ISO 9001 2008 Internal Audit Program

This web page will introduce our ISO 9001 2008 Internal Audit Program.
However, it will not present the complete audit program. Instead, it will
show you how our audit program is organized and it will explain how it
works. Once you've examined our approach, we hope you'll consider

purchasing our complete ISO 9001 2008 Internal Audit Program.

Our ISO 9001 Internal Audit Program (Title 22) is 177 pages
long, and is available in both pdf and MS doc file formats.

It is
easy to understand and ready to use.

Introduction to Audit Program

Our ISO 9001 Audit Program has five parts:

  1. Compliance Audit Program

  2. Policy Audit Program

  3. Procedures Audit Program

  4. Process Audit Program

  5. Records Audit Program

Each of these five programs will be discussed below.

We begin with a table of contents. It shows how we've organized our
ISO 9001 Internal Audit Program. While the content of each program
is different, the following table shows that each one of our five audit
programs is organized in the same way.


ISO 9001 2008 INTERNAL AUDIT PROGRAM

TITLE 22 TABLE OF CONTENTS

PART

INTRODUCTION

PAGE

1

Introduction to ISO 9001

4

2

Introduction to Audit Program

5

A

ISO 9001 COMPLIANCE AUDIT PROGRAM

14

1

Compliance Audit Procedure

14

2

Compliance Audit Profile

15

3

Compliance Audit Questions

SAMPLE
HTML

4

Compliance Audit Scores

79

5

Compliance Audit Summary

80

6

Compliance Audit Conclusions

81

7

Compliance Audit Recommendations

82

8

Compliance Audit Implementation Record

83

B

ISO 9001 POLICY AUDIT PROGRAM

84

1

Policy Audit Procedure

84

2

Policy Audit Profile

85

3

Policy Audit Questions

86

4

Policy Audit Scores

89

5

Policy Audit Summary

91

6

Policy Audit Conclusions

92

7

Policy Audit Recommendations

93

8

Policy Audit Implementation Record

94

C

ISO 9001 PROCEDURES AUDIT PROGRAM

95

1

Procedures Audit Procedure

95

2

Procedures Audit Profile

96

3

Procedures Audit Questions

97

4

Procedures Audit Scores

103

5

Procedures Audit Summary

105

6

Procedures Audit Conclusions

106

7

Procedures Audit Recommendations

107

8

Procedures Audit Implementation Record

108

D

ISO 9001 PROCESS AUDIT PROGRAM

109

1

Process Audit Procedure

109

2

Process Audit Profile

110

3

Process Audit Questions

SAMPLE PDF

4

Process Audit Scores

111

5

Process Audit Summary

154

6

Process Audit Conclusions

156

7

Process Audit Recommendations

157

8

Process Audit Implementation Record

158

E

ISO 9001 RECORDS AUDIT PROGRAM

159

1

Records Audit Procedure

160

2

Records Audit Profile

160

3

Records Audit Questions

161

4

Records Audit Scores

162

5

Records Audit Summary

170

6

Records Audit Conclusions

172

7

Records Audit Recommendations

173

8

Records Audit Implementation Record

174

F

ADMINISTRATIVE INFORMATION

175

MAR 2009

COPYRIGHT © 2009 BY PRAXIOM RESEARCH GROUP LIMITED 

VER 4.0


Overview of Compliance Audit Program

Our Compliance Audit Program uses questions to list the ISO 9001
quality management system (QMS) requirements. Like ISO’s five sets
of requirements, our Audit Program consists of five separate
questionnaires:

  1. General Audit Questionnaire

  2. Management Audit Questionnaire

  3. Resource Audit Questionnaire (SAMPLE)

  4. Realization Audit Questionnaire

  5. Remedial Audit Questionnaire

Our audit starts with section 4 because ISO's requirements start there.

In general, our Audit Program asks two types of questions: questions
that specify mandatory quality management system requirements and
questions that specify requirements that may be excluded or ignored
under some special circumstances. Questions that point to mandatory
requirements allow two response options: YES or NO, while questions
that specify requirements that may be excluded offer three response
options: YES, NO, or N/A. An N/A response option is provided
because you may exclude or ignore some requirements if
you can justify doing so.

