ISO 9000 Quality System Development Plan

If you want to be certified, you have to develop a quality system. You have to develop a system that meets ISO's requirements. Our Quality System Development Plan is designed to help you achieve this important objective.


Our Quality System Development Plan has five steps:

  1. Plan your ISO 9000 Development Project
  2. Deliver your ISO 9000 Awareness Program
  3. Develop your own Quality Assurance Program
  4. Implement your Quality Assurance Program
  5. Evaluate and Improve your Quality System

Our process begins with a Plan. This plan must clarify how your quality system development project will be carried out. Once you're clear about what you're going to develop and how you're going to develop it, you can tell everyone about it. You can develop and deliver an Awareness Program.

Next, you can begin the development of a Quality Assurance Program. In order to make this step more manageable, we have subdivided the Quality Assurance Program into the following 12 Quality Programs:

  1. Quality Leadership Program
  2. Quality Design Program
  3. Quality Purchasing Program
  4. Quality Contracts Program
  5. Quality Production Program
  6. Quality Inventory Program
  7. Quality Inspections Program
  8. Quality Nonconformance Program
  9. Quality Measurement Program
  10. Quality Service Program
  11. Quality Audit Program
  12. Quality Training Program

ISO does not directly talk about developing a Quality Assurance Program, nor does it talk about creating 12 Quality Programs. This is our innovation. ISO simply lists 20 (or less) quality requirements and leaves the problem of how to meet these requirements up to you. This puts you in a tough spot. There is a huge gap between a simple list of quality requirements and the existence of an integrated quality system, a gap that our Quality System Development Plan can certainly help you to fill.

Once you've developed your quality assurance program, you're ready to implement it. This implementation creates your system. This is true because your quality assurance program is the paper version of your actual quality system. By applying your quality assurance program you are automatically creating your quality system. Once you've implemented your program and created your system, you can evaluate and improve its effectiveness.

The following table describes our Quality System Development Plan in greater detail. The table does two things. It provides a brief overview of our detailed development process, and it distinguishes between sequential and parallel steps. For example, steps 3.1 to 3.10 can be carried out simultaneously (if you have the manpower). And once these steps are done, you can carry out steps 3.11 and 3.12, followed by step 3.13. Step 4 follows a similar logic. It says that quality training should be carried out before you ask everyone to implement your quality programs. And once these quality programs have been implemented, you can audit them.

QUALITY SYSTEM DEVELOPMENT PLAN
STEP 1. PLAN YOUR ISO 9000 DEVELOPMENT PROJECT
STEP 2. DELIVER YOUR ISO 9000 AWARENESS PROGRAM
STEP 3. DEVELOP YOUR QUALITY ASSURANCE PROGRAM
STEP 3.1. DEVELOP QUALITY LEADERSHIP PROGRAM    
STEP 3.2. DEVELOP QUALITY DESIGN PROGRAM STEP 3.11. DEVELOP QUALITY AUDIT PROGRAM
STEP 3.3. DEVELOP QUALITY PURCHASING PROGRAM
STEP 3.4. DEVELOP QUALITY CONTRACTS PROGRAM STEP 3.13. INTEGRATE PRECEDING 12 QUALITY PROGRAMS
STEP 3.5. DEVELOP QUALITY PRODUCTION PROGRAM
STEP 3.6. DEVELOP QUALITY INVENTORY PROGRAM STEP 3.12.
DEVELOP
QUALITY
TRAINING
PROGRAM
STEP 3.7. DEVELOP QUALITY INSPECTIONS PROGRAM
STEP 3.8. DEVELOP QUALITY NONCONFORMANCE PROGRAM  
STEP 3.9. DEVELOP QUALITY MEASUREMENT PROGRAM
STEP 3.10 DEVELOP QUALITY SERVICE PROGRAM  
STEP 4. IMPLEMENT YOUR QUALITY ASSURANCE PROGRAM
STEP 4.1. IMPLEMENT QUALITY TRAINING PROGRAM STEP 4.2. IMPLEMENT QUALITY LEADERSHIP PROGRAM STEP 4.12 IMPLEMENT QUALITY AUDIT PROGRAM
STEP 4.3. IMPLEMENT QUALITY DESIGN PROGRAM
STEP 4.4 IMPLEMENT QUALITY PURCHASING PROGRAM
STEP 4.5 IMPLEMENT QUALITY CONTRACTS PROGRAM
STEP 4.6 IMPLEMENT QUALITY PRODUCTION PROGRAM
STEP 4.7 IMPLEMENT QUALITY INVENTORY PROGRAM
STEP 4.8 IMPLEMENT QUALITY INSPECTIONS PROGRAM
STEP 4.9 IMPLEMENT QUALITY NONCONFORMANCE PROGRAM
STEP 4.10 IMPLEMENT QUALITY MEASUREMENT PROGRAM
STEP 4.11 IMPLEMENT QUALITY SERVICE PROGRAM
STEP 5. EVALUATE AND IMPROVE YOUR QUALITY SYSTEM

