ISO 13485:2016 vs 13485:2012

The European standard, EN ISO 13485:2012 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes, has been published, after approval by CEN on January 24, 2012. This replaces EN ISO 13485: 2003, although the text of the global standard ISO 13485:2003 is unchanged, only the foreword and annexes in the European version have been revised. Therefore, there is no different requirements in ISO 13485:2012 compared to ISO 13485:2003. 

To identified new  requirements of ISO 13485:2016 vs 13485:2003, at the end of the new ISO 13485:2016, in Annex A there is a table - Comparison of content between ISO 13485:2003 and ISO 13485:2016, where you can see all new requirements and differentiation between these two versions. 

On the following link, there is an article with the list of mandatory documents required by ISO 13485:2016: https://advisera.com/13485academy/blog/2017/01/18/list-of-mandatory-documents-required-by-iso-134852016/ 

On the following link you can download free matrix ISO 13485:2016 vs. ISO 13485:2003: https://info.advisera.com/13485academy/free-download/iso-13485-2016-vs-iso-13485-2003-matrix

Also, you can find on Advisera 13485 blog a lot of articles considering certain requirements from ISO 13485: 2016 and how you can fulfill them: ISO 13485 Blog https://advisera.com/13485academy/blog/