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  1. Kishnu Vaarma ROSS

    Kishnu Vaarma ROSS Member

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    Hi,
    my company is due to have its Stage 1 certification audit coming January. My question is that whilst the QMS and its associated procedures are being developed (extracted from our Group ISO 9001 :)) how are we to provide a management review and internal audit documentation apart from the procedures and templates?

    I mean, we are going for the audit to achieve the certification, how is carrying out a management review and internal audit on QMS effectiveness that is planned annually going to suffice?

    Appreciate any advice Thanks!
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Do them before the Stage 1?
     
    John C. Abnet likes this.
  3. Kishnu Vaarma ROSS

    Kishnu Vaarma ROSS Member

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    Thank you for your feedback! much appreciated :)
     
  4. Kishnu Vaarma ROSS

    Kishnu Vaarma ROSS Member

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    Hi Andy,
    firstly thanks a mil for all the advices and guidance you've shared in this forums.. its really amazing help to the rest of us!

    There's a clause in ISO 13485 that states the organization shall produce a medical device file for each medical device type or medical device family.. however since my company is going to be acting as a external contract manufacturer, not having a product on its own nor have anything to do with design, I am stating within the manual that we do not maintain the medical device file apart from clients design papers, manufacturing inputs and product quality requirements prior packaging.

    I believe that would suffice, what would be your opinion?

    Kind regards,
    Kishnu