This is an action requested of the misuser or of a POSHP or other party responsible for making the product
by the certification body to eliminate the consequences of the misuse and to remove the hazard as possible.
available as considered appropriate far as necessary and practically
3
3.1 that
Conditions
under
which
corrective
action
is taken
the mark of conformity has been affixed to a product
The certifying body requires a misuser to take corrective action whenever
is hazardous,
or to bear the mark of conformity, e.g. because there is no record of the product in question having been CQKrequirements to the extent that the integrity of the mark of conformity is
is not authorized
tified; or does not comply with the applicable certification jeopardized, or
122
: SP
60 :1993
bears an unauthorized
form of mark of conformity agreement.
(e.g. counterfeit
certification
label), or
is in violation of the certification
3.2
When either a report of misuse of a mark of conformity body should production determine the scope of misuse, involved.
or of a hazard involved with a product bearing a mark of conformity Where it is established that misuse has occurred, model number, serial numbers, factory products,
is the
received by the certifying body, the validity of the report should be investigated. certifying facilities, including runs and quantities
production
Types
of corrective
action :
in the opinion of the
Corrective
action could be one or more of the following
a) notification by the certification body of parties authorized and responsible for instituting a recall when, body, such recall is necessary to protect the public, and to permit implementation of action; b) removing the mark of conformity from the product.
(This is normally done only at the factory or other central location so that
the product in question is removed from the stockroom, marketplace, distribution sites or users possession. Alternatively, the mark of conformity could be removed from the product on the site, provided such removal is in collaboration with the involved regulatory c) authorities who would then proceed to accept or reject the product.); requirements. (It is preferred that the rebuilding be to the factory, e.g. electric
rebuilding the product so that it complies with the governing certification however, when it is not practicable may be authorized or large furnaces, rebuilding
done at the factory; switchgear
to recall some of the units in question to be done in the field.);
d) scrapping or suitably replacing a returned product because it is not practicable either to remove the mark of conformity rebuild the product so that it complies with the governing certification requirements; e) where a hazardous condition exists and it is not practical to implement
or to
a), b), c) or d), a notice to the general public about the
hazard should be issued or action taken consistent

NOTE Where a POSHP is wwolved the certification
with other national legislation.

action to take the initiative to have the standard re-
body should itself take corrective
quirements upgraded conformity.
to eltminate the hazard and to take such action as to ensure that products involving the same hazard do not bear the mark of
5 5.1
5.2
Choice
of action
against
the misuser
by the nature of the misuse and its subsequent consequences.
The type of corrective
action to be taken will be influenced
When the mark of conformity
has been used but not under contract or not in compliance action will be.
with the contract,
legal proceedings
might result in a court of law deciding what the corrective
6
6.1
Timing
When
of correctivb
the facts indicating
action
a need for corrective action are conclusive, the certification body will initiate corrective action im-
mediately provided there is a misuser to be held responsible for such action or a POSHP.
6.2
When the facts are conclusive and corrective action is indicated but there is no misuser or POSHP is bankrupt), the certification body should obtain advice from legal counsel and notify appropriate
to be held responsible regulatory
(e.g. and
the company marketplace, public bodies.
or the product in question has not been produced for a number of years and is no longer available in the governmental,
7 7.1
Initiating
corrective
action
with
misuser
corrective action the
When there is conclusive proof that a product is hazardous or is involved in misuse of the mark of conformity, the product. In such instances, by telephone or telex of the problem, and authorization
should be initiated by the body that certified
the misuser of the mark and, where appropriate,
regulatory authorities shall be notified immediately formity to the involved product shall be suspended.
to apply the mark of con-
123
SP
60
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7.2 Also in the case of a hazardous product bearing the mark of conformity, the certification body should inform the misuser of the need to take appropriate user notification action, advising of the hazard and the action to be taken. 7.3 The initial notification to the misuser should always be confirmed in writing by registered (or equivalent) letter with copies to the appropriate regulatory authorities and/or other bodies when relevant. (This letter is written to suit the particular circumstances, e.g. depending on whether or not it is practicable for the product in question to be recalled to the factory.) In either case it would normally contain : the reason(s) for corrective action, any hazardous conditions that may exist, the actions to be taken by the misuser to resolve the problem and a statement covering the action to be taken to ensure that the mark of conformity is not applied to ineligible products.
