You are on page 1of 5

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)
5 LEADERSHIP
5.1 Leadership and commitment
5.1.1 General
Top management shall demonstrate leadership and 1) Show me how top management demonstrates
commitment with respect to the quality leadership and commitment with regards to the QMS
management system by: by taking accountability of the effectiveness of the
QMS.
a) taking accountability for the effectiveness of the
quality management system; 2) How is the quality policy and objectives
b) ensuring that the quality policy and quality established for the QMS and how are they
objectives are established for the quality compatible with the strategic direction and the
management system and are compatible with the organizational context?
context and strategic direction of the organization;
c) ensuring the integration of the quality 3) How is the quality policy communicated within the
management system requirements into the organization? Show me how this is understood and
organization’s business processes; applied.
d) promoting the use of the process approach and
risk-based thinking; 4) How are the requirements of the QMS integrated
e) ensuring that the resources needed for the quality into the business processes?
management system are available;
f) communicating the importance of effective quality 5) How do you promote awareness of the process
management and of conforming to the quality approach?
management system requirements;
g) ensuring that the quality management system 6) How do you ensure that resources needed for the
achieves its intended results; QMS are available?
h) engaging, directing and supporting persons to
contribute to the effectiveness of the quality 7) How do you communicate the importance of
management system; effective quality management?

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)

i) promoting improvement; 8) How do you communicate the importance of


j) supporting other relevant management roles to conforming to the QMS requirements?
demonstrate their leadership as it applies to their
areas of responsibility. 9) How do you ensure that the QMS achieves its
intended results?

10) How do you engage, direct and support people to


contribute to the effectiveness of the QMS?

11) How do you promote continual improvement?

12) How do you support other relevant management


roles to demonstrate leadership in their areas of
responsibility?

5.1.1.1 Corporate responsibility


The organization shall define and implement Have you define and implement corporate
corporate responsibility policies, including at a responsibility policies includes an anti bribery policy,
minimum an anti-bribery policy, an employee code of an employee code of conduct and an ethics
conduct, and an ethics escalation policy (''whistle- escalation policy (whistle blowing policy)
blowing policy'')

5.1.1.2 Process effectiveness and efficiency


Top management shall review the product realization Is your department KPI measure effeciveness and
processes and support processes to evaluate and efficiency of QMS?
improve their effectiveness and efficiency. The
results of the process review activities shall be
included as input to the management review (see
Section 9.3.2.1.).

5.1.1.3 Process owners


Top management shall identify process owners who 1) Do you have JD?
are responsible for managing the organization’s
processes and related outputs. Process owners shall 2) Is your JD include job description and comptency
understand their roles and be competent to perform level?
those roles (see ISO 9001, Section 7.2)
Rev No: 0 Effective Date: 3 April 2023 Document No: F/QA/0130
Top management shall identify process owners who 1) Do you have JD?
are responsible for managing the organization’s
processes and related outputs. Process owners shall 2) Is your JD include job description and comptency Conform CAR#
Clause understand their roles and be competent to perform level?
Requirements Item Audited / Questions Remarks
those roles (see ISO 9001, Section 7.2) Yes No (If any)

5.1.2 Customer focus


Top management shall demonstrate leadership and 1) Show me how top management demonstrates
commitment with respect to customer focus by leadership and commitment with regards to
ensuring that: customer focus ensuring requirements and
applicable statutory and regulatory requirements are
a) customer and applicable statutory and regulatory determined and met.
requirements are determined, understood and
consistently met; 2) How are risks and opportunities that can affect
b) the risks and opportunities that can affect conformity of products and services determined?
conformity of products and services and the ability to
enhance customer satisfaction are determined and 3) How is the ability to enhance customer satisfaction
addressed; determined and addressed?
c) the focus on enhancing customer satisfaction is
maintained 4)How is the focus on consistently providing products
and services that meet customer and applicable
statutory and regulatory requirements maintained?

5) How is customer satisfaction maintained?

5.2 Policy
5.2.1 Establishing the quality policy
Top management shall establish, implement and 1) How does top management establish, review and
maintain a quality policy that: maintain a quality policy?

a) is appropriate to the purpose and context of the 2) How is it determined to be appropriate to the
organization and supports its strategic direction; purpose and context of the organization?
b) provides a framework for setting quality
objectives; 3) Does it provide a framework for setting and
c) includes a commitment to satisfy applicable reviewing quality objectives?
requirements;
d) includes a commitment to continual improvement 4) Does it contain a commitment to satisfy applicable
of the quality management system. requirements?

5) Does it include a commitment to continual


improvement of the QMS?

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


5) Does it include a commitment to continual
improvement of the QMS?
Conform CAR#
Clause Requirements Item Audited / Questions Remarks
Yes No (If any)

5.2.2 Communicating the quality policy


The quality policy shall: 1) Where is the quality policy available as
documented information?
a) be available and be maintained as documented
information; 2) How is it communicated?
b) be communicated, understood and applied within
the organization; 3) Show me how it is understood and applied within
c) be available to relevant interested parties, as the organization.
appropriate.
4) How have you made it available to relevant
interested parties?

5.3 Organizational roles, responsibilities and authorities


Top management shall ensure that the 1) How does top management ensure that
responsibilities and authorities for relevant roles are responsibilities and authorities for relevant roles are
assigned, communicated and understood within the assigned, communicated and understood within the
organization. Top management shall assign the organization?
responsibility and authority for:
2) How does top management assign the
a) ensuring that the quality management system responsibility and authority for:
conforms to the requirements of this International a) Ensuring that the QMS conforms to the
Standard; international standard?
b) ensuring that the processes are delivering their b) Ensuring processes are delivering their intended
intended outputs; outputs?
c) reporting on the performance of the quality
management system and on opportunities for 3) How is the performance of the QMS, opportunities
improvement (see 10.1), in particular to top for improvement and the need for change or
management; innovation reported to top management?
d) ensuring the promotion of customer focus
throughout the organization; 4) How is customer focus promoted within the
e) ensuring that the integrity of the quality organization?
management system is maintained when changes to
the quality management system are planned and 5) How is the integrity of the QMS maintained when
implemented. changes to the QMS are planned and implemented?

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)

5.3.1 Organizational roles, responsibilities, and authorities


-Top
supplemental
management shall assign personnel with the 1) Do you have organization chart?
responsibility and authority to ensure that customer
requirements are met. These assignments shall be 2) Have you establish JD for each designation?
documented. this includes but is not limited to the
selection of special characteristics, setting quality 3) What are their roles, responsibilities, authorities
objectives and related training, corrective and and comptency requirements for the role?
preventative actions, product design and
development, capacity analysis, logistics information,
customer scorecards and customer portals.

5.3.2 Responsibility and authority for product


requirements
Top management and shall
corrective
ensureactions
that: 1) Who has the authority to stop machine, stop
production & stop shipment?
a) personnel responsible for conformity to product
requirements have the authority to stop shipment 2) Who is responsible for corrective action?
and stop production to correct quality problems;
b) ersonnel with authority and responsibility for 3) Who is the customer representative?
corrective action are promptly informed of products
or processes that do not conform to requirements to 4) Do you have quality personnel working at all
ensure that nonconforming product is not shipped to production shifts?
the customer and that all potential nonconforming
product is identified and contained; 5) Who is responsible in determining the product and
c) production operations across all shifts are staffed process special characteristics?
with personnel in charge of, or delegated
responsibility for, ensuring conformity to
requirements

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

You might also like