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ISO 13485 Standards was updated on 1^st 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.