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4.1 and 4 2 requirements?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Qualmx, Jan 14, 2018.

  1. Qualmx

    Qualmx Well-Known Member

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    Hi all
    It is not clear for me , what to do for the monitoring and reviewing?
    Another, what evidences, have to show to auditor?
    Thanks.
     
  2. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    It isn't enough to list internal and external issues if they can impact our operations, is it? It makes sense to review them to determine if they need to be acted on. It also makes sense to review them periodically because they may change, or there may be new ones. A SWOT analysis as part of management review is an excellent place to do such strategic thinking.
     
  3. Qualmx

    Qualmx Well-Known Member

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    Thanks, but my doubt it is , what activity comply vs monitoring and reviewing?
    The swot analysis will be done to comply to get the context, and in MR, will only revise for changes, finally, what evidences are requested by the auditor for monitoring and reviewing?
    Thanks Jenni
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    You seem to be overly concerned about what an auditor will ask or accept. The fact is that you'll never know. Auditors aren't who you should be thinking about. I'd suggest that you consider what the organization needs as information to cover these points and leave it at that. To try to shape a QMS to individual auditors - who aren't even necessarily as knowledgeable as you - is a futile exercise.
     
  5. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Dictionary.com defines monitor as
    16.
    to oversee, supervise, or regulate:
    to monitor the administering of a test.
    17.
    to watch closely for purposes of control, surveillance, etc.; keep track of; check continually:
    to monitor one's eating habits.

    and review is defined as
    12.
    to go over (lessons, studies, work, etc.) in review.
    13.
    to view, look at, or look over again.

    We monitor something periodically to keep track of it. We review it in order to monitor it. These are not mutually exclusive activities.

    Please do not over-complicate this. Updating a SWOT clearly indicates both reviewing and monitoring have taken place, as SWOTs do not update themselves.
     
  6. Golfman25

    Golfman25 Well-Known Member

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    Yes, do this. But be prepared for the "clueless auditor." Which is why it is good to know what they typically look for.

    I'll give you an example. Back many years ago we came up with our metrics and would review them in our management meetings. But here was the thing. I, as the top dog, actually calculated the metrics -- I did the math. So review was simply going over them with my people -- listing them on the white board or something. Then during one audit, the auditor wanted "proof" that the metrics were reviewed by upper management. She was looking for a summary, dashboard type of doc. which would be handed out at the meetings. So I would calculate the metrics and then from those documents create a summary for myself which was completely unnecessary because I already knew the numbers. She never picked up on the fact that I, top management, was the guy actually doing the math. She was used to a larger company. Had I been more prepared, I would have realized it and probably could have avoided the whole thing.
     
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  7. tony s

    tony s Well-Known Member

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    If you find it unnecessary, would you still do it to satisfy the auditor?
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Why do you pay for this?
     
  9. Golfman25

    Golfman25 Well-Known Member

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    Yes. This was back in the day and we where less inclined to question things. Whether you do something to satisfy and auditor it a question of risk vs. reward. You pick you battles. If all it takes is to provide a summary sheet, then that is no big deal even if unnecessary. Other things, maybe not so much.
     
  10. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Auditors are expected to be able to note performance trends and look for progress/response to poor performance. That data is usually in management review. Do you always produce data on the spot for managers during MR, and if so how are you going to show trending as is now included in 9.3?
     

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