How to restructuring Quality manual?
(Sep.4w,2005)

Mr. M: The chapters of my company’s quality manual (QM) are aligned with the same sequence as ISO9001:2000 and some translated Japanese words are still unfamiliar for us. The sequence is not same as our company’s job sequence. So with the unfamiliar words, interested parties of my company rarely read QM. Naturally every time when surveillance is just around the corner we often thumb through QM. The surveillance is generally done according to QM and often the results are that we are not able to answer for assessors’ properly.
The situation has been lasting these ten years.
Now, to solve the situation now we are going to improve QM as more readable and practical one.
I have an idea to align the chapters of QM with the concept shown below in four items. Please give me your comment.

1. Make the total chapters of QM be aligned with PDCA sequence.
2. Make the words more familiar to us.
3. Make Japanese translation more suitable.
4. Make duplicated requirements in the Standards simple.
My comment: Your misunderstanding is that ISO9001: 2000 is basically constructed by PDCA sequence. But problem is that the application of PDCA is not perfect (refer to “A critical misapplication of the PDCA model: 2002, May.3w” in 4.1 of Individual clause relating ISO9001:2000 corner on this web-site).
In this standpoint of view the application of PDCA for ISO14001:2000 is better.
Therefore if you restructure QM based on PDCA model, its right application is most important.
Summarizing my concept written on my web-site, basic points are described in the following eleven items.
1. “7.6 Control of monitoring and measuring devices” should be included in 6.3 clause which requires providing and maintaining the infrastructure needed.
2.
Requirements from 7.1 to 7.5 are not about production processes but about management activities on them (refer to “Does a quality management system include product realization processes? ：Oct.4w,2002“ in Basic knowledge corner on this web-site).
3.
If you have not determination of requirement relating to a product, you will be definitely unable to plan and develop the processes needed for its realization. Then 7.1 should be placed after 7.2.
But you must be careful that there are the two kinds of product realization plans. The one is about a new product or project which needs determination when design activities should be done and should come before 7.3. The other is about production processes which come after the determination of product design (7.3).
4.
You may include process design in 7.3. Outputs of process design are product realization plans for production stage.
5.
Actions based customer satisfaction should be handled quickly during production realization stages to enhance customer satisfaction.
6.
Product inspections should be carried out at appropriate stages of the product realization processes to ensure its product quality.
7.
To prevent unintended use or delivery of nonconforming product it control activities should be done quickly during production realization stages.
8. About 8.2.3, there the two kinds of monitoring and measurement are considered. The one is for quality management processes and the other is for product realization processes. The former is already covered by 8.2.2 and by from 7.1 to 7.5. So there are no needs for independent requirements of 8.2.3 (refer to “Duplication of monitoring of processes over internal audits: Jan.2w, 2004” in 8.2.2 of Individual clause relating ISO9001:2000 corner on this web-site).
9. “4.2.4 Control of records” should be placed at the latter parts of the Standards like ISO14001: 2004. Basically no clear difference between document and record results this confusion (refer to “The end of history of confusion ‘DOCUMENT with RECORDS’:2000, Aug-5” in 4.2 of Individual clauses relating ISO9001:2000 corner and “The cause of difference in dealing with ‘Record control” between ISO9001 and ISO14001: Aug.3w, 2004” in ISO14001 Standards corner on this web-site).
10.
8.5.3 Preventive should be placed on Plan or during Do stage. Therefore requirements from 4. to 7. are aimed at preventive actions( refer to “Why is it difficult to deal with preventive action?: Apr.4w,2005” in 8.5 of Individual clauses relating ISO9001:2000 on this web-site).
For instance 8.3 Control of nonconforming product is aimed not to prevent its unintended use or delivery. After “Do” no preventive action is possible.
11. “5.6 Management review” should be placed at the final part of the Standards like ISO14001: 2004.



The following table is the summary of the comment of mine. Numbers shown in Explanation column are item numbers shown above.

MG=Management activities, PR=Product realization activities, EXP=Explanation
IMP=Improvemen
Classification
ISONo.
MG 1/2
PR in a wide sense
MG 2 /2
EXP
Before Do
During Do
After Do
Plan
Control of Do
Do
Check
Act
Document control
8.5.3
4.2.1(Exclusive of e）
○
 
 
 
 
9
4.2.2
○
 
 
 
 
4.2.3
○
 
 
 
 
PolicyOrganize
5(Exclusive of 5.6）
○
 
 
 
 
9、11
ResourceMG
6.1
6.2
○
 
 
 
 
 
6.3
○
 
 
 
 
6.4
○
 
 
 
 
7.6
○
 
 
 
 

1
Control of PR
7.2（7.1）
 
○
Sales
 
 
2、3
7.3
 
○
Product design
 
 
7.1
 
○
Process design
 
 
3、4
7.4
 
○
Purchasing
 
 
 
7.5
 
○
Production(PR in a narrow sense）
 
 
 
8.2.1
 
○
Customer focus
 
 
 
5
7.4.3、8.2.4
 
○
Inspection
 
 
6
8.3
 
○
Disposal of defectives
 
 
7、10
Audit
8.2.2(Independent 8.2.3 is unnecessary)
 
 
 
○
 
8
Control of records
4.2.1e)、4.2.4
 
 
 
○
 
9
Analysis of data
8.4
 
 
 
○
 
 
IMP
8.5.1、8.5.2
 
 
 
 
○
10
MG review
5.6
 
 
 
 
○
11