SADCAS F 40a - Checklist ISO IEC 17021-2015 Conformity Assessment - Requirements For Bodies Providing Audit and Cert MS (Issue 1) PDF
SADCAS F 40a - Checklist ISO IEC 17021-2015 Conformity Assessment - Requirements For Bodies Providing Audit and Cert MS (Issue 1) PDF
SADCAS F 40a - Checklist ISO IEC 17021-2015 Conformity Assessment - Requirements For Bodies Providing Audit and Cert MS (Issue 1) PDF
CB’S
ISO/IEC 17021 REQUIREMENTS COMMENT BY ASSESSOR
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5 General requirements
CB’S
ISO/IEC 17021 REQUIREMENTS COMMENT BY ASSESSOR
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5.2 Management of impartiality
CB’S
ISO/IEC 17021 REQUIREMENTS COMMENT BY ASSESSOR
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Note 2: Interested parties can include personnel and
clients of the CB, customers and organizations whose
systems are certified, representatives of industry
trade associations, representatives of governmental
regulatory bodies or other governmental services, or
representatives of non-governmental organizations
including consumer organizations.
See Note 1
See Note 1
See Note 1
CB’S
ISO/IEC 17021 REQUIREMENTS COMMENT BY ASSESSOR
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Are there any implications by CB that
certification would be simpler, easier, faster or
less expensive if a specified consultancy
organization is used?
6. Structural requirements
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ISO/IEC 17021 REQUIREMENTS COMMENT BY ASSESSOR
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overall authority and responsibility for each of
the following:
a) development of policies relating to the
operation of the body?
b) supervision of the implementation of
policies and procedures?
c) ensuring impartiality?
d) supervision of the finances of the body?
e) development of management system
certification services and schemes?
f) performance of audits and certification
and responsiveness to complaints?
g) decisions on certification?
h) delegation of authority to committees or
individuals, as required, to undertake
defined activities on its behalf?
i) contractual arrangements?
j) providing adequate resources for
certification activities?
7 Resource requirements
CB’S
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Does a CB have a process to ensure that
personnel have appropriate knowledge and
skills relevant to the types of management
systems and geographical areas in which it
operates?
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ISO/IEC 17021 REQUIREMENTS COMMENT BY ASSESSOR
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7.2.4 Does the CB have defined processes for:
• Selecting
• Training
• Formally authorizing auditors and
• Selecting technical experts?
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Competence reviewed to identify training
needs?
• Relevant qualifications;
• Training;
• Experience;
• Affiliations;
• Professional status; and
• Competence?
7.5 Outsourcing
See Notes
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ISO/IEC 17021 REQUIREMENTS COMMENT BY ASSESSOR
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7.5.3 Does the CB:
a) take responsibilities for all activities
outsourced?
b) ensure that the body that provides
outsources activities:
• conforms to the CB’s requirements
• conforms to the applicable provisions
of this international standard
including competence, impartiality
and confidentiality?
c) ensure that the outsourced services are
not involved in any way that impartiality
could be compromised?
See Notes
8 Information requirements
8.1 Publicly accessible information
a) audit processes;
b) certification processes;
c) types of management systems and
certification schemes in which it operates,
d) the use of the CB’s name and certification
mark and logo,
e) processes for handling requests for
information, complaints and appeals, and
f) policy on impartiality
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ISO/IEC 17021 REQUIREMENTS COMMENT BY ASSESSOR
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8.2.1 Does the CB provide certification documents to
the certified client by any means it chooses?
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c) the certification body issuing the
certificate.
See Note
8.4 Confidentiality
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ISO/IEC 17021 REQUIREMENTS COMMENT BY ASSESSOR
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client or individual disclosed to a third party
without the written consent of the client or
individual concerned?
8.4.4 Where the CB is required by law to release
confidential information to a third party, is the
customer or individual concerned, unless
regulated by law, notified in advance of the
information provided?
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ISO/IEC 17021 REQUIREMENTS COMMENT BY ASSESSOR
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3 make provisions where applicable to
accommodate the presence of
observers (e.g. accreditation auditors
or trainee auditors)?
e) Documents describing the rights and
duties of certified clients including
requirements when making reference to
its certification in communication of any
kind in line with the requirements in 8.3?
9 Process requirements
9.1.1 Application
Does the CB require an authorized
representative to provide the necessary
information to enable the CB to establish the
following :
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d) the standards or other requirements for
which the applicant organization is
seeking certification,
e) whether consultancy relating to the
management system to be certified has
been provided and, if so, by whom.
CB’S
ISO/IEC 17021 REQUIREMENTS COMMENT BY ASSESSOR
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See Note
CB’S
ISO/IEC 17021 REQUIREMENTS COMMENT BY ASSESSOR
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9.1.4.4 Does the CB include time spent by any team
member that is not assigned as an auditor?
9.1.5 Multi‐‐site sampling
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9.2.1.4 Is the audit criteria used as a reference against
which conformity is determined and does it
include:
See Note
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ISO/IEC 17021 REQUIREMENTS COMMENT BY ASSESSOR
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functions, sites, areas or activities and are such
assignments taking into account the need for
competence?
9.2.2.2.1 Observers
Prior to the conduct of the audit does the
client agree to the presence and justification of
observers during an audit activity?
See Note
See Note
9.2.2.2.3 Guides
Is each auditor accompanied by a guide, unless
otherwise agreed to by the audit team leader
and the client?
Does the audit team ensure that guides do not
influence or interfere in the audit process or
outcome of the audit?
