Two Day

Awareness cum Internal

Auditor’s
Training Programme
on ISO 17065-2012

R C Mathew
Director
Center for Quality Development
Kochi
Objectives
 Understanding the requirements as per
IS/ISO/IEC 17065: 2012
 Principles of conformity assessment
 Documentation Requirements for ISO

17065:2012
 Application of ISO 17065:2012 to

Accreditation
 Internal Auditing (ISO 19011:2011)
IS/ISO/IEC 17065:2012 – Conformity
assessment- Requirements for bodies
certifying products, processes and services

 Covers requirements for the competence,

consistent operation and impartiality of product,
process and service certification body
 Need not offer all types of products, processes

and services certification

 Certification of product, process and service is a

third party conformity assessment activity.

 Product can be read as process or service
Normative reference
 ISO/IEC 17000 – Conformity Assessment – Vocabulary and
general principles
 ISO/IEC 17020 – Conformity Assessment – Requirements

for the operation of various types of bodies performing

inspection
 ISO/IEC 17021 – Conformity Assessment – Requirements

for bodies providing audit and certification of

management systems
 ISO/IEC 17025 – General Requirements for the

competence of testing and calibration laboratories

For Dated reference, only the dated reference, only the

edition cited applies. For undated references, the latest

edition of the reference document applies
Terms and definition
 Client- Organization of person responsible to a
certification requirements including product
requirements are fulfilled
 Consultancy- Participation in:
The designing, manufacturing, installing, maintaining
or distribution of a certified product to be certified, or
The designing, implementing operating or maintaining
of a certified process or a process to be certified, or
The designing, implementing, providing or maintaining
of a certified service or a service to be certified
Terms and definition (cont..)

 Evaluation – combination of the selection and

determination functions of conformity
assessment activities
 Product – result of process
 Process- set of interrelated or interacting

activities which transform inputs to outputs

 Service- result of at least one activity

necessarily performed at the interface

between the supplier and the customer,
which is generally intangible
Terms and definition (cont..)

 Certification requirement- specified requirement,

including product requirements, that is fulfilled
by the client as a condition o establishing or
maintaining certification
 Product requirement- requirement that relates

directly to a product, specified in standards or in

other normative documents identified by the
certification scheme
 Certification scheme- certification system related

to specific products, to which the same specified

requirements, specific rules and procedures apply
Terms and definition (cont..)

 Scope of certification- Identification of:

◦ The products, processes or services for which the
certification is granted
◦ The applicable certification scheme, and
◦ The standards and other normative documents,
including their date of publication, to which it is
judged that the products, processes or services
comply
 Scheme owner- person or organization
responsible for developing and maintaining a
specific certification scheme
Terms and definition (cont..)

