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Updating QM to 13485:2016 - We do not make medical devices

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Nikki, Sep 25, 2018.

  1. Nikki

    Nikki Well-Known Member

    Jul 31, 2015
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    Hello All,

    I am updating our quality manual from ISO 13485:2003 to the 2016 version.

    We are a medical plastics compounder. We make the plastic pellets that medical device manufacturer’s use to make their medical devices. We do not made medical devices.

    With that said, there are several clauses in section 7 we are excluding.

    Our quality manual was basically the standard written in a different tense. So my question is….

    When it comes to sections that I can’t exclude, but they mention medical devices – should my quality manual still call out that? I am thinking not, but was hoping for your thoughts.

    For example – I am updating the QM right now with section 7.3.7 Design and Development Validation. We line up fine with the first part – but then it goes into saying that evaluations are needed to be performed on the “medical device” and connected or interfacing “medical devices”.

    Do I have to keep “medical device” in that section?

    Do I simply replace it with our product “compounded plastic”?

    Since we do not make medical devices – can I exclude this portion? Do I need to include it at all?

    Thanks in advance! Transition audit is coming up soon.
  2. judegu

    judegu Active Member

    Jul 11, 2018
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    I am a stranger of ISO 13485. However, the quality manual which was basically standard written in a different tense may be not a desirable one for the pratical use.
    Nevertheless with regard to your question above, I agree with you on this term changing thing. Actually in my opinion, you should do some modification based on the real situation.

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