New Revision of ISO 13485 Released
ISO 13485, Quality Management System Requirements, has been revised. The new standard, ISO 13485:2016 has been published.
Businesses that are currently registered to ISO 13485:2003 that wish to maintain certification have to make the transition.
FREQUENTLY ASKED QUESTIONS
Where can I purchase the latest version of the standard?
How long will ISO 13485:2003 be recognized?
During the next three years, ISO 13485:2003 and ISO 13485:2016 will coexist, allowing companies time to transition to the new standard.
Companies will still be able to be accredited for either ISO 13485:2003 or ISO 13485:2016 for the first two years of the transition period; however, after the second year, new accreditation will only be given for ISO 13485:2016.
After the three year transition, all certified companies must comply with ISO 13485:2016.
What are the differences between ISO 13485:2016 and ISO 13485:2003?
The revised standard maintains the same structure as the 2003 version of the standard.
WCH has provided a video at the top of this page that provides additional information about the new revision.