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ISO 13485:2016 Update Workshop.

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You need this course if...

  • You are responsible for managing an ISO 13485:2003 (or EN ISO 13485:2012) based Quality Management System
  • You own or manage Quality Management System processes in your organization
  • You are an Internal Auditor of an ISO 13485:2003 (or EN ISO 13485:2012) based Quality Management System
  • You require an understanding of the extent and nature of the changes in this revision of ISO 13485:2016 in order to facilitate a smooth transition and raise awareness of the changes and the preparation needed within your organization

You will learn...

  • The principal changes introduced in ISO 13485:2016, together with the new and enhanced requirements, in order to recognize to what extent your Quality Management System requires adapting
  • The differences between ISO 13485:2003 (or EN ISO 13485:2012) and ISO 13485:2016
  • How long a transition period you have before the changes become mandatory

You will need

  • Some knowledge of the current ISO 13485:2003 (or EN ISO 13485:2012) requirements
  • Some knowledge of ISO 9001:2008

Course length

Half day

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