This is an introductory to intermediate level training course for accreditation managers and assessment personnel of APAC Members. It will cover the use of ISO/IEC 17021-1:2015 Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 1: Requirements to accredit medical device quality management system (MDQMS) certification bodies. Certification bodies provide MDQMS certification to their clients on the basis of ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes. The course will also cover relevant IAF requirements, including IAF MD 8:2020 Application of ISO/IEC 17011:2017 in the Field of Medical Device Quality Management Systems (ISO 13485) and IAF MD 9:2017 Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems (ISO 13485).
The facilitators will provide an overview of how accreditation of MDQMS certification is conducted and the participants will be encouraged to share their experiences and ask questions.
The sequential sessions time are (Coordinated Univeral Time (UTC)):
Session 1 – 02:00-05:00, 7 Sep, UTC
Session 2 – 02:00-05:00, 8 Sep, UTC
Session 3 – 02:00-05:00, 9 Sep, UTC