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ISO 13485:2016 is finally here!

Posted on March 10, 2016 in Articles


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 3rd 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.

Transition planning
The EN ISO 13485:2012 was also superseded by the EN ISO 13485:2016 and similarly, organizations that certified with the EN ISO 13485 will have 3 years to transit to the new EN ISO standard.

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