Completing a successful certification body
corrective
action with a misuser who has an agreement
with the
When the corrective action has been resolved to the satisfaction of the certification body, the following should be undertaken :
a)
All recipients of the letter which called for corrective action should be sent a second letter which states the suspension imposed upon the misuser has been lifted and that authorization to use the mark of conformity has been reinstated; summarizes the corrective action taken by the misuser;
when applicable, describes the new marking required to distinguish the product in its corrected state from its previous unacceptable condition. b) Certification records should be revised to include any modifications necessitated by the corrective action.
The certifying body shall also carry out an audit of :
its own approval and surveillance duties to determine whether part of the misuse is due to a weakness in its own organization;
its procedures to determine the means whereby the approval and surveillance responsibilities of the certifying body, or its laboratory, can be altered to ensure so far as realistic to do so that such a misuse of the mark cannot be repeated.
Degree of corrective
action to be achieved
6.1 The certification body desires the corrective action to be taken on one hunderd percent of the particular product involved. This, of course, frequently is not possible, especially if the product has been on the market for a considerable time. Normally the certification body considers that corrective action as appropriate has been carried out satisfactorily if : a) the misuser has made a proper public announcement when asked to do so;
b) the products in the marketplace and distribution sites have been recalled, rebuilt, replaced or destroyed under supervision, or other corrections thereto made as required to the maximum degree feasible; c) the misuser has agreed to continue the required corrective action on units which are in the.possession of the user until the certification body is satisfied that the maximum practical result has been achieved, and d) such necessary steps have been instituted in the manufacturing process to obviate the production of productswhich will again require similar corrective action.
10
Refusal to take corrective
action
10.1 When a misuser refuses to take corrective action, the following steps should be taken by the certification body :
a) cancellation of appropriate certification contracts with the misuser may be processed;
b) regulatory authorities involved and/or other bodies, when relevant, shall be informed that the misuser has refused to take corrective action and that certification contracts in the name of the misuser have been cancelled, where the severity of the case warranted such action;
124
SP 60
: 1993
c) legal counsel shall be obtained as to other action that may be taken (e.g. court injuctions, a press release by the certification body prosecution). 10.2 A POSHP would probably take corrective action voluntarily upon learning that his product contained a hazard even though conforming to the applicable standard(s). 10.3 In the unlikely event that the POSHP refused to take corrective action, discussionswith concerned regulatory authorities and legal counsel should be held to decide upon a course of action. In addition to action that regulatory authorities might take, some possiMe courses of action open to the certifiition body would include a) obtaining rapid revision of the standard to eliminate the hazard and requiring all certified products of the type involved to meet the new criteria at an early date following publication of the revision to the standard, and b) notifying the public of the discovered hazard via the most appropriate news media.
SP 60 : 1993
CHAPTER 2
GENERAL REQUIREMENTS FOR THE ACCEPTANCE INSPECTION BODIES (ISO]IEC GUIDE 39 :I9881
OF
Scope
of which is
3.2.2 client : Any party which employs an inspection body for any purpose. This term can thus refer to a commercial customer or to a certification body who uses the services of the
This Guide sets out general criteria, the observance
intended to provide that the services of inspection bodies are conducted with technical competence, impartiality, confidentiality and thor0ughness, careful observation and accurate reporting by competent qualified staff, and to serve the needs of individual users, national government, local government,
inspection
body.
4 4.1
Organization
An inspection a)
and operational
body shall
procedures
certificationl accreditation and other bodies, as they relate to certification and related activities.
NOTES 1 The inspection body or the functions it performs could be an in-
be legally identifiable; have an organizational the capability to structure that enables it to mainperform its technical functions
tegral part of a certification entity. 2
or other body, or it could be a separate
b) tain
satisfactorily;
Where an inspection body carries out its function on behalf of a cerbody, it is normally required to work to the specific instrucbodv. tification
c)
have
a technical
manager
and
a deputy,
however in and
tions, of the certification
named,
who are appropriately of the inspection for ensuringthat
qualified and experienced the specified objectives
the operation responsibility
body and who have overall
References
Guide 2
the criteria contained
herein are met; by
ISO/IEC
: 1986, General terms and their definitions

