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Certification

Transitioning to ISO 13485:2003 Overview – Virtual Course

Detailed Course Agenda: (Return to Main)

  1. Introduction
  2. Learning Objectives
  3. Review ISO 13485:2000
  4. Philosophy
  5. 8 Quality Management Principles
  6. Major Changes From ISO 13485:1996
  7. Details – New Standard, Regulatory and Transition Issues
  8. Process Approach
  9. Internal Auditing Program

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