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Purchasing data review requirements

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by K Muela, Apr 26, 2016.

  1. K Muela

    K Muela New Member

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    We have an automated system for POs, and there is no capability for review and approval by a second party. Is it acceptable "evidence" of review to have the buyer make a notation in comments that they themselves have reviewed the PO for accuracy?
     
  2. David Sanabria

    David Sanabria Active Member

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    Which standard and requirements are you making a reference to?
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Well, it's posted in the 13485/14969 forum...
     
  4. David Sanabria

    David Sanabria Active Member

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    While an excellent observation - many companies have multiple certificate and so the question was to clarify the issue with the individual making the post. Having said there, there is that .9% that I could be stretching my imagination and they posted the question in the wrong forum. :))
     
  5. matkins151

    matkins151 New Member

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    I don't see any requirement in ISO13485 for review and approval of purchase orders by a second party. If this is required in your internal procedures, you can also state how the review is to be documented. Or change your procedure to eliminate the requirement.