Mandatory documents required by ISO 13485
Strahinja Stojanovic
Updated: September 19, 2023. The new ISO 13485 is based on ISO 9001:2008, which means that the ISO 13485 2016...
Updated: September 19, 2023. The new ISO 13485 is based on ISO 9001:2008, which means that the ISO 13485 2016 documentation requirements are based on the requirements of the previous version of ISO 9001, with...
Infographic: What’s new in the 2016 revision of ISO 13485
To get a better overview of the relationship between ISO 9001 and ISO 13485, see this article: ISO 9001 vs....
To get a better overview of the relationship between ISO 9001 and ISO 13485, see this article: ISO 9001 vs. ISO 13485. The new 2016 revision of ISO 13485, the leading international standard for...