and related activities. Vocabulary.
concerning IS0 8402
standardization
d) clearly define the areas of technology to becovered its inspection services and for which it is qualified;
: 1986, Quality -
e) be able to demonstrate, on request, that it is capable of providing the required inspection services; f) be so organized as not to subject staff members to undue pressure or inducement that might influence their judgement or the results of their work; interest, nor be part of an organizpro-
3
3.1
Definitions
The relevant
definitions
contained
in ISO/IEC
Guide 2
g)
have no commercial
and IS0 8402 are applicable.
ation having direct commercial cess or serv,ice to be inspected; definitions
interest in the product,
3.2
For the purposes of this guide, the following
are also applicable.
h) not engage in, or.have engaged in, any consultancy service that conflicts with its role as an inspection body.
3.2.1 inspection body the organization, staffing, understood ommending production opertitions, in factories, to include
: Third party impartial body having

competence such and integrity to pet-form services are reca) clear demarcation between actual. inspection services and any certification, b) auxiliary or unrelated while performing functions; an inspection, directed; to as assessing, 4.2 An inspection body shall have procedures for
inspection services to specified criteria. Inspection functions for acceptance and subsequent
audit of suppliers
and testing facilities, laboratories
personnel and quality control of products on site or limiting its activities, as directed. those functions for which it is specifically
and selection and evaluation or elsewhere
1)
A recommended
format for providing information
on the inspection
body is given in annex 8, which is not an integral part of this Guide.
127
SP 60 : 1993
cl ensuring that inspection procedures and other matters are continuously co-ordinated with the certification body or others using the services of the inspection body; d) ensuring that the integrity of inspection results and procedures are not compromised by external relationships; e) dealing with feedback and corrective action whenever inspection discrepancies are detected; fi dealing with technical complaints;
b) to ensure that all changes of documents or amendments to documents are covered by the correct authoritation and processed in a manner which will ensure direct and speedy action at the effective point; c) to ensure that superseded documents are removed from use throughout the organization and its agencies; d) to notify relevant parties of significant changes.
6
g) the consideration and resolution of appeals against its decisions. 4.3 The inspection body may also barequired to provide information on items such as a) if formal recognition is sought, the history of the inspection bodys experience in the area for which recognition is sought; b) the geographical area currently served by the inspection body and the categories of clients which use its services, e.g. suppliers, government agencies, etc.: c) any other technical services provided by the inspection body in the areas for which it seeks recognition; d) if formal recognition is sought, details of recognition granted by other bodies to the inspection body; e) f) the ownership of the inspection body; the qualification of its managers and staff.
Staff
6.1 The inspection body shall have sufficient staff to carry out the work for which it claims to be competent. The staff shall have the necessary education, up-to-date training, technical knowledge and experience for their assigned functions, and shall be subject to effective supervision.
6.2 Staff having responsibility for making initial recommendations for acceptance of suppliers quality assurance systems on products shall be a) qualified in appropriate disciplines;
bl suitably experienced in the practical applicationof quality assurance, inspection techniques and production methods. 6.3 Staff having responsibility for subsequent monitoring of a suppliers quality assurance system, if not professionally or academically qualified, shall be supervised by qualified staff, and the requirements of 6.2a) shall be met. The proportion of such staff to qualified staff shall be such as not to degrade the work undertaken.
Quality system
5.1 The inspection body shall operate an effective internal quality system appropriate to the type, range and volume of work performed. The quality system shall address all of the criteria contained in this Guide and shall be documented. The documentation shall be available for use by the staff of the inspection body. It shall be maintained relevant and current by a responsible member of the staff. A person or persons having responsibility for quality assurance within the inspection body shall be designated by the management of the inspection body and shall have direct accessto top management. 5.2 The quality system shall be systematically and periodically audited and reviewed by or on behalf of management to ensure the effectiveness of the arrangements. Such audits and reviewa shall be recorded together with details of any action taken. 6.3 The inspection body shall maintain a system for control of all documentation relating to its quality system so as a) to ensure that the current issues of the appropriate documentation are available at all relevant locations and to all relevant staff;
6.4 All staff shall be aware of the extent and any limitations of their responsibilities. 6.5 Remuneration of staff shall not be influenced by the frequency or the results of inspections.
6.6 There shall be a job description for each technical position category, which includes the necessary requirements for education, training, technical knowledge and experience.
Inspection
methods and procedures
7.1 The inspection body shall use methods and procedures detailed in the requirements against which the inspection is to be performed. The requirements shall be available to staff performing the inspection. 7.2 The inspection body shall have and use adequate documented instructions on standard sampling and inspection techniques, where the absence of such instructions could jeopardize the efficacy of the inspection process. All instructions, stahdards or written procedures, worksheets, check lists and reference data relevant to the work of the inspection body shall be maintained up-to-date and be readily available to the staff.
120
SP
60 :1993
7.3
When
it is necessary
to use methods any deviations,
and procedures to or ex-
12
12.1 with
Report
The work carried out by the inspection the requirements of the body utilizing body shall be and
which are not as required,
additions
clusions from the requirements
shall be recorded.
covered by a report to its clients which shall be in accordance its services
8
8.1
Handling
of samples
samples shall be applied, either
which accurately, clearly results of the investigation. identification.
and unambiguously conveys the All reports shall carry a distinctive
A system for identifying
through documents or through marking, to ensure that there can be no confusion regarding the identity of the samples or items.
12.2 All reports should normally be approved or reviewed by the inspection bodys staff at an appropriate supervisory level.
8.2
A procedure shall exist for bonded storage of items when 12.3 The inspection body, the certification body and any other body involved which has legitimate access to the reports
necessary.
8.3 items,
At all stages precautions for example
of storing,
handling
and preservation
of
samples,
shall be taken to prevent damage to the by contamination, corrosion or the appli-
shall ensure that at all times such reports are maintained fidential and secure for an appropriate period.
con-
cation of stresses, any of which would invalidate the later test or inspection results. Any relevant instructions provided with the item ,shall be observed.
12.4
Consistent with the wishes of the party utilizing the serbody, particular care shall be given to of inspection reports, especially with regard to of the inspection carried out. data and ease of assimilation
vices of the inspection the arrangement the presentation
8.4
There shall be clear rules for the receipt,
retention
and
by the reader. The format shall be specifically designed for each type of inspection
disposal of samples.
Financial
stability
body shall be financially sound.
12.5 Corrections or additions to an inspection report after issue shall be made only by a further document suitably marked, e.g. Supplement to inspection report serial number
The inspection
..
10
Communication
capability
13
13.1
Confidentiality
The inspection information.
and security
body shall have adequate of proprietary security rules rights and con-
