Preparing for ISO 13485:2016

Medical Devices Monitor ImagePreparing for ISO 13485:2016
One Day

You need this course if ...

  • You want to learn about the latest ISO 13485 standard and have responsibility for managing the transition to your quality management system

You will learn …

  • The structure of ISO 13485:2016 and how it interrelates with the Plan Do Check Act cycle
  • The differences between EN ISO 13485:2012 and ISO 13485:2016
  • How the principal changes defined in the new standard may be accommodated by an organization that already has ISO 13485 certification and the transition timelines that apply
  • The role of the Medical Devices Single Audit Program (MDSAP)
  • The interrelationships between ISO 13485:2016 and the associated European Directives / Regulations
  • How ISO 13485:2016 aligns with the quality management system requirements defined in ISO 9001:2015, which is based on Annex SL
  • The significance of the new and enhanced requirements in ISO 13485:2016 in terms of your own organization’s QMS and initiate preparations for a smooth transition

You will need …

  • Ideally you will have an appreciation of ISO 13485:2003 and / or EN ISO 13485:2012

Your future development

Course length

  • 1 day

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