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MSASF29 Assessment Checklist for PNS ISO IEC 17065 2012
PAB checklist for PNS/ISO/IEC
Your Browser Doesn't Support Canvas. Showing the Text Content of the PDF Instead: Philippine Accreditation Bureau
Management System Accreditation
Assessment Checklist for
ISO/IEC 17065: 2012
Document ID
Issue Number
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Conformity assessment – Requirement for bodies certifying products, processes and
services
Legend: C – Complies, O – Observation, T – To Address at Audit, N – Nonconformity, N/A – Not
Applicable
Clause Requirement
2 Normative References
Where does the CB establish the following normative references:
ISO/IEC 17000: Conformity assessment – Vocabulary and general principles.
ISO/IEC 17020: Conformity assessment – General criteria 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 - Conformity assessment – General requirements for the competence of
testing and calibration laboratories.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
4 General requirements
4.1 Legal and contractual matters
4.1.1 Legal responsibility
How does the certification body demonstrate that it is a legal entity, or a defined part of a legal entity?
*A governmental certification body is deemed to be a legal entity on the basis of its governmental
status.”
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
4.1.2 Certification agreement
4.1.2.1 How does the certification body establish a legally enforceable agreement for the provision of
its certification activities details the responsibilities of the certification body and its clients?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
Philippine Accreditation Bureau
Management System Accreditation
Assessment Checklist for
ISO/IEC 17065: 2012
Document ID
Issue Number
Revision Number
Effectivity Date
Page
MSA/SF29
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01
September 2018
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Clause Requirement
4.1.2.2 Does the certification agreement require that the client at least, comply with the following:
a) always fulfils the certification requirements (3.7) including implementing appropriate changes
when they are communicated by the certification body;
b) if the certification applies to ongoing production, the certified product continues to fulfil the product
requirements (3.8)
c) make all necessary arrangements for
1) the conduct of the evaluation (3.3) and surveillance (if required), including provision for
examining documentation and records, and access to the relevant equipment, location(s),
area(s), personnel, and client's subcontractors, and;
2) investigation of complaints;
3) the participation of observers, if applicable;
d) makes claims regarding certification consistent with the scope of certification (3.10);
e) does not use its product certification in such a manner as to bring the certification body into
disrepute and does not make any statement regarding its product certification which the
certification body may consider misleading or unauthorized;
f) upon suspension, withdrawal, or termination of certification, it discontinues its use of all
advertising matter that contains any reference thereto and takes action as required by the
certification scheme ( e.g. returns certification documents) and takes any other required measure;
g) if the client provides copies of the certification documents to others, the documents shall be
reproduced in their entirety or as specified in the certification scheme;
h) in making reference to its product certification in communication media such as documents,
brochures or advertising, complies with the requirements of the certification body or as specified
by the certification scheme;
i) complies with any requirements that may be prescribed in the certification scheme that relate to
the use of marks of conformity, and on information related to the product;
j) keeps a record of all complaints made known to the client relating to the compliance with
certification requirements and to make these records available to the certification body when
requested; and
1) takes appropriate action with respect to such complaints and any deficiencies found in
products that affect compliance with the requirements for certification;
2) documents the actions taken;
k) informs the certification body, without delay, of changes that may affect its ability to conform with
the certification requirements?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
4.1.3 Use of license, certificates and marks of conformity
4.1.3.1 How does the Certification Body exercise control as specified by the certification scheme over
ownership, use and display of licenses, certificates, marks of conformity, and any other mechanisms
for indicating a product is certified?
*Guidance on the use of certificates and marks permitted by the certification body can be obtained
from ISO/IEC Guide 23.
**ISO/IEC 17030 provides requirements for third-party marks.
Philippine Accreditation Bureau
Management System Accreditation
Assessment Checklist for
ISO/IEC 17065: 2012
Document ID
Issue Number
Revision Number
Effectivity Date
Page
MSA/SF29
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01
September 2018
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Clause Requirement
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
4.1.3.2 How are incorrect references to the certification scheme or misleading use of licenses,
certificates, marks, or any other mechanism for indicating a product is certified, found in
documentation or other publicity dealt with by suitable action?
*Such actions are addressed in ISO Guide 27 and can include corrective actions, withdrawal of
certificate, publication of the transgression and, if necessary, legal action.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
4.2 Management of impartiality
4.2.1 How does the certification body declare that its activities shall be undertaken impartially?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
4.2.2 How does the certification body ensure that commercial, financial or other pressures do not
compromise impartially?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
4.2.3 How does the certification body identify risks to its impartiality on an ongoing basis?
Does this include those risks that arise from its activities, from its relationships, or from the
relationships of its personnel (see 4.2.12)? However, such relationships may not necessarily present
a certification body with a risk to impartiality?
*A relationship presenting a risk to impartiality of the certification body can be based on ownership,
governance, management, personnel, shared resources, finances, contracts, marketing (including
branding), and payment of a sales commission or other inducement for the referral of new clients, etc.
**Identifying risks does not imply risk assessment as stated in ISO 31000.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Philippine Accreditation Bureau
Management System Accreditation
Assessment Checklist for
ISO/IEC 17065: 2012
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Issue Number
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Effectivity Date
Page
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Clause Requirement
Findings/Comments: (To be filled-up by the AB)
4.2.4 If a risk to impartiality is identified, how does the certification body demonstrate how it eliminates
or minimizes such risk?
