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  #1  
Old 6th December 2007, 12:14 AM
zerodefect zerodefect is offline
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Let Me Help You How to Establish Quality Manual Not Following the Structure of the Standard?

As I know, most of organization’s quality manuals are almost duplicate copy of ISO 9001 or TS/16949 international standard clauses, only add a relevant reference to procedure documentation in some factors. We know the standard does not request us to establish a manual following the structure of the standard, only requests us to describes the scope of the manual and the justification for any exclusion and the reference to procedures and the interaction between processes.
I think quality manual shall be a great stage to exhibit organization’ ability and characteristics. But, what a pity! In reality, a quality manual only is a combination of some abstract concepts!
Do you think so? Do you supply some ideas? Thanks!
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Old 6th December 2007, 10:34 AM
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Re: How to Establish Quality Manual Not Following the Structure of the Standard?

zerodefect, I agree with you. Making the manual into a sort of response to the standard's requirements serves to show how the requirements are being met; however the manual might be doing a poor job of what it should do: describe the QMS.

It can work to use the same numbering system and describe the system subject by subject. This way, the manual can be more of a narrative and still be structured in a way that helps one draw connections between requirements and what is being done.
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Old 6th December 2007, 11:01 AM
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Re: How to Establish Quality Manual Not Following the Structure of the Standard?

I worked with one company who based their entire QMS on their processes. The QM also followed their processes. I really liked the layout and flow. Their registrar didn't like it because it was too hard to find out where each "shall" in TS was located. They had to make a matrix of the TS "shalls" and reference where in their QMS the shall was addressed. Which really was no big deal, because I made them do it earlier so they would know how their QMS related to the requirements and to ensure they had in fact, addressed each of TS requirements.
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Old 6th December 2007, 04:36 PM
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Lightbulb Re: How to Establish Quality Manual Not Following the Structure of the Standard?

Quote:
In Reply to Parent Post by zerodefect View Post

As I know, most of organization’s quality manuals are almost duplicate copy of ISO 9001 or TS/16949 international standard clauses, only add a relevant reference to procedure documentation in some factors.
It used to be like that, yes.... These days however, many organizations have moved on to a very lean manual containing only what the standard requires. That is what we did. Others (mainly smaller organizations) choose the opposite path, and cram their entire systems into their manuals. There is no right or wrong here, of course: It is a matter of what happens to suit your organization.

Quote:
In Reply to Parent Post by zerodefect View Post

We know the standard does not request us to establish a manual following the structure of the standard, only requests us to describes the scope of the manual and the justification for any exclusion and the reference to procedures and the interaction between processes.
You just described our manual: What used to be an entire binder (which incidentally nobody but an external auditor or two ever read) turned into single document of seven pages when we converted our system to ISO 9001:2000. The trick was to build the system first. We created the manual only when everything else was in place.

We have discussed this topic at great lengths. I suggest a look in this old thread: Quality Manual Organization and Structure including Numbering

/Claes
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