“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 implement effective 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.
Learning objectives
- Understand quality management definitions, concepts, and guidelines
- Understand the quality management principles
- Interpret all clauses of ISO 13485
- Apply Principles of PD CEN ISO/TR 14969:2005 and ISO 14971:2007
- Apply principles of ISO 19011:2002 to the auditing process
- Plan, Conduct, and Report Effective Internal Audits to ISO 13485:2003
- Understand the registration process
Course materials
Students receive comprehensive course manuals with reference materials.
Who should attend
- Quality managers
- RA managers
- Auditors of medical device manufacturing firms (internal and external)
- Cross functional team members implementing the standard
Prerequisite
Participants should have a working knowledge of quality management systems, ISO 9001, or ISO 13485.
Note: Students taking the Understanding ISO 13485:2003 course will also attend the first day of the class.
There is a written exam on Day 3 at 4:00 PM. Detailed exam instructions are provided during the course. Certificates of completion are provided for students who exceed a 70% on both the continual evaluation and the exam. Certificates of attendance are provided to those who do not pass. All certificates are provided within 6 weeks of course completion.