As the above table reiterates, our Quality Assurance Program is made up of 12 Quality Programs (see 3.1 to 3.12). But, as you probably know, ISO has 20 sets of requirements. So, how do we reconcile this difference?

The following table shows that each of our 12 Quality Programs is designed to meet a subset of ISO's 20 requirements. For example, our Quality Leadership Program is designed to meet ISO requirement 4.1 Management responsibility, 4.2 Quality system, 4.5 Documents and data, 4.16 Quality records, and 4.18 Training. If you study the following table, you will see that our 12 Quality Programs meet all 20 ISO requirements.

  OUR QUALITY PROGRAMS   ISO'S REQUIREMENTS
1 QUALITY LEADERSHIP PROGRAM MEETS 4.1, 4.2, 4.5, 4.16, 4.18
2 QUALITY DESIGN PROGRAM MEETS 4.1, 4.2, 4.4, 4.5, 4.16, 4.18
3 QUALITY PURCHASING PROGRAM MEETS 4.1, 4.2, 4.5, 4.6, 4.16, 4.18
4 QUALITY CONTRACTS PROGRAM MEETS 4.1, 4.2, 4.3, 4.5, 4.16, 4.18
5 QUALITY PRODUCTION PROGRAM MEETS 4.1, 4.2, 4.5, 4.9, 4.16, 4.18
6 QUALITY INVENTORY PROGRAM MEETS 4.1, 4.2, 4.5, 4.7, 4.8, 4.9, 4.15, 4.16, 4.18
7 QUALITY INSPECTIONS PROGRAM MEETS 4.1, 4.2, 4.5, 4.10, 4.11, 4.12, 4.16, 4.18
8 QUALITY NONCONFORMANCE PROGRAM MEETS 4.1, 4.2, 4.5, 4.13, 4.14, 4.16, 4.18
9 QUALITY MEASUREMENT PROGRAM MEETS 4.1, 4.2, 4.5, 4.11, 4.16, 4.18, 4.20
10 QUALITY SERVICE PROGRAM MEETS 4.1, 4.2, 4.5, 4.9, 4.16, 4.18, 4.19
11 QUALITY AUDIT PROGRAM MEETS 4.1, 4.2, 4.5, 4.16, 4.17, 4.18
12 QUALITY TRAINING PROGRAM MEETS 4.1, 4.2, 4.5, 4.16, 4.18

We have taken this approach because ISO fails to make a very important distinction. As we studied ISO's 20 requirements, it slowly became clear to us that ISO was really talking about two different types of requirements, without making this distinction clear to the reader.

The first set of requirements specify which functional areas need to be controlled. These include areas such as design, purchasing, production, and inspection. We have identified 12 such areas which correspond to our 12 Quality Programs.

The following table lists these 12 functional requirements and shows how they relate to the second set of requirements. The second set is made up of 10 requirements. These 10 requirements specify how control should be exercised within each of these 12 programs and what form this control should take. This second set specifies how quality documents, data, and records should be handled, what form quality policies, plans, procedures, and instructions should take, and how all of this should be organized.

