SENIOR LEADERSHIP

QUESTION EVIDENCE FOLLOW- CAR #, IF

UP APPLICABLE
REQUIRED?
Performance of the QMS—Clauses 5.1 and 5.3.c

1. How does the organization ensure that the QMS

is effective at achieving its intended results?

2. How have QMS requirements been integrated

into business processes? Can you show me some
examples please?

3. What organizational objectives have been

established that are relevant to the QMS? (Note:
These may be in the form of key performance
indicators [KPIs], MBO targets, corporate
directives, and so on.)

4. (Verify that the quality objectives are aligned

with the strategic direction of the organization.)

5. How does the organization manage business risk

related to the QMS? (Note: This could be risk of
not achieving the quality objectives, risk of not
conforming to customer requirements, reduced
market share due to dissatisfied customers, risk
of not meeting requirements of external parties
such as regulatory bodies, and so on. Verify
conformance to the organization’s process.)

6. How does the organization identify opportunities

Leadership
 to improve conformance to customer and
regulatory requirements and enhance customer
satisfaction?

7. How does the organization communicate the

importance of meeting QMS requirements?

8. How are employees encouraged to engage in the

QMS, recommend opportunities for
improvement, and otherwise contribute to the
effectiveness of the QMS? May I see some
examples please?

9. Who is accountable for reporting to senior

leadership on the performance of the QMS and
opportunities for improvement? How is that
done? What actions have been taken based on
this information to improve performance? What
improvements have been implemented in the last
year? May I see some examples please?

Quality policy—Clause 5.2

1. How is the quality policy communicated
throughout the organization? (Note: the
effectiveness of the communication will be
assessed at each process-specific audit.)

2. (Verify during the audit that the quality policy:

a. Is appropriate to the context of the
organization
b. Supports the organization’s strategic
direction
c. Provides a framework for setting the

Leadership
 quality objectives
d. Includes a commitment to satisfy
applicable requirements
e. Includes a commitment to continual
improvement of the QMS
f. Is made available to relevant interested
parties, as applicable.

Leadership