ISO 9004 2009

ISO 9004 2009 COMPLIANCE AUDIT TOOL (TITLE 26)

PART

TABLE OF CONTENTS

PAGE

INTRODUCTION TO AUDIT PROCESS

1

2

3

Overview of ISO 9004 Compliance Audit

Profile of ISO 9004 Compliance Audit

Summary of ISO 9004 Compliance Audit

3

10

11

COMPLIANCE AUDIT QUESTIONNAIRES

4

5

6

7

8

9

Success Management Audit Questionnaire

Strategic Management Audit Questionnaire

Resource Management Audit Questionnaire

Process Management Audit Questionnaire pdf

Evaluation Management Audit Questionnaire

Change Management Audit Questionnaire

12

17

27

<SAMPLE

54

78

QUALITY IMPROVEMENT PLANS

10

11

12

13

14

15

Success Management Improvement Plan

Strategic Management Improvement Plan

Resource Management Improvement Plan

Process Management Improvement Plan

Evaluation Management Improvement Plan

Change Management Improvement Plan

86

87

88

89

90

91

APPENDICES

16

17

Plain English ISO 9004 Terms and Definitions

License Agreement and Contact Information

92

109

APR 2011

COPYRIGHT © 2011 BY PRAXIOM RESEARCH GROUP LIMITED

VER 1.0

Before you start your audit, you will be asked to fill out a form entitled
Profile of ISO 9004 Compliance Audit (Part 2). First record the name of the
organization being audited, its address, the areas being audited, the address
of the audit, and a brief description of the actual scope or focus of the audit.
Also use the form to record the names of your auditors and the audit start
date. Once you’ve completed the audit, use the same form to record when
the audit was finished, who reviewed the audit and when, and any review
comments (if any).

Our audit tool uses questions to list the six sets of quality management
recommendations that make up ISO 9004. Accordingly, it contains six
separate questionnaires:

4. Success Management Audit Questionnaire
5. Strategic Management Audit Questionnaire
6. Resource Management Audit Questionnaire
7. Process Management Audit Questionnaire
8. Evaluation Management Audit Questionnaire
9. Change Management Audit Questionnaire

Our audit questionnaires start with Part 4 because
the ISO 9004 2009 recommendations start in section 4.

For each audit question, three answers are possible: YES, NO, or N/A.
A YES answer means you’re in compliance with the standard, a NO
answer means you’re not in compliance, while an N/A answer means that
this question is not applicable in your situation. NO answers reveal gaps
that exist between the ISO 9004 standard and your organization's practices.
Please answer each question by selecting one of these three answers. To
the right of your answers you will also find a column that you can use to
record any comments or observations you might have.

Once you’ve completed our compliance audit questionnaires, study your
NO answers and use the associated questions to formulate remedial actions.
Use the forms at the end of this audit process (Parts 10 to 15) to record your
remedial actions and to create quality management improvement plans.

In most cases, remedial actions can be formulated by simply turning an
audit question into an action statement. For example, an audit question
might ask: “Have you established quality management objectives?”.
If you answered NO, you would create a remedial action statement by
simply writing: “Establish quality management objectives”. Once all
quality management improvement plans have been implemented and
all gaps have been filled, your process-based quality management
system will comply with the ISO 9004 standard.

As previously mentioned, the ISO 9004 recommendations are presented
in Parts 4 to 9. Our Audit Tool preserves this numbering system in order
to make it easy to cross-reference the original ISO 9004 standard with our
material. Accordingly, our Audit Tool starts with Part 4. However, at the
detailed level we have added a numbering system that you won’t find in
the original ISO 9004 standard. We have sequentially numbered all questions
within each of the 6 parts (4 to 9) that make up the core of the standard. We
have done this in order to make it easier for you to work with our
questionnaires.

In addition, we have used paragraph indents to distinguish between general
questions and specific questions. This approach makes it easy to see how
our questionnaires are structured. In most cases, a general question is
immediately followed by several specific questions which usually help clarify
what the general question means. If you’re not sure what a general question
is asking, just keep reading. In most cases, the more detailed questions will
clarify what the general questions are trying to ask. But, if you’re still not
sure about what a question or word means, please check out our plain
English definitions in Part 16.

We suggest that you read every page of this publication before you start
answering questions. This will broaden your perspective and give you a
better feel for what you need to do. It will also introduce the standard
and clarify how it is organized.

Once you’ve answered all the audit questions and prepared your quality
management improvement plans, you can also summarize your quality
management audit quantitatively (see Part 3). The idea here is to measure
precisely how compliant your QMS actually is. And if you carry out regular
quality management audits, you can also use our approach to measure
whether or not your QMS is improving over time.

This is how it works. For each section of the audit (4 to 9), count the number
of YES answers and the number of NO answers and record the totals for
each section in the Form provided in Part 3. To calculate the compliance
score for each section, divide the total YES answers by the total YES+NO
answers and multiply the total by 100 to get a percentage. To calculate the
average compliance score for the entire audit, do the same for the grand
totals. Detailed instructions for doing all of this will be found in Part 3.