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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.

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  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
    Gr.rksh, Jun 29, 2017
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  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.
     
    Andy Nichols, Jun 29, 2017
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  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
     
    Qualmx, Jul 1, 2017
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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Can you explain further? I'm confused by your post.
     
    Andy Nichols, Jul 2, 2017
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  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.
     
    tony s, Jul 6, 2017
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  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.
     
    Jennifer Kirley, Jul 6, 2017
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