Is information made available to the mechanism specified in 5.2?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
4.2.5 Does the certification body have top management commitment to impartiality?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
4.2.6 How does the certification body and any part of the same legal entity and entities under its
organization control (7.6.4) ensure that it is not:
a) the designer, manufacturer, installer, distributer or maintainer of the certified product;
b) the designer, implementer, operator or maintainer of the certified process;
c) the designer, implementer, provider or maintainer of the certified service;
d) offer or provide consultancy (3.2) to its clients
e) offer or provide management system consultancy (3.3 of ISO/IEC 17021:2011) or internal auditing
to its clients where the certification scheme requires the evaluation the client’s management
system?
*This does not preclude the following:
- the possibility of exchange of information (e.g. explanations of findings or clarifying requirements)
between the certification body and its clients;
- the use, installing and maintaining of certified products which are necessary for the operations of
the certification body.
**”Management system consultancy” is defined in ISO/IEC 17021:2011, definition 3.3.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
4.2.7 How does the certification body ensure that activities of separate legal entities with which the
certification body or the legal entity of which it forms a part has relationships do not compromise the
impartiality of its certification activities?
*See 4.2.3, Note 1.
Philippine Accreditation Bureau
Management System Accreditation
Assessment Checklist for
ISO/IEC 17065: 2012
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Issue Number
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Clause Requirement
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
4.2.8 When the separate legal entity in 4.2.7 offers or produces the certified product (including
products to be certified) or offers or provides consultancy (3.2), how do the certification body’
management personnel and personnel in the review and certification decision making process ensure
that they are not involved in the activities of the separate legal entity?
Are the personnel of the separate legal entity involved in the management of the certification body,
the review, or certification decision?
*For the evaluation personnel, impartiality requirements are stipulated in Clause 6 and additional
requirements are given in the other relevant International Standards cited in 6.2.1 and 6.2.2.1.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
4.2.9 Are the certification body’s activities marketed or offered as linked with the activities of an
organization that provides consultancy (3.2)?
How does the certification body state or imply that certification would be simpler, easier, faster or less
expensive if a specified consultancy organization were used?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
4.2.10 Does the certification body specify a period within which personnel shall not be used to review
or make a certification decision for a product for which they have provided consultancy (3.2)?
*The period can be specified in the certification scheme or, if specified by the certification body, it
reflects a period that is long enough to ensure that the review or decision does not compromise
impartiality. A specified period of two years is often used.
**For the evaluation personnel, impartiality requirements are stipulated in Clause 6 and additional
requirements are given in the other International Standards cited in 6.2.1 and 6.2.2.1.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
4.2.11 How does the certification body take action to respond to any risks to its impartiality arising
from the actions of other persons, bodies or organizations of which it becomes aware?
Philippine Accreditation Bureau
Management System Accreditation
Assessment Checklist for
ISO/IEC 17065: 2012
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Clause Requirement
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
4.2.12 Do all certification body personnel, either internal or external, or committees, who could
influence the certification activities, act impartially?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
4.3 Liability and financing
4.3.1 How does the certification body have adequate arrangements (e.g. insurance or reserves) to
cover liabilities arising from its operations?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
4.3.2 How does the certification body have the financial stability and resources required for its
operations?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
4.4 Non-discriminatory conditions
4.4.1 Are the policies and procedures under which the certification body operates and their
administration non-discriminatory?
How does the CB ensure that procedures are not used to impede or inhibit access by applicants,
other than as provided for in this International Standard?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
4.4.2 How does the certification body make its services accessible to all applicants whose activities
fall within the scope of its operations?
Philippine Accreditation Bureau
Management System Accreditation
Assessment Checklist for
ISO/IEC 17065: 2012
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Issue Number
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Clause Requirement
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
4.4.3 How does the CB ensure that access to the certification process is conditional upon the size of
the client or membership of any association or group, or certification conditional upon the number of
certifications already issued?
Are there any undue financial or other conditions?
*A certification body can decline to accept an application or maintain a contract for certification from a
client when fundamental or demonstrated reasons exists, such as the client participating in illegal
activities, having a history of repeated non-compliances with certification/products requirements, or
similar client related issues.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
4.4.4 How does the certification body confine its requirements, evaluation, review, decision, and
surveillance (if any) to those matters specifically related to the scope of the certification?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
4.5 Confidentiality
4.5.1 How is the certification body responsible, through legally enforceable commitments, for the
management of all information obtained or created during the performance of certification activities?
Except for information that the client makes publicly available, or when agreed between the
certification body and the client (e.g. for the purpose of responding to complaints) is all other
information considered proprietary information and regarded as confidential?
How does the certification body inform the client, in advance, of the information it intends to place in
the public domain?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
4.5.2 When the certification body is required by law or authorized by contractual arrangements to
release confidential information, how is the client or person concerned, unless prohibited by law,
notifies of the information provided?