The inspection body shall be able to communicate effectively with the users of its services in the relevant geographical area. Where required, competency facilities, in appropriate languages, ineluding translation shall be demonstrated.
and measures for the protection fidential
11
11.1
Records
The inspection body shall maintain a record system to of other involving in-
13.2 The inspection body shall be willing to observe terms and conditions to provide for confidentiality and security of its practices as required by its clients.
suit its particular spection.
circumstances
and the requirements relationships
bodies with which it has contractual
13.3
Inspection bodies may in the course of their duties receive information such as manufacturing processes, market information, volume or value of production, which is of a secret that this nature or confidential. It is of the greatest importance
11.2
The inspection,body
shall retain on record all inspection
reports, original observations, calculations and derived data and the final inspection report for a predetermined period. The records for each inspection shall contain sufficient information to permit satisfactory repetition of the inspection. NOTE - In some countries it may be necessary fo maintain records for a period specified by law.
confidentiality
be respected at all times and be subject to a clear body, its clients and the
understanding between the inspection manufacturer subject to inspection.
13.4
All inspection staff shall be made aware of the need for confidentiality and security of their work. The distribution of confidential information within the staff shall be limited to those persons whose job requires that they have such information.
11.3
The inspection
body,
the certification
body,
and any con-
other body involved which has legitimate access to the records shall ensure that at all times such records are maintained fidential and secure for an appropriate period.
13.5
All staff engaged in field inspection work shall be issued with positive distinct identification.
129
SP
60
: 1993
i4
14.1
Facilities
and equipment
The inspection inspection.
body shall advise and obtain agreement to sub-contract any portion
from of the
its clients of its intention The inspection body shall have suitable and adequate facilities and equipment to permit all needed activities associated with the inspection services to be carried out.
16.2
The inspection body shall record and retain details of its
investigation of the competence and compliance of its subcontractors and maintain a register of all subcontracting. These
14.2
The inspection staff shall, when applicable, be furnished with the equipment required for the performance of
details shall be available recognition.
on demand
to the body
granting
their services.
16 15
15.1
Co-operation
The inspection body shall afford the client reasonable of the
Sub-contracting
16.1
co-operation inspection 16.2
to enable him to monitor the performance in relation to its contract.
Inspection bodies shall themselves normally perform the inspection which they contract to undertake.
The inspection body shall afford the body with which it relations involving inspection services such with
has contractual When an inspection body sub-contracts any part of the inspection, it shall ensure that its responsibilities and obligations for the inspection conducted on its behalf are fully met. The inthat its spection body shall ensure and be able to demonstrate
reasonable cooperation as necessary to assure compliance these requirements and other criteria.
sub-contractor is competent to perform the services in question and where applicable complies with the criteria stipulated in this guide and with any additional being sub-contracted. requirements for the work
17
Formal
recognition
of inspec-
Information regarding issuance of formal recognition tion bodies is contained in Annex A.
SP
60
: 1993
Annex Recommendations for formai
A of inspection bodies
recognition
A.1
As used here recognition srgnrfies a forrnalrred judge ment granted by another body that the inspectron body has an acceptable level of competence rn providing services identified in the recognrtron and further
e) upon the termination of its recognition (however determrned) forthwith discontinue its use and all advertising matters which contain any refererlce f) make it clear in all contracts thereto;
demonstrated the inspection
has entered into a written agreement to comply with the requirements of this Guide and all other requirements of the body granting recognition.
with its clients that the in reports
spection bodys recognition
or any of its inspection
by themselves in no way constitute or imply product or system approval by the body granting recognition or by any other body; gl endeavour to ensure that no inspection
Recognition should not be regarded as in any way diminishing the normal contractual responsibilities between an inspectron body and its clients. While recognition will normally be a sound of t.he inspection body, it
report or any
I indicator of the technical competence
part thereof shall be used by a client, or be authorized
by a
cannot be taken to constitute a guarantee by the body granting recognition that the inspection body always maintains a particular level of performance.
client for use, for promotional or publicity purposes, if the body granting recognition may reasonably consider such use to be misleading.
A.2
The following
additional
requirements
shall be met by
A.3
In making
reference
to its recognition
status in com-
inspecti,on bodies seeking recognition a) at all times comply
:
and with
munication media such as documents, brochures or advertising, the inspection body shall use the following phrase as aprecognition;
with these requirements by the body granting
other criteria prescribed b)
propriate : an inspection body recognized by lbody granting recognition1 for the inspection of [product, services or field of inspection for which recognition has been granted1 identified by registration number(s)
claim that it is recognized for which
only in respect to inspection granted -recognition and with these requirements recog-
services
it has been
which are carried out in accordance and other criteria prescribed nition; c) pay such fees
by the body granting
A.4
The inspection body shall requite that its clients who refer to use of a recognized inspection body shall use the following phrase as appropriate : Inspected by [name of inspection body1 which is recognized by lbody granting recogherein and iden-
for application,
membership,
assess-
ment, surveillance and other services as shall be from time to time determined by the body granting recognition having regard to the costs involved; d) not use its recognition in such a manner as to bring the body granting recognition into disrepute and not make any statement recognition relevant to its authority may reasonably which the body granting consider to be misleading;
nition] for the inspection services described tified by registration number(s) _
A.5
The body granting
recognition
shall be notified
by the
inspection body of any changes bearing on its competence with these requirements and other criteria affecting the inspection bodys capability or scope of activity.
1)
Inclusion of thusclause is at the discretion of the body granting recognition.
131
SP 60 : 1993
Annex
B body
Information recommended to be provided by the inspection on application for recognition or during assessment
B,l
B.l.l
Introduction
and instructions
8.2.6
This document together with a contract will form the basis under which inspection/surveillance visits by the body granting recognition will be carried out.
Detail geographical areas covered by above recognitions and indicate clearly if any limitations exist in area of operation.
B.2.7 Describe technical area and type of inspections, and geographical area, for which recognition is sought.
8.1.2 All sections of this document should be completed and supplements should be included where necessary. The statements should relate to the facilities available at the date of completion of this form.
8.1.3
.B.3
8.3.1
Organization
Name technical manage&J (however named) who has (have) overall responsibility for ensuring that aims and criteria are met. 8.3.2 Basic organization of inspection body
8.2
8.2.1
General
Inspection bodys name and address :
....................................................... ....................................................... ....................................................... ....................................................... ....................................................... .......................................................

