Background to ISO 13485:2016 version
(Note that the changes are listed in Annex A of the published standard ISO 13485:2016)
Alignment with global regulatory requirements
- wide breadth of international regulatory changes that have occurred since the 2003 – no longer enough to merely comply with FDA requirements; companies must address the demands of regulators from countries around the world.
- The most recent European version of the standard, EN ISO 13485:2012, tried to do just that, linking EU medical device directives to the ISO quality standard.
- Another objective of the working group is to make the standard more applicable to the entire supply chain in the medical device industry.
- While the existing version is mainly tailored to device manufacturers, the DIS aims to be relevant to suppliers of components and services, as well.
- Exclusions are now allowed for sections 6 and 8, in addition to section 7, of the standard if they are not applicable to the activities undertaken by the organization or to the nature of the medical device for which the quality management system is applied.
- Greater emphasis on risk management, due to the fact that notified bodies and international regulatory authorities are now paying greater attention to it.
- While the current ISO 13485 standard focuses primarily on risk management in design controls (see section 7), the new standard takes a risk-based view of the entire quality system.
Applies to Entire Lifecycle
- The new standard seeks to address the entire lifecycle of a device. The current standard concentrates on quality up until the device is delivered into the hands of the customer.
- But thanks to the Poly Implant Prothèse (PIP) breast implant scandal and the resulting international regulatory scrutiny around product safety — including unannounced notified body audits — the working group wants to ensure that the quality standard covers all aspects of the product lifecycle.