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.
ISO 13485 is an international standard based on ISO 9001. ISO 13485 takes into account specific requirements of medical devices, and reflects the legal regulations and preferences of each country. Medical device manufacturers with ambitions for global markets as well as domestic markets are required to establish a quality management system that adheres to ISO 13485.
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.
“The new ISO 13485 is a medical device quality system standard revised in 2016 and is a product of recently redrawn European medical device regulations. During a transition period of 3 years, medical device manufacturers must learn new requirements articulated in ISO 13485 and enhance the quality systems that are currently in operation. These changes will help construct a more efficient quality system, and will require persistent monitoring and education from medical device manufacturers,” says Ms.Hana Na, Medical Auditor at TÜV Rheinland Korea.
TÜV Rheinland, established in 1872, is headquartered in Cologne, Germany and holds approximately 500 branches across 69 countries around the world. With this global network, TÜV Rheinland provides a one-stop medical device testing and certification service that meets standards such as CE, CB, cTÜVus, and INMETRO that are necessary for succeeding in global markets in Japan, China, Taiwan, the United States, Canada, Brazil, Russia, and more.
TÜV Rheinland Korea is the first foreign certification organization to enter the Korean market, and celebrates its 30th anniversary this year. TÜV Rheinland Korea continues its efforts as a reliable partner in testing and certification as well as helping domestic firms export to global markets.