Process

Audit
Checklist
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ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing

Guidance
About this Checklist
The audit checklist is just one of the many tools which are available from the auditor’s toolbox that help ensure your audits address the necessary
requirements. It stands as a reference point before, during and after the audit process and if developed for a specific audit and used correctly will provide the
following benefits:

 Ensures the audit is conducted systematically;

 Promotes audit planning;
 Ensures a consistent audit approach;
 Actively supports your organization’s audit process (ISO 9001:2015, Clause 9.2.1);
 Provides a repository for notes collected during the audit;
 Ensures uniformity in the performance of different auditors;
 Provides reference to objective evidence.
This audit checklist comprises tables of the certifiable (‘shall’) requirements, from Section 4.0 to Section 10.0 of ISO 9001:2015, each required is phrased as a
question. This audit checklist may be used for element compliance audits and for process audits. If you wish to create separate process audit checklists, select
the clauses from the tables below that are relevant to the process and copy and paste the audit questions into a new audit checklist. We suggest that you
retain this audit checklist as your ‘master copy’.

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ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing

Audit Scoring Criteria

A risk-based internal audit approach allows the internal audit to concentrate on reviewing the major risks to your organization. The audit’s role is to provide
assurance that key risks to your organization’s objectives are being well controlled.

The audit findings ‘traffic lights’ are intended to visually communicate the risk posed by the audit finding of any system or processes being audited. The rating
system is stratified from ‘compliant’ to ‘major non-conformance’ to convey a concise and consistent method for scoring each audit finding. At the end of the
audit, you can transfer the findings into an Excel spreadsheet to create charts, summary tables and trend data to paste into your audit report or management
review documentation.

This methodology should be uniformly applied to all types of internal audit (gap analysis, system audits and process audits) that your organization will likely
undertake.

Finding Definition/Impact Action/Mitigation

COMPLIAN Compliant means adherence with the requirements of the standard and the QMS. The
process is implemented and documented and records exist to verify this. Continue to monitor trends/indicators.
T

A low risk issue that offers an opportunity to improve current practice. Processes may Review and implement actions to improve the process(s).
OFI cumbersome or overly complex but meet their targets and objectives. Unresolved OFIs may Monitor trends/indicators to determine if improvement was
degrade over time to become non-compliant. achieved.

A medium risk, minor non-conformance resulting in deviation from process practice not
likely to result in the failure of the management system or process that will not result in the Investigate root cause(s) and implement corrective action by
MINOR N/C
delivery of non-conforming products nor reduce the effectiveness of the QMS. next reporting period or next scheduled audit.

A high risk, major non-conformance which directly impacts upon customer requirements, Implement immediate containment action, investigate root
MAJOR N/C likely to result in the customer receiving non-conforming products or services, or which may cause(s) and apply corrective action. Re-audit in 4 weeks to
reduce the effectiveness of the QMS. verify correction.

Document Ref: Page 2 of 19

 Page 3 of 19 Document Ref:
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PROCESS OUPUTS: PROCESS NAME/DESCRIPTION: PROCESS INPUTS:
What is the product produced by this process? What steps are involved in the process? What triggers the process?
Are product measures in place to ensure that product meetsWhat happens at each step in the process?
requirements? What inputs are required?
How are processes measured? What documents and records are generated? Where do the inputs come from?
Are product and process measures achieved? Is the process implemented in accordance with procedures, instructions or plans? Are they received in a timely manner?
What feedback is received from customers? Are controls applied as described? Are they fit for purpose?
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gets apply process? Is equipment suitable and properly maintained? Is the work environment maintained?
ints are there? What acceptance criteria exist? Is there evidence of appropriate maintenance of all equipment used by this process?
Process Activity Map
System & Process Compliance Auditing
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ISO 9001:2015 Process Audit Checklist
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ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing

Process Audit Checklist

Process Definition

Audit Findings Opportunities for

Audit Evidence
(Score ‘1’ per box) Improvement (OFI)

Ref Audit Question

COMPLIANT

MAJOR N/C
MINOR N/C
OFI
Provide reference to documented Provide suggestions for process
information to justify the finding improvement

1 Is the process defined and documented?

Is the process owner identified? (Process map,

2
procedure or work instruction, etc.)

