Voting has now closed on the next revision to ISO 13485 “Medical devices — Quality management systems — Requirements for regulatory purposes”.

All comments received by the ISO/TC 210 working group (the ISO group that is revising the standard), the comments will now be reviewed and the Final Draft International Standard (FDIS) should be published around September 2014.

If the FDIS is accepted by the National Standards Bodies and all other interested parties, the next revision of ISO 13485 should be published around March/April/May 2015.

What are the major changes:

  • Management responsibility – possibly similar to the changes in ISO 9001:2015
  • Corrective Action Preventative Action (CAPA)
  • Software validation
  • Supply chain and Outsourcing
  • Risk management
  • Post market activities
  • Process validation
  • Product lifecycle management
  • Annex Z to EN ISO 13485
  • Alignment with ISO 9001 (although ISO 9001 is changing in 2015)

The revised standard should include tables in the back of the standard to show how the ISO 9001 and ISO 13485 compare in terms of clause numbers etc, plus tables to show the previous version of ISO 13485.

In addition, the new revised standard will include supplementary Annex Z’s to enable support for the European Medical Devices Directives – this would allow ISO 13485 and the EN ISO 13485 to be aligned to provide a “presumption of conformity” under the relevant clauses of the EU Directives.