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.”