ISO 13485:2016 published

The countdown ended by the end of February 2016. The new ISO13485:2016 is published.
Compared to the 2003 version the following key areas need attention:
  • Risk based approach for the QMS processes;

  • More emphasis on the responsibilities and commitment of top management and to applicable regulatory requirements;

  • Increased control over suppliers and outsourced activities;

  • Risk management is emphasized throughout the product life cycle;

  • And some more minor changes in various clauses;

It is good to order the standard and start getting familiar with the new requirements.
 
Estonian Centre For Standardization is my preferred source for standards. They provide you an option to preview the full text for € 2,00 or buy the standard for a little more. See their website https://www.evs.ee/products/evs-en-iso-13485-2016.
 
Make a GAP analysis and start making your transition plan. I use the new requirements as the reference during internal audits and consultancy activities at our customers.
 
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