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Requirement to link Quality Manual to ISO 9001 clause numbers?

Tagin

Tagin

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#11
#11
Candi1024 said:
Our auditor stated this was a requirement. I can see where this can be useful, but I still can't find a requirement. This was listed as a recommendation for 9001, and in that recommendation it was stated we would required to do this for 13485, but no clause was given.
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Just to clarify: is your organization certified to 9001, 13485 or both? I'm trying to understand why the auditor is referring to both standards.
 
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Tidge

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#12
#12
Keeping such a reference can be helpful for the auditor, but it might also be helpful for executive management to know how certain elements of your Quality System are satisfying the various parts 13485. I'm tempted to add that such a reference could be helpful for explaining why things exist to folks below the level of executive management, but such folks should be able to accept "management has established these policies to comply with 13485", even if they must grumble while doing so.
 
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Candi1024

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#13
#13
Tagin said:
Just to clarify: is your organization certified to 9001, 13485 or both? I'm trying to understand why the auditor is referring to both standards.
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The entire plant is being certified to 9001, while 1 line for now is being certified to 13485. At this point we have only had our documentation audit for both.
 
Tagin

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#14
#14
Candi1024 said:
The entire plant is being certified to 9001, while 1 line for now is being certified to 13485. At this point we have only had our documentation audit for both.
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Ah, ok. For 13485, 4.2b would be the relevant clause. For 9001, as many already noted, it is not a requirement to even have a quality manual. But unless you want to run dual QMS systems, it would be necessary for the one QMS to meet the 13485 requirement.
 
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