Ccourse begins with a review of ISO 13485:2003 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 14971:2007, “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. (4.0 CEUs)
08FI26000 Dec 1 – 5 (M-Th, 8am–7pm; F, 8am–12:15pm)
$2095
Continuing Education Center | 1100 South Marietta Parkway, Building #WE | Marietta, GA | 30060 | 678-915-7240