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Certification to ISO 14971 ?

Discussion in 'ISO 14971 - Medical Devices Risk Management' started by Quality Manager Liz, Dec 8, 2017.

  1. Quality Manager Liz

    Quality Manager Liz Member

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    Hi

    I have just been asked if you can be certified to ISO 14971, is this possible?

    Thanks in advance for any replies.

    Liz
     
  2. Marcelo Antunes

    Marcelo Antunes Active Member

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    No, ISO 14971 was not created to be certifiable - IEC even published a note some years ago to clarify this, because some organizations begun selling certification to the standard.
     
  3. Quality Manager Liz

    Quality Manager Liz Member

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    Thank you Marcelo, it is what I was expecting from the research I have carried out. Always good to have it confirmed.
     

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