What are standards ?

Standards of length were once represented by the distance between two marks on a solid metal bar. Copies of these standards were displayed in public places so that people could check the accuracy of the rules they were using.

Standards Of Length (1876) Trafalgar Square

What are standards ?

Origins of the meter go back to at least the 18th century
Two competing approaches to the definition of a standard unit of length. define the meter as the length of a pendulum having a half-period of one second define the meter as one ten-millionth of the length of the earth's meridian along a quadrant (1791) French Academy of Sciences chose the meridian force of gravity varies slightly over the surface of the earth, affecting the period of the pendulum. meter equal 10-7 of the length of the meridian through Paris from pole to the equator. prototype was short by 0.2 millimeters because researchers miscalculated the flattening of the earth due to its rotation. (1960) used a definition based upon a wavelength of krypton-86 radiation (1983) meter replaced by the following definition: The meter is the length of the path traveled by light in vacuum during a time interval of 1/299 792 458 of a second.

International Prototype Meter standard bar made of platinum-iridium

What are standards ?

International System of Units uses the character "l" (lower-case L) to denote the metric unit of volume litre (liter).
It is often difficult to distinguish between the character "l" and the digit "1" in certain fonts or when handwritten. International System of Units only permits the use of a capital letter when the unit is named after a person.

1 liter

Kenneth Woolner of the University of Waterloo perpetuated a hoax in the April 1978 issue of CHEM 13 News

Woolner created the fictional character of Claude mile Jean-Baptiste Litre with a distinguished scientific career where he purportedly proposed a unit of volume measurement.

since no such person existed for "L", it seemed reasonable that one should be invented. Reg suggested that I should write a "biography" for the April issue of CHEM 13 NEWS, and over the course of an evening (which included, I think I recall, most of a bottle of scotch) we generated much of the substance of an 18th century life, full of drama, revolution and romance. Dr. Woolner , 1988

International Organization for Standardization

www.iso.org

ISO's name : a user's guide

ISO
International Organization for Standardization
Shouldn't the acronym be " IOS " ?
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 Three official languages English, French and Russian

French: Organisation internationale de normalisation

Russia: Mezhdunarodnaya organizaciya po standartizacii

English: International Organization for Standardization

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ISO's name
"ISO" is a word, derived from the Greek isos, meaning "equal "

From "equal" to "standard

What is ISO ?
worldwide federation of national standards bodies from some 100 countries MISSION: to promote the development of standardization and related activities in the world to facilitating the international exchange of goods and services, and to developing cooperation in the spheres of intellectual, scientific, technological and economic activity

ISO's work results in international agreements which are published as International Standards.
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What are standards ?

Standards are documented agreements containing technical specifications or other precise criteria to be used consistently as rules, guidelines, or definitions of characteristics, to ensure that materials, products, processes and services are fit for their purpose.
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Main Products: International Standards. Other Publications: Technical Reports, Technical Specifications, Publicly Available Specifications, Technical Corrigenda, and Guides.[

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What fields are covered ?

The scope of ISO is not limited to any particular branch; it covers all standardization fields except electrical and electronic engineering, which is the responsibility of IEC. The work in the field of information technology is carried out by a joint ISO/IEC technical committee (JTC 1).
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By default, the ISO Standards listing presents the complete listing of Published standards AND Standards under development..
The user chooses whether to access the listing By ICS (classified by subject in accordance with the International Classification for Standards) or By TC (sorted according to the ISO Technical Committee responsible for the preparation and/or maintenance of the standards

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Reference number
ISO[/IEC][/ASTM] [IS] nnnnn[:yyyy] Title, Where nnnnn is the number of the standard, yyyy is the year published, and Title describes the subject.

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ISO/IEC
ISO/IEC denotes a joint ISO and IEC (International Electrotechnical Commission) publication 1976 Agreement: the IEC covers the field of electrical and electronic engineering, all other subject areas being attributed to ISO When necessary, attribution of responsibility for work programmes to ISO or IEC is made by mutual agreement. In specific cases of mutual interest, joint technical bodies or working groups are set up.
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ISO/ASTM joint ISO and ASTM (American Society of Testing and Materials) International Standard

ISO/CIE: joint ISO and CIE (International Commission on Illumination) International Standard
ISO/HL7 joint ISO and HL7 (Health Level Seven) International Standard ISO/IEEE: joint ISO and IEEE (Institute of Electrical and Electronics Engineers) International Standard

ISO/OECD joint ISO and OECD (Organisation for Economic Cooperation and Development) International Standard
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Why is international standardization needed ?

1. Worldwide progress in trade liberalization

2. Interpenetration of sectors
3. Worldwide communications systems 4. Global standards needs for emerging technologies

5. Developing countries
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Who makes up ISO ?

member body of ISO is the national body "most representative of standardization in its country".
Four principal tasks:
informing potentially interested parties in their country of relevant international standardization opportunities and initiatives,

organizing so that a concerted view of the country's interests is presented during international negotiations leading to standards agreements,
ensuring that a secretariat is provided for those ISO technical committees and subcommittees in which the country has an interest, providing their country's share of financial support for the central operations of ISO, through payment of membership dues.
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Who makes up ISO ?