YES answers mean you’re in compliance with the standard, NO answers
mean you’re not in compliance, and N/A answers mean that a question is
not applicable in your case. NO answers to Compliance Audit questions
point to compliance problems (also known as nonconformities or
noncompliances).

Once you’ve answered all the Compliance Audit Questions, you’re ready
to summarize your audit, calculate compliance scores, draw general audit
conclusions, and make and implement recommendations to address your
compliance problems.


Overview of Policy Audit Program

Our ISO 9001 Policy Audit covers the following topics:

  1. Management

  2. Documentation

  3. Usability

  4. Training

  5. Implementation

  6. Changes

Start by selecting a policy that you want to audit. Then prepare your Policy
Audit Profile. Before you begin answering policy audit questions, please
record the name of this policy at the top of the Policy Audit questionnaire.
This will help to maintain the focus of your audit.

Three response options are provided: YES, NO, and N/A. NO answers point
to policy performance problems, YES answers identify positive areas, while
N/A responses identify questions that are not applicable in your situation.

Once you’ve answered all the audit questions, you’re ready to summarize
your internal audit, calculate policy performance scores, draw general audit
conclusions, and make and implement recommendations to address your
policy performance problems.


Overview of Procedures Audit Program

Our ISO 9001 Procedures Audit covers the following topics:

  1. Management

  2. Documentation

  3. Content

  4. Compliance

  5. Usability

  6. Training

  7. Control

  8. Records

  9. Changes

Start by selecting a procedure that you want to audit. Then prepare
your Procedures Audit Profile. Define the scope of your audit, identify
the participants, and prepare a brief audit plan.

Before you begin answering procedures audit questions, please record
the name of this procedure at the top of the Audit questionnaire. This
will help auditors to maintain the focus of their audit.

Three response options are provided: YES, NO, and N/A. NO answers point
to procedural performance problems, YES answers identify positive areas,
while N/A responses identify questions that are not applicable in your
situation.

Once you’ve answered all the audit questions, you’re ready to summarize
your audit, calculate procedural performance scores, draw general audit
conclusions, and make and implement recommendations to address your
procedural performance problems.


Overview of Process Audit Program

Our ISO 9001 Process Audit covers the following topics:

  1. Develop Process >>> SAMPLE PDF
    1. Organization
    2. Documents
    3. Outputs
    4. Inputs
    5. Information
    6. Monitoring
    7. Measurement
    8. Training
    9. Resources
  2. Implement Process
    1. Management
    2. Competence
    3. Communication
    4. Infrastructure
    5. Records
  3. Maintain Process
    1. Management
    2. Competence
    3. Information
    4. Communication
    5. Infrastructure
    6. Records
  4. Control Process
    1. Management
    2. Outputs
    3. Inputs
    4. Monitoring
    5. Measurement
  5. Evaluate Process
    1. Scope
    2. Focus
    3. Methods
  6. Improve Process
    1. Information
    2. Methods
    3. Implementation
    4. Management

Clause 4.1 of ISO 9001 makes it clear that organizations must identify
and manage the processes that make up their quality management
systems. Therefore, the process approach is now a requirement.

The process approach is a management strategy. When managers use
a process approach, it means that they manage the processes that make
up their organization, the interaction between these processes, and the
inputs and outputs that “glue” these processes together.

But, what’s a process, and what are inputs and outputs? Briefly put, a
process uses inputs to generate outputs. Or, more precisely, a process is
an integrated set of activities that uses resources to transform inputs into
outputs. A system exists whenever several processes are interconnected
using such input-output relationships.

Processes are interconnected because the output from one process
becomes the input for another process. In effect, processes are “glued”
together by means of such input-output relationships. And because the
output of one process becomes the input of another process, inputs and
outputs are really the same thing. In general, there are three basic types
of inputs/outputs: products, services, and information.

