BSI’s Implementing ISO 13485:2003 course introduces the concepts needed to understand, develop, and implement a quality management system as outlined in the medical devices standard ISO 13485. This course also discusses the use of ISO 14971, which contains key principles and guidance for risk management. PD CEN ISO/TR 14969, “Medical devices – quality management systems – guidance on the application of ISO 13485:2003” will also be used as a learning tool. Experienced instructors explain how to integrate ISO 13485 system implementation with the overall business, prepare for audits, and achieve ISO 13485 certification. Exercises prepare students to identify key requirements, create documentation, develop project plans, and prepare a scope map.
Learning objectives
- Understand quality mangement definitions, concepts, and guidelines
- Understand the process approach
- Interpret all clauses of ISO 13485
- Understand the role of mangement In ISO 13485 implementation
- Understand the proper use of ISO/TR 14969
- Learn best practice processes to implement each clause of ISO 13485
- Prepare for an audit
- Plan for registration
Course materials
Students receive comprehensive course manuals with reference materials.
Who should attend
- Anyone involved in defining, planning, or implementing an ISO 13485-based quality management system
- Management representatives
- Implementation team members
Prerequisite
This is an introductory course designed for individuals with little or no previous knowledge of implementing a quality management system. Basic knowledge of medical devices, ISO 9001, or ISO 13485 would be beneficial.
