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Mandatory Changes in Quality Documentation

Discussion in 'ISO 9001:2008 - Quality Management Systems' started by Padym, Oct 20, 2015.

  1. Padym

    Padym Active Member

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    If Org modifies their Context with new objectives and mission, which are the mandatory Documents or records it should reflect besides other requirement to be compliant with ISO 9001:2008 requirements.
    From my experience
    1. Content in Quality Policy document and relevant reference - Quality Document
    2. Business Strategic Plans defining new Objectives and alignment to Company's Context. (What, When, How)
    3. Reference in Management Review Outputs - Quality Document
    4. Communication to all staff on the new objectives, Individual roles and their performance to align with Org vision. ( Staff KPIs)
    5. Sources for the need of Changes required in Org Context (e.g as a result of analysis, evaluation of last year achievement, customer complaints/ expectation, csat, internal Process measurements, strategic requirement, internal Audit, other external / internal issues) - Monitoring, Measurement and Analysis - Quality documentation.

    Thanks in advance.
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It's going to depend upon the nature of the modifications as well as other factors. I can't see a clear answer to your question, in any case, since there are zero "mandatory" documents these days - it's all dependent upon what YOUR organization determines is required. Clearly, management review is a core requirement where much of what you describe would be on the table for discussion, so records of that and actions/changes arising is "mandatory" in that respect...
     
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  3. Pancho

    Pancho Active Member

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    I'm with Andy. Nothing in ISO 9001, either 2008 or 2015, requires your objectives and mission changes to affect "mandatory documents or records".

    Despite that, if a QMS is useful, any significant high level changes should trigger a cascade of other changes through many documents in the system, even perhaps only sparing them "6 documented procedures".
     
    Andy Nichols likes this.

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