![Advisera Strahinja Stojanovic](https://advisera.com/wp-content/uploads/blog_authors/strahinjastojanovic.jpg)
December 6, 2016
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 medical devices, is finally in front of us. Now we can see exactly what has changed and what needs to be done to achieve compliance with the new version.
The new version of ISO 13485 is aligned with ISO 9001:2008, which may pose challenges for organizations that need to comply with both ISO 9001 (for which the 2015 version complies with the High Level Structure) and ISO 13845.
Companies certified against the 2003 revision of ISO 13485 must transition to the new version by March of 2019.
Both versions have the same number of clauses; however, the new version requires additional documents and allows exclusions from clauses 6, 7, and 8.
There are some new requirements, but the most significant are the incorporation of risk-based approaches in the context of the safety and performance of the medical device, and in meeting regulatory requirements and harmonization of the requirements for software validation for different software applications in different clauses of the standard.
Since ISO 13485:2016 doesn’t follow Annex SL, it kept most of the requirements from the previous version, so the transition wouldn’t be too dramatic. However, it brings changes in the following areas:
ISO 13485:2016 will bring to your QMS:
Click here to download a free white paper Clause by clause explanation of ISO 13485 to see the requirements of the new standard.