Q# ISO 9001:2015 Clause
4.4q3 The organization shall maintain documented
information to the extent necessary to support the
operation of processes and retain documented
information to the extent necessary to have
confidence that the processes are being carried out
as planned.
5 Leadership
5.1 Leadership and commitment
5.1.1 Leadership and commitment for the quality management system
5.1.1q1 Top management shall demonstrate leadership
and commitment with respect to the quality
management system by:
a) taking accountability of the effectiveness of the
quality management system;
b) ensuring that the quality policy and quality
objectives are established for the quality
management system and are compatible with the
strategic direction and the context of the
organization;
c) ensuring that the quality policy is communicated,
understood and applied within the organization;
d) ensuring the integration of the quality
management system requirements into the
organization’s business processes;
e) promoting awareness of the process approach;
f) ensuring that the resources needed for the
quality management system are available;
g) communicating the importance of effective
quality management and of conforming to the
quality management system requirements;
h) ensuring that the quality management system
achieves its intended results;
i) engaging, directing and supporting persons to
contribute to the effectiveness of the quality
management system;
j) promoting continual improvement;
k) supporting other relevant management roles to
demonstrate their leadership as it applies to their
areas of responsibility.
Audit Question Audit Evidence
What documented information exists to Documented information to support the operation of
support the operation of processes? How is processes.
this documented information retained? How
is confidence that the processes are being
carried out as planned determined?
Show me how top management
demonstrates leadership and commitment
w.r.t. the QMS by taking accountability of
the effectiveness of the QMS.
How is the quality policy and objectives
established for the QMS and how are they
compatible with the strategic direction and
the organizational context?
How is the quality policy communicated
within the organization? Show me how this
is understood and applied.
How are the requirements of the QMS
integrated into the business processes?
How do you promote awareness of the
process approach?
How do you ensure that resources needed
for the QMS area available?
How do you communicate the importance of
effective quality management?
How do you communicate the importance of
conforming to the QMS requirements?
How do you ensure that the QMS achieves
its intended results?
How do you engage, direct and support
people to contribute to the effectiveness of
the QMS?
How do you promote continual
improvement?
How do you support other relevant
management roles to demonstrate
leadership in their areas of responsibility?
Page 3
Q# ISO 9001:2015 Clause Audit Question Audit Evidence
NOTE Reference to “business” in this International Standard can be interpreted broadly to mean those
activities that are core to the purposes of the organization’s existence; whether the organization is public,
private, for profit or not for profit.

5.1.2 Customer focus

5.1.2q1 Top management shall demonstrate leadership
and commitment with respect to customer focus by
ensuring that:
a) customer requirements and applicable statutory
and regulatory requirements are determined and
met;
b) the risks and opportunities that can affect
conformity of products and services and the ability
to enhance customer satisfaction are determined
and addressed;
c) the focus on consistently providing products and
services that meet customer and applicable
statutory and regulatory requirements is
maintained;
d) the focus on enhancing customer satisfaction is
maintained.
5.2 Quality policy
5.2.1
5.2.1q1 Top management shall establish, review and maintain
a quality policy that:
a) is appropriate to the purpose and context of the
organization;
b) provides a framework for setting and reviewing
quality objectives;
c) includes a commitment to satisfy applicable
requirements;
d) includes a commitment to continual improvement of
the quality management system.
5.2.2
Show me how top management
demonstrates leadership and commitment
w.r.t. customer focus ensuring requirements
and applicable statutory and regulatory
requirements are determined and met.
How are risks and opportunities that can
affect conformity of products and services
determined?
How is the ability to enhance customer
satisfaction determined and addressed?
How is the focus on consistently providing
products and services that meet customer
and applicable statutory and regulatory
requirements maintained?
How is customer satisfaction maintained?
How does top management establish,
review and maintain a quality policy?
How is it determined to be appropriate to
the purpose and context of the
organization?
Does it provide a framework for setting and
reviewing quality objectives?
Does it contain a commitment to satisfy
applicable requirements?
Does it include a commitment to continual
improvement of the QMS?

Page 4