Is there evidence that process inputs are accurately

3
defined and understood by all employees involved?

Is there evidence that process activities are accurately

4
defined and understood by all employees involved?

Is there evidence that process outputs are accurately

5
defined and understood by all employees involved?

6 Are inputs defined and prioritized based on risk?

Document Ref: Page 4 of 19

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ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing

Audit Findings Opportunities for

Audit Evidence
(Score ‘1’ per box) Improvement (OFI)
Ref Audit Question

COMPLIANT

MAJOR N/C
MINOR N/C
OFI
Provide reference to documented Provide suggestions for process
information to justify the finding improvement

Have procedures, instructions, and forms been

7
established as needed to control the process?

Are procedures, instructions and forms used in

8
controlling the process readily available?

Do procedures, instructions and forms accurately

9 reflect the practices? (Note: Requires the auditor review
and observation!)

Are there adequate plans in place to achieve the

10
objectives?

Is relevant customer feedback available? (Feedback

11
from subsequent processes)

12 Are documents understood by process participants?

Document Ref: Page 5 of 19

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ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing

Process Resources

Audit Findings Opportunities for

Audit Evidence
(Score ‘1’ per box) Improvement (OFI)

Ref Audit Question

COMPLIANT

MAJOR N/C
MINOR N/C
OFI
Provide reference to documented Provide suggestions for process
information to justify the finding improvement

Is there evidence of management commitment,

13
involvement and allocation of resources?

How many people participate in the process, is this

14
adequate to achieve process requirements?

Are participants adequately trained to carry out roles,

15
responsibilities, and authorities?

Is equipment (e.g. manufacturing, measuring &

monitoring equipment; transport/logistics;
16
hardware/software; PPE; etc.) adequate for its intended
use?
Is equipment identified to allow participants to
17 determine its readiness for safe use prior to and during
the operation?

Are process owners accountable for the performance

18
and compliance of their processes?

Document Ref: Page 6 of 19

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ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing

Audit Findings Opportunities for

Audit Evidence
(Score ‘1’ per box) Improvement (OFI)
Ref Audit Question

COMPLIANT

MAJOR N/C
MINOR N/C
OFI
Provide reference to documented Provide suggestions for process
information to justify the finding improvement

19 Are employees satisfied with their work area?

20 Is the work area clean and safe?

21 Is there adequate equipment/tools/IT support?

Are employees motivated and encouraged to make

22
suggestions for process improvement?

Are all employees aware of the organizational

23 objectives and the current status of these
measurements?

Are all employees aware of who their customers are

24
and whether they are satisfied?

Are employees aware of the process metrics which

25
their activities can affect?

Document Ref: Page 7 of 19

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ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing

Audit Findings Opportunities for

Audit Evidence
(Score ‘1’ per box) Improvement (OFI)
Ref Audit Question

COMPLIANT

MAJOR N/C
MINOR N/C
OFI
Provide reference to documented Provide suggestions for process
information to justify the finding improvement

Are they aware of the current data analysis related to

26
these metrics and the plans in place to achieve them?

Document Ref: Page 8 of 19

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ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing

Process Execution

Audit Findings Opportunities for

Audit Evidence
(Score ‘1’ per box) Improvement (OFI)

Ref Audit Question

COMPLIANT

MAJOR N/C
MINOR N/C
OFI
Provide reference to documented Provide suggestions for process
information to justify the finding improvement

Is the observed process activity consistent with

27
approved plans and procedures?

Is the process flow constructed to avoid unnecessary

28
movement of materials and personnel?

Are redundant and non-value adding activities

29
minimized?

30 Is material usage maximized to avoid waste?

Is waste material effectively removed and segregated

31
from the process?

Are unused materials returned to the correct location

32
in conditions suitable to allow re-use?

