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Independent review and approval?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Rick Schellenberg, Nov 25, 2019.

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  1. Rick Schellenberg

    Rick Schellenberg Member

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    On a recent audit, we got a "major violation" that said one of our documents "was approved by the author himself. It has to be independently reviewed and approved before implementation."

    My question is where in ISO 9001:2015 does it say that a document has to be independently reviewed and approved before implementation? And is it appropriate to have a system that has only one signer and approver?

    As you might be able to tell, I am rather new to ISO 9001

    Thanks
     
    Rick Schellenberg, Nov 25, 2019
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  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome Rick:

    The auditor is totally off here. Was it actually written as a "major" non-conformity? Whatever it is - major or minor - if they left you with an action item, then you should push it back to the CB management and tell them it's bogus.
     
    Andy Nichols, Nov 25, 2019
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  3. Rick Schellenberg

    Rick Schellenberg Member

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    Thanks Andy for the quick response. This was a supplier audit and it was listed as a "Major Observation".

    So, I take it that it is not necessarily a violation to have a document that has only been approved by one person, is that right?
     
    Rick Schellenberg, Nov 25, 2019
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  4. Golfman25

    Golfman25 Well-Known Member

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    Supplier audits are a crap shoot. Why they would be looking at "approval" is beyond me. Our documents are usually written and approved by the same person -- usually the party most affected by the document. Never been a problem. As for your "non-conformance," I would "ignore" it and see what happens. Good luck.
     
    Golfman25, Nov 25, 2019
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  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Correct: Since it says nothing in ISO 9001 - or any other standard I'm aware of - about this topic. As Golfman says, supplier audits are a crapshoot. I'd still be appealing this, if they expect you to take action on it, unless the document(s) is one pertaining to their product and it's an easy fix. If it's a general statement of compliance, he's crazy. Reply, asking where it states as much in the standard. I'm guessing he's not citing a supplier QA requirement of his organization's, just ISO 9001 (?)
     
    Andy Nichols, Nov 25, 2019
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  6. tony s

    tony s Well-Known Member

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    It is written at the back of the last blank page of the standard.:eek: Seriously, there's no mention of such type of review and approval.
     
    tony s, Nov 26, 2019
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  7. Leonid

    Leonid Well-Known Member

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    7.5.2 reads: When creating and updating documented information, the organization shall ensure appropriate:
    c) review and approval for suitability and adequacy.
    Nothing is said that review and approval be carried out by different persons.
     
    Leonid, Dec 14, 2019
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