Checklist ISO 14971:2007 to ISO 14971:2019 FREE


This checklist can be used to identify changes to your processes, procedures, templates and risk management records when transitioning from ISO 14971:2007/EN ISO 14971:2012 to ISO 14971:2019.



Why is it useful

The checklist will identify some of the most commmon changes that you will be carrying out when updating to ISO 14971:2019 and save time in that process.

How to use it

  1. Go through the checklist to identify needed changes in your system and records.
  2. Review the standard for additional changes.


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