A correspondent member is usually an organization in a country which does not yet have a fully developed national standards activity. Correspondent members do not take an active part in the technical work, but are entitled to be kept fully informed about the work of interest to them. A subscriber membership, for countries with very small economies. These subscribers pay reduced membership fees that nevertheless allow them to maintain contact with international standardization.

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How are ISO standards developed ?

ISO standards are developed according to the following principles:

Consensus The views of all interests are taken into account Industry-wide Global solutions to satisfy industries and customers worldwide.

Voluntary International standardization is market-driven and therefore based on voluntary involvement of all interests in the market-place. .
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QUALITY
Quality is fitness for use. Juran [1988]

Quality consists of the capacity to satisfy wants... Edwards [1968]

Quality is the degree to which a specific product satisfies the wants of a specific consumer. Gilmore [1974] In the final analysis of the marketplace, the quality of a product depends on how well it fits patterns of consumer preferences. Kuehn & Day [1962] The core of a total quality approach is to identify and meet the requirements of both internal and external customers. Oakland [1989]

ISO 8402 defines quality as "the totality of

features and characteristics of a product or service that bears on its ability to meet a stated or implied need".
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ISO 9001:2008 Quality management systems Requirements ISO 14001:2004 Environmental management systems - Requirements with guidance for use

ISO/IEC 27001:2005 Information technology - Security techniques Information security management systems Requirements
ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories

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Laboratory Quality Management System: The operations or processes of the laboratory which define its policies and objectives and the manner in which they are implemented to ensure that the objectives are met. eg: ISO 9001:2000. www.iso.org Quality: The ability of the qualitative (analyte identification) and quantitative (accuracy, precision) data to satisfy the requirements of their purpose. The QA/QC(/QA) programme: The part of the laboratory management system that focuses on the quality of the data generated by the laboratory

Quality Assurance: Documented procedures in place within an analytical laboratory that define how the laboratorys work is to be conducted so as to be confident that the obtained data are of the required quality. QA consists of quality control and quality assessment activities. Quality Control: The practices and procedures that lead to the achievement of quality analytical data (suitable facilities, staff competence and training, good laboratory practices, standard operating and reporting procedures). Quality Assessment: The practices and the data generated by them that illustrate that the QC activities have been effected and that the data generated are of the quality required (SRMs, spiking, replicates, inter-laboratory comparisons, control charts, auditing, statistical analyses).
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ISO 17025 General Requirements for the competence of testing and calibration laboratories

1. Scope 1.1 applies to all laboratories (not just chemical) regardless of size. 1.4 this international standard is for use by laboratories in developing their quality, administrative and technical systems that govern their operations. Laboratory clients, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories.

2. Normative references
3. Terms and definitions Refer to ISO 9001:1994 , 9002:1994 and ISO/IEC Guide 2, These have now been incorporated into ISO 9000:2000, ISO 9001:2000.

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ISO 17025 General Requirements for the competence of testing and calibration laboratories (cont.)

4. Management requirements

4.1 Organization
The laboratory shall (amongst other things) be legally responsible; operate a management system covering work in the laboratories permanent facility and at sites away from its permanent facility (if relevant) have technical management with responsibility for the technical operations and the provision of resources have a quality manager with defined responsibility and authority for ensuring that the quality system is implemented and followed at all times

4.2 Quality System The laboratory shall (amongst other things) establish, implement and maintain a quality system (like ISO9001:2000) document its policies, systems, programmes, procedures and instructions the quality system policies, and objectives shall be defined in a quality manual include technical procedures.
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ISO 17025 General Requirements for the competence of testing and calibration laboratories (management requirements cont.)

4.3 Document Control

4.4 Review of requests, tenders and contracts 4.5 Subcontracting of tests and calibrations 4.6 Purchasing 4.7 Service to client 4.8 Complaints 4.9 Control of nonconforming testing and/or calibration work

4.10 Improvement
4.11 Corrective action 4.12 Preventative action 4.13 Control of records 4.14 Internal audits 4.15 Management reviews
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MANAGEMENT REQUIREMENTS

ISO 17025:2005

Related to the operation and effectiveness of the quality management system within the laboratory and has similar requirements to ISO 9001.
Divided into fifteen chapters

4.1 Organization

ISO 17025:2005

Ensures the roles and responsibilities of the laboratory and the management and key personnel are defined.

Key points are:

1.1.1 An organizational structure and responsibilities and tasks of management and staff should be defined. 1.1.2 The organizational structure should be such that departments having conflicting interests do not adversely influence the laboratorys quality of work. 1.1.3 A quality assurance manager should be appointed. 1.1.4 All personnel should be free from any commercial and financial pressure that may adversely impact the quality of calibration and test results.

4.2 Management System

ISO 17025:2005

Ensures that a management system is implemented, maintained and continually improved.

Key points are:

1.2.1 There should be policies, standard procedures and work instructions to ensure the quality of test results. 1.2.2 There should be a quality manual with policy statements that are issued and communicated by top level management. 1.2.3 The effectiveness of the management system should be continually improved.