Telephone:......................................... Telex: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Telefax : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B.2.2 The inspection body should appoint a person who will be the contact with the body granting recognition and shall also appoint other persons who may be contacted in the absence of the main appointee : Nominee and title : , . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Describe how areas of technology are defined and 8.3.2.1 made known to staff.
Describe how staff are made aware of the extent and 0.3.2.2 limits of their responsibilities.
8.3.2.3 Describe how co-ordination of interpretation and operating procedures are observed. 8.3.2.4 Describe how supervision of staff is achieved.
Describe lines of demarcation between actual inspec8.3.2.5 tion operation and any auxiliary/unrelated functions.
8.3.2.6
Give any other information on basic organization.
....................................................
Deputies: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .................................................... 8.2.3 State if inspection body is recognized nationally/internationally
8.3.3 Are appropriate technical and managerial staff under direct control of inspection body and are they appropriate to declared areas of technology? (See 8.2.5.) 8.3.4
If the inspection body is part of a larger organization, show its relationship to that organization. .
B.2.4 Detail any existing recognitions by certification or other bodies

8.2.5 Detail areas of technologies covered by above recognitions and indicate clearly those areas covered by this assessment.
8.3.5 Where applicable, describe how the inspection body is related to external organizations. 8.3.6
How are staff protected from commerciat or other influences?
132
SP
60
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B.3.7 Is there a prescribed system for detecting deficiencies in inspection and their cause, and for correcting unfavourable trends?
B.6.2 recording
Is there
a system
for
updating,
implementing
and
changes to these documents?
B.6.3 B.3.8 State any other considerations affecting organization. spection
Are documents, body?
including work sheets and check lists, work performed by the in-
available for each type of inspection
B.4
Quality
system
of the
8.6.4
Are documents condition?
and reference
data maintained
in an
up-to-date B.4.1 Name person responsible for the co-ordination quality system of the inspection body.
:
of the
B.4.2
Are
policy and procedures
for the operation
B.6.5 etc.?
Is obsolete
data promptly ,.
removed
from documents,
inspection 8.4.3
body documented? for quality management B.6.6 Are there inspection work? clearly documented procedures for the
Have the persons responsible and authority solutions?
the responsibility initiate effective
to identify quality problems and B.6.7 Are inspection methods and procedures manuals, recorded etc.? which are not called up in specifications,
8.4.4
Does the documentation
contain
procedures
for the
supervision of any unqudlified
staff?
B.7
B.4.5 Is there a prescribed audit quality management functions? procedure for checking B.7.1
Handling
of samples
Are work and sampling instructions prescribed and imfor the selection, preparation, handling, marking, of samples?
plemented
storing and dispatch
B.5
B.S.1
Staffing
B.7.2 Totalnumberofstaff: Are appropriate or damage storage areas arranged to prevent deterioration to the items concerned?
8.5.2 ture.
a)
Provide organizational
chart showing
staff strut
B.7.3
Are storage methods
prescribed,
including special en
vironments? for each position shown
b) Provide list of job qualifications on organizational chart.
8.7.4 storage?
Are there procedures
for the inspection
of samples in
c) List under appropriate job those persons who exercise supervision of the functions shown on the organizationai chart.
6.7.5 Are persons?
storage
areas
accessible
only
to
authorized
8.5.3
Indicate
practical
experience
in quality and/or
assurance
of
B.7.6
Is provision
made
to ensure
that all samples
to be
staff with
responsibilities
for assessment supervision
recommend
stored, packed or dispatched are adequately identified
to testing laboratory
or elsewhere
ding acceptance quality control.
or subsequent
of manufacturers
and labelled?
B.5.4
Indicate extent of non-qualified of this category
staff and describe how
8.8
Records
and reports
body and
supervision
of staff is achieved. B.8.1 Indicate documentation used by inspection the methods of scheduling inspection visits.
8.5.5
Language
are staff fluent in
(language
to be
specified by body granting recognition)? interpretation/translation facilities exist?
If not, do adequate 8.8.2 and maintain 8.8.3 current, quired? Are there arrangements for ensuring that records are complete, accurate and held confidential where reAre observations and calculations inspection recorded and stored as to provide a permanent record?
8.5.6
Are training
methods
applied
to attain
skills with due attention
to quality requirements?
B.6 8.6.1
Inspection
Are manuals,
methods
work
and procedures
regulations, stan-
instructions,
B.8.4
How are records maintained?
dards, work sheets, check lists, etc. to be used by staff readily available? B.8.5 Indicate report format to be used
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60
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8.8.6
B.8.7
Do inspection reports contain all required information?
B.10
8.10.1
Other
requirements
body accept that there will be basis by the body
Does the inspection
Is the inspection body prepared to make arrangements granting basis?
to send copies of inspection reports to the body recognition, where required, on a strictly confidential
supervision and monitoring granting recognition? B.10.2 bearing
on a continuing
B.8.8 spection
Designate reports.
staff
having
responsibility
for signing
in-
Detail any other considerations which may have a on the recognition of the inspection body, such as agreements, local legal or operating prac-
possible reciprocal tices and the like. B.10.3 What other bodies? affecting their
type of inspection
work
is sub-contracted
to
B.9 B.9.1
work?
Confidentiality
and security
Are staff made aware of confidentiality
8.10.4 Are there written guidelines for co-operation wlrh clients and with bodies granting recognition to the inspection body?
8.9.2
Are
staff
assessed
for security?
Is there
a security
bond or are there clauses in contracts
covering
security!
B.ll
The
Authentication
information contained in this declaration is true and
B.9.3 work?
What actions are taken in respect of security and conof documentation relating to any sub-contract
accurate. Name of inspection body Date
fidentiality
: .._ :
: _...........................
officer (signature and title)
B.9.4 Are staff issued with equivalent means of identification
an identification by the inspection
card body?
or
Authorized
SP
60
: 1993
CHAPTER
GENERAL REQUIREMENTS FOR THE ACCEPTANCE OF CERTIFICATION BODIES (lSO/IEC GUIDE 40 :1983)
This Guide is one of a series covering the requirements for the acceptance of testing laboratories of inspection bodies (ISO/IEC Guide 39) and the acceptance of certification bodies themselves
(ISOIIEC (ISO/IEC
Guide 381, the acceptance Guide 40).
1
1.1
Scope
and field
of application
criteria, the observance a third-party of which is intended system to ensure that certification facilitate bodies possess or recog-
The object
of this Guide is to set forth
the necessary competence and reliability to operate nition on a national or international basis.
certification
and thereby
their acceptance
1.2
The Certification bodies.
Body may operate
its own testing
and inspection
activities
or oversee
these activities
carried
out on its behalf
by other
References
concerning standardization, certification and testing laboratory accreditation.
IS0 Guide 2, General terms and their definitions IS0 Guide 27, Guidelines for corrective ISOIIEC
action to be taken by a certification certification
body in the event of misuse of its mark of conformity.
Guide 28, General rules for a model third-party
Definitions
definitions contained in IS0 Guide 2 are applicable.
The relevant
4
4.1
General
requirements
Body shall be able to provide procedures and perform the functions specified in ISO/IEC
The Certification
Guide 28 and IS0
Guide 27.
4.2
Access to the services manner.
of the Certification to restrict
Body shall not be conditional participation. The procedures
upon membership under which
in any association
or group,
nor shall in a
there be undue financial non-discriminatory
conditions
the body operates
shall be administered
Administrative
Body
structure
shall have permits without the choosing of members of the governing board from among those interests involved in the pro-
The Certification a) a structure
which
cess of certification b) a permanent
any single interest
predominating; executive responsible to the governing board to carry out the day-to-day in the products or services opera-
staff under the senior full-time
tions in such a way as to be free from control
by those who have a direct commercial
interest
being cer-
tified . 135
SP 60
: 1993
Terms
of reference
board
of the governing
for relating
board
The governing a) . b) c) d)
shall be responsible of po/ILy matters
the formulation an overview an overview the se:tiny
to the operation
of the Certification
Body;
of the implementation of the finances

