TÜV Rheinland Korea hosted a seminar on ISO 13485:2016, a new medical device quality management system certification, earlier revised in March 2016. The seminar, titled “Introduction and Understanding of ISO 13485: 2016,” was prepared in collaboration with TÜV Rheinland Japan and presented at the Korea International Medical & Hospital Equipment Show (KIMES) on March 17th 2017.
At this seminar, which attracted approximately 200 attendees from medical device manufacturers and the medical industry, TÜV Rheinland introduced the structure of ISO/TC210 and the QMS standard. Key issues shared include (i) background behind the revision of ISO 13485, (ii) major differences compared to the preceding ISO 13485:2003, (iii) implemented changes and transition period, (iv) the correlation between the new standard and ISO 9001:2015, and lastly, (v) the quality management system in Japan.
Exhibitor: TÜV Rheinland