Who and how many Approvers do I need for QMS Documents?

[ssz102]

i have a suggestion as below:
the documents was draw up by responsible or responsible dept and then reviewed by related someboy involved this documents, BTW, the personal who are develop and approval of document can not the same people

[abigailt]

Our document control policy contains a minimum requirement for 2 people to approve any document. Where it is a department specific document these can be two people from the same department or they can be representatives from multiple departments that the document affects.

There are multiple regulatory requirements that mean amended documents need to be approved by the same people as the original so this should also be in the policy. We state "representatives of the same areas" as the exact same person may no longer be available for a number of reasons.

We have used this sucessfully for ISO9001, ISO13485 and FDA Part 820 for 20 years now and have never had issues on it.

I would steer clear from a requirement for QA/Management representative to approve all documents within the QS - whilst it may be a manageable job now it can become a burden if the company is sucessful and continues to expand.

[Faulk]

THANK YOU EVERYONE!

Your comments have been extremely valuable and are much appreciated. I sincerely appreciated everyone's commentary and would like to specifically thank HOWSTE for referencing the Doc Control section of 13485 which clearly I glossed over over but didn't comprehend. Also, thank you to RCBeyette for the check and balance on approving vs. auditing and Abigailt for sharing your company's experience with the approval process.

Thank you!
I hope in the future I can be as helpful

It's a great Friday
Cheers!
JT