ISO 13485:2016 Requirements On-demand eLearning

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.  

eLearning - 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 organisations 
  • 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

What's included?

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


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.