BSI’s ISO 9001:2000 Lead auditor course with emphasis on ISO 13485:2003 course begins with a review of ISO 13485 and continues to teach the principles of process auditing in accordance with quality management system standards and ISO 19011:2002, “Guidelines for Quality and/or Environmental Management Systems Auditing.” In addition, the concepts of ISO 14971, “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 and how to apply the guidance of ISO 19011:2002 to implement effective audit programs for medical device manufacturing organizations.
This course is certified by the RABQSA. Students successfully completing this course (by passing the continual evaluation and the written examination) fulfill the RABQSA training requirements for QMS Auditor and QMS Lead Auditor certification.
Students receive comprehensive course manuals with reference materials.
A pre-course assignment must be completed before the first day of the course. A prior review of the ISO 13485 standard and internal audit experience are strongly recommended for this course.