up of conlrnittees
of its policies; Body; defined activities are delegated.
of the Certlflcation as reyulred,
to which
Organization
Body
structure
shall have and make available chart showing clearly on request
The Certification al b) c)
an organization a description ,a documented
the responsibility the organization systems
and reporting obtains financial
structure support;
of the organization;
of the mealns by which statement with
of its certificatlor Guide 28;
(including
its ruies and procedures
for obtaining
certification),
which
shall
be in accordance dl documentation
ISO!IEC
cleariy
identifying
its legal status
Staff
instructions
of the Certification Body shall have available to them clear documented instructions pertaining to their duties and respon
The staff sibilities.
These instructions
shall be maintained
up to date.
9
The
Documentation
Certlilca:ian
and change
sllall maintain
control
for the control of all documentation relating to the certl cation system such as
Body
a system
a) b)
to ensure
that the currfnt
issues ot :he apjiropriate of docunlents direct
documentation to documents
is available
at all relevant
locations; authorization an@ -ocessed
to ensure that all changes which will ensure
OI amendments action
are covered point;
by the correct
in a manner cl d) to ensure
and speedy
at the effective frorn
that superseded that licensees
documents and other
are removed
use throughout in its certitlcation
the organization schemes
and its agencies; of changes*.
to ensure
users or participants
are notified
10
Records
Body shall maintain reports (see clause records to demonstrate 11). period and shall be available to those persons whom it is considered by the Certhe way in which each certification procedure was applied including test
The Certification and inspection The records tification
shall be retained to have a right
for a pre-determined
Body
of access to these records.
This maybe
accomplished
by direct
mailing
or,bq
issuance
of a periodic
publication
136
SP 60 :1993
11
11.1
Testing
and inspection
facilities
required
by the Certification
Body
these activities shall conform Guides 38 and 39). to the relevant
When the Certification
Body operates
its own testing and inspection activities, of testing and inspection bodies (ISOIIEC
clauses of the documents
for the acceptance
11.2 Where testing and inspection are carried out on its behalf by external bodies, the Certification bodies conform to the requirements of the documents mentioned in 11.1,
Body shall ensure that these
12
Confidentiality
Body shall ensure the confidentiality of its activities and those of the testing and inspection bodies it commissions.
The Certification
13 13.1
Publications
The Certification Body shall publish and update as necessary a Directory of certified products. by identification of the licensee. The list shall be available to the public. Each product mentioned in the
list shall be accompanied
13.2
A description
system(s)
shall be available in puolished form.
14
Appeals
Body shall have provision for the consideration of appeals against its decisions.
The Certification
137
Amend
No. 1 to SP 60 : 1993
AMENDMENT
NO. 1
NOVEMBER
1994
SP 60 : 1993 GUIDELINES FOR COMPETENCE ACCEPTANCE AND ACCREDITATION OF LABORATORIES, INSPiCTION BODIES, CERTIFICATION BODIES AND SYSTEMS OF CERTIFICATION ( Page 41, Section 3, Chapter 1 ) - Substitute the following for the existing chapter:
CHAPTER 1
GUIDELINES FOR DRAFTING OF STANDARDS SUITABLE FOR USE FOR CONFORMITY ASSESSMENT (ISO/IEC GUIDE 7 : 1994)
1 Scope
and in their delegations to meetings of the relevant technical committees, persons with experience of conformity assessment.
This Guide sets out guidelines to assist technical committees in drafting standards suitable for use for conformity assessment of products. The guidelines contained herein may also be used as
appropriate for the drafting of standards intended conformity assessment of processes and services. for
4.2
Standards suitable for use for conformity assessthat they can be applied by
ment should be so written any of the following:
a manufacturer or supplier (first party); a user or purchaser (second patty); an independent body (third party).
References
ISOPEC Guide 2: 1991, General terms and their definitions

concerning standardization and related activities. for the
ISO/IEC Directives, Part 2: 1992, Methodology

development of International Standards.
4.3 Each standard-that the responsible technical committee considers suitablefor use for conformity assessment should contain a clear statement to this effect in its scope. 4.4 Parties making use of a standard suitable for use for conformity assessment should be able to derive from the contents of the standard a common understanding of its meaning and intent. The standard should be so clear and precise that it results in accurate and uniform interpretation. 4.5 The standard should specify requirements or tests which should be designated as intended for one of the following purposes: type evaluation; routine production; surveillance.
IEC/ISO Directives, Part 3: 1989, Drafting

tation of International Standards.
and presen-
Definitions
Forthe purposes of this Guide, the relevant definitions in ISO/IEC Guide 2:1991 and the following definition apply. 3.1 conformity assessment: Any activity concerned with determining directly or indirectly that relevant requirements are fulfilled. NOTE 1 Examples of conformity-assessment activities are sampling, testing and inspection, evaluation, verification and assurance of conformity (suppliers declaration, certification), registration, accreditation and approval as well as their combinations.
General
4.6 Sample selection requirements relating to conformity assessment should appear in an annex or in a separate document, which should be referenced in the standard. A clear statement regarding whether the sampling requirements are normative or informative should bs given. A sample selection requirement may contain a specified statistically calculated sampling and compliance schedule. 4.7 The following items may be included in the standard in informative annexes or in the foreword; they should
4.1 For conformity-assessment purposes a number of aspects with which standards should normally comply, such as those covered by the ISO/lEC Directives, Part 2, including its annexes, require emphasis. These relate to the specific inclusion or exclusion of items in the standard so as to ensure its suitability for use for conformity assessment. For that reason, national member bodies should include, in their relevant national advisory groups
Grl
Amend No. 1 to SP 69 : 1993
not be normative unless the standard is identified for use in a quality assessment system such as the IECQ, in which case, one or more of these items may be normative: a) matters relating to marks or labels of conformity, certificates of conformity or manufacturers or suppliers declarations of conformity; b)
c1
5.4 The standard should specify the sequence of tests when the sequence can influence the results. 5.5 Where the testing of a number of specimens is required to determine compliance with specific clauses in the standard, the number of required specimens should be given.
NOTE 2 It is recommended that the standard also include a statement about additional specimens which may be needed to reducethe time for completion of all tests.
dates of implementation or allocation of iesponsirequirements for manufacturing processes, unless
bilities to various parties inaking use of the standard;
it is impossible to specify adequately the product without doing so; d) requirements duction. for quality control during pro6
Specification of test methods

