QUALITY SYSTEM PROCEDURE

QP3
INTERNAL AUDIT

[Your Company]

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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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Quality System Procedure
[Your Company]

QP3 Version 1 Page 2 of 5

INTERNAL AUDIT

Table of Contents
1. 2. 3. 4. INTRODUCTION & PURPOSE ................................................................................................ 3 TERMS & DEFINITIONS ....................................................................................................... 3 APPLICATION & SCOPE....................................................................................................... 3 REQUIREMENTS ................................................................................................................. 3 4.1 5. Internal Auditor Qualification................................................................................... 3

PROCESS .......................................................................................................................... 4 5.1 5.2 5.3 5.4 Audit Preparation .................................................................................................... 4 Audi Initiation .......................................................................................................... 4 Audit Completion..................................................................................................... 5 Audit Documentation & Records............................................................................. 5

6. 7.

REFERENCES..................................................................................................................... 5 REVISION HISTORY ............................................................................................................ 5

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Quality System Procedure
[Your Company]

QP3 Version 1 Page 3 of 5

INTERNAL AUDIT

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 Document Procedure Quality Manual Record Specification Clause 3.7.2 3.4.5 3.7.4 3.7.6 3.7.3 Definition Information and its supporting medium Specified way to carry out an activity or a process Document specifying the QMS of an organization Document stating results or evidence of activities performed 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.
4.1

Requirements
Internal Auditor Qualification
Internal Auditor candidates are selected from permanent staff members Internal Auditor candidates must successfully complete an auditor training course Internal Auditor qualifications must be maintained in the employee training records

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Quality System Procedure
[Your Company]

QP3 Version 1 Page 4 of 5

INTERNAL AUDIT

5.
5.1

Process
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: Establish and implement audit programme Evaluate and select competent Internal Auditors Define the audit criteria, scope and method Assign audit duties to the Internal Auditors Maintain records of briefings Top Management is required to: Provide authority to the audit programme Communicate audit mandate Internal Auditor is required to: Review relevant requirements of ISO 9001:2008 Conduct document review Review and prepare audit checklist

5.2

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

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Quality System Procedure
[Your Company]

QP3 Version 1 Page 5 of 5

INTERNAL AUDIT

5.3

Audit Completion
Quality Management Representative is required to: Review and approve audit report Communicate audit report findings Make recommendations for improvement Update the audit programme and audit schedule Obtain feedback on the audit process Improve audit process Top Management is required to: Use audit evidence to drive improvement 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 Internal Audit Schedule Internal Audit Assignment Internal Audit Checklist Internal Audit Report Internal Audit Feedback Non Conformance Report Non Conformance Report Log Corrective Action Request Corrective Action Request Log Section 8.2.2 Form F103.1 Form F103.2 Form F103.3 Form F103.4 Form F103.5 Form F104.1 Form F104.2 Form F105.1 Form F105.2

7.

Revision History
Revision Date Name Change Ref.

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