Philippine Accreditation Bureau
Management System Accreditation
Assessment Checklist for
ISO/IEC 17065: 2012
Document ID
Issue Number
Revision Number
Effectivity Date
Page
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Clause Requirement
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
4.5.3 Is information about the client obtained from sources other than the client (e.g. complainant,
regulators) treated as confidential?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
4.6 Publicly available information
How does the certification body maintain (through publications, electronic media or other means) and
make available on request, the following:
a) Information about (or reference to) the certification scheme(s), including evaluation procedures,
rules and procedures for granting, maintaining, extending or reducing the scope of, suspending,
withdrawing or refusing certification;
b) A description of the means by which the certification body obtains financial support and general
information on the fees charged to applicants and to clients;
c) A description of the rights and duties of applicants and clients, including requirements, restrictions
or limitations on the use of the certification body’s name and certification mark and on the ways of
referring to the certification granted;
d) Information about procedures for handling complaints and appeals?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
5 Structural requirements
5.1 Organizational structure and top management
5.1.1 Are certification activities structured and managed so as to safeguard impartiality?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
5.1.2 How does the certification body document its organizational structure, showing duties,
responsibilities and authorities of management and other certification personnel and any committees?
When the certification body is a defined part of a legal identity, how does the structure include the line
of authority and the relationship to other parts within the same legal entity?
Philippine Accreditation Bureau
Management System Accreditation
Assessment Checklist for
ISO/IEC 17065: 2012
Document ID
Issue Number
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Effectivity Date
Page
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Clause Requirement
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
5.1.3 Has the management of the certification body identified the board, group of persons, or person
having overall authority and responsibility for each of the following:
a) Development of policies relating to the operation of the certification body;
b) Supervision of the implementation of the policies and procedures;
c) Supervision of the finances of the certification body
d) Development of certification activities;
e) Development of certification requirements;
f) Evaluation (7.4);
g) Review (7.5);
h) Decisions on certification (7.6);
i) Delegation of authority to committees or personnel, as required, to undertake defined activities on
its behalf;
j) Contractual arrangements;
k) Provision of adequate resources for certification activities;
l) Responsiveness to complaints and appeals;
m) Personnel competence requirements;
n) Management system of the certification body (see 8)?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
5.1.4 Does the certification body have formal rules for the appointment, terms of reference and
operation of any committees that are involved in the certification process (see 7)?
Are such committees free from any commercial, financial and other pressures that might influence
decisions?
How does the certification body retain authority to appoint and withdraw members of such
committees?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
Philippine Accreditation Bureau
Management System Accreditation
Assessment Checklist for
ISO/IEC 17065: 2012
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Clause Requirement
5.2 Mechanism for safeguarding impartiality
5.2.1 Does the certification body have a mechanism for safeguarding its impartiality?
How does the mechanism provide input on:
a) The policies and principles relating to the impartiality of its certification activities;
b) Any tendency on the part of a certification body to allow commercial or other considerations to
prevent the consistent impartial provision of certification activities;
c) Matters affecting impartiality and confidence in certification, including openness?
*Other tasks or duties (e.g. taking part in decision-making process) can be assigned to the
mechanism, provided these additional tasks or duties do not compromise its essential role of
ensuring impartiality.
**A possible mechanism can be a committee established by one or more certification bodies, a
committee implemented by a scheme owner, a governmental authority or an equivalent party.
***A single mechanism for several certification schemes can satisfy this requirement.
****If the certification body also provides management systems certification, a committee that fulfils
ISO/IEC 17021:2011, 6.2, can also fulfil this sub clause (5.2) providing that all requirements of 5.2
have been met.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
5.2.2 Is the mechanism formally documented to ensure:
a) A balanced representation of significantly interested parties such that no single interest
predominates (internal or external personnel of the certification body are considered to be a
single interest, and shall not predominate);
b) Access to all the information necessary to enable it to fulfil all its functions?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
5.2.3 If the top management of the certification body does not follow the input of this mechanism, how
does the mechanism have the right to take independent action (e.g. informing authorities,
accreditation bodies, stakeholders)?
In taking appropriate action, is the confidentiality requirements of 4.5 relating to the client and
certification body respected?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
Philippine Accreditation Bureau
Management System Accreditation
Assessment Checklist for
ISO/IEC 17065: 2012
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Clause Requirement
5.2.4 Although every interest cannot be represented in the mechanism, how does the certification
body identify and invite significantly interested parties?
*Such interested parties can include clients of the certification body, customers of clients,
manufacturers, suppliers, users, conformity assessment experts, representatives of industry trade
associations, representatives of governmental regulatory bodies or other governmental services, and
representatives of non-governmental organizations, including consumer organizations. It can be
sufficient to have one representative of each interested party in the mechanism.
**These interest can be limited, depending on the nature of the certification scheme.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
6 Resource requirements
6.1 Certification body personnel
6.1.1 General
6.1.1.1 Does the certification body employ or have access to a sufficient number of personnel to
cover its operations related to the certification schemes and to the applicable standards and other
normative documents?
*The personnel include those normally working for the certification body, as well as persons working
under an individual contract of a formal agreement that places them within the management control
and systems/procedures of the certification body (see 6.1.3).
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
6.1.1.2 Are the personnel competent for the functions they perform, including making required
technical judgments, defining policies and implementing them?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
6.1.1.3 How do the personnel, including any committee members, personnel of external bodies, or
personnel acting on the certification body’s behalf, keep confidential all information obtained or
created during the performance of the certification activities except as required by law or by the
certification scheme?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Philippine Accreditation Bureau
Management System Accreditation
Assessment Checklist for
ISO/IEC 17065: 2012
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Clause Requirement
Findings/Comments: (To be filled-up by the AB)
6.1.2 Management of competence for personnel involved in the certification process
6.1.2.1 Has the certification body established, and does it implement and maintain a procedure for
management of competencies of personnel involved in the certification process (see 7)?
