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9.3.2 evidences for Auditor

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Qualmx, Nov 1, 2018.

  1. Qualmx

    Qualmx Well-Known Member

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    Hi all
    I wonder how an auditor could raise an NC in changes in 9.3.2?, if I say simply, didn't have need of changes, however I don't have evidences that really I revised need of changes.
    Should the auditor ask evidences (e.g. minutes of meetings, when revision was done)? or just to believe what I say (I will say no changes).
    What does the auditor expect from me as evidence?

    9.3.2

    Outputs from the management review must include decisions and actions related to:

    • Continual improvement opportunities
    • Any need for changes to QMS, including resource needs
     
  2. tony s

    tony s Well-Known Member

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    Are you asking about 9.3.2b (changes in external and internal issues that are relevant to the quality management system)? or 9.3.3b (any need for changes to the quality management system)?
     
  3. Golfman25

    Golfman25 Well-Known Member

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    We use a checklist. We note that we considered changes and whether any would be implemented.
     
  4. Qualmx

    Qualmx Well-Known Member

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    Tony s Is 9.3 3 b,
    Golfman, I think a checklist would be enough? Or maybe a minute of meeting with someone on which is commented "no changes, or some changes".
    Tony's , Golfman, do you think so?
     
  5. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @Qualmx;
    I would caution against adding layers of burden to your organization and teams. I would council that most organizations perform the requirements of “management review” during the course of normal events....
    1- shift change meetings
    2- monthly operation meetings
    3- weekly project meetings
    4- annual business planning
    5- etc....

    I would agree that SIMPLE minutes from these meetings should be kept , NOT for the auditor but to ensure a continuum and follow up to concerns or actions raised or delegated within those meetings as well as a historical body of knowledge. This would benefit the organization while allowing evidence to be available.
    If a decision to make a change arises during these
    “management review” events, does your organization not already have a change point control log/process/method of assigning/reviewing/tracking changes? I would suggest simply using that same system and not creating an additional layer or process. To paraphrase a comment by forum member @andynichols, if you create a monster, your team will expend all of their energy feeding it.
     
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  6. Golfman25

    Golfman25 Well-Known Member

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    This is correct. And what we do is "carry around" our management review checklist to these meetings. So if we cover something on the checklist we make a note of it. Some things may get covered 2 or 3 times in a period. Others only once. But we know over the course of a year, we have hit everything. We show the auditor and move on.
     
  7. tony s

    tony s Well-Known Member

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    Changes resulting from management reviews don't need to be extensive. Small changes can be determined during the reviews since the intention is to "ensure continuing suitability, adequacy, effectiveness and alignment with the strategic direction". The decisions and actions related to any need for changes can be simply captured by meeting minutes. Auditors should not impose that every review must have documented evidence/s of decisions and actions related to any need for changes. There is no need to declare in the minutes if the organization deemed no change is needed.
     
  8. BufferMess

    BufferMess Member

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    The 9.3.2 Management Review Inputs is about "Changes in external and internal issues relevant to QMS".

    This is not about "need of changes", your "planned changes" or "managed changes". The clause requires you to review the monitoring results of your changing environment, i.e. changing internal and external issues.

    An auditor will ask you for evidences of information submitted to review and evidences of decisions for changes to the QMS.

    To comply with the requirement, you need to describe in your QMS performance report all changes in the internal and external issues. Then the MAN will review these changes and take necessary actions for changes to the QMS.

    Simply saying that "we didn't have any changes" is not accepted.
     
  9. Golfman25

    Golfman25 Well-Known Member

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    Ok. What if you didn't have any changes?
     
  10. BufferMess

    BufferMess Member

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    Like I said above, if you didn't have any changes (meaning positive or negative trends) in the internal and external issues throughout the year, you just mention this in your QMS Performance Report and make your MAN-R decisions for the unchanged issues and requirements of the relevant parties. The MAN-R will just evaluate the current situation with the issues and decide that the QMS does not need any changes for the next year. The decision must be in a written form. However, note that the decision will only cover internal and external issues and requirements of the relevant parties. You might still have other inputs potentially signalling for changes in a specific activity or process.

    ISO9001 requires us to review all information sources related to the organization's QMS but advices to decide for only three: improvement, change and resources. Some information sources, like monitoring of external issues and requirements of the relevant parties, might not be as effective to give you the necessary data or could just fail to detect slowly changing environment. But your internal information sources should actively provide you with the results of the implemention of QMS to enable MAN-R to decide for changes to the QMS.
     
  11. Artem

    Artem Member

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    Often auditor would ask within „changes“
    a) if you track changes in applicable regulation (do you do this by the way)
    b) list of corrective actions (and how those influenced your processes)
    c) risks you identify and monitor and how those impact the processes
     

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