ISO 13485:2016 published
The countdown ended by the end of February 2016. The new ISO13485:2016
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.
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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