IRCA Certified ISO 13485:2016 Lead Auditor Training Course

This course aims to provide learners with the knowledge and skills required to perform first, second and third-party audits of medical device quality management systems against ISO 13485 and applicable international regulatory standards in accordance with ISO 19011, ISO/IEC 17021.

It provides hands on training to ensure that auditor thoroughly understands the role of an auditor and acquires the expertise needed or required to perform the ISO 13485 qms audits effectively. It is structured to provide in-depth understanding of ISO 13485 medical device quality management system requirements for regulatory purposes. With this medical device ISO 13485 training, participants will gain knowledge and skills required to assess the OH&S management system of an organisation. This intensive ISO 13485 lead auditor course is a key requirement for becoming a registered Lead Auditor. It is a participative ISO 13485 training, which uses case studies, role plays, exercises, workshops and group discussions for improving the overall understanding of the participants.