ISO 13485:2016 Clause by Clause

This two day course has been designed to provide an in depth understanding of ISO 13485:2016.

On completion of this training, participants will be able to apply their knowledge to the development of a ISO 13485:2016 compliant quality management system and help maintain ongoing certification of their organization.

Who should attend?

  • Regulatory, quality, research, design, development, and manufacturing personnel who will be involved in working with ISO 13485:2016 and need to have a greater understanding of the management system
  • Organizations preparing to put ISO 13485:2016 in place
  • Personnel who have joined an organization who have ISO 13485:2016 and require in depth knowledge
  • Delegates attending the Lead Auditor to ISO 13485:2016 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 ISO 13485:2016
  • Describe the requirements of ISO 13485:2016
  • Explain how to interpret the requirements of the standard within your organization
  • Develop your knowledge of how the requirements of ISO 13485:2016 are established and maintained in an organization
  • Identify the systems that are required to implement an ISO 13485:2016 QMS in order to gain or maintain certification to ISO 13485:2016

How will I benefit?

  • Describe the requirements and structure of ISO 13485:2016
  • Interpret and apply requirements relevant to your organization
  • Appreciate how a QMS can be applied as a framework to produce safer medical devices
  • Evaluate how requirements can be effectively implemented to meet and maintain regulatory compliance

What's included?

You will gain:

  • 14 CPD points on completing the course
  • Training course notes

Additional course options

  • Discover our ISO 13485 Qualifications - Our ISO 13485 auditor qualifications will give you a BSI Mark of Trust, reassuring your customers and suppliers that your skills have been validated. You can achieve Practitioner or Professional status by successfully completing courses, exams and demonstrating practical application. Find out more

  • In-house training - If you have a group of people to train an expert tutor can deliver training at your premises. Want to know more? 
    Request a quote for in-house training


Classroom-based training: Ready when you are

When you’re ready for face-to-face training again, we’re ready to welcome you.

As we all adjust to greater freedom around travel and meetings, we want to reassure you that our training team has worked with venues and tutors to enhance measures to keep you safe. Our carefully selected training venues continue to operate social distancing procedures, with readily available sanitizer stations at high-touch points throughout the venue. Rigorous deep cleaning procedures continue, providing you with peace of mind during your time at the venue.

If you have any questions regarding your booking of a classroom-based training course, please contact training@bsigroup.com or call +44 345 086 9000.