9.2.3.1 General
See Note
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ISO/IEC 17021 REQUIREMENTS COMMENT BY ASSESSOR
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CB’S
ISO/IEC 17021 REQUIREMENTS COMMENT BY ASSESSOR
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Does the CB provide the name and, when
requested, make available background
information of each member of the audit team
with sufficient time for the client organization
to object to the appointment of any particular
auditor or technical expert and for the CB to
reconstitute the team in response to any valid
objection?
9.3.1.1 General
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f) to provide a focus for planning the Stage 2
audit by gaining a sufficient understanding
of the client’s management system and
site operations in the context of possible
significant aspects?
g) to evaluate if the initial audits and
management review are being planned
and performed and that the level of
implementation of the management
system substantiates that the client is
ready for the Stage 2 audit?
For most management systems it is
recommended that at least part of the Stage
1 audit be carried out at the client’s premises
in order to achieve the objectives stated
above.
9.3.1.2.3 Are Stage 1 audit findings documented and
communicated to the client organization
including identification of any areas of concern
that could be classified as nonconformity
during Stage 2 audit?
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f) management responsibility for the client
organization’s policies?
9.4.1 General
On-site audits?
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e) Confirmation that the resources and
facilities needed by audit team are
available;
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9.4.3.3 Does the team leader review with the client
any need for changes to the audit scope which
becomes apparent as on-site auditing activities
progress and report this to the CB?
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ISO/IEC 17021 REQUIREMENTS COMMENT BY ASSESSOR
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d) confirm the appropriateness of the audit
programme or identify any modification
required (e.g. scope, audit time or dates,
surveillance frequency, competence).
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Does the report provide accurate, concise and
clear record of the audit and does it include the
following:
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ISO/IEC 17021 REQUIREMENTS COMMENT BY ASSESSOR
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a) Statement on the conformity and
effectiveness of the management system
together with a summary of the evidence
relating to the capability of the
management system to meet applicable
and expected outcomes, the internal audit
and management review process ;
See Note
CB’S
ISO/IEC 17021 REQUIREMENTS COMMENT BY ASSESSOR
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standard as persons employed by or under
contract with the CB ?
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ISO/IEC 17021 REQUIREMENTS COMMENT BY ASSESSOR
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9.5.3.3 When a transfer of certification is envisaged
from one CB to another, does the accepting CB
have a process for obtaining sufficient
information in order to take decision on
certification ?
9.6.1 General
Does the CB maintain certification based on
demonstration that the client continues to
satisfy the requirements of the management
system standard?
Does the CB maintain an organization’s
certification based on a positive
recommendation by the audit team leader
without further independent review
provided that:
9.6.2.1 General
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9.6.2.1.2 Do surveillance activities include on-site audits
assessing the certified client’s management
system fulfilment of specified requirements
with respect to the standard to which the
certification is granted?
9.6.3 Recertification
9.6.3.1 Recertification audit planning
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ISO/IEC 17021 REQUIREMENTS COMMENT BY ASSESSOR
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9.6.3.1.1 Is a recertification audit planned and
conducted to evaluate the continued fulfilment
of all the requirements of the relevant
management system standard or other
normative document?
See Note
CB’S
ISO/IEC 17021 REQUIREMENTS COMMENT BY ASSESSOR
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Does the CB inform the client about the
consequences?
CB’S
ISO/IEC 17021 REQUIREMENTS COMMENT BY ASSESSOR
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• The client’s certified management system
has persistently or seriously failed to meet
certification requirements including
requirements for the effectiveness of the
management system?
• The certified client does not allow
surveillance or recertification audits to be
conducted at the required frequencies? or
• The certified client has voluntarily
requested a suspension?
See Note
9.6.5.5 Does the CB reduce the client’s scope of
certification to exclude the parts not meeting
the requirements when the client has
persistently or seriously failed to meet the
certification requirements for those parts of
the scope of certification?
9.7 Appeals
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c) ensuring that any appropriate correction
and corrective action is taken.
9.8 Complaints
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b) tracking and recording complaints
including actions undertaken to resolve
them?
c) ensuring that an appropriate correction
and corrective actions are taken?
See Note
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g) committee deliberations and decisions, if
applicable?
h) documentation of the certification
decisions?
i) certification documents including the
scope of certification with respect to
product, process or services as applicable?
See Note
10.2.1 General
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Does the CB establish, Document, implement
and maintain a management system capable of
supporting and demonstrating the consistent
achievement of the requirements of the
standard?
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e) To ensure that documents remain legible
and readily identifiable?
f) To ensure that documents of external
origin are identified and their distribution
controlled? and
g) To prevent the unintended use of
obsolete documents and to apply suitable
identification to them if they are retained
for any purpose?
See Note
See Note
10.2.5.1 General
Did the CB’s top management establish
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?
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ISO/IEC 17021 REQUIREMENTS COMMENT BY ASSESSOR
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f) Follow-up actions from previous
management reviews?
g) Fulfilment of objectives?
h) Changes that could affect the
management? and
i) Appeals and complaints?
See Note
10.2.6.2 Is an audit programme planned taking into
consideration the importance of the processes
and areas to be audited as well as the results of
previous audits?
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ISO/IEC 17021 REQUIREMENTS COMMENT BY ASSESSOR
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e) Any opportunities for improvement are
identified?
10.3.1 General
Does the CB establish and maintain a
management system in accordance with the
requirements of ISO 9001, capable of
supporting and demonstrating the consistent
achievement of the requirements of the
standard, amplified by 10.3.2 to 10.3.4?
10.3.2 Scope
Does the scope of the management system
include the design and development
requirements of its certification services?
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When developing its management system,
does the CB consider the credibility of
certification and address the needs of all
parties (as set out in 4.1.2) that rely upon its
audit and certification services, not just its
clients?
Additional /General Comments (This space may be used to expand on comments in specific sections)
Signed Date:
Lead /Technical Assessor: