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8.5.6 Control of changes

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by jaltangerel, May 11, 2018.

  1. jaltangerel

    jaltangerel Member

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    Hi everyone? it’s nice to see again :)
    Could someone explain, what is mean review and control changes on clause 8.5.6?
    is this review about the changes that will be done?
    or review the effectiveness of changes that had already been done?
    or both above?
     
  2. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    The review is for changes that are to be done, in order to avoid haphazard changes and allow authorized personnel to consider potential risks/side effects before they happen.
     
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  3. jaltangerel

    jaltangerel Member

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    Thank you Jennifer Kirley. Goodness for you.
     
  4. tony s

    tony s Well-Known Member

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    Just to add to this topic. In retaining documented information as evidence of conformity with the 2nd paragraph of 8.5.6, I'd like to share the following forms.
     

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  5. Izadiine

    Izadiine New Member

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    Hello everyone...... we sat for hours in a meeting to find ways to address clause 8.7 (control of non conforming outputs). I would appreciate if you could share your views regarding this clause.
    This clause stipulates that the organisation shall ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery.
    In the last version the term product was used instead of outputs. Therefore we restricted ourselves to end products. Now that the term output is being used and according to definition an output is the result of a process, should we consider outputs from every single process in our organisation even support processes?
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Not all processes have more than one out. However, some do - for example, data as well as product. The product may be good, but the (inspection/test data) may be incorrect. You'd need to do something about the data, through this control.
     
  7. tony s

    tony s Well-Known Member

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    Here's a thread related to this post.