Specification of requirements
5.1 Standards should always be written in such a way that they facilitate and do not retard the development of technology. Usually, this is accomplished by specifying performance requirements rather than product design requirements. 5.2 The requirements should be clearly specified, together with the required limiting values and tolerances, and the test methods to verify the specified characteristics. The requirements should be free from subjective elements; the use of such phrases as .sufficiently strong to or of adequate strength should be avoided. 5.3 It is often necessary to allow for more than one category, type or grade of a product within the same standard (or in separate standards, if necessary). Designers, users and consumers often need such variants for specific purposes or for economic reasons. Standards should therefore be written in such a way that these needs can be met. It is important that variants are clearly defined and that identification of those which have been subject to conformity assessment can be made, either as a part of the marking, or on a label accompanying the product.
6.i Test methods should be clearly identified and be consistent with the purpose of the standard. They should be objective, concise and accurate, and produce unambiguous, repeatable and reproducible results, so that results of tests made under defined conditions are comparable.
NOTE 3 It is recommended that the description of test methods incorporate a statement as to their accuracy, reproducibility and repeatability.
6.2 To the extent practicable and consistent with their objective, the tests should provide results within a reasonable period of time and at a reasonable cost. 6.3 Non-destructive test methods should be chosen, whenever they can replace, within the same level of confidence, destructive test methods.
6.4 When choosing test methods, account should be taken of standards for general test methods and of related tests for similar characteristics in other standards. As
regards the description of test methods, it is recommended that reference be made to other relevant standards, rather than quote the test methods in full in each standard. 6.5 Where test equipment is only available from one source or is not commercially available and has to be individually manufactured, the standard should include such specifications for the equipment as to ensure that comparable testing can be conducted by all involved parties.
11 IECQ is the IEC Quality assessment evetern for electronic components.
Annex A Bibliography
ISO/IEC Guide 51:1990, Guidelines for the inclusion of safety aspects in standards. ISO/IEC Compendium of conformity assessment documents, 1991. /SO 9000 Compendium, 2nd edition, 1992. ISO/IEC book Certification and related activities, 1992.
( Page 135, Section 4, Chapter 3 ) -
Insert the following chapter after this chapter: CHAPTER 4
GUIDELINES
FOR THE PRESENTATION OF INSPECTION ( ISO/IEC GUIDE 57 : 1991)
RESULTS
Introduction
This Guide has been ptepared as an expansion 0: ISO/IEC Guide 39 as far as the presentation of inspection results is con-
Definitions
The relevant definitions contained in ISO/IEC Guide 2 are applicable. In addition, the following definition applies: inspection body: Third-party impartial body having the organization, staffihg, competence and integrity to perform inspection services to specified criteria. Inspection services are understood to include such functions as assessing, recommending for acceptance and subsequent audit of suppliers production.and testing facilities, personnel and quality control operations, and selection and evaluation of products on site or in factories, laboratories or elsewhere as directed. . [ISO/IEC Guide 39 : 1988 subclause 3.2.11
cerned .
Inspection activities are important parts of the industrial and trade processes. Time and effort are saved if the inspection reports in which inspection results are presented are made clear, complete and uniform. There is also less risk of misreading, misunderstanding, or of omitting relevant information. It is recognized that the degree of relevance and applicability of some of the provisions in this Guide will differ from case to case, depending on the area of inspection, the type of information and the intended use of the inspection results. The requirements of <his Guide have been worded to take this into account as far as possible.
4 Information to be presented inspection report

