ISO 13485:2016 Update Workshop

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  ISO 13485 Update Workshop

  0.5 Day


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 a day

Dates and Venues