QUALITY SYSTEM

PROCEDURE
QP3
INTERNAL AUDIT

[Your Company]

Signature Position Date

Prepared By

Reviewed By

Approved By

COMPANY PROPRIETARY INFORMATION

This document is an uncontrolled copy of a controlled document held by the Quality Management System. Prior to
use, ensure this document is the most recent revision by checking the Master Document List. To request changes,
submit a Document Change Request to the Document Control Representative.

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Table of Contents

1. INTRODUCTION & PURPOSE ................................................................................................ 3

2. TERMS & DEFINITIONS ....................................................................................................... 3
3. APPLICATION & SCOPE....................................................................................................... 3
4. REQUIREMENTS ................................................................................................................. 3
4.1 Internal Auditor Qualification................................................................................... 3
5. PROCESS .......................................................................................................................... 4
5.1 Audit Preparation .................................................................................................... 4
5.2 Audi Initiation .......................................................................................................... 4
5.3 Audit Completion..................................................................................................... 5
5.4 Audit Documentation & Records............................................................................. 5
6. REFERENCES..................................................................................................................... 5
7. REVISION HISTORY ............................................................................................................ 5

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1. Introduction & Purpose

The purpose of this procedure is to define [Your Company’s] process for undertaking
internal audits in order to assess the effectiveness of the application of ISO 9001:2008.

2. Terms & Definitions

Internal Audit is taken to mean a managerial tool which evaluates effectiveness of the
quality management system.

Internal Auditor is taken to mean any competent person(s) with responsibility of

undertaking internal audits.

Non-conformance is taken to mean an observation that indicates a policy or practice

is contrary to the requirements of the standard or documented procedures.

The following terms and definitions are taken from ISO 9000:2005:

Term Clause Definition

Document 3.7.2 Information and its supporting medium
Procedure 3.4.5 Specified way to carry out an activity or a process
Quality Manual 3.7.4 Document specifying the QMS of an organization
Record 3.7.6 Document stating results or evidence of activities performed
Specification 3.7.3 Document stating requirements

3. Application & Scope

The scope of this procedure is focused on assessing the effectiveness of [Your
Company’s] quality management system. Where such processes are found to be
deficient, the audit will lead to improvement in those processes.

By applying the principles of auditing [Your Company] ensures that all audits are
conducted with due professional care, integrity and independence. All conclusions
derived from the audit are based upon objective, traceable evidence.

4. Requirements
4.1 Internal Auditor Qualification

ƒ Internal Auditor candidates are selected from permanent staff members

ƒ Internal Auditor candidates must successfully complete an auditor training course

ƒ Internal Auditor qualifications must be maintained in the employee training records

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5. Process
5.1 Audit Preparation

ISO 9000 procedures are audited a minimum of twice a year. The maximum interval
between audits is six months [amend as applicable]. Audits may be completed with a
greater frequency if determined by the Quality Management Representative.

Quality Management Representative is required to:

ƒ Establish and implement audit programme

ƒ Evaluate and select competent Internal Auditors
ƒ Define the audit criteria, scope and method
ƒ Assign audit duties to the Internal Auditors
ƒ Maintain records of briefings

Top Management is required to:

ƒ Provide authority to the audit programme

ƒ Communicate audit mandate

Internal Auditor is required to:

ƒ Review relevant requirements of ISO 9001:2008

ƒ Conduct document review
ƒ Review and prepare audit checklist

5.2 Audit Initiation

Internal Auditor is required to:

ƒ Arrange audit appointment and conduct opening meeting

ƒ Conduct audit using audit method described by the QMR
ƒ Sample and observe necessary process inputs/outputs to establish audit trail
ƒ Record objective evidence to verify compliance or non-conformance
ƒ Initiate non-conformance process where required, update log
ƒ Initiate corrective/preventive action processes where required, update log
ƒ Conduct follow-up audit to verify close out of non-conformances
ƒ Follow-up audit to verify effectiveness of corrective/preventive actions
ƒ Conduct close out meeting
ƒ Report audit findings to the Quality Management Representative

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5.3 Audit Completion

Quality Management Representative is required to:

ƒ Review and approve audit report

ƒ Communicate audit report findings
ƒ Make recommendations for improvement
ƒ Update the audit programme and audit schedule
ƒ Obtain feedback on the audit process
ƒ Improve audit process

Top Management is required to:

ƒ Use audit evidence to drive improvement

ƒ Use audit evidence to promote best practice

5.4 Audit Documentation & Records

All documentation and records generated by the internal audit process will be managed
in accordance with ISO 9001:2008 Clauses 4.2.3 & 4.2.4.

6. References

Quality Management Systems Manual Section 8.2.2

Internal Audit Schedule Form F103.1
Internal Audit Assignment Form F103.2
Internal Audit Checklist Form F103.3
Internal Audit Report Form F103.4
Internal Audit Feedback Form F103.5
Non Conformance Report Form F104.1
Non Conformance Report Log Form F104.2
Corrective Action Request Form F105.1
Corrective Action Request Log Form F105.2

7. Revision History

Revision Date Name Change Ref.

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