BSI’s Overview of ISO 13485:2003 gives students a broad understanding of the quality management system requirements outlined in the medical devices standard ISO 13485. Students learn how ISO 13485 helps organizations improve their ability to meet customer and regulatory requirements and enhance the quality and safety of their products. 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.” An experienced BSI instructor provides examples and real world experience, while students are encouraged to ask questions specific to their organizations.
Learning objectives
- Interpret all clauses of ISO 13485
- Recognize the basic requirements of 13485
- Learn the benefits of implementing ISO 13485
- Understand differences between ISO 13485:1996 and ISO 13485:2003
- Understand the role of management in ISO 13485 implementation
- Recognize the relationship between risk management and ISO 14971
- Understand the linkage between ISO 13485 and GMPs
Who should attend
- Quality managers in the medical device industry
- Individuals who seek an understanding of the key concepts of ISO 13485
- Individuals involved in the transition from ISO 13485:1996 to ISO 13485:2003
- Cross functional team members implementing ISO 13485
Prerequisite
Students should have a basic understanding of medical device manufacturing before taking this course.
System requirements
An internet connection with at least Microsoft Internet Explorer 5 or Netscape 5. Also, Corporate Firewalls may prevent the dowload of the MP3 Audio file which can cause the course to hang. Only your IT department can determine if MP3's are being blocked.
