Anyone responsible for transitioning a firm's existing ISO 13485 quality management system.
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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.
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Course Data
- CEU Hours: 0.70
- ASQ RU: 0.70
- Provider: ASQ
- Course ID: TISO13485O
- Course Length: 7 hours
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