BSI’s Understanding ISO 13485:2003 course gives students a broad understanding of the quality management system requirements outlined in the medical devices standard ISO 13485. The course focuses on teaching the process approach for quality management and how ISO 13485 and GMPs complement each other. In addition, students gain an introduction to the concept of risk management as described in the standard ISO 14971, “Application of Risk Management to Medical Devices.” The course includes exercises to provide students with the opportunity to practice the information taught in the course. Our instructors also encourage discussion and debate as part of the learning process.
Learning objectives
- Interpret all clauses of ISO 13485
- Understand the role of management in ISO 13485 implementation
- Understand the proper use of PD CEN ISO/TR 14969
- Recognize the relationship between risk management and ISO 14971
- Understand the linkage between ISO 13485 and GMPs
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 basic knowledge of quality management systems, ISO 9001, or ISO 13485.
