ISO 13485:2016 is finally here!
Understanding the changes - ISO Standard for Medical Devices ISO 13485 :2016
The ISO 13485:2016 was published on 25th February 2016, after a long 13 years gap since the publication of the second edition.
ISO 13485:2016 surprises many, especially the implementers, where it does not adopt the very much anticipated High Level Structure (Annex SL) which already adopted by the ISO 9001:2015; but maintained with the 8 clauses structure with additional requirements incorporated to align with global regulatory requirements.
Some key changes in this new edition:
- Additional terms and definitions
- Applicability of the standard to organizations throughout the medical devices life-cycle (from design & development to the disposal of medical devices), as well as in supply chain and to external parties that provide QMS-related services
- Risk-based approach, pertaining to safety and performance requirement of the medical devices
- “Non-application” now applicable to any requirements in clause 6 and 8 as well
- Greater emphasis to documentation (i.e Medical Device File, Design and Development File)
Transition Planning Guidance for ISO 13485:2016
All ISO 13485:2003 certified organizations are given 3 years to work towards full transition to ISO 13485:2016 from the date of the publication.
The EN ISO 13485:2012 was also superseded by the EN ISO 13485:2016 and similarly, organizations that certified with the EN ISO 13485 will have 3 years to transit to the new EN ISO standard.