Are process outputs passed on to subsequent

33
processes only when all planned process activities are

Document Ref: Page 9 of 19

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ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing

Audit Findings Opportunities for

Audit Evidence
(Score ‘1’ per box) Improvement (OFI)
Ref Audit Question

COMPLIANT

MAJOR N/C
MINOR N/C
OFI
Provide reference to documented Provide suggestions for process
information to justify the finding improvement

completed?

Is there evidence of continuity between the various

34
support processes?

Do the interfaces between the departments operate

35
smoothly?

Does product information flow freely between the

36
support processes?

Is there evidence for the reduction in measurement

37
system and process variation?

Document Ref: Page 10 of 19

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ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing

Process Monitoring

Audit Findings Opportunities for

Audit Evidence
(Score ‘1’ per box) Improvement (OFI)

Ref Audit Question

COMPLIANT

MAJOR N/C
MINOR N/C
OFI
Provide reference to documented Provide suggestions for process
information to justify the finding improvement

Is the process monitored, measured, analyzed and

38
improved?

Are monitoring activities carried out according to

39
approved plans and procedures?

Is process monitoring compared against standards to

40
determine the current status of the process?

Is process status communicated to appropriate

41
members of the process team?

Are records of process monitoring maintained

42
according to approved procedures?

Have key performance indicators (KPI) been

43 established to allow the effectiveness of the process to
be evaluated?

Document Ref: Page 11 of 19

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ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing

Audit Findings Opportunities for

Audit Evidence
(Score ‘1’ per box) Improvement (OFI)
Ref Audit Question

COMPLIANT

MAJOR N/C
MINOR N/C
OFI
Provide reference to documented Provide suggestions for process
information to justify the finding improvement

Are KPI consistent with quality and business

44
objectives?

45 Are KPI consistent with customer requirements?

Are KPI reviewed and communicated to the process

46
team, as appropriate, by process leaders?

Is the process measured for effectiveness and

47
efficiency?

When a process is not performing, is there evidence of

48
data analysis to determine the root cause?

When a process is not performing, is there evidence

49 that the cause(s) are dealt with in accordance with
procedure?
Are records of process monitoring reviewed regularly
50 to determine opportunities for corrective and
preventive action?

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ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing

Document Ref: Page 13 of 19

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ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing

Process Improvement

Audit Findings Opportunities for

Audit Evidence
(Score ‘1’ per box) Improvement (OFI)

Ref Audit Question

COMPLIANT

MAJOR N/C
MINOR N/C
OFI
Provide reference to documented Provide suggestions for process
information to justify the finding improvement

Is the performance of the process reviewed at an

51
appropriate frequency by top management?

Are process improvement objectives aligned with

52
organizational objectives, e.g. the business plan?

53 Is there evidence of an effective PDCA cycle?

Can the process owner demonstrate how PDCA applies

54
to their process?

Can the process owner to show examples of

55
improvements driven by their PDCA cycle?

Can employees demonstrate areas of previous

56
continual improvement?

Are records of process upsets and actions taken

57
reviewed to determine the need for

Document Ref: Page 14 of 19

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ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing

Audit Findings Opportunities for

Audit Evidence
(Score ‘1’ per box) Improvement (OFI)
Ref Audit Question

COMPLIANT

MAJOR N/C
MINOR N/C
OFI
Provide reference to documented Provide suggestions for process
information to justify the finding improvement

corrective/preventive action?
Where corrective/preventive actions have been
58 implemented, have the action(s) taken been
demonstrated as effective?
Where opportunities for improvement have been
59 implemented, have the action(s) taken been
demonstrated as effective?

Are all process participants encouraged to be involved

60
in identifying improvements?

Document Ref: Page 15 of 19

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ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing

Findings Summary
Non-conformance
No. ISO/Specification Ref. Summary Root Cause NCR No. Rectification Date

Corrective Action
No. ISO/Specification Ref. Summary Root Cause CAR No. Rectification Date

Opportunities for Improvement

No. ISO/Specification Ref. Summary Root Cause PAR No. Implementation Date

Document Ref: Page 16 of 19

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ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing

Observations, Comments & Notes

Document Ref: Page 17 of 19