BSI's "ISO 13485:2003 Internal Quality Systems Auditor" course, designed for those with knowledge of medical device manufacturing, 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 14971:2007, "Application of Risk Management to Medical Devices," are introduced. Through small group activities, audit roleplays, 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 implementeffective internal 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 an internal quality systems auditor.
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Students receive comprehensive course manuals with reference materials.
Participants should have a working knowledge of quality management systems, ISO 9001:2008, or ISO 13485:2003.
