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Certification

Transitioning to an ISO 13485 Quality Management System (Two-Day)

DETAILS (Return to Main)

Who Should Attend
Quality assurance, engineers, ISO coordinators and other personnel responsible for transitioning a firm's existing ISO 13485 quality management system.

Learning Outcomes

  • Review requirements of ISO 13485:2003.
  • Review major changes to the ISO 13485 standard.
  • Learn transition steps.
  • Understand the process approach to management.
  • Draft process-based documentation to meet requirements.
  • Examine internal auditing changes.

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