Description:Medical device manufacturers need to transition their ISO 13485:1996 quality management system to the 2003 revision. This one-day course reviews the following:
- Basic requirements of ISO 13485:2003
- Transition issues for existing users of the 1996 standard
- The process approach to management
- Participants will gain an understanding of the importance of quality objectives, the relationship of processes to procedures and the major changes to internal auditing.
Member: $575
Non-Member: $750
Length:7.50
Source:
Contact:ASQ Customer Service
CPEs:0.00
RU Hours:0.70
CEU Hours:0.70
Goals: - Review the requirements of ISO 13485:2003
- Understand the new responsibilities of top management
- Discover the importance of quality objectives and process approach to business
- Examine regulatory industry changes
- Learn transition steps
- Learn about audit program changes
Delivery Method:Classroom-based only
Audience:Anyone responsible for transitioning a firm's existing ISO 13485 quality management system.
