The long awaited ISO 13485:2016 has just been published, sadly it does not follow the annex SL format but does address risk and opportunity as part of the requirements.
The revised Standard, applicable to a wide range of medical products from bandages to remote robot surgical systems and everything in between. Like all the revised standards there is more emphasis on suppliers and the roles they have to play, including products and services; looking at the entire life-cycle of products
There are a number of new elements that have been introduced:
- Work environment now includes contamination control;
- Particular requirements for validation of processes for sterilisation and sterile barrier systems;
- Reporting to regulatory authorities;
- Actions in response to nonconforming product detected after delivery;
- Rules for medical software as a product.
Organisations that have a combined ISO 9001 and ISO 13485 will have to consider whether these Standards will have to be audited separately as they have somewhat diverged. This will, of course, have a cost implication.