Does the procedure require the certification body to:
a) Determine the criteria for the competence of personnel for each function in the certification
process taking into account the requirements of the schemes;
b) Identify training needs and provide, as necessary, training programs on certification processes,
requirements, methodologies, activities and other relevant certification scheme requirements;
c) Demonstrate that the personnel have the required competencies for the duties and
responsibilities they undertake;
d) Formally authorize personnel for functions in the certification process;
e) Monitor the performance of the personnel?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
6.1.2.2 Does the certification body maintain the following records on the personnel involved in the
certification process (see 7):
a) Name and address;
b) Employer(s) and position held;
c) Educational qualification and professional status;
d) Experience and training;
e) The assessment of competence;
f) Performance monitoring;
g) Authorizations held within the certification body;
h) Date of most recent updating of each record?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
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Management System Accreditation
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ISO/IEC 17065: 2012
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Clause Requirement
6.1.3 Contract with personnel
Does the certification body require personnel involved in the certification process to sign a contract or
other document by which they commit themselves to:
a) Comply with the rules defined by the certification body, including those relating confidentiality
(see 4.5) and independence from commercial and other interest;
b) Declare any prior and/or present association on their own part, or on the part of their employer,
with:
1) A supplier or designer of products, or
2) A provider or developer of services, or
3) An operator or developer of processes
to the evaluation or certification of which they are to be assigned; and
c) Reveal any situation known to them that may present them or the certification body with a conflict
of interest (see 4.2)?
How does the certification body use this information as input to identifying risks to impartiality raised
by the activities of such personnel or by the organizations that employ them (see 4.2.3)?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
6.2 Resources for evaluation
6.2.1 Internal resources
When the certification body performs evaluation activities either with its internal resources or with
other resources under its direct control, how does it ensure it meets the applicable requirements of
the relevant International Standards and, as specified by the certification scheme, of other
documents?
The relevant International Standards include for testing ISO/IEC 17025, for inspection ISO/IEC 17020
and for management system auditing ISO/IEC 17021.
Are the impartiality requirements of the evaluation personnel stipulated in the relevant standard
always applicable?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
6.2.2 External resources (outsourcing)
6.2.2.1 How does the certification body only outsource evaluation activities to bodies that meet the
applicable requirements of the relevant International Standards and, as specified by the certification
scheme of other documents?
The relevant International Standards include for testing ISO/IEC 17025, for inspection ISO/IEC 17020
and for management system auditing ISO/IEC 17021.
Are the impartiality requirements of the evaluation personnel stipulated in the relevant standard
always applicable?
Philippine Accreditation Bureau
Management System Accreditation
Assessment Checklist for
ISO/IEC 17065: 2012
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Clause Requirement
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
6.2.2.2 Where evaluation activities are outsourced to non-independent bodies (e.g. client
laboratories), how does the certification body assure that the evaluation activities are managed in a
manner which provides confidence in the results, and that records are available to justify the
confidence?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
6.2.2.3 Does the certification body have a legally binding contract with the body that provides the
outsourced service, including confidentiality and conflict of interest as described in 6.1.3 c)?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
6.2.2.4 How does the certification body:
a) take responsibility for all activities outsourced to another body;
b) ensure that the body that provides outsourced services, and the personnel that it uses, are not
involved, either directly or through any other employer, in such a way that the credibility of the
results could be compromised;
c) have documented policies, procedures and records for the qualification, assessing and monitoring
of all bodies that provide outsourced services used for certification activities;
d) maintain a list of approved providers of outsourced services;
e) implement corrective actions for any breaches of the contract in 6.2.2.3 or other requirements in
6.2.2 of which it becomes aware; and
f) inform the client in advance of outsourcing activities, to provide the client an opportunity to object?
*If the qualification, assessing and monitoring of the bodies that provide outsourced services are
performed by other organizations (e.g. by accreditation bodies, peer assessment bodies or
governmental authorities), the certification body can take this qualification and monitoring into
account provided that:
- it is provided for within the scheme requirements;
- the scope is applicable to the work being undertaken;
- the validity of the qualification, assessing and monitoring arrangements is verified at a
periodicity determined by the certification body.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
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Findings/Comments: (To be filled-up by the AB)
7 Process requirements
7.1 General
7.1.1 Does the certification body operate one or more certification scheme(s) covering its certification
activities?
*The elements of such schemes can be coupled with surveillance of production, or with the
assessment and surveillance of the client’s management system, or both.
**General guidance on the development of schemes is given in ISO/IEC 17067, in combination with
ISO/IEC Guide 28 and ISO/IEC Guide 53.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.1.2 How are the requirements against which the products of a client evaluated contained in
specified standards and other normative documents?
*Guidance for developing normative documents suitable for this purpose is contained in ISO/IEC
17007.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.1.3 If explanations are required as to the application of these documents (see 7.1.2) for a specific
certification scheme, how are they formulated by relevant and impartial persons or committees
possessing the necessary technical competence, and made available by the certification body upon
request?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
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7.2 Application
For application how does the certification body obtain all the necessary information to complete the
certification process according to the relevant certification scheme?
