www.fdanews.com/articles/178013-tga-maps-transition-to-iso-quality-management-standard
![AustralianTherapeutic Goods Administration (TGA) Australian](https://www.fdanews.com/ext/resources/test/Device_Images/TGA-logo.gif?t=1589234466&width=430)
TGA Maps Transition to ISO Quality Management Standard
August 17, 2016
Australia’s Therapeutic Goods Administration will transition to the ISO 13485:2016 standard governing medical device quality management systems over the next three years.
The agency clarified that the 2003 standard and the 2016 standard will co-exist during the three-year transition period.
Users of ISO 13485:2003 should work with the TGA or their EU Notified Body or the Medical Devices Single Audit Program organization to schedule an upgrade audit during the transition period. — Tamra Sami