Standards Adoption Workshop - Impact of ISO 13485:2016 on medical device quality management systems

The ISO 13485 is regulatory requirement for the manufacturing of medical devices and in-vitro diagnostic devices in many countries including Singapore. This International Standard provides the essential quality management system framework to ensure the consistency in design, product development, manufacturing processes, installation of equipment and delivery requirements to direct customers or distributors. The global medical device manufacturing industry is current undergoing a 3-year transition period as the ISO 13485:2016 will supersede the ISO 13485:2003 by March 2019.

Backed by industry’s demand, SMF-SDO is conducting the 3rd ISO 13485:2016 transition training. This full-day training session consists of two workshops. Workshop 1 covered the background of this International Standard and the impact of ISO 13485:2016 on the current quality management system from the Notified Bodies’ point of view. The rationale of the new changes were explained in detail to ensure participating organisations transiting from ISO 13485:2003 to ISO 13485:2016 have proper understanding and are prepared to make the necessary changes to their operation procedures. Workshop 2 focuses on the relationship between ISO 13485:2016 with ISO 9001:2015 and EN ISO 13485:2003 as well as how organisations should prepare and plan their transition timeline to ensure all additional requirements for implementing the new revision ISO 13485:2016 are met.

Ms Jocelyn Reyes engaging participants at the Standards Adoption Workshop