Below you will find a list of some of the processes that can
be audited using our Process Audit Program:

  1. Production process
  2. Assembly process
  3. Purchasing process
  4. Design process
  5. Delivery process
  6. Marketing process
  7. Management process
  8. Maintenance process
  9. Manufacturing process
  10. Service provision process
  11. Communications process
  12. Document control process
  13. Record keeping process
  14. Administrative process
  15. Measurement process
  16. Monitoring process
  17. Planning process
  18. Training process

Of course, this does not exhaust the list of possible processes that could
be audited using our approach. Your organization’s processes will certainly
include many more processes that we have failed to mention.

Start your audit by selecting a process. Then prepare your Audit Profile. Define the scope of your audit, prepare an audit plan, and identify the
inputs that are used by this process and the outputs that are generated.

Before you begin answering process audit questions, please enter
the name of your process at the top of the Process Audit questionnaire.
Three response options are provided: YES, NO, and N/A. NO answers
point to process performance problems, YES answers identify positive
areas, while N/A responses identify questions that are not applicable
in your situation.

Once you’ve answered all the audit questions, you’re ready to summarize
your audit, calculate process performance scores, draw general audit
conclusions, and make and implement recommendations to address
your process performance problems.


Overview of Records Audit Program

Our Records Audit Program is partly based on the ISO 15489-1
records management standard and covers the following topics:

  1. Management
  2. Initiation
  3. Recording
  4. Revisions
  5. Access
  6. Maintenance
  7. Retention
  8. Destruction
  9. Reporting
  10. Usability
  11. Authenticity
  12. Protection
  13. Continuity
  14. Training
  15. Auditing
  16. Compliance

Start by selecting a set of records. Our Program can be used to audit
virtually any type of record keeping system. Examples that you may
wish to consider include the following: training records, design records, production records, service delivery records, measurement records,
product traceability records, audit records, manufacturing records, management review records, and calibration records.

Once you’ve chosen which records to audit, you’re ready to prepare your
Records Audit Profile. Specify the scope of your audit, its location, the
participants, and prepare a brief audit plan.

Before you begin answering record keeping audit questions, please enter
the name of the records being audited at the top of the audit questionnaire.
This will help to ensure that the focus of the internal audit is maintained.
Three response options are provided: YES, NO, and N/A. NO answers
point to record keeping performance problems, YES answers identify
positive areas, while N/A responses identify questions that are not
applicable.

Once you’ve answered all the audit questions, you’re ready to summarize
your audit, calculate record keeping performance scores, draw general
audit conclusions, and make and implement recommendations to
address your record keeping performance problems.


SAMPLE AUDIT QUESTIONS

A. COMPLIANCE AUDIT PROGRAM

3. COMPLIANCE AUDIT QUESTIONS

SECTION 6. RESOURCE AUDIT QUESTIONS

6.1 PROVIDE REQUIRED QMS RESOURCES

 
1 Did you identify the resources that your QMS needs? YES NO    
2   Did you identify the resources that
are needed to support your QMS?
YES NO    
3     Did you identify the resources needed
to implement your organization's QMS?
YES NO    
4     Did you identify the resources needed
to maintain your organization's QMS?
YES NO    
5     Did you identify the resources needed
to improve your organization's QMS?
YES NO    
6       Did you identify the resources that you
need in order to be able to continually
improve the effectiveness of your QMS?
YES NO    
7   Did you identify the resources needed to
help enhance your customers' satisfaction?
YES NO    
8     Did you identify the resources needed to ensure
that customer requirements are being met?
YES NO    
9 Do you provide the resources that your QMS needs? YES NO    
10   Do you provide resources needed
to support your organization's QMS?
YES NO    
11     Did you provide resources needed to
implement
your organization's QMS?
YES NO    
12     Did you provide resources needed to
maintain
your organization's QMS?
YES NO    
13     Did you provide resources needed to
improve
your organization's QMS?
YES NO    
14       Do you provide the resources needed to
continually improve the effectiveness of
your organization's QMS?
YES NO    
15   Do you provide resources needed to help
enhance your customers' satisfaction?
YES NO    
16     Do you provide resources needed to ensure
that customer requirements are being met?
YES NO    

