ISO 9001 and ISO 13485 are internationally recognized standards that help organizations to improve their quality. ISO 13485 is the international standard that sets out the requirements for a quality management system specific to the medical devices industry. As a medical device manufacturer and contract medical device manufacturer you would need to comply with ISO 13485 and ISO 9001 to demonstrate your quality management system fulfils industry standards.
Agenda
Webinar duration 1 hour: 45-minute presentation / 15-minute Q&A
- Introduction to Standard ISO 9001:2015 and ISO 13485:2016
- Risk Management of ISO 14971
- Similarities between ISO 9001:2015 and ISO 13485:2016
- Where do the two differ
- Areas to combine
- Benefit of combining
Target audience: This webinar is aimed at entrepreneurs in the Importer, Market authorization holder, and Distributor business
Date & Duration: 20 April 2022 online time 2-3 p.m. (Bangkok local time)
Language: Thai
Cost: No charge