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Risk Assessment according to ISO 9001:2015

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Gr.rksh, Jun 29, 2017.

  1. Gr.rksh

    Gr.rksh New Member

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    Hello everyone,

    I am currently writing my Thesis on Risk Management according to ISO 9001:2015. My Primary Tasks is to implement FMEA as an effective tool to Identify, Assess and evaluate risks through FMEA.

    * I am not clear about, in which sections of ISO 9001:2015 will FMEA fit in?
    * If FMEA is implemented to identify the Risks and Actions are taking during Product development, does it completely meet the requirement of Risk assessment

    Thank you
    Rakesh
     
    Last edited by a moderator: Jun 29, 2017
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    The primary purpose of FMEA is applied to either product design(s) and subsequent production process(es). In ISO 9001, that would be in the Operations section(s) 8.0.
     
  3. Qualmx

    Qualmx Well-Known Member

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    But first off, does not requiere a special methodology to address the risk.
    It says, to apply RBT (risk based thinking).

    Take a look in ISO 31000, 31010 about types of methodologies to address risks.

    Regards
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Can you explain further? I'm confused by your post.
     
  5. tony s

    tony s Well-Known Member

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    In manufacturing companies particularly the automotive sector, FMEA is a pre-requisite to develop a Control Plan. So it's a tool for product/process planning and development. ISO 9001:2015 clauses where FMEA will fit includes: 6.1.1; 6.1.2; 8.1; and 8.3.2.
     
  6. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I think Qualmx is (correctly) pointing out that FMEA is not the sole methodology for addressing risk; the requirement is to apply risk-based thinking.
     

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