Another Revision of ISO 13485 starts this year

Why so soon?

Last revision published in 2016 and the transition period for migration to this version has not yet ended (due date 31st Mar 2019).  This is indeed a unique situation – a new revision to an ISO management system standard started before the transition to the previous version has been completed.  But why?

There has been much criticism about the structure of the 2016 standard retaining, as it did, the structure of the ISO 9001:2008 standard.  This did not create a significant problem for medical device manufacturers but, for component manufacturers, logistics companies and the like,  working to ISO 13485:2016 for medical device sector customers and to ISO 9001:2015, with its HLS – High Level Structure – for their other customers created needless additional administrative burden and, frankly, was a waste of time.

Following consultation with interested parties in November 2018, a decision has now been made by the relevant Technical Committee, ISO/TC 210, to initiate work of a new revision early in 2019 (2 years ahead of the normal 5-year review).  We can expect the publication of the new standard in 2021.  A more precise estimate of the publication date will emerge once the revision process has commenced.

February 01, 2019

Comments are closed.