New ISO 13485: Device Companies Have Three Years to Transition

By Michael Mezher

The International Organization for Standardization (ISO) late last month released its long-awaited revision to ISO 13485, the global standard for medical device quality management systems (QMS), which replaces the previous version from 2003.

The new revision places a greater emphasis on QMS throughout the supply chain and product lifecycle, as well as device usability and postmarket surveillance requirements.

Over the next three years, ISO 13485:2003 and ISO 13485:2016 will coexist, allowing manufacturers, accreditation/certification bodies and regulators time to transition to the new standard.

According to a draft transition planning guidance, organizations 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 third year, the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”


Many organizations involved with medical device development, including manufacturers and service providers use ISO 13485 to “demonstrate [their] ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.”

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Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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