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Medical Device Inspection - Independence & Authority

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Grasshopper, Aug 4, 2016.

  1. Grasshopper

    Grasshopper New Member

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    Can a production supervisor for medical devices inspect his area'
    s work as if he was a quality inspector?
     
  2. RoxaneB

    RoxaneB Moderator Staff Member

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    Are you asking based on ISO 9001 or based on a medical device standard?
     
  3. Candi1024

    Candi1024 Well-Known Member

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    Our internal policy says no, but I don't know if that is a medical device standard or simply internal.
     
  4. tony s

    tony s Well-Known Member

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    If you're referring to ISO 9001, there's no prohibition. If you're referring to ISO 13485, not so sure but probably the same with ISO 9001.
     

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