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Guidance 3 About this Checklist 3 Audit Scoring Criteria 3 Principles of Auditing 4 Audit Methodology 5 Introduction 5 Preparation 7 Documented 

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Internal Audit

Checklist

System & Process Compliance Auditing

ISO 9001:2015 Audit Checklist

System & Process Compliance Auditing

www.iso-9001-checklist.co.uk Page 1 of 78

Contents

Guidance ____________________________________________________________________________________________________________________________________________________________ 3

About this Checklist _____________________________________________________________________________________________________________________________________________ 3

Audit Scoring Criteria ___________________________________________________________________________________________________________________________________________ 3

Principles of Auditing ___________________________________________________________________________________________________________________________________________ 4

Audit Methodology _____________________________________________________________________________________________________________________________________________ 5

Introduction ____________________________________________________________________________________________________________________________________________________ 5

Preparation _____________________________________________________________________________________________________________________________________________________ 7

Documented Information Review ______________________________________________________________________________________________________________________________ 7

Process Criteria, Metrics and Objectives ________________________________________________________________________________________________________________________ 7

Previous Audit Findings ________________________________________________________________________________________________________________________________________ 7

Customer Complaints and Corrective Actions __________________________________________________________________________________________________________________ 8

Inputs and Outputs _____________________________________________________________________________________________________________________________________________ 8

Relevant ISO standards _________________________________________________________________________________________________________________________________________ 8

Review Performance ____________________________________________________________________________________________________________________________________________ 8

Review Competencies __________________________________________________________________________________________________________________________________________ 8

Review Linkages & Interactions ________________________________________________________________________________________________________________________________ 9

Review the Process _____________________________________________________________________________________________________________________________________________ 9

Review the Findings ___________________________________________________________________________________________________________________________________________ 10

Prepare the Report ____________________________________________________________________________________________________________________________________________ 10

Audit Checklist Part 1 ___________________________________________________________________________________________________________________________________________ 11

Section 4.0 Context of the Organization ______________________________________________________________________________________________________________________ 11

Audit Findings Summary _______________________________________________________________________________________________________________________________________ 16

Audit Checklist Part 2 ___________________________________________________________________________________________________________________________________________ 17

ISO 9001:2015 Audit Checklist

System & Process Compliance Auditing

www.iso-9001-checklist.co.uk Page 2 of 78

Section 5.0 Leadership _________________________________________________________________________________________________________________________________________ 17

Audit Findings Summary _______________________________________________________________________________________________________________________________________ 22

Audit Checklist Part 3 ___________________________________________________________________________________________________________________________________________ 23

Section 6.0 Planning____________________________________________________________________________________________________________________________________________ 23

Audit Findings Summary _______________________________________________________________________________________________________________________________________ 28

Audit Checklist Part 4 ___________________________________________________________________________________________________________________________________________ 29

Section 7.0 Support ____________________________________________________________________________________________________________________________________________ 29

Audit Findings Summary _______________________________________________________________________________________________________________________________________ 37

Audit Checklist Part 5 ___________________________________________________________________________________________________________________________________________ 38

Section 8.0 Operation __________________________________________________________________________________________________________________________________________ 38

Audit Findings Summary _______________________________________________________________________________________________________________________________________ 62

Audit Checklist Part 6 ___________________________________________________________________________________________________________________________________________ 65

Section 9.0 Performance Evaluation __________________________________________________________________________________________________________________________ 65

Audit Findings Summary _______________________________________________________________________________________________________________________________________ 73

Audit Checklist Part 7 ___________________________________________________________________________________________________________________________________________ 74

Section 10.0 Improvement _____________________________________________________________________________________________________________________________________ 74

Audit Findings Summary _______________________________________________________________________________________________________________________________________ 78

ISO 9001:2015 Audit Checklist

System & Process Compliance Auditing

www.iso-9001-checklist.co.uk Page 3 of 78

Guidance

About this Checklist

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 (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 , 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

Audit Scoring Criteria

A risk-based internal audit approach allows the internal audit to concentrate on reviewing the major risks to your organization. The

assurance that key risks to your organization

The audit findings are intended to visually communicate the risk posed by the audit finding of any system or processes being audited. The rating

system is stratified major non- 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.

ISO 9001:2015 Audit Checklist

System & Process Compliance Auditing

www.iso-9001-checklist.co.uk Page 4 of 78

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

COMPLIANT 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.

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

MINOR N/C

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 delivery of non-conforming products nor reduce the effectiveness of the QMS. Investigate root cause(s) and implement corrective action by next reporting period or next scheduled audit.

MAJOR N/C

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

Principles of Auditing

Auditing relies on a number of principles whose intent is to make the audit become an effective and reliable tool that suppor

policies and procedures whilst providing suitable objective information that your company can act upon to continually improve its performance. Adherence to

the following principles are considered to be a prerequisite for ensuring that the conclusions derived from the audit are accurate, objective and sufficient. It

also allows auditors working independently from one another to reach similar conclusions when auditing in similar circumstances. The following principles

relate to auditors.

1. Ethical conduct: Trust, integrity, confidentiality and discretion are essential to auditing;

2. Fair presentation: Audit findings, conclusions and reports reflect truthfully and accurately the audit activities ;

3. Professional care: Auditors must exercise care in accordance with the importance of the task they perform;

ISO 9001:2015 Audit Checklist

System & Process Compliance Auditing

www.iso-9001-checklist.co.uk Page 11 of 78

Audit Checklist Part 1

Section 4.0 Context of the Organization

Clause Ref Audit Question

Audit Findings

(Score box) Audit Evidence Opportunities for

Improvement (OFI)

COMPLIANT

OFI

MINOR N/C

MAJOR N/C

Provide reference to documented

information to justify the finding

Provide suggestions for

process improvement 4.1 1 Has your organization determined external and internal issues relevant to its purpose and its strategic direction that affect its ability to achieve the intended result(s) of its QMS?

4.1 2 Does your organization monitor and review

information about these external and internal issues?

4.2 3 Does the organisation determine the interested parties

that are relevant to the QMS?

4.2 4 Does the organisation determine the requirements of

these interested parties that are relevant to the QMS? 4.2 5

Does your organization monitor and review

information about these interested parties and their relevant requirements?

ISO 9001:2015 Audit Checklist

System & Process Compliance Auditing

www.iso-9001-checklist.co.uk Page 16 of 78

Audit Findings Summary

Manually transfer any adverse audit findings from the Section 4.0 audit checklist above into the audit findings summary table below. 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.

Clause Ź 4.1 4.2 4.3 4.4 4.4.1 4.4.2

Question No. Ź

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Criteria ź

OFI

MINOR N/C

MAJOR N/C

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