 Certification body- third-party conformity

assessment body operating certification
schemes
 Impartiality- presence of objectivity
General requirements- clause 4
 4.1.1 Legal responsibility
◦ CB shall be a legal entity or defined part of a legal
entity such that, legal entity can be held legally for
all its certification activities
◦ Governmental certification body is deemed to be a
legal entity
 4.1.2 Certification agreement
◦ CB shall have a legally enforceable agreement for
provision of certification activities to its client
◦ Agreement to include responsibilities of CB and
client
General requirements- clause 4
◦ Agreement to include:
 Client always fulfills certification requirements,
including appropriate changes
 If certification applies to ongoing production, the
certified product continues to fulfill the product
requirements
 Client make necessary arrangement for
 Conduct of evaluation and surveillance
 Investigation of complaints
 Participation of observers if applicable
 Client makes claims regarding certification consistent
with scope only
General requirements- clause 4
 Client does not use product certification to bring
disrepute to CB, no misleading or unauthorized
statements
 Client discontinues use of all advertising matter in case
of suspension, withdrawal, termination of certification
 When copies of the certification documents are
provided to others, document shall be reproduced in
full
 Any advertising promotion to contain matter in
compliance with CB requirement
 Complies with the requirements of the scheme
General requirements- clause 4
 Client keeps record of complaints and makes these
records available to CB
 Appropriate actions with respect to such compliance
 Documents the action taken on complaints
 Client informs CB of any changes that may affect ability
to confirm with certification requirements
General requirements- clause 4
 4.1.3-
Use of license, certificates and mark of
conformity
◦ CB shall exercise the control as specified by the
certification scheme over ownership, use and
display of licenses, certificates, mark of conformity
and any other mechanisms for indicating a product
is certified
General requirements- clause 4
 4.2 Management of impartiality
◦ 4.2.1 – Certification activities shall be taken
impartially
◦ 4.2.2 – CB shall be responsible for impartiality of its
certification activities
 Shall not allow commercial, financial or other pressures
to compromise impartiality
◦ 4.2.3 – CB shall identify risk to its impartiality on an
ongoing basis
 This shall include those risks that arise from its
activities, from its relationships, or from the
relationships of the personnel
General requirements- clause 4
◦ 4.2.4 – If a risk to impartiality is identified, CB shall be able to
demonstrate how it eliminates or minimizes such risk.
◦ 4.2.5 – CB shall have top management commitment to
impartiality
◦ 4.2.6 – The CB or any part of the same legal entity and entities
under its organizational control shall not
 Be the designer, manufacturer, installer, distributor or maintainer of
the certified product
 Be the designer, implementer, operator or maintainer of the
certified process
 Be the designer, implementer, provider or maintainer of the
certified service
 Offer or provide consultancy to its clients
 Offer or provide management system consultancy or internal
auditing to its clients.
General requirements- clause 4
◦ 4.2.9 – CB activities shall not be marketed or
offered a linked with the activities of an
organization that provides consultancy. CB shall not
sate or imply that certification would be simpler,
easier, faster or less expensive, if a specified
consultancy organization Is used
◦ 4.2.10 – within a period specified by CB, personnel
shall not be used to review or make a certification
decision if consultancy was provided
◦ 4.2.11 – CB shall respond to any risk to impartiality
General requirements- clause 4
◦ CB personnel internal or external shall act
impartially.
 4.3 – Liability and Financing
◦ 4.3.1 - CB shall have adequate arrangements to
cover liabilities arising from its operations
◦ 4.3.2- CB shall have the financial stability and
resources required for its operations
General requirements- clause 4
 4.4- Non discriminatory conditions
◦ 4.4.1- CB shall be non discriminatory in its
approach. Procedures shall not be used to impede
or inhibit access by applicants
◦ 4.4.2- CB shall make its services accessible to all
applicants whose activities are within the scope.
◦ 4.4.3- Access to certification process shall not be
conditional
General requirements- clause 4
 4.5 – Confidentiality
◦ 4.5.1- CB shall be responsible through legally
enforceable commitments for the management of
all information obtained or created.
◦ Information obtained is considered proprietary and
shall be regarded as confidential
◦ CB shall inform client in advance of the information
it intends to place in the public domain
General requirements- clause 4
◦ 4.5.2- Client to be notified unless prohibited by law if
CB releases confidential information
◦ 4.5.3- Information about the client obtained from
sources other than the client shall be treated as
confidential
 4.6 – Publically available information
◦ CB shall maintain and make available, upon request,
the following:
 Information about the certificate scheme including
evaluation procedures, riles and procedures for granting,
for maintaining, extending or for reducing the scope of,
for suspending, for withdrawing or for refusing
certification.
General requirements- clause 4
 Description of the means by which certification body
obtains financial support and general information on
the fees charged to applicants and to clients
 A description of the rights and duties of applicants and
clients
 Information about procedure for handling complaints
and appeals
Structural requirements- clause 5
 5.1
Organizational structure and top
management
◦ 5.1.1- Certification activities shall be structured
and managed so as to safeguard impartiality.
◦ 5.1.2- CB shall document its organizational
structure showing duties, responsibilities and
authorities of management, other certification
personnel and committees. When CB is a part of a
legal entity, the structure shall include the line of
authority and the relationship to other parts within
the same legal entity.
Structural requirements- clause 5
◦ 5.1.3- The management of the CB shall identify the
board, group of persons or persons having overall
authority and responsibility for ah of the following:
 Development of policies relating to the operation of the
CB
 Supervision of the implementation of the policies and
procedures
 Supervision of the finances of the CB
 Development of certification activities
 Development of certification requirements
 Evaluation
 Review
 Decision on certification
Structural requirements- clause 5
 Delegation of authority to committee or personnel, as
required, to undertake defined activities on its behalf
 Contractual arrangements
 Provision of adequate resources for certification
activities
 Responsive to complaints and appeals
 Personnel competence requirements
 Management system of the certification body
Structural requirements- clause 5
◦ 5.1.4- CB shall have formal rules for the
appointment, terms of reference and operation of
any committees that are involved in the certification
process
◦ Committee shall be free from any commercial,
financial and other pressures that might influence
decisions
◦ CB shall retain authority to appoint and withdraw
members of such committees.
Structural requirements- clause 5
 5.2- Mechanism for safeguarding impartiality
◦ 5.2.1- CB shall have mechanism for safeguarding
its impartiality
◦ The mechanism to provide input on the following:
 The policies and principles relating to impartiality of its
certification activities
 Any tendency on the part of the CB to allow
commercial or other considerations to prevent the
consistent impartial provision of certification activities
 Matters affecting impartiality and confidence in
certification, including openness
Structural requirements- clause 5
◦ 5.2.2-Impartiality mechanism to be formally
documented to ensure:
 A balanced representation of significantly interested
party such that no single interest predominates
 Internal and external personnel of the CB are
considered to be a single interest and shall not
predominate
 Access to all information necessary to enable it to
fulfill its function
Structural requirements- clause 5
◦ 5.2.3- If the top management of the certification boy does
not follow the input of this mechanism, the mechanism
shall have the right to take independent action (informing
authorities, accreditation bodies, stakeholders)
◦ Input that is in conflict with the operating procedures of
the CB or other mandatory requirements should not be
followed
◦ Management should document the reasoning behind the
decision to not follow the input and maintain the
document for review by appropriate personnel
◦ 5.2.4- although every interest cannot be represented in
the mechanism, a CB shall identify and invite significantly
interested parties
Resource Requirements clause 6
 6.1 Certification body personnel

