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Who must write Quality Manual as per ISO 9001 Clause 5.5.2?

Q

QC JEWEL

#21
#21
I was working as a QMS Coordinator, my company didn't have a QM for the system, I wrote it based on a QM sister plant. The QM is electronically approved by all managers in the plant.
QC J
 
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#22
#22
Some of this may have been stated already, but I'll reiterate...

qmsboy said:
Is it mandatory that the Management Representative must write the quality manual for a company as per ISO 9001 clause 5.5.2?If not who must write the quality manual as per ISO clause?
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The right question is not "who must write the quality manual", but rather "who should write the quality manual". In reality, it should be someone with good technical writing abilities who can make the document an informative yet valuable asset to the company. This person should be given the responsibility and authority per 5.5.1, not 5.5.2.

qmsboy said:
Is it possible for an outside agency to write the quality manual and put the signature of QA Engineer in the prepared column, MR in the reviewed column and CEO in the authorised/approved column to get it approved?
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Yes it is possible, and hiring an outside agency or consultant to perform such tasks is not that uncommon. But don't forget the fact that this is not just a one-time project. Once they achieve their task of drafting and approving the quality manual, there still remains the ongoing task of updating and re-approving, once that agency or consultant has left. Remember that the organization will ultimately be responsible for making sure the content in the quality manual remains accurate and continues to provide value to that organization. How that is done - is up to you and should be made as simple as possible.

Brian :rolleyes:
 
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A

AndyN

Moved On
#23
#23
iso 9001 standard said:
:) There is not certain rule that iso 9001 quality manual must has to written by any person. Organization can use standard iso quality manual.
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One fallacy is that someone outside the organization can write a meaningful manual! It may get past some (poor) auditors, but frankly, manuals which slavishly follow the ISO standard format are quite useless, in my experience!
 
B

Big Jim

Super Moderator
#24
#24
AndyN said:
One fallacy is that someone outside the organization can write a meaningful manual! It may get past some (poor) auditors, but frankly, manuals which slavishly follow the ISO standard format are quite useless, in my experience!
Click to expand...
Which one of the three things a quality manual must have would a good auditor have trouble with?
 
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