ISO 13485 Standards was updated on 1st March 2016.
With the ongoing reviewing and updating of all the Management Standards, it is interesting to note that ISO 13485 is the exception. In particular
ISO 13485 follows the previous Standard (and ISO 9001: 2008) Index layout. This is in-spite of ISO specifying that all new or revised Management Standards in 2013 will comply to the new Annex SL format as used in ISO 9001: 2015 and ISO 14001: 2015
All the ISO 9001 derived management Standards, have had the core requirement of complying with Customer Expectations. ISO 13485, the emphasis has changed to Regulatory compliance.
Risk has been extended throughout the Standard
Compliance is the core requirement, unlike ISO 9001.
There is a 3 year Transition as with ISO 9001: 2015. For assistance in Transition to ISO 13485: 2016, please contact us.