ISO 13485 - Revised Medical Device Standard Soon To Be Released

Monday, 25 January 2016
ASR Editor
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Medical device 4Sometime in the first quarter of 2016 we will see the release of ISO 13485 for medical device manufacturers. The final voting on the ISO 13485 was concluded December 29, 2015 and now we will wait for the official release in 2016. 

Minor clerical changes are permitted but no significant technical changes should occur.  

ISO 13485 was last revised back in 2003. The latest update of ISO 13485 is to the 2008 version of ISO 9001 NOT the 2015 version.

Structurally, the updated ISO 13485 uses
eight sections rather than the ten sections found in ISO 9001:2015.

The subcommittee revising ISO 13485 received a "waiver" from ISO officials to use the 2008 version. Reportedly, the subcommittee has plans to upgrade to the 2015 version of ISO 9001 at a later date.

Some of the revisions address software and life cycle of a product. Also, ISO 13485:2016 defines "risk" as probability of occurrence and the severity of harm. This is the FMEA approach.

Existing documentation as written against ISO 13485:2003 should provide a starting point for modification to the new 2016 version of ISO 13485. There is a three year transition period.

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