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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/EN ISO 13485:2012 based Quality Management System
  • You own or manage Quality Management System processes in your organisation
  • You are an Internal Auditor of an ISO 13485:2003 / 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 organisation.

You will learn...

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

You will need...

  • To possess some knowledge of the current ISO 13485:2003/EN ISO 13485:2012 requirements
  • To possess some knowledge of ISO 9001:2008.

Course length

Half day in-house only.

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