ISO 13485:2016 Implementation

Medical Devices Monitor ImageISO 13485:2016 Implementation
Two Days

You need this course if ...

  • You want to know how to design and implement an effective QMS based on ISO 13485:2016
  • You are preparing for ISO 13485 certification
  • You want to improve the effectiveness of your current system

You will learn …

  • How to implement a QMS based on ISO 13485:2016
  • How to develop a quality policy and objectives
  • The need for documenting systems, processes and typical methods
  • Key features of risk assessment as defined in ISO 13485
  • The importance and relevance of legislation
  • The design requirements in ISO 13485
  • The significance of process and environmental controls (e.g. clean rooms, sterilisation, personnel controls)
  • To plan and manage your internal quality auditing activities
  • How to eliminate the causes of problems through effective corrective action
  • To develop an appropriate management review process and implement processes for improving the effectiveness of the system

You will need …

Your future development

Course length

  • Two days

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Course Dates & Booking


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