ISO 13485:2016 Archives

Hospital hallway with medical devices following ISO 13485 quality management and accredited with IAD MD 9:2022 requirements.

IAF MD 9:2022 – Changes in Medical Device Quality Management Systems

ByBrenda Bissell, Senior Accreditation Manager June 15, 2022May 23, 2025

IAF MD 9:2022, Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems specifies normative criteria for conformity assessment bodies (CABs) auditing…

Doctor holding black endoscope following ISO 13485.

ANSI | Quality Management

Outline of Changes to ISO 13485:2016 Compared with the Previous Edition ISO 13485:2003

ByRobert Russotti March 16, 2016May 30, 2025

ISO 13485:2016 incorporates significant changes to quality management systems requirements for medical devices. The most significant changes pertain to added requirements: • document management• management review•…