IATF 16949:2016 QMS AUDIT CHECKLIST

Audit Area : Audit Date :

Auditee : Auditor :

IATF Clause No :

Conform CAR#
Clause Requirements Item Audited / Questions Remarks
Yes No (If any)
4 CONTEXT OF THE ORGANIZATION
4.1 Understanding the organization and its context
The organization shall determine external and 1) Has you determined the external and internal
internal issues that are relevant to its purpose and its issues that are relevant to xxx purpose and strategic
strategic direction and that affect its ability to direction?
achieve the intended result(s) of its QMS.
2) Have you considered the relevant issues that
The organization shall monitor and review affect your ability to achieve the intended results of
information about these external and internal issues. the QMS?

3) How do you monitor and review the information

related to the external and internal issues?

4.2 Understanding the needs and expectations of

interested parties
Due to their effect or potential effect on the 1) How have you determined what interested parties
organization's ability to consistently provide products are relevant to the QMS?
and services that meet customer and applicable
statutory and regulatory requirements, the 2) What requirements of these interested parties
organizaton shall determine: that are relevant to the QMS?

a) the interested parties that are relevant to the QMS 3) How has impact or potential impact been
b) the requirements of these interested parties that determined?
are relevant to the QMS
4) How do you monitor and review the information
The organization shall monitor and review about the interested parties and their relevant
information about these interested parties and their requirements?
relevant requirements

Rev No: 0 Effective Date: 3 April 2023 Document No: F/QA/0130

 The organization shall monitor and review about the interested parties and their relevant
information about these interested parties and their requirements?
relevant requirements
Conform CAR#
Clause Requirements Item Audited / Questions Remarks
Yes No (If any)

Rev No: 0 Effective Date: 3 April 2023 Document No: F/QA/0130

 Conform CAR#
Clause Requirements Item Audited / Questions Remarks
Yes No (If any)
4.3 Determining the scope of the QMS
The organization shall determine the boundaries and 1) To establish the scope of the QMS: have you
applicability of the QMS to establish its scope. determined the boundaries and applicability of the
QMS?
When determining this scope, the organization shall
consider: 2) When determining the scope of the QMS, have
you considered the:
a) the external and internal issues referred to in 4.1; a) External and internal issues?
b) the requirements of relevant interested parties b) Requirements of relevant interested parties?
referred to in 4.2; c) The products and services of your company?
c) the products and services of the organization.
3) When a requirement of ISO 9001:2015 can be
The organization shall apply all the requirements of applied, has your company applied the requirement?
this International Standard if they are applicable
within the determined scope of its quality 4) Is the scope of the QMS available and maintained
management system. as documented information?

The scope of the organization’s QMS shall be 5) In the scope of the QMS, have you stated the
available and be maintained as documented products and services covered by the QMS?
information. The scope shall state the types of
products and services covered, and provide 6) Has Feytech provided justification for any instance
justification for any requirement of this International where a requirement of the standard cannot be
Standard that the organization determines is not applied?
applicable to the scope of its QMS.

Conformity to this International Standard may only

be claimed if the requirements determined as not
being applicable do not affect the organization’s
ability or responsibility to ensure the conformity of
its products and services and the enhancement of
customer satisfaction.

Rev No: 0 Effective Date: 3 April 2023 Document No: F/QA/0130

 Conform CAR#
Clause Requirements Item Audited / Questions Remarks
Yes No (If any)
4.3.1 Determining the scope of the QMS - supplemental
Supporting functions, whether on site or remote 1) In the QM, have you stated the:
(such as design centers, corporate headquarters, and
distribution centres) shall be included in the scope of a) Nature of business?
the QMS. The only permitted exclusion for this b) Types of automotive products processes?
Automotive QMS Standard relates to the product c) Any product design responsibility?
design and development requirements within ISO d) On site or manufacturing site?
9001, Section 8.3. The exclusion shall be justified and e) Remote support location, if any?
maintained as documented information (see ISO
9001, Section 7.5).

Permitted exclusions do not include manufacturing

process design.

4.3.2 Customer-specific requirements

Customer specific requirements shall be evaluated Is the CSR incorporated into QM, procedures,
and included in the scope of the organization's QMS formats and practices?

Rev No: 0 Effective Date: 3 April 2023 Document No: F/QA/0130

 Conform CAR#
Clause Requirements Item Audited / Questions Remarks
Yes No (If any)
4.4 QMS and its processes
4.4.1 The organization shall establish, implement, maintain 1) Has you obtained the current version of the ISO
and continually improve a quality 9001:2015 international standard?
management system, including the processes needed
and their interactions, in accordance with the 2) As required by the standard, have you established,
requirements of this International Standard. documented implemented, maintained and
continually improved the QMS?
The organization shall determine the processes
needed for the quality management system and their 3) Have you determined the processes need for the
application throughout the organization, and shall: QMS, their interactions and applications throughout
your company?
a) determine the inputs required and the outputs
expected from these processes; 4) For the QMS processes have you determined the:
b) determine the sequence and interaction of these a) Inputs required and the outputs expected from
processes; the processes?
c) determine and apply the criteria and methods b) Sequence and interaction of the processes?
(including monitoring, measurements and related c) Criteria, methods, including measurements and
performance indicators) needed to ensure the related performance indicators needed to ensure the
effective operation and control of these processes; effective operation, and control of the processes?
d) determine the resources needed for these d) Resources needed and ensure their availability?
processes and ensure their availability; e) Assignment of the responsibilities and authorities
e) assign the responsibilities and authorities for these for these processes?
processes; f) Risks and opportunities, and plans to implement
f) address the risks and opportunities as determined the appropriate actions to address them?
in accordance with the requirements of 6.1; g) Methods for monitoring, measuring, and
g) evaluate these processes and implement any evaluation of processes and, if needed, the changes
changes needed to ensure that these processes to processes to ensure that they achieve intended
achieve their intended results; results?
h) improve the processes and the quality h) Opportunities for improvement of the processes
management system. and the QMS?

Rev No: 0 Effective Date: 3 April 2023 Document No: F/QA/0130

 Conform CAR#
Clause Requirements Item Audited / Questions Remarks
Yes No (If any)
4.4.1.1 Conformance of Products and Processes
The organization shall ensure conformance of all
products and processes, including service parts and
those that are outsourced, to all applicable customer,
statutory and regulatory requirements (see Section
8.4.2.2)

4.4.1.2 Product Safety

All organization shall have documented processes for
the management of product-safety related products
and manufacturing processes, which shall include but
not be limited to the following, where applicable:

a) identification by the organization of statutory and

regulatory product-safety requirements
b) customer notification of requirements in item a)
c) special approval for design FMEA
d) identification of product safety-related
characteristics
e) identification and controls of safety-related
characteristics of product and at the point of
manufacture
f) special approval of control plans and processes
FMEAs
g) reaction plans

4.4.2 To the extent necessary, the organization shall: 1) Have you maintained the necessary documented
information to support the operation of processes?
a) maintain documented information to support the
operation of its processes; 2) Has your company retained the necessary
b) retain documented information to have documented information to provide the confidence
confidence that the processes are being carried out that the processes are being carried out as planned?
as planned.

Rev No: 0 Effective Date: 3 April 2023 Document No: F/QA/0130