*The following are examples of necessary information:
- the product(s) to be certified;
- the standards and/or other normative documents for which the client is seeking certification
(see 7.1.2);
- the general features of the client, including its name and the address(es) of its physical
location(s), significant aspects of its process and operations (if required by the relevant
certification scheme), and any relevant legal obligations;
- general information concerning the client, relevant to the field of certification for which the
application is made, such as the client’s activities, its human and technical resources,
including laboratories and/or inspection facilities, and its functions and relationship in a larger
corporation, if any;
- information concerning all outsourced processes used by the client that will affect conformity
to requirements; if the client has identified a legal entity/entities for producing the certified
product(s) that is different from the client, then the certification body can establish appropriate
contractual controls over the legal entity/entities concerned, if necessary for surveillance; if
such contractual controls are needed, they can be established prior to providing formal
certification documentation (see 7.7);
- all other information needed in accordance with the relevant certification requirements, such
as information for initial evaluation and surveillance activities, e.g. the locations where the
certified product(s) are produced and contact personnel at these locations.
**A variety of media and mechanisms can be used to collect this information at various times,
including an application form. Such information gathering can be in conjunction with, or separate
from, the completion of legally binding agreement (the certification agreement) specified in 4.1.2.
***Application for an extension of the certification scope could be involve similar products, different
locations, etc.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.3 Application review
7.3.1 How does the certification body conduct a review of the information obtained (7.2) to ensure
that:
a) the information about the client and the product is sufficient for the conduct of the certification
process;
b) any known difference in understanding between the certification body and the client is resolved
including agreement regarding standard or normative document;
c) the scope of certification sought is defined;
d) the means to perform all evaluation activities are available;
e) the certification body has the competence and capability to perform the certification activity?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
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Findings/Comments: (To be filled-up by the AB)
7.3.2 How does the certification body identify when the client´s request for certification includes:
a type of product; or
a normative document; or
a certification scheme
where the certification body has no prior experience?
*Products can be considered to be the same type when knowledge of the requirements,
characteristics and technology related to one product is sufficient to understand the requirements,
characteristics and technology of another product.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.3.3 In these cases (7.3.2) how does the certification body ensure it has the competence and
capability for all certification activities it must undertake and maintain a record of the justification for
the decision to undertake certification?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.3.4 How does the certification body decline to undertake a specific certification if it lacks any
competence or capability for the certification activities it must undertake?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.3.5 If the certification body relies on certifications it has already grated to the client or has already
granted to other clients to omit any activities, how does the certification body then reference the
existing certification(s) in its records?
If requested by the client, how does the certification body provide justification for omission of
activities?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
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7.4 Evaluation
7.4.1 How does the certification body plan for the evaluation activities to allow for the necessary
arrangements to be managed?
*Depending on characteristics of the certification scheme and the product requirements, the plan can
be either generic plan applicable to all activities, including evaluation of the quality management
system, when applicable, or specific one for a particular activity, or combination of both.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.4.2 How does the certification body assign personnel to perform each evaluation task which it
undertakes with its internal resources (6.2.1)?
*Outsourced tasks are completed by personnel usually assigned by the organization to which the task
is outsourced. Such personnel are not normally assigned by the certification body.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.4.3 How does the certification body ensure all needed information and/or documentation is made
available for performing the evaluation tasks?
*The evaluation tasks can include activities such as design and documentation review, sampling,
testing, inspection and audit.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.4.4 How does the certification body carry out the evaluation activities which it undertakes with its
internal resources (6.2.1) and manage outsourced resources (6.2.2) in accordance with the
evaluation plan (7.4.1)?
How are the products evaluated against the requirements covered by the scope of certification and
other requirements specified in the certification scheme?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
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7.4.5 Does the certification body only rely on evaluation results related to certification completed prior
to the application for certification where it takes responsibility for the results and satisfies itself that the
body that performed the evaluation fulfils the requirements contained in 6.2.2 and those specified by
the certification scheme?
*This can include work carried out under recognition agreements between certification bodies.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.4.6 How does the certification body inform the client of all nonconformities?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.4.7 If one or more nonconformities have arisen, and if the client expresses interest in continuing
certification process, how does the certification body provide information regarding the additional
evaluation tasks needed to verify that nonconformities have been corrected?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.4.8 If the client agrees to completion of the additional evaluation tasks, how is the process specified
in 7.4 repeated to complete the additional evaluation tasks?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.4.9 How are the results of all evaluation activities documented prior to review (7.5)?
*This documentation can provide an opinion as to whether product requirements (including
requirements such as those for the quality management system under which the product is produced,
if required by the certification scheme) have been fulfilled.
**The certification scheme can indicate whether the evaluation is performed by the certification body,
under its responsibility, or is performed prior to the application 9see 7.2) for the certification process.
In the latter case, the requirements of 7.4 are not applicable.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
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Findings/Comments: (To be filled-up by the AB)
7.5 Review
7.5.1 How does the certification body assign at least one person to review all information and results
related to the evaluation?
How is the review carried out by person(s) who have not been involved in the evaluation process?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.5.2 How are recommendations for a certification decision based on the review documented, unless
the review and certification decision are completed concurrently by the same person?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.6 Certification decision
7.6.1 Is the certification body responsible for and how does it retain authority for its decision relating
to certification?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.6.2 Has the certification body assigned at least one person to make the certification decision based
on all information related to the evaluation, its review, and any other relevant information?
How is the certification decision carried out by a person or group of persons (e.g. a committee, see
5.1.4) which has not been involved in the process for evaluation (7.4)?
*The review and the certification decision can be completed currently by the same person or group of
persons.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
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7.6.3 Are the person(s) (excluding members of committees – see 5.1.4) assigned by the certification
body to make a certification decision employed by or under contract with
the certification body (6.1); or
an entity under the organizational control of the certification body (7.6.4)?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.6.4 Is the certification body’s organizational control:
whole or majority ownership of another entity by the certification body; or
majority participation by the certification body on the Board of Directors of another entity; or
documented authority by the certification body over another entity in a network of legal
entities (in which the certification body resides) linked by ownership or Board of Directors
control?
*For governmental certification bodies, other parts of the same government can be considered to be
“linked by ownership” to the certification body.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.6.5 How do the persons employed by or under contract with entities under organizational control
fulfils the same requirements of this International Standard, as persons being under employment or
contract with the certification body?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.6.6 How does the certification body notify the client of a decision not to grant certification identifying
the reasons for the decision?
*If the client expresses interest in continuing the certification process, the certification body can
resume the process for evaluation from 7.4
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
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7.7 Certification documentation
7.7.1 How does the certification body provide to the client formal certification documentation that
clearly conveys, or permits identification of:
a) The name and address of the certification body;
b) The date certification is granted; the date shall not precede the date the certification decision was
completed;
c) The name and address of the client;
d) The scope of certification (3.10);
*Where the standard(s) or other normative document(s) (see 7.1.2) to which conformity is being
certified include reference to other standards or normative documents, these do not need to be
included in the formal certification documentation.
e) The term or expiration date of certification if certification expires after an established period; and
f) Any other information required by the certification scheme?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.7.2 Does formal certification documentation include the signature or other defined authorization of
the person(s) of the certification body assigned such responsibility?
*The name and title of an individual whose agreement to be responsible for certification
documentation is on record at the certification body is an example of a “defined authorization” other
than signature.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.7.3 How is formal certification documentation (7.7) only issued after or concurrent with:
a) The decision to grant or extend the scope of certification (7.6.1) has been made; and
b) Certification requirements being fulfilled; and
c) The certification agreement (4.1.2) has been completed/signed?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
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7.8 Directory of certified products
How does the certification body maintain information on certified products which contains at least:
a) Identification of the product;
b) The standard(s) and other normative documents to which conformity has been certified;
c) Identification of the client?
Are the parts of this information which have to be published or made available on request (through
publications, electronic media or other means) in a directory stipulated by the relevant scheme(s)?
As a minimum how does the certification body inform on request about the validity of a given
certification?
*Where the certification body provides the information to a scheme, the scheme directory would
satisfy this requirement.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.9 Surveillance
7.9.1 If surveillance is required by the certification scheme or as described in sub clauses 7.9.3 or
7.9.4, how does the certification body initiate surveillance of the products(s) covered by the
certification decision in accordance with the certification scheme?
*ISO/IEC 17067 provides examples of surveillance activities in certification scheme.
**The criteria and process for surveillance activities are defined by each certification scheme.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.9.2 When surveillance utilizes evaluation, review or certification decision, how are the requirements
in 7.4, 7.5 or 7.6 fulfilled?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.9.3 When continuing use of a certification mark is authorized for placement on a product (or its
packaging or information accompanying it) (for process or service, see 7.9.4) of a type which has
been certified, how is surveillance established and does it include periodic surveillance of marked
products to assure ongoing validity of the demonstration of fulfilment of product requirements?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
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Findings/Comments: (To be filled-up by the AB)
7.9.4 When continuing use of certification mark is authorized for a process or service, is surveillance
established, does it include periodic surveillance activities to ensure ongoing validity of the
demonstration of fulfilment of process or service requirements?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.10 Changes affecting certification
7.10.1 When the certification scheme introduces new or revised requirements that affect the client
how does the certification body ensure these changes are communicated to all clients?
How does the certification body verify the implementation of the changes by its clients and does it
take actions required by the scheme?
*Contractual arrangements with clients can be necessary to ensure implementation of these
requirements. A model of license agreement for the use of certification, including the aspects related
to a notice of changes, s far as applicable, is given in ISO/IEC Guide 28:2004, Annex E.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.10.2 How does the certification body consider other changes affecting certification including
changes initiated by the client and decide upon the appropriate action?
*Changes affecting certification can include new information related to the fulfilment of certification
requirements obtained by the certification body after certification has been established.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
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7.10.3 Do the actions to implement changes affecting certification include, if required:
Evaluation (7.4);
Review (7.5);
Decision (7.6);
Issuance of revised formal certification documentation (7.7) to extend or reduce the scope of
certification; and/or
Issuance of certification documentation of revised surveillance activities (if surveillance is part
of the certification scheme)?
How are these actions completed in accordance with applicable parts of 7.4, 7.5, 7.6, 7.7 and 7.8?
Do records (7.12) include the rationale for excluding any of the above activities (e.g. when a
certification requirement that is not a product requirement changes and no evaluation, review or
decision activities are necessary)?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.11 Termination, reduction, suspension or withdrawal of certification
7.11.1 When a nonconformity with certification requirements is substantiated, either as a result of
surveillance or otherwise, how does the certification body consider and decide upon the appropriate
action?
*Appropriate action can include the following:
a) Continuation of certification under conditions specified by the certification body (e.g. increased
surveillance);
b) Reduction in the scope of certification to remove nonconforming products variants;
c) Suspension of the certification pending remedial action by the client;
d) Withdrawal of the certification.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.11.2 When the appropriate action includes evaluation, review or certification decision, how are the
requirements in 7.4, 7.5 or 7.6 fulfilled?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
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7.11.3 If certification is terminated (by request of the client) suspended or withdrawn, how does the
certification body take actions specified y the certification scheme and does it make all needed
modifications to formal certification documents, public information, authorizations for use of marks,
etc. to ensure it provides no indication that the product continues to be certified?
If a scope of certification is reduced how does the certification body take actions specified by the
certification scheme and does it make all needed modifications to formal certification documents.
Public information, authorizations for use of marks, etc. to ensure the reduced scope of certification is
clearly communicated to the client and clearly described in certification documentation and public
information?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.11.4 If certification is suspended, how does the certification body assign one or more persons to
formulate and communicate to the client:
Actions needed to end suspension and restore certification for the product(s) in accordance
with the certification scheme; and
Any other actions required by the certification scheme?
Are these persons competent in their knowledge and understanding of all aspects of the handling of
suspended certifications (6.1)?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.11.5 How are any evaluations, reviews or decisions needed to resolve the suspension or that are
required by the certification scheme completed in accordance with the applicable parts of sub clauses
7.4, 7.5, 7.6, 7.7.3 and 7.9 and 7.11.3?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.11.6 If certification is reinstated after suspension how does the certification body make all needed
modifications to formal certification documents, public information, authorizations for use of marks,
etc. to ensure all appropriate indications exist that the product continues to be certified?
If a decision to reduce the scope of certification is made as a condition of reinstatement, how does
the certification body make all needed modifications to formal certification documents, public
information, authorizations for use of marks, etc. to ensure the reduced scope of certification is clearly
communicated to the client and clearly described in certification documentation and public
information?
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Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.12 Records
7.12.1 Does the certification body retain record to demonstrate that all certification process
requirements (in this International Standard and those of the certification scheme) have been
effectively fulfilled (see also 8.4)?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.12.2 How does the certification body keep records confidential?
How are the records transported, transmitted and transferred in a way that ensures confidentiality is
maintained (see also 4.5)?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.12.3 If the certification scheme involves complete re-evaluation of the product(s) within a
determined cycle, are record retained at least for the current and the previous cycle?
Otherwise, are records retained for a period defined by the certification body?
*In defining retention times, legal circumstances and recognition arrangements can be considered.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.13 Complaints and appeals
7.13.1 Does the certification body have a documented process to receive, evaluate and make
decisions on complaints and appeals?
How does the certification body record and track complaints and appeals and actions undertaken to
resolve them?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
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7.13.2 Upon receipt of a complaint or appeal, how does the certification body confirm whether the
complaint or appeal relates to certification activities for which it is responsible, and if so, does the CB
address it?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.13.3 How does the certification body acknowledge receipt of a formal complaint or appeal?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.13.4 How is the certification body responsible for gathering and verifying all necessary information
(to the extent possible) to progress the complaint or appeal to a decision?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.13.5 How is the decision resolving the complaint or appeal made by, or reviewed and approved by,
person(s) not involved in the certification activities related to the complaint or appeal?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.13.6 To ensure that there is no conflict of interest, how are personnel including those acting in a
managerial capacity who have provided consultancy (3.2) for, or been employed by a client,
prevented from being used by the certification body to review or approve the resolution of a complaint
or appeal for that client within two years following the end of the consultancy or employment?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.13.7 Whenever possible, how does the certification body give formal notice of the outcome and end
of the complaint process to the complainant?
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Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.13.8 How does the certification body give formal notice of the outcome and end of the appeal
process to the appellant?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
7.13.9 How does the certification body take any needed subsequent action to resolve the complaint
or appeal?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
8 Management system requirements
8.1 Options
8.1.1 General
Has the certification body established and does it maintain a management system that is capable of
achieving the consistent fulfilment of the requirements of the International Standard in accordance
with either Option A or Option B?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
8.1.2 Option A
The management system of the certification body shall address the following:
General management system documentation (e.g. manual, policies. Definition of
responsibilities (8.2);
Control of Documents (8.3);
Control of Records (8.4);
Management Review (8.5);
Internal Audit (8.6);
Corrective Actions (8.7);
Preventive Actions (8.8);
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Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
8.1.3 Option B
A certification body that has established and maintains a management system in accordance with the
requirements of ISO 9001, and that is capable of supporting and demonstrating the consistent
fulfilment of the requirements of this International Standard, fulfil the management system clause (8.2
to 8.8) requirements.
*Option B is included to enable a certification body which operates a management system in
accordance with ISO 9001 to use that system to demonstrate fulfilment of the management system
requirements in 8.2 to 8.8 of this International Standard. Option B does require that the certification
body’s management system is certified to ISO 9001.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
8.2 General management system documentation (Option A)
8.2.1 How does the certification body’s top management establish, document, and maintain policies
and objectives for fulfilment of this International Standard and the certification scheme and how does
it ensure the policies and objectives are acknowledged and implemented at all levels of the
certification body’s organization?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
8.2.2 How does the certification body’s top management establish, document, and maintain policies
and objectives for fulfilment of this International Standard and the certification scheme and ensure the
policies and objectives are acknowledged and implemented at all levels of the certification body’s
organization?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
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8.2.3 Has the certification body’s top management appointed a member of management who,
irrespective of other responsibilities, shall have responsibility and authority that include:
a) Ensuring that processes and procedures needed for the management system are established,
implemented and maintained, and
b) Reporting to top management on the performance of the management system and any need for
improvement.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
8.2.4 Are all documentation, processes, systems, records, etc. related to the fulfilment of the
requirements of this International Standard included, referenced, or linked to documentation of the
management system?
