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6.3 planning of changes

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Qualmx, Oct 22, 2017.

  1. Qualmx

    Qualmx Well-Known Member

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    Hi everybody

    A question, please share your comments
    In management review meetings (below)

    9.3.3 Management review outputs
    The outputs of the management review shall include decisions and actions related to:
    a) opportunities for improvement;
    b) any need for changes to the quality management system;

    What we report regarding this point, it is what we do when we plan changes?
    and what type of changes, major ,minors? or are there other out of this clause that have to be reported?

    Thanks
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'm not certain what your question is asking. You have to address the need for changes to the quality system, pure and simple. I'm not sure what you mean or imagine about major or minor - a change is a change and the plan should address that. DO you understand that the model for a QMS is that once it is shown to work, that is the QMS is controlling the processes, their results against the objectives, the QMS should be left alone, unless management decide something needs improvement. There may be a need for a change too, due to risk and/or opportunity, or an external requirement (customer, regulation, ISO standard etc). If you recall the section 4 requirements directly link to section 6. THAT is what needs consideration.
     
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  3. Qualmx

    Qualmx Well-Known Member

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    Thanks Andy
    The question is:
    If we want to comply with 9.3.3 b,is what we do when we document changes in 6.3 (planning of changes)?
    Thanks again
     
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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'm still not sure what you are asking, what's 9.3.3b? Give me some concrete examples, please, instead of very open ended questions. You have to identify changes you will need to make to the QMS. So, you need a plan, which is implemented and then measure/monitor the implementation to know if your plan was achieved. This isn't difficult stuff.
     
  5. Golfman25

    Golfman25 Well-Known Member

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    9.3.3 is a decision. Coming out of management review, a change has become necessary.

    6.3 is implementation. When you go ahead and implement that change, do it in a planned manner.
     
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  6. tony s

    tony s Well-Known Member

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    Nice correlation with the clauses.:)
     
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