Differences between ISO 13485:2003 and ISO 13485:2016

1. What are the exact differences between ISO 13485:2003, ISO 13485:2016?

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 are no different requirements in ISO 13485:2012 compared to ISO 13485:2003. 

To identify 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/

2. What portions of FDA cGMPS, are being revised to comply with ISO 13485:2016?

While adherence to ISO 13485 is not explicitly required, FDA 21 CFR Part 820 Quality System Regulations is the law for medical device companies manufacturing and selling products for the U.S. market. there are some differences between FDA 21 CFR Part 820 and ISO 13485. Yet prior to the publishing of ISO 13485:2016, it has been a very common practice for medical device companies to establish a QMS to address both FDA 21 CFR Part 820 and ISO 13485:2003.

For more information about differences and similarities between FDA 21 CFR Part 820 and ISO 13485, please see the following link:

• Differences and similarities between FDA 21 CFR Part 820 and ISO 13485 https://advisera.com/13485academy/blog/2017/10/05/differences-and-similarities-between-fda-21-cfr-part-820-and-iso-13485/