Revised Medical Device Standard Released Soon

ISO 13485 medical pills industry factor 31Expect a first quarter release of ISO 13485 for medical device manufacturers. Voting on the Final Discussion version of ISO 13485 concluded December 29, 2015 and now the wait is on for the 2016 revision to be officially released.

ISO 13485 was last revised 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 8 sections rather than the 10 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.

Request a quote for a review or an ISO standards auditSome 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 3 year transition period.

As soon as ISO 13485 is officially released, ASR's summary of the changes will be available in the ASR newsletter.

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