Do all personnel involved in certification activities have access to the parts of the management
system documentation (and related information above) that is applicable to their responsibilities?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
8.2.5 Do all personnel involved in certification activities have access to the parts of the management
system documentation and related information that are applicable to their responsibilities?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
8.3 Control of documents (Option A)
8.3.1 Has the certification body established procedures to control the documents (internal and
external) that relate to the fulfilment of this International Standard?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
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8.3.2 Do the procedures define the controls needed to:
a) Approve documents for adequacy prior to issue;
b) Review and update (as necessary) and re-approve documents;
c) Ensure that changes and the current revision status of documents are identified;
d) Ensure that relevant versions of applicable documents are available at points of use;
e) Ensure that documents remain legible and readily identifiable;
f) Ensure that documents of external origin are identified and their distribution controlled; and
g) Prevent the unintended use of obsolete documents, and to apply suitable identification to them if
they are retained for any purpose?
*Documentation can be in any form or type of medium.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
8.4 Control of records (Option A)
8.4.1 Has the certification body established procedures to define the controls needed for the
identification, storage, protection, retrieval, retention time and disposition of its records related to the
fulfilment of this International Standard?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
8.4.2 Has the certification body established procedures for retaining records (7.12) for a period
consistent with its contractual and legal obligations?
Is access to these records consistent with the confidentiality arrangements?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
8.5 Management review (Option A)
8.5.1 General
8.5.1.1 Has the certification body’s top management established procedures to review its
management system at planned intervals to ensure its continuing suitability, adequacy and
effectiveness, including the stated policies and objectives related to the fulfilment of this International
Standard?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
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Findings/Comments: (To be filled-up by the AB)
8.5.1.2 Are these reviews conducted at least once a year?
Alternatively, is a complete review broken up in to segments completed within a 12 month time
frame?
Are records of reviews maintained?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
8.5.2 Review Inputs
How does the input to the management review include information related to:
a) Results of internal and external audits;
b) Feedback from clients and interested parties related to the fulfilment of this International
Standard;
*Interested parties can include scheme owners.
c) Feedback from the mechanism for safeguarding impartiality;
d) The status of preventive and corrective actions;
e) Follow-up actions from previous management reviews;
f) The fulfilment of objectives;
g) Changes that could affect the management system; and
h) Appeals and complaints?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
8.5.3 Review outputs
Does the outputs from the management review include decisions and actions related to the following:
a) Improvement of the effectiveness of the management system and its processes;
b) Improvement of the certification body related to the fulfilment of this International Standard;
c) Resource needs?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
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8.6 Internal audits (Option A)
8.6.1 How does the certification body establish procedures for internal audits to verify that it fulfils the
requirements of this International Standard and that the management system is effectively
implemented and maintained?
*ISO 19011 provides guidelines for conducting internal audits.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
8.6.2 Is an audit program planned, taking into consideration the importance of the processes and
areas to be audited, as well as the results of previous audits?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
8.6.3 Re internal audits normally be performed at least once every 12 months or completed within a
12 month time frame for segmented (or rolling) internal audits?
Is a documented decision-making process followed to change (reduce or restore) the frequency of
internal audits or the time frame in which internal audits shall be completed?
Are such changes based on the relative stability and ongoing effectiveness of the management
system?
Are record of decisions to change the frequency of internal audits or the time frame, in which they will
be completed, including the rationale for the change, maintained?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
8.6.4 How does the certification body ensure that:
a) Internal audits are conducted by personnel knowledgeable in certification, auditing and the
requirements if this International Standard;
b) Auditors do not audit their own work;
c) Personnel responsible for the area audited are informed of the outcome of the audit;
d) Any actions resulting from internal audits are taken in a timely and appropriate manner; and
e) Any opportunities for improvement are identified?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
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Clause Requirement
8.7 Corrective action (Option A)
8.7.1 How does the certification body establish procedures for identification and management of
nonconformities in its operations?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
8.7.2 How does the certification body also, where necessary, take actions to eliminate the causes of
nonconformities in order to prevent recurrence?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
8.7.3 Are corrective actions appropriate to the impact of the problems encountered?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
8.7.4 Do the procedures for corrective actions define requirements for:
a) Identifying nonconformities (e.g. from complaints and internal audits);
b) Determining the causes of nonconformity;
c) Correcting nonconformities;
d) Evaluating the need for actions to ensure that nonconformities do not recur;
e) Determining and implementing in a timely manner, the actions needed;
f) Recording the results of actions taken; and
g) Reviewing the effectiveness of corrective actions?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
8.8 Preventive actions (Option A)
8.8.1 How does the certification body establish procedures for taking preventive actions to eliminate
the causes of potential nonconformities?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
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Findings/Comments: (To be filled-up by the AB)
8.8.2 Are preventive actions taken appropriate to the probable impact of the potential problems?
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)
8.8.3 Do the procedures for preventive actions define requirements for;
a) Identifying potential nonconformities and their causes;
b) Evaluating the need for action to prevent the occurrence of nonconformities;
c) Determining and implementing the action needed;
d) Recording the results of actions taken; and
e) Reviewing the effectiveness of the preventive actions taken?
*The procedures for corrective and preventive actions do not necessarily have to be separate.
Describe briefly the CB’s established policies and procedures: (To be filled-up by the CB)
Findings/Comments: (To be filled-up by the AB)