ISO 13485:2016 Quality Management for Medical Devices

Standards last year and this year seem to be like buses, nothing for ages them all come at once, there have been a rush of enhancements to various Standards and most have gone with the new format ISO Annex SL, where all the Standards have ten clauses to allow easier integration.

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;
• Rework;
• Rules for medical software as a product.

There will be a transition period of three years to allow organisations to take the revised Standard on board.

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.