 CB shall employ or half access to sufficient

number of personnel
 Personnel to be competent for the functions

they perform including Technical judgments,

defining policies, implementing them
 All information shall be kept confidential

except as required by law or scheme.

Management of Competence of personnel(6.1.2)

 Procedure for management of competence

mandatory
 Determine the criteria for competence of

personnel for each function

 Identify training needs & provide
 Demonstrate competence
 Authorize personnel for functions in the

process
 Monitor performance of the personnel
 Maintain records(clause 6.1.2.2 )
Contract with Personnel clause6.1.3
 Personnel to sign a contract or other
document of their commitment.
 Use as input for identifying Risk to

impartiality
Resources for Evaluation clause 6.2
 Internal resources for evaluation
activities(6.2.1)
 Testing(17025),Inspection (17020),

Management system Auditing(17021)

 External resources for evaluation

activities(6.2.2)
 Outsource activities only to bodies that meet

the applicable requirements

 Legally binding contract with outsourced

services provider
Process Requirements clause 7
 CB shall operate one or more certification
scheme
 Specified standards to be used or normative

documents
Process Requirements clause 7
 7.2 Application
 CB shall obtain all necessary information to

complete the application process

 Variety of media & mechanism can be used to

collect information
Process Requirements clause 7
 7.3 Application review
 Conduct a review of the information obtained

1. Information about the client & product is

sufficient
2. Any no difference in understanding between
CB & Client is resolved
3. Scope of certification defined
4. Means available to perform all evaluation
activities
5. CB has the competence & capacity
Process Requirements clause 7
 CB shall have a process to identify when the
clients request for certification with which CB
has no prior experience
Eg: Type of product, Normative document,
Certification Scheme
 Maintain record of justification if accepted
 Decline if it lacks competence or capability
 Provide justification for omission of activities
Process Requirements clause 7
7.4 Evaluation
 Plan for evaluation activities
 Assign personnel for each evaluation task

 All necessary information/ Documentation made

available for evaluation

 Evaluation activities through internal resources

or manage outsourced resources as per

evaluation plan
 Rely on evaluation result related to certification

completed prior to application only where it take

responsibility
Process Requirements clause 7
 Inform client of all non conformities
 Inform additional evaluation task needed for

verification of NC
 Document result of all evaluation activities