Course Details

Fundamentals of ISO 13485: 2016

Course Area

Medical Devices


Available for 365 days after enrollment

Approximate Course Run Time

3 hours

Continuing Education Units


Course Fee

CAD $300.00

E-learning content is available on demand


Course Details

This training course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with ISO 9001:2015 and also it serves to facilitate global alignment for Medical Device quality management systems.  

E-Learning - training that’s even more flexible

If you need to understand the requirements of this ISO 13485:2016 quality management system standard and are confident enough not to need tutor-led training, this online, self-paced course offers you complete flexibility.

You can study in your own time when it suits you, and you can access the course from any internet-enabled device 24/7. You will be able to access the training for 12 months.

Who should attend?

Senior management, quality managers, regulatory affairs managers, internal and external auditors, consultants and anyone involved with the implementation of the standard.

There are no formal prerequisites, however it will be useful for delegates to read the standard before attending the course

What will I learn?

You'll learn about:

  • Gain an appreciation for the origins of ISO13485
  • Understand the use of ISO13485 as the basis for a Quality Management System for Medical Device organizations 
  • Awareness of the key differences to the ISO9001:2015 standard
  • Appreciate the process approach concept of the standard and the Plan-Do-Check-Act (PDCA) framework
  • Knowledge of the overall structure of ISO 13485:2016 
  • Recognize the key clauses of the ISO 13485:2016 standard

How will I benefit?

This course will help you:

  • Take the first steps towards ISO 13485:2016 certification
  • Understand how you can better meet regulatory requirements leading to increased patient safety
  • Find ways to increase efficiency and cost savings through quality management
  • Monitor supply chains to achieve continuous improvement
  • Develop safe and effective medical devices
  • Motivate employees through CPD


3-4 hours

What will I gain?

On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate. 

Further information

This eLearning course is ideal if you cannot attend one of our tutor-led classroom or virtual training courses. To benefit from the expertise of a tutor, and interaction with other delegates, choose the virtual online or classroom version of this course.

Related training

You may also be interested in attending our ISO 13485:2016 Clause by Clause, Implementation, Internal Auditor and Lead Auditor courses.

Live Online Classes

Certified, convenient, and interactive, with no travel costs.

Private Class

Interested in a private or customized version of this course? Request a quote.


For questions regarding any of our courses, contact us or call 1.800.862.6752.


For questions regarding any of our courses, contact us or call 800.217.1390 (USA) 800.862.6752 (Canada)

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