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.

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