1.0
Leadership requirements
are made up of:
01. Policy requirements
02. Planning requirements
03. Procedural requirements
04. Instructional requirements
05. Personnel requirements
06. Organizational requirements
07. Documentation requirements
08. Record keeping requirements
09. Technological requirements
10. Resource requirements
2.0
Product design requirements
are made up of:
01. Policy requirements
02. Planning requirements
03. Procedural requirements
04. Instructional requirements
05. Personnel requirements
06. Organizational requirements
07. Documentation requirements
08. Record keeping requirements
09. Technological requirements
10. Resource requirements
3.0
Purchasing requirements
are made up of:
01. Policy requirements
02. Planning requirements
03. Procedural requirements
04. Instructional requirements
05. Personnel requirements
06. Organizational requirements
07. Documentation requirements
08. Record keeping requirements
09. Technological requirements
10. Resource requirements
4.0
Contract review requirements
are made up of:
01. Policy requirements
02. Planning requirements
03. Procedural requirements
04. Instructional requirements
05. Personnel requirements
06. Organizational requirements
07. Documentation requirements
08. Record keeping requirements
09. Technological requirements
10. Resource requirements
5.0
Production requirements
are made up of:
01. Policy requirements
02. Planning requirements
03. Procedural requirements
04. Instructional requirements
05. Personnel requirements
06. Organizational requirements
07. Documentation requirements
08. Record keeping requirements
09. Technological requirements
10. Resource requirements
6.0
Inventory management requirements
are made up of:
01. Policy requirements
02. Planning requirements
03. Procedural requirements
04. Instructional requirements
05. Personnel requirements
06. Organizational requirements
07. Documentation requirements
08. Record keeping requirements
09. Technological requirements
10. Resource requirements
7.0
Inspection and testing requirements
are made up of:
01. Policy requirements
02. Planning requirements
03. Procedural requirements
04. Instructional requirements
05. Personnel requirements
06. Organizational requirements
07. Documentation requirements
08. Record keeping requirements
09. Technological requirements
10. Resource requirements
8.0
Nonconformance management requirements
are made up of:
01. Policy requirements
02. Planning requirements
03. Procedural requirements
04. Instructional requirements
05. Personnel requirements
06. Organizational requirements
07. Documentation requirements
08. Record keeping requirements
09. Technological requirements
10. Resource requirements
9.0
Measurement requirements
are made up of:
01. Policy requirements
02. Planning requirements
03. Procedural requirements
04. Instructional requirements
05. Personnel requirements
06. Organizational requirements
07. Documentation requirements
08. Record keeping requirements
09. Technological requirements
10. Resource requirements
10.0
Service requirements
are made up of:
01. Policy requirements
02. Planning requirements
03. Procedural requirements
04. Instructional requirements
05. Personnel requirements
06. Organizational requirements
07. Documentation requirements
08. Record keeping requirements
09. Technological requirements
10. Resource requirements
11.0
Internal audit requirements
are made up of:
01. Policy requirements
02. Planning requirements
03. Procedural requirements
04. Instructional requirements
05. Personnel requirements
06. Organizational requirements
07. Documentation requirements
08. Record keeping requirements
09. Technological requirements
10. Resource requirements
12.0
Training requirements
are made up of:
01. Policy requirements
02. Planning requirements
03. Procedural requirements
04. Instructional requirements
05. Personnel requirements
06. Organizational requirements
07. Documentation requirements
08. Record keeping requirements
09. Technological requirements
10. Resource requirements

In more general terms, we think of the first set as 12 program requirements, and the second set as 10 process requirements. The first set specifies what programs are needed and the second set specifies what kind of process should be followed by each program.

As you can see, our 12 Quality Programs meet 12 program requirements. And, because of the way these 12 Programs are designed, each of them also meets 10 process requirements. In this way, all of ISO's many requirements are met.

In other words, if you follow our Quality System Development Plan by designing and implementing our 12 Quality Programs, you will automatically meet all of ISO's many quality system requirements!


Of course, we've only been able to scratch the surface here. Our actual Quality System Development Plan is considerably more detailed. As far as we know, it's the most complete Quality System Development Plan available anywhere.

If you would like to order the detailed version of our
Quality System Development Plan, please click the following hyperlink.
Notice that our Quality System Development Plan is part of Title 1.
Title 1: How to Develop a Quality System Using ISO 9000
Title 1 covers ISO 9001, ISO 9002, ISO 9003, and presents a
Quality System Development Plan
I want to order Title 1

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This web page was first published on May 25, 1997
This web page was updated on April 23, 1999
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