4.3 Document Control

ISO 17025:2005

Ensure that all documents related to management system are uniquely identified and created, approved, issued and changed following documented procedures.

Key points are:

1.3.1 All official documents should be authorized and controlled. 1.3.2 Documents should be regularly reviewed and updated if necessary. 1.3.3 Changes to documents should follow the same review process as for development of initial documents.

4.4 Review of Requests, Tenders and Contracts

ISO 17025:2005

Ensure that requirements of requests, tenders and contracts are well defined, reviewed, understood and documented. Key points are:
1.4.1 The review by the laboratory supervisors should ensure that the laboratory has technical capability and the resources to meet the requirements. 1.4.2 Changes in contract should follow the same process as the initial contract.

4.9 Control of nonconforming work

ISO 17025:2005

Policies and procedures for situations when many aspect of work is problematic

-Management of nonconforming work situations

-Evaluate significance -customer notification -Authorize work resumption When corrective action is required

4.10 Improvement
ISO 17025:2005
Continuous improvement of management systems -Quality Policy

-Quality Objectives
-Audit Results

-Analysis of Data
-Corrective and preventive actions

-Management Review

4.11 Corrective action

ISO 17025:2005
Cause analysis Selection and Implementation of corrective actions Monitoring corrective actions Additional Audits

4.12 Preventive action

ISO 17025:2005
Action plans: develop, implement, monitor
-reduce likelihood of nonconformities -opportunities for improvement Initiations of actions, application of controls to ensure effectiveness

4.13 Control of Records

ISO 17025:2005

Ensures that all records in a laboratory are uniquely identified

Readily available when needed

Protected against non-authorized access for viewing and access

4.13 Control of Records

ISO 17025:2005

Key points
Procedures for identification, collection, indexing, storage, retrieval and disposal of records Storage of records such that its security, confidentiality, quality and integrity are ensured throughout the required retention time Technical records should be retained together with processing parameters

4.13 Control of Records

ISO 17025:2005
Record format can be hard copies or electronic media. Records can be corrected if there are mistakes. In this case the original record should be crossed out and still be visible When electronic record systems are used, the same principle applies.

4.14 Internal Audits

ISO 17025:2005
Should verify that the laboratory complies with ISO/IEC 17025 and with internal technical and quality procedures An excellent preparation for external assessment Thus can help to continually improve the quality system

4.14 Internal Audits

ISO 17025:2005
Key points
The laboratory should have a procedure and a schedule for internal audits. The schedule should be such that each element of the quality system and each section of the laboratory are audited yearly. The audit program should be managed by the quality manager.

4.14 Internal Audits

ISO 17025:2005
Audit findings related to the quality of test and calibration results should be reported to customers Audit follow-up activities should include corrective and preventive action plans (CAPA). The effectiveness of the plans should be monitored.

4.15 Management reviews

ISO 17025:2005

Ensure the continued suitability and effectiveness of the quality system, policies and testing and calibration procedures

4.15 Management reviews

ISO 17025:2005

Key points
Schedule and procedure for periodic management reviews Recommended review frequency is once a year Includes discussion on the outcome from recent internal audits and external assessments, corrective and preventive actions, results of proficiency testing, customer complaints and feedback and any recommendations for improvements Management should decide on follow-up activities

ISO 17025 General Requirements for the competence of testing and calibration laboratories (cont.) 5. Technical requirements 5.1 General 5.1.1 Many factors determine the correctness and reliability of the test and/or calibrations performed by a laboratory. These factors include contributions from: human factors,

accommodation and environmental conditions,

test and calibration methods and method validations, equipment, measurement traceability, sampling and handling of test and calibration items. The laboratory shall take into account these factors in developing tests and

calibration procedures , in training and qualification of personnel, and in the

selection and calibration of the equipment it uses.
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ISO 17025 General Requirements for the competence of testing and calibration laboratories. (technical requirements cont.) 5.2 Personnel (competence, training, job descriptions, responsibilities) 5.3 Accommodation and environmental conditions (permanent and in the field, sterility , dust, temperature, vapors, access, ) 5.4 Test and calibration methods and method validation shall use appropriate methods and procedures including sampling, handling, transport, storage and preparation of items to be tested . shall use test and/or calibration methods, including methods of sampling, which meet the needs of the client and which are appropriate Methods published in international, regional or national standards shall preferably be used. shall confirm (verify) that it can properly operate standard methods before introducing the tests or calibrations.

Methods developed shall have been validated appropriately before use.

shall have and shall apply procedures for estimating uncertainty of measurement. 53 (duplicates, replicates)

ISO 17025 General Requirements for the competence of testing and calibration laboratories. (technical requirements cont.)

5.5 Equipment (scope, operation, maintenance, calibration) 5.6 Measurement traceability (calibrations to international standards; sample to result; reference standards and materials) 5.7 Sampling shall have a sampling plan and procedures for sampling sampling plans shall, whenever reasonable, be based on appropriate statistical methods. 5.8 Handling of test and calibration items (transportation, preservation, storage). 5.9 Assuring the quality of test and calibration results

5.10 Reporting the results

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