ISO 13485 Revision

ISO/DIS 13485:201X, “Medical devices — Quality management systems — Requirements for regulatory purposes,” was published in February 2014.  The five month voting period for comments to be submitted by the National Standards Bodies to the ISO Central Secretariat will close in July 2014.

The DIS comments will be reviewed at a September 2014 meeting of the ISO/TC 210 Working Group 1. The Final Draft International Standard (FDIS) version should be issued for a two month vote late in 4Q/2014. Assuming the FDIS is approved, ISO 13485:201X should be published late 1Q/2015 or early 2Q/2015.

Expected Changes

ISO 13485:2003 was based on ISO 9001:2000. The draft ISO 13485:2015 is based on ISO 9001:2008 and its clause structure, not the new requirements and clause structure of ISO 9001:2015. To assist users in understanding and applying this new standard, additional tables correlating ISO 9001 and the previous version of ISO 13485 have been included.

Also, the supplementary Annex Z in support of the European Medical Devices Directives have been included (anticipating the next revision of ISO 13485 being harmonized under the three Medical Device Directives).

This means ISO 13485 and EN ISO 13485 would be published in a similar timeframe. Organizations can then use the Harmonized Standard within Europe which provides for the “Presumption of Conformity” under the applicable clauses of the Directives.

Transition Period

With the introduction of ISO 13485:2015, it is anticipated that a transition period will be announced. Adherence to this timescale is important recognizing the progress and development of ISO 9001:2015, due to be published 4Q/2015, and the requirements of Annex SL applicable to all new and updated Management System Standards.

This revision has also been drafted recognizing that it will have to support the existing European Medical Devices Directives and the proposed European Medical Device Regulations when they are published in the future. Some of the content has therefore been specifically drafted to accommodate this requirement.

Note: Some of this information was extracted from a BSI email providing an update on ISO 13485:201X.