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ISO 9001 Internal Audit Checklist for Quality Management Systems

ISO 9001 Internal Audit Checklist for Quality Management Systems

Run this checklist to perform an internal audit on a quality management system (QMS) against the ISO 9001:2015 requirements.
1
Introduction:
2
Enter basic details
3
Preparing for the audit:
4
Establish context of the audit
5
Establish objectives of the audit
6
Establish scope of the audit
7
Establish criteria of the audit
8
Ensure audit monitoring systems are in place
9
Request documented information from auditee
10
Assign audit roles and responsibilities:
11
Assign audit team
12
Assign audit team lead
13
Reviewing documented information:
14
Review auditee's documented information
15
(Conditional) Resolve documented information issue(s)
16
Prepare an audit plan
17
Assign work to audit team
18
Initiating the audit:
19
Make arrangements with the auditee
20
Conduct open meeting
21
Ensure relevant audit information is accessible
22
Collecting evidence (context of the organization):
23
Assess the organization and its context
24
Assess needs and expectations of interested parties
25
Assess scope of QMS
26
Collecting evidence (leadership):
27
Assess leadership of the QMS
28
Assess customer focus
29
Assess quality policy
30
Assess organizational roles and responsibilities
31
Collecting evidence (QMS planning):
32
Assess documentation of risks and opportunities
33
Assess quality objectives
34
Assess procedures for changes to QMS
35
Collecting evidence (support):
36
Assess organization and allocation of QMS resources
37
Assess HR integration with QMS
38
Assess QMS infrastructure
39
Assess QMS work environment
40
Assess systems for monitoring and measurement of resources
41
Assess organizational knowledge of the QMS
42
Assess QMS competence
43
Assess QMS awareness
44
Assess communication of QMS within the organization
45
Assess documented information
46
Collecting evidence (operation):
47
Assess process control
48
Assess determination of requirements for products and services
49
Assess design and development of products and services
50
Assess design and development inputs
51
Assess design and development controls
52
Assess design and development outputs
53
Assess design and development changes
54
Assess control of externally provided products and services
55
Assess type and extent of control
56
Assess information for external providers
57
Assess control of production and service provision
58
Assess identification and traceability of production control
59
Assess control of external provider/customer property
60
Assess preservation procedures
61
Assess post-delivery activities
62
Assess control of changes
63
Assess release of products and services
64
Assess control of nonconforming outputs
65
Collecting evidence (performance evaluation):
66
Assess QMS performance evaluation
67
Assess customer satisfaction
68
Assess performance analysis and evaluation procedures
69
Assess internal audit procedures
70
Assess management review procedures
71
Collecting evidence (improvement):
72
Assess procedures for nonconformity and corrective action
73
Assess procedures for continuous improvement
74
Audit findings:
75
Review audit evidence and findings
76
Closing the audit:
77
Prepare audit report
78
Issue audit report
79
(Conditional) Prepare for audit follow-up
80
Prepare for closing meeting
81
Conduct closing meeting
82
Complete the audit
83
Sources:
84
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