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ISO9001:2015 - 6.1 Risk & Opportunities

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by nirooshani, Nov 25, 2016.

  1. nirooshani

    nirooshani New Member

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    What i have to consider here ? Human risk? environmental risk ? or business risk? could you give me example for this (we are manufacturing company)
     
  2. MCW8888

    MCW8888 Well-Known Member

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    Types of risk: people, asset integrity, environment, reputation, loss of contract, regulatory. product quality
     
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  3. tony s

    tony s Well-Known Member

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    Since ISO 9001:2015 is a quality management system standard, risks here are those that will hinder your organization to provide products/services that meet customer and applicable statutory/regulatory requirements.
     
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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Why not ask your top management? Most business leaders understand the risks associated with getting product to customers and attaining their business objectives. THEY are the best people to ask. Once you've found out, come back and tell us what you discovered!
     
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  5. nirooshani

    nirooshani New Member

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    Thank you very much.
    i got answer from you.

    regards
     
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  6. Gerald

    Gerald Member

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    I met with top management from the different areas of the company that directly affect the QMS. We did a modified FMEA on the base processes that will affect our ability to meet our customer's expectations. It was actually a very eye opening experience and led to the implementation of several new processes based on what we found. As a byproduct of performing the FMEAs we also met the requirement of the standard, which was a plus.
     
  7. normzone

    normzone Well-Known Member

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    Thank you very much, [Gerald]. Bookmarked this in my 9001:2015 Transition folder, and this will come in handy.
     

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