HOW TO DEVELOP AN ISO 9003 QMS

ISO 9003 1994 is now obsolete. See ISO 9001 2008.

ISO 9003 lists many requirements. But how do you get from a
simple list of requirements to an integrated quality management
system? In order to get from a list to a system, you've got to add
some structure. This is what we've tried to do below.

The ISO 9003 requirements can be organized by grouping
them into the following eight sets of program requirements:

1. Leadership requirements

2. Contract review requirements

3. Inventory management requirements

4. Inspection and testing requirements

5. Nonconformance management requirements

6. Measurement requirements

7. Internal audit requirements

8. Training requirements

In addition, we have subdivided each of the above program
requirements further into the following 10 process requirements:

1. Policy requirements

2. Planning requirements

3. Procedural requirements

4. Instructional requirements

5. Personnel requirements

6. Organizational requirements

7. Documentation requirements

8. Record keeping requirements

9. Technological requirements

10. Resource requirements

As you can see, we have identified eight sets of general
requirements, and within each of these we have identified ten
additional requirements. We think of the first set as program
requirements and the second set as process requirements.
The first set specifies what programs are needed and the second
set specifies what kind of process each program should follow.

The first set of eight requirements indicates what functional
areas need to be controlled. These include areas such as
measurement, inspection, and training.

The second set of ten requirements specify how this control
should be exercised within each of these eight areas and what
form this control should take. This second set specifies how
quality documents, data, and records should be managed,
what form quality policies, plans, procedures, and instructions
should take, what technologies and resources are required,
and how all of this should be organized.

In other words, the first set points to eight organizational
functions that need to be performed, while the second set
points to the methods, tools, and techniques that should
be used to perform each of these general functions.

We distinguish between these two types of requirements
for a good reason. It allows us to approach the quality system
development process in an organized way. It allows us to think in
terms of eight quality programs that meet eight sets of program
requirements. Furthermore, it allows us to develop each of these
eight programs by addressing the ten process requirements that
make up each program. Finally, it allows us to combine these eight
quality programs into a single quality assurance program which,
when implemented, automatically brings a complete quality
management system into existence.

If you use this approach, your Quality Assurance Program
would be made up of the following eight Quality Programs:

1. Quality Leadership Program

2. Quality Contracts Program

3. Quality Inventory Program

4. Quality Inspections Program

5. Quality Nonconformance Program

6. Quality Measurement Program

7. Quality Audit Program

8. Quality Training Program

When you implement this eight part Quality Assurance Program,
you will automatically create a Quality Management System.

RELATED PAGES

ISO 9001 Introduction

Quality Management Principles

ISO 9001 2008 versus ISO 9001 2000

Plain English Quality Management Definitions

ISO 9001 2008 Translated into Plain English

ISO 9004 2009 Translated into Plain English

ISO 9001 Quality Management Audit Program

ISO 9004 Quality Management Audit Program

Quality Management Gap Analysis Tool

How to Develop a Process-based QMS

Process-based QMS Development Plan

Plain English Process Approach

Frequently Asked Questions

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Updated on September 20, 2011. On the Web since May 25, 1997.