ISO 9001 Document Review and Approval Form Requirements

L

Ladyrunaway

#1
In our company we are currently using a paper based review/approval form, wherein checker and appover writes down their comments on the check review form, sometimes checker would make the mark-ups on the document itself (check copy) where the originator then can update the document based on the review that were made.

My question is:

what does ISO 9001 says regarding the paper copy of the review form, do we have to keep/archive a copy of the document with mark ups to show that it has been checked or does the review form with signature is enough to show that the document has been reviewed and checked?
 
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ScottK

Not out of the crisis
Staff member
Super Moderator
#2
Re: Review / approval form

In our company we are currently using a paper based review/approval form, wherein checker and appover writes down their comments on the check review form, sometimes checker would make the mark-ups on the document itself (check copy) where the originator then can update the document based on the review that were made.

My question is:

what does ISO 9001 says regarding the paper copy of the review form, do we have to keep/archive a copy of the document with mark ups to show that it has been checked or does the review form with signature is enough to show that the document has been reviewed and checked?
ISO doesn't say.
It's up to you and your system.
If you find value in keeping markups then make sure your procedures tell people what to do with them as they are quality records.
If you find no value, then just keep the signed approval sheet.
Just make sure your document control and control of records procedures reflect what actually happens.
 
T

timesup1

#3
Re: Review / approval form

CAn the same person Originate and Approve a document or does the approver need to be different than the originator?
 

Pancho

wikineer
Super Moderator
#4
Re: Review / approval form

Can the same person Originate and Approve a document or does the approver need to be different than the originator?
Section 4.2.3a requires your organization to "define the controls needed to approve documents for adequacy prior to issue". It does not mandate that the author and the person who approves be different.

So you get to decide whether the author and the person who approves the document need be different.

For example, if the person writing the documents is a consultant that is not very familiar with your processes, then it would be an excellent idea to have someone that is an expert approve the document. But if the expert writes it in the first place, and the process will not collapse if you have a typo in the document, then you might allow self-approval.
 
#5
Welcome to the Cove!

I'd add that it doesn't matter who originates/creates a document, only the approval is "important". If you found a nice looking form on the Elsmar Cove and used it, it doesn't matter who created it, only that it was approved for use in your own QMS
 
K

kgott

#6
In our company we are currently using a paper based review/approval form, wherein checker and appover writes down their comments on the check review form, sometimes checker would make the mark-ups on the document itself (check copy) where the originator then can update the document based on the review that were made.

My question is:

what does ISO 9001 says regarding the paper copy of the review form, do we have to keep/archive a copy of the document with mark ups to show that it has been checked or does the review form with signature is enough to show that the document has been reviewed and checked?
Is there any particular reason you don't use electronic generation, review and approval? Would it not speed the process up and make records of the review, if you wanted to keep them, much more efficient?

How big is the operation and what sort of business is it?
 
T

timesup1

#7
Thanks for your support. Company is about 6,000 people and each department has thier own set of procedures for operation. A couple of the departments use the same person to originate and approve their working procedures. That was my original concern. These are not salary or manager personel, but they are the ones using the procedures. So a change could effect quality of our product and thier managers would not know until later.
 
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