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Quality System Procedure

INTERNAL AUDIT
QSP8.2.2

[Company name / Logo]

The signatures below certify that this procedure has been reviewed and accepted, and demonstrates that the
signatories are aware of all the requirements contained herein and are committed to ensuring their provision.
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.

ISO 9001:2008 Quality Manual

Contents
1. Introduction & Purpose ............................................................................................................................................ 5
2. References ............................................................................................................................................................... 5
3. Terms & Definitions ................................................................................................................................................. 5
4. Application & Scope ................................................................................................................................................. 5
5. Requirements........................................................................................................................................................... 6
6. Audit Process ........................................................................................................................................................... 6
6.1 Audit Planning ............................................................................................................................................................ 6
6.1.1 Audit Team Evaluation & Selection ..................................................................................................................... 6
6.2 Audit Preparation....................................................................................................................................................... 7
6.3 On-site Audit .............................................................................................................................................................. 7
6.4 Wrap-up Meeting....................................................................................................................................................... 7
6.5 Follow-up ................................................................................................................................................................... 7
6.6 Reporting ................................................................................................................................................................... 7
6.7 Review ........................................................................................................................................................................ 8
6.8 Records ...................................................................................................................................................................... 8
6.9 Audit Process Matrix .................................................................................................................................................. 9
6.10 Audit Process Map ................................................................................................................................................. 11

Document: QSP8.2.2

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ISO 9001:2008 Quality Manual

1. Introduction & Purpose


The purpose of this procedure is to define Your Companys process for undertaking internal audits in order to assess
the effectiveness of the application of ISO 9001:2008 and also to define the responsibilities for planning, and
conducting audits, reporting results and retaining associated records.

2. References
Reference

Title

8.2.2

Quality System Manual

QF8.2.2-1

Internal Audit Schedule

QF8.2.2-2

Internal Audit Plan

QF8.2.2-3

Internal Audit Assignment

QF8.2.2-4

Internal Audit & Gap Analysis Checklist

QF8.2.2-5

Internal Audit Report

QF8.2.2-6

Internal Audit Feedback

3. Terms & Definitions


Opportunity for Improvement a situation/condition of the QMS that may be weak, cumbersome, redundant, overly
complex, or in some other manner, may, in the opinion of the auditor, offer an opportunity for an organization to
improve its current status.
Minor Non-conformance is a non-conformity that, based on the judgment of the auditor, is not likely to result in the
failure of the QMS or reduce its ability to assure a controlled process.
Major Non-conformance the absence, omission or total breakdown of a system to meet a specified requirement.
A number of minor non-conformities against one requirement can represent a total breakdown of the system and thus
be considered a major non-conformity.
Preventive action is taken when we anticipate a potential problem and take action to eliminate the possible causes to
prevent the occurrence a non-conformance.
Corrective action is taken upon detection of a non-conformance to prevent it from happening again; we act to
prevent a repeat of a detected non-conformance.

4. Application & Scope


The scope of this procedure is focused on assessing the effectiveness of Your Companys 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, outlined by ISO 19011:2002, Your Company ensures that all internal audits are
conducted with due professional care, integrity and independence. All conclusions derived from the audit are based
upon objective and traceable evidence.

Document: QSP8.2.2

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ISO 9001:2008 Quality Manual

6.10 Audit Process Map


Quality Management
Representative

Audit Team

Responsible Manager

Top Management

Audit Considerations
ISO 9001 requirements
Customer complaint
QMS requirements
Quality objectives/policy
Corrective actions
Statutory/legal requirements
Management decisions
Concerns raised by 3rd parties
Results of 3rd party audits
Employee concerns
Management Review concerns

Additional Considerations
Status
Importance
Frequency

Establish Audit Schedule


and Prepare Audit Plan

Document Review

Prepare Audit Checklist

Conduct Audit

Noncompliances
found?

YES
Initiate Corrective Actions

NO

Review Audit Findings

Prepare Audit Report

Close-out Corrective
Actions

UPDATE

Recommendations for
Improvement

Verify Close-out at
Follow-up Meeting

Management Review

Document: QSP8.2.2

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