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Reviewer and Approver level

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Mabel Ng, Sep 5, 2024.

  1. Mabel Ng

    Mabel Ng New Member

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    Hi, can anyone advise as ISO 13485 does not specify that the document preparer, reviewer and approver should be different people. Some of the company practised having same person as reviewer and approver while others practise having only preparer and approver 2 level only. What will be the acceptance for ISO 13485? Thanks
     
    Mabel Ng, Sep 5, 2024
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  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome. ISO 13485 doesn't prescribe such details. It's entirely up to your organization. You must, however, demonstrate that your choice is effective.
     
    Andy Nichols, Sep 5, 2024
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    Mabel Ng likes this.
  3. yodon

    yodon Well-Known Member

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    @Andy Nichols is right: nothing prescribed. And you can really bog things down if you require signatures for all those folks. Keep it simple. From my observations, most ISO findings around this are related to companies not following their own procedures.
     
    yodon, Sep 5, 2024
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    Andy Nichols and John C. Abnet like this.