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

[qmsboy]

Hi There,

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?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?Please throw some light on this as I am

Thanks

[silentrunning]

4.2.2 Doesn't specify authorship. It just states that the "organization" must establish and maintain a Quality Manual. To me that means anyone in the organization or hired by the organization can write the manual. In most cases the Management Representative would be the natural choice.

[Geoff Cotton]

Whats the size of your organisation, also which IT platforms have you got?

This may help get you the answer you are looking for.

[sagai]

I am not sure if it should be signed ...
Cheers

[Geoff Cotton]

In the past 3 companies where I've worked, the quality manual has been in digital format on the intranet. Not signed.

[db]

In Reply to Parent Post by qmsboy

Hi There,

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?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?Please throw some light on this as I am

Thanks

Actually, regarding who must write the quality manual might be better answered in 5.5.1. There is simply states that responsibilities and authorities have to be defined and communicated.

So to answer your question, I suppose anyone could write the manual. Or, you could even buy one on ebay (although I doubt it would meet your needs without modification). And as others have commented, there is no requirement for a signature either.

Hope that helps

[steve hussain]

I think 4.2.3 (a) says that we must have some means of approving a document before it is issued.

[db]

In Reply to Parent Post by steve hussain

I think 4.2.3 (a) says that we must have some means of approving a document before it is issued.

You are correct, the document control procedure must define the controls needed to approve documents. However, it does not say that a signature is required.