Regulators around the world use ISO 13485 as a base standard as part of their regional requirements to address medical device quality management systems. The 2016 version is the first revision in over 10 years, as it replaces the 2003 version implemented by over 26,000 manufacturing sites [PDF] worldwide. The major changes include more emphasis on taking a risk based approach, better controls over suppliers and verification processes for connected devices.
“UL is committed to making sure our medical Quality System Registration customers are able to demonstrate compliance with the latest standards and current requirements,” said Michael Windler, regulatory service operations head for the UL Health Sciences division.
UL will work together with current and new customers to assess the opportunity to upgrade their certification. All new ISO 13485 customers will automatically be certified under ISO 13485:2016. With the SCC accreditation, UL qualified staff can begin to audit to ISO 13485:2016 and issue certificates.
ISO 13485 concepts are part of most Regulatory QMS requirements, including the new Medical Device Single Audit Program (MDSAP) for which UL is an Authorized Auditing Organization (AO).
SCC accredited certificates to ISO 13485:2003 will remain valid until the end of February 2019. Regulatory bodies that recognize a national version of ISO 13485 as part of their regulatory requirements will each define their own transition schedule.