ISO 13485:2016 Implementation

Our Implementing ISO 13485:2016 two-day course has been designed to provide participants with the knowledge and process steps to enable them to effectively implement a quality management system in line with the requirements for ISO 13485:2016 certification.

The course introduces the concepts needed to understand, develop, and implement a quality management system.


Who should attend?

  • Anyone involved in defining, planning, or implementing an ISO 13485:2016 based quality management system
  • Management representatives
  • Implementation team members

This training course is HRDF approved under the SBL scheme

What will I learn?

On completion of this training, participants will be able to:

  • Describe the fundamentals of quality management systems
  • Explain the purpose, structure and requirements of ISO 13485:2016
  • Apply a process of implementing a quality management system that meets the requirements of ISO 13485:2016
  • Prepare for ISO 13485:2016 certification

How will I benefit?

  • Take the first steps towards ISO 13485:2016 certification
  • Understand how you can better meet customer and regulatory requirements
  • Find ways to increase efficiency and cost savings through quality management
  • Monitor supply chains to achieve continuous improvemen

What does the fee cover?

  • Training course notes
  • Lunch
  • Refreshments
  • Loan copy of the standard (to be returned after the course)
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