ISO 13485 Medical Devices Quality Management System (QMS) Transition

Transition Course to ISO 13485:2016

Summary :

This two-day course includes the most recent information and interpretation of the ISO 13485 requirements.

This course enables participants to acquire the necessary knowledge to support an organization in their process of transitioning to ISO 13485:2016. Participants will learn the different components on how to plan and implement the transition to the new version of the standard. Moreover, the training course will also explore on the time frame of implementation and the influence on current processes.


Who should attend?

  • Senior management
  • Persons responsible for the EMS transition and meeting new requirements in their organization
  • Persons considering implementing a new environmental management system
  • ISO 13485 auditors and quality practitioners
  • Trainers and consultants
  • Operations personnel
  • Management Representatives

Learning objectives:

  • Understand the new structure of ISO 13485:2016
  • Learn about the advantages and disadvantages of ISO 13485:2016 as compared to ISO 13485:2003
  • Understand the goal, content and correlation between ISO 13485:2003 and ISO 13485:2016




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