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

[JoeDM]

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

In my last company, all documents were electronic. None were 'signed', but all were approved electronically by the appropriate approvers. In the case of the quality manual, I required the CEO to 'approve' the document as the only approver, because I wanted his committment to what was said in the manual. In fact though, he just approved what was sent to him for approval.

 

[Big Jim]

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

Consultants can and do write quality manuals. I have written more than I care to count.

 

[kgott]

In my last company, all documents were electronic. None were 'signed', but all were approved electronically by the appropriate approvers. In the case of the quality manual, I required the CEO to 'approve' the document as the only approver, because I wanted his committment to what was said in the manual. In fact though, he just approved what was sent to him for approval.

I agree that electronic documents and electronic approval is the best way to go but how do you generate the evidence that the approver has approved the document?

I generally suggest that emails saying that the document is approved are filed in the project folder or some other suitable location but I still think that somehow there must be a better way but I dont know what that is so could you please elaborate on that.

thanks

 

[Jim Wynne]

I agree that electronic documents and electronic approval is the best way to go but how do you generate the evidence that the approver has approved the document?

I generally suggest that emails saying that the document is approved are filed in the project folder or some other suitable location but I still think that somehow there must be a better way but I dont know what that is so could you please elaborate on that.

thanks

There are digital signatures, and if you're using MS Office (on an Exchange server), you can use Outlook voting buttons for recording document approvals.

 

[Big Jim]

Why are you hung up on signatures?

 

[RedWings]

When I'm doing Doc approvals I send an email to the Doc Owner with the document attached that has track changes turned on so they can see the final changes. The subject line contains doc name, doc #, and new revision level.

When they reply saying it is approved, that email is saved in a folder on the server for doc approvals. A copy of the document showing the markup is archived. The final document has all changes accepted prior to posting.

Unfortunately we don't have any documentation management system so I use this process to ensure all my bases are covered.

 

[ssz102]

as my point, it is not important i thought whoever create quality manual, but the contents must be comply with the actually status of your company

generally speaking, most of company are made by MR

 

[silentrunning]

I don't have anyone sign the documents, but I do have top management (owner) sign all the Document Change Orders. I consider this a good practice just in case there is some question in the future as to authenticity.

 

[AnaMariaVR2]

I would say ideally a team of writers that master not only the content and the purpose of a Quality Manual but also possesses decent technical writing skills. Anybody with those traits may write it. Remember, it is not a novel...keep it simple!

 

[Jim_Barnett]

From my experience no. When I started with my current firm the manual was written by an external consultant and was signed ?Approved? by the management rep. Trouble is that the consultants tend to sell off the shelf manuals that they can sell to all manner of clients and this often results in a manual that is not right for your business. We were a classic example, I managed to take our consultants 60 page quality manual and reduce it to just 12. Life is now much simpler.

With regard to the signature thing it varies depending upon the assessor. Ours (NQA) still insists upon a printed copy, I did have one assessor gripe about the fact that my ?Signature? was scanned in but I told him to get over it which he did with reasonably good grace.