The international Medical Devices Quality Management Systems (QMS) ISO 13485 standard was revised and published in March 2016, giving us ISO 13485:2016.
Why update the standard?
The old ISO 13485:2003 standard was based on the old ISO 9001:2000, and a lot has changed in the medical device industry since then, therefore an update was long overdue. The technical group (ISO TC 210) that updates this particular standard chose to base the new revision on the old ISO 9001:2008 (and not the latest ISO 9001:2015 standard), as they felt the older 2008 revision better suited the needs of medical device suppliers and their customers.
We discuss some of the changes below, but this list is not exhaustive. If you need a detailed understanding of the changes please checkout our ISO 13485:2016 Transition Workshop
The term “statutory and regulatory requirements” has now been removed and replaced simply by “regulatory requirements”, recognising that this already includes statutory, legal, local/national requirements.
A three year transition period has been proposed following the official publication. Batalas will provide further info of both the ISO and EN versions as soon as they are available.
The working group have decided to follow the original Design Specification from over 5 years ago, which means that the new revision of ISO 13485:2016 will be based on ISO 9001:2008. This means that this current revision will not align with the High Level Structure contained in Annex SL as applied in the new ISO 9001:2015.
This is obviously a big blow for those organisations who currently hold dual certification to 9001 and 13485, as it could potentially mean that you need to hold separate certifications in future.
Those in this position will need to be aware of the changes, and start transition planning to allow for a smooth migration.
The working group is now developing a matrix document to help to support organisations who wish to adopt the latest revisions of both ISO 13485:2016 and ISO 9001:2015. They are also publishing a document that tables the clause references between ISO 1384:2003, ISO 13485:2016 and ISO 9001:2015.
Please note that there will not be an updated version of ISO 14969 – Guidance on the application of ISO 13485:2003. The working group are considering an alternative proposal to publish a handbook with guidance and interpretation of the requirements of ISO 13485:2016.
All Batalas ISO 13485 training courses now include the latest 2016 revision (unless otherwise stated). We also offer a transition training course for those who wish upgrade their existing ISO knowledge – click here for more information