4.1
Designation of the document
in an
Scope
The document presenting inspection results should be designated as INSPECTION REPORT. A reference to this Guide may be added if all its requirements are met. 4.2
1 .l This Guide sets forth requirements for the presentation of inspection results and other information of relevance to the understanding of the procedures followed and the results obtained in performing inspection functions. Inspection functions may be identified to cover such work as assessing, recommending for acceptance and subsequent audit of suppliers production and testing facilities, personnel and quality assurance operations, and selection and evaluation of products, processes or services on site or in factories, laboratories or elsewhere as directed. This Guide is intended to be used by inspection bodies or other parties reporting on inspection activities. Its intent is not to replace other ISO/IEC guidelines such as those on the accreditation of testing laboratories, the presentation of test results or the assessment of quality systems.
Identification
of the document
1.2
The inspection report shall have a date of issue and a unique identification repeated on every page. The identification could be a serial number. The report shall be paginated, and the total number of pages shall be indicated on each page.
4.3
Identification
of the bodv issuing the report
1.3
The name and address of the body issuing the report shall be given. Further information on this body may be added, such as its position within a largeporganization of which it may be a part. If the body issuing the report is formally recognized or accredited for the specific inspection reported, this should also be indicated in accordance with the rules set by the recognizing or accrediting body. 4.4 Identification inspection of the party ordering the
References
ISO/IEC Guide 2 : 1991, General terms and their definitions concerning standardization and related activities. ISO/IEC Guide 39 : 1988, General requirements for the acceptance of inspection bodies.
The name and address of the party ordering the inspection shall be given.
4.5
Description of the inspection work ordered
The inspection work-ordered shall be described in a way that allows clear and unambiguous results to be reported. If the inspection performed does not cover all the requirements included in the documents referred to by the party ordering the inspection, this fact shall be stated in the inspection report.
NOTE - It should be stated whether the inspection is one of a series executed at regular/irregular intervals, or is executed only once.
4.8.4 Sampling and handling of samples, if not adequately described in the applicable inspection method, shall be described in a separate report which shall identify the sampling and handling procedure and indicate by whom, where, how and when the samples were obtained, and which shall be referenced in the inspection report. 4.8.5 The inspection report shall include a statement to the effect that the inspection results relate to the service ordered (see also 4.51, and a statement that the inspection report shall not be reproduced except in full, without the approval of the body issuing the report and of the party ordering the inspection services.
NOTE An inspection report should not include any advice or recommendation arising from the inspection results; except where re-
4.6
Inspection methods and procedures
The inspection methods and procedures shall be identified and,. where appropriate, explicitly described or referenced. When it is necessary to use methods and procedures which are not as required, any deviations, additions to or exclusions from the requirements shall be agreed by the party ordering the inspection and shall be stated.
quired by the party ordering the inspection.
4.9
Additional information
4.7
Use of sub-contractors
If sub-contractors have been employed to carry out part(s) of the inspection, the sub-contricted work and the subcontractor shall be identified.
4.6
Inspection results
Additional information may be given on anything that is of relevance to the technical contents of the inspection report, to its further use or to the legal rights and obligations of the body issuing the report and the client associated with the inspection report. Such information may include conditions for the publication of the inspection report.
NOTE - In some countries legislation may limit the possibilities of the body issuing the report to restrict the future use of the inspection
report.
4.8.1 The report shall present accurately, clearly, and unambiguously the results of the investigation, in accordance with instructions that may be part of the inspection procedure. The date(s) of performance of the inspection shall be given. 4.8.2 Inspection results could, as appropriate, be:
4.10
Names and signatures
a) results of the evaluation of the organization and operation of the supplier; b) results of the assessment of critical aspects of the suppliers equipment, facilities, methods, procedures, if applicable - calibrations, data preparation and reporting, and quality assurance practices related to the specific technical tasks for the inspected product, process or service; cl results of the assessment (by interview, by observing technical tasks being performed or arrangement of practical audit procedures) of the knowledge and technical competence of staff in the area of the supplier; d) findings from sampling and from witnessing tests;
The inspection report shall bear the name(s), signature(s) and title(s), or equivalent marking, to indicate the person(s) performing thd inspettion and accepting responsibility for it on behalf of the body issuing the report. One signatory shall have sufficient authority to be able to control all factors having an influence on the inspection results. One signatory shall be able to communicate directly with the party ordering the inspection on the technical details of the inspection report. These signatories may be one and the same person. 4.11 Corrections and additions
e) findings from visual examination or practical use of the inspected items; f) derived results or any other observation results from the inspection activities; g) further observations relevant to the inspection (e.g. environmental and storage conditions of the products concerned) . 4.8.3 Inspection results could be supported by photographs, sketches, Tables or graphical information of any kind, appropriately identified. These should be provided as annexes, and a list of these annexes should be included, in the inspection report.
4.11.1 Except as indicated below, corrections and additions to an inspection report may be made only before it has been issued. Each correction - with the exception of misspellings and the like - shall be initialled by a person taking responsibility for the correction, and shall be dated. 4.11.2 Corrections and additions to an inspection report after issue shall be made only by a further document which shall meet all relevant requirements in this Guide. Such a document may be designated as: SUPPLEMENT TO INSPECTION REPORT SERIAL NUMBER . . . . immediately followed by the unique identification of the inspection report in question, or
Amend No. 1 to SP 60.: 1993
it may be a new inspection report cancelling and superseding the previous one, or it may take the form of corrected and revised pages provided that these clearly indicate that they are replace-
merit pages and bear the new currentpreparation date and the page numbers and issue date bf the pages being replaced. In all IX&, adequate safeguards shall be provided against misunderstanding or misrepresentation.
6
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( Reaffirmed 2004 )

and testing laboratories . .. .. . **.

testing (ISO/IEC Guide 43 :1984) General requirements . .. . .. for . ..

suitable for product certification certification systems

Code of principles on third-party (ISO/IEC Guide 16 : 1978)

standards or other . .. ..a . .. certification .,, . .. systems .. . .. . . .. a*.

and registration quality

in third-party product . .. . .. . .. quality system .,, .. . .. .

body of its own internal

BODIES AND CERTlFlCATlON body in the event of *,, . .. . ..

121 127 135

General requirements for the acceptance of certification bodies (ISO/lEC Guide 40 :

As in the Original Standard, this Page is Intentionally Left Blank

As in the Original Standard, this Page is Intentionally Left Blank

As in the Original Standard, this Page is Intentionally Left Blank

Reasons for the 1966 revision

Equivalent terms in non-official languages

1.2 subject of standardization:

need not imply unanimity.

1.6 level of standardization: Geographical, political or aconomic extant of involvement in standardization.

Selection of the optimum number of

Publicly available standards:

sizes or types of products, prevailing needs.

3.2.1 NOTE Variety corrtro/ k usually concerned with variety reduction. an

that is adopted orgafrization

standardizing/standards to the public.

standardizing/standards to the public.

that is adopted by a na-

balanceof a numberof factors,includingnon-technicalfactors suchas

body and made available

level of a territorial the public.

and made available to

standards: branch may

may aleo be adopted and company impact covering

on other Such several

bases, e.g. standards countries.

A doctmwnt ia to be understood as any medium with information recorded on or in it.

technical specification: Docurrwnt

baastandard, a pert of a standani or

rules, that is adopted

national standards body: Standards body recognized

nical requirements, porating the content code of practice.

that provides techeither directly or by referring to or incortechnical specification or 4.4.2

regional standards organization : Standards

national body from every country.

4 Bodies responsible and regulations 4.1

body (1) : Legal or administrative

entity that has specific

Body that has legal powers and rights.

An authority can be regional, national or local.

organization : Sody that is based on the membership

regulatory authority : Authority

that is responsible for

for enforcing regulations. NOTE The enforcement

organization whose national body from political or economic

membership each country area only.

is open to the relevant within one geographical,

15.1 basic standard:

plication or as a basis for other standards.

is concerned and, etc. examples,

testing standard : Standard

that is concerned with other

with test provisions