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:
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:
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 |
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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: |
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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: |
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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: |
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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: |
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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: |
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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: |
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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: |
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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: |
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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: |
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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: |
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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: |
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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: |
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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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