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. Students gain a broad understanding of the ISO 13485 quality management system requirements. 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. 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.
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 and ISO 14971
- Apply principles of ISO 19011:2002 to the auditing process
- Plan, conduct, and report effective internal audits to ISO 13485
- 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.
