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  • 1.  ISO 9001 Documentation Author, Reviewer and Approver

    Posted 12/18/19 12:39 PM
    I'm trying to find an official or expert response to whether an approver can also be the author for our QMS documentation.  We have implemented a QMS against the ISO 9001:2015 standard and in some cases the author is also the approver but we make sure the reviewer is different.  In our recent surveillance audit the auditor commented on this but didn't note it as a finding.  They stated the author and reviewer can never be the same - agreed as a best practice - but again no official reference to point to.  But they went on to express concerns over author and approver being the same.  I have been unable to find any official reference to this through the standard, on the ISO site or other general web searches.  Hoping that someone here has some information that can help.  Thanks!


  • 2.  RE: ISO 9001 Documentation Author, Reviewer and Approver

    Posted 12/18/19 01:03 PM
    For this it's best to go to principles, as I do not believe there is explicit guidance in the ISOs (in regulated industries that can be a whole different discussion).


    We all make mistakes, and competent checking to capture this is as important as competent authoring. (Although the authoring must be good enough that there aren't so many mistakes that the checker "can't see the wood for the trees".) As we are all human we need one person to write and the other person to check. Otherwise you aren't really doing a check.


    It's useful here to break out review and approval:
    • A review examines the document from a content perspective. It is performed by subject matter experts who are able to determine if the information is complete, clear and accurate.

    • An approval considers the document more from an organizational perspective; that it is appropriate to implement and its use will be supported and enforced beginning on the document's effective date.


    I can easily see times when the author and the approver is the same person. The person who wrote a document is also the person to approve it from an organizational perspective (again care for this should be applied in regulated environments like pharmaceuticals). But a separate reviewer should exist to ensure completeness, clarity and accuracy.


    Or you can have the author as one person and the reviewer/approver as a second.


     


  • 3.  RE: ISO 9001 Documentation Author, Reviewer and Approver

    Posted 12/18/19 01:22 PM
    Thank you Jeremiah for the quick and thorough response!  It's a good reminder on defining reviewer and approver and why those checks are in place.  We are looking at options to evaluate those cases where the current approver can be assigned to someone else, maybe the next tier management role rather than the current author/approver situation we have now.  The reviewer is currently a peer in the respective functional area.  In most cases the functional manager will have the requisite knowledge to review the content for accuracy and appropriateness and ultimately sign-off we will just need to look at the exceptions where the manager is also the author.  We may be making it more complicated than necessary but want to be honest while having it make sense for our organization.  Thanks again!


  • 4.  RE: ISO 9001 Documentation Author, Reviewer and Approver

    Posted 12/19/19 08:30 AM
    Just to give some other considerations, I will add that Jeremiah is correct in the ideal from a principle standpoint, but as an auditor myself, I will tell you that how you do it is completely up to your organization and it is not for the auditor to tell you whether it is right or wrong. You need a process for how documents will be reviewed and approved but the process can be anything you want. I have many audit clients that for various reasons have the same author, reviewer and approver. I also have audit clients that their process states that the author reviews as part of the document creation and no other approvals are necessary. I may cringe from a principle standpoint and offer a suggestion to consider changing that but it is in compliance and I cannot write a nonconformance because I don't like the process you've defined. Hope that helps with just another side to the coin. 


  • 5.  RE: ISO 9001 Documentation Author, Reviewer and Approver

    Posted 12/19/19 11:58 AM
    Thank you Christianna for the additional feedback and consideration from an auditor's perspective.  We will continue our assessment to determine when author and approver really need to be the same but your feedback really helped as we enter into our next audit cycle!  It gives me peace of mind, thank you!