Description This BSI Management Systems course is designed for those with knowledge of medical device manufacturing and starts with one full day of review of ISO 13485:2003. Students gain a broad understanding of the ISO 13485:2003 quality management system requirements. In addition, the concepts of ISO/TR 14971:2001, “Application of Risk Management to Medical Devices,” are introduced.
Through small group activities, audit role-plays, lively discussions, and instructor-led lectures, students gain a thorough understanding of the principles of auditing. Students also learn how to apply the guidance of ISO 19011:2002, “Guidelines for Quality and/or Environmental Management Systems Auditing,” to implement effective internal audit programs for medical device manufacturing organizations.
