Why is ISO 13485 being revised so soon?
The last ISO 13485 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. However, for component manufacturers, logistics companies and the like, they can. 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 a needless additional administrative burden. And, frankly, it 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 ISO 13485:2019 in 2021. A more precise estimate of the publication date will emerge once the revision process has commenced.
What Changes in the Recent ISO 13485 Revision?
While emphasising that we are in the field of speculation, there are a number of serious issues that need to be addressed. These include:
- The High-Level Structure - HLS – A switch to the HLS would ease the implementation and maintenance of a QMS meeting both ISO 9001 and ISO 13485 requirements.
- EU MDR and IVDR – The Annexes of the 2016 standard relate to EU Regulations that are currently being phased out. New Annexes that address the 2017 Regulations are needed.
- Simultaneous publication date for International and EN version of the standard – with both versions having the same publication date, the suggestion that the difference between the two versions goes beyond the addition of Annexes to the EN version is eliminated. Confusion for those unfamiliar with the standard (e.g. those preparing tender documents or letter of credit documents) is consequently reduced.
- MDSAP compatibility – Canada Health is implementing MDSAP – the Medical Device Single Audit Programme – early in 2019, and the US FDA and others are working diligently towards adopting it also. Streamlining the Programme requirements with those of ISO 13485 would seem of obvious benefit.
- Maintain IMDRF acceptance of ISO 13485 – The International Medical Device Regulators Forum – IMDRF – is a global body of regulators who were the instigators of the MDSAP and of the incorporation of ISO 13485 into that Programme. There is a need for the ISO/TC to ensure ongoing acceptance by the IMDRF of any proposed ISO 13485 changes.
Implications for ISO 13485 Implementation
These are likely minimal regarding processes, procedures and record keeping. The rewriting/restructuring of Quality Manuals, quality policy statements and the like will be necessary.
Overall, it's not likely to be highly disruptive to day-to-day operations of ISO 13485 or of joint ISO 13485/ISO 9001 QMS.
And why are we interested? As providers of ISO 13485 ISO Auditor online training courses, we are going to have to revise all eight of our Courses two years earlier than planned with consequential disruption to our other product development plans.
That being said, while one would hope that the revision to ISO 13485 will proceed smoothly – we have seen no suggestions of fundamental changes to requirements. We will watch developments with interest. With so much change in the world of medical device regulations at present, we hope that this revision won’t add to the burden.