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Need examples of ISO 9001:2015 Clause 4.1

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by ganesh, Feb 8, 2017.

  1. ganesh

    ganesh New Member

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    I HAVE COMPLETED THE SWOT ANALYSIS TABLE AND IDENTIFIED THE STRENGTH, WEAKNESS, OPPORTUNITIES, THREAD AND I DONT WHATS THE NEXT STEP TO SATISFIED CALUSE 4.1

    CAN ANY ONE PLEASE HELP ME
     
  2. yodon

    yodon Active Member

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    This is apparently going to be one of those weird areas. 4.1 doesn't have any requirement for documented information so about all an auditor could do would be to see if you have an understanding of the organization and its context. I heard one auditor say they would start at the Management Review and try to unravel things from there.

    That said, I believe the intent is just to get you considering the full scope of your operation. The outputs from your SWOT analysis can feed into the identification of interested parties (4.2), can help refine the scope of the QMS (4.3), can certainly drive risk-based planning and actions (6), and may compliment pretty much everything else downstream. For example, you might have a group of highly skilled individuals who each have "tribal knowledge" that only they possess. Your SWOT analysis might identify this as a threat (or opportunity) and you may drive some knowledge-sharing activities (training).

    Try to keep in mind the big picture of (complying with) the standard: ensure you are operating your business to consistently produce quality products or services. Use this data to help ensure your company is better positioned to do so while continually striving to do better.
     
  3. tony s

    tony s Well-Known Member

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    Clauses 4.1 and 4.2 are needed as basis for determining the scope of the QMS (see 4.3) and as basis for planning for the QMS (see 6.1.1). Evidences that can be presented to demonstrate that both 4.1 and 4.2 requirements were fulfilled can include:
    • information used by the organization and its management when they established their statement for the QMS scope. For example: A manufacturer that caters parts for automotive and non-automotive companies decided to limit their scope to cover only the automotive related processes. Information on their decision to have a limited scope should ensure that internal/external issues referred in 4.1 and needs/expectations of interested parties referred in 4.2 were considered.
    • for companies who plan for their goals thru business planning, corporate planning, strategic planning or operational planning, the inputs for these types of planning should include the internal/external issues (4.1) and needs/expectations of interested parties (4.2). Tools like SWOT is valuable for these planning approaches and can be used as evidence to satisfy 4.1 and 4.2.
    • management review records can satisfy the 2nd sentence of both 4.1 and 4.2 (i.e. "monitor and review information"). Satisfying clause 9.3.2b will satisfy 2nd sentence of 4.1. Satisfying clauses 9.3.2c1, c2, c3, c7, can satisfy 2nd sentence of 4.2.
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    That auditor should get a prize! That's the most suitable answer I've heard so far!

    I am working with a number of clients and they are making clear statements in their review records and that's all.
     

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