6.2 PROVIDE COMPETENT QMS PERSONNEL

6.2.1 ENSURE THE COMPETENCE OF WORKERS

 
17 Do you ensure the competence of anyone within
your QMS who could directly or indirectly affect
your ability to meet product requirements?
YES NO    
18   Do you ensure that your QMS
workers have the right experience?
YES NO    
19   Do you ensure that your QMS
workers have the right education?
YES NO    
20   Do you ensure that your QMS
workers have the right training?
YES NO    
21   Do you ensure that your QMS
workers have the right skills?
YES NO    

6.2.2 MEET COMPETENCE REQUIREMENTS

 
22 Do you identify the competence requirements of
personnel within your QMS who perform work that
could directly or indirectly affect your organization's
ability to meet product requirements?
YES NO    
23 Do you provide training, or take other suitable
steps, to meet your organization's unique QMS
competence requirements?
YES NO    
24   Do you make your personnel aware of how
their activities can affect your organization's
ability to meet product requirements and
how important their efforts are?
YES NO    
25     Do you explain how personnel can help your
organization to achieve its quality objectives?
YES NO    
26 Do you evaluate the effectiveness of your
QMS training and awareness activities?
YES NO    
27 Do you maintain suitable records which show
that personnel within your QMS are competent?
YES NO    
28   Do you maintain suitable records of training? YES NO    
29   Do you maintain suitable records of education? YES NO    
30   Do you maintain suitable records of experience? YES NO    
31   Do you maintain suitable records of skills? YES NO    

6.3 PROVIDE NECESSARY INFRASTRUCTURE

 
32 Did you identify the infrastructure that your
organization needs in order to ensure that
product requirements are met?
YES NO    
33   Did you identify your building needs? YES NO    
34   Did you identify your workspace needs? YES NO    
35   Did you identify your utility needs? YES NO    
36   Did you identify your process equipment needs? YES NO    
37     Did you identify your process hardware needs? YES NO    
38     Did you identify your process software needs? YES NO    
39   Did you identify your support service needs? YES NO    
40     Did you identify your transportation needs? YES NO    
41     Did you identify your communication needs? YES NO    
42     Did you identify your information needs? YES NO    
43 Do you provide the infrastructure that your
organization needs in order to ensure that
product requirements are met?
YES NO    
44 Etcetera ...        

Attention

Now that you know what our internal audit
program looks like, please consider purchasing
Title 22: ISO 9001 2008 Internal Audit Program

If you purchase our ISO 9001 2008 Audit Program, you'll find
that it's integrated, detailed, exhaustive, and easy to understand.
You'll find that we've worked hard to create a high quality product.
In fact, we
guarantee the quality of our internal audit program!

Title 22 can be delivered to you on CD or as an email attachment.
Title 22 is 177 pages long and comes in pdf and MS doc file formats.

Place an Order

Check our Prices

Check our License


MORE ISO 9001 PAGES

ISO 9000 Introduction

Quality Management Principles

ISO 9001 2008 versus ISO 9001 2000

Plain English Quality Management Definitions

ISO 9001 2008 Translated into Plain English

How to Develop Your Process-based QMS

Process-based QMS Development Plan

Quality Management Gap Analysis Tool

How to Upgrade to the New Standard

How to Audit Your Audit Program

Process Management Approach

Frequently Asked Questions

Auditing Standard

OTHER AUDIT TOOLS


Home Page

Our Libraries

A to Z Index

Customers

How to Order

Our Products

Our Prices

Guarantee

Praxiom Research Group Limited        help@praxiom.com        780-461-4514

Updated on November 30, 2013. First published on September 10, 2000.

 Legal Restrictions on the Use of this Page
Thank you for visiting this page. You are, of course, welcome to view our
 material as often as you wish, free of charge. And as long as you keep intact
 all copyright notices, you are also welcome to print or make one copy of this
 page for your own personal, noncommercial, home use. But, you are not
 legally authorized to print or produce additional copies or to copy and paste
 any of our material onto another web site or to republish it in any way.

Copyright © 2000 - 2013 by Praxiom Research Group Limited. All Rights Reserved.

Praxiom Research Group Limited