ISO 13485 Clause by Clause

This two day course has been designed to provide an in depth understanding of ISO 13485.

On completion of this training, participants will be able to apply their knowledge to the development of a ISO 13485 compliant quality management system and help maintain on going certification of their organization.


Who should attend?

  • Regulatory, quality, research, design, development, and manufacturing personnel who will be involved in working with ISO 13485 and need to have a greater understanding of the management system.
  • Organizations preparing to put ISO 13485 in place
  • Personnel who have joined an organization who have ISO 13485 and require in depth knowledge
  • Delegates attending the Lead Auditor to ISO 13485 course who do not already have a good knowledge of the standard

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What will I learn?

  • Explain the scope and the structure of the ISO 13485
  • Describe the requirements of ISO 13485
  • Explain how to understand and interpret and apply the requirements of the standard within an organization
  • Develop an understanding of how the requirements of ISO 13485 are established in an organization and maintained
  • Consider the systems that are required to implement an ISO 13485 quality management system 
  • Discuss how to ensure that the requirements of the system are effectively implemented to allow the organizations quality system to be certified and/or maintain certification

How will I benefit?

  • Understand how to apply the requirements of the ISO 13485 within your organization
  • Gain an in depth understanding of the requirements of ISO 13485
  • Learn how to ensure the maintenance of the ISO 13485 quality management system within your organization
  • Be confident supporting the maintenance of regulatory requirements within the organization
  • Help to maintain ISO 13485 certification
  • Get the confidence to develop a ISO 13485 compliant quality management system

What's included?

You will gain:

  • 14 CPD points on completing the course
  • Training course notes
  • Lunch
  • Refreshments.