Quality Management systems (QMS) in the medical device world is critically important to the safety of patients around the world. BSI has developed a short session that makes you aware of what ISO 13485 is, why it is important and how your organization can use it to help maintain patient safety. It also considers how you are a vital piece of the jigsaw and what you can do to help your organization.

On-demand - training that’s even more flexible BSI’s

on-demand courses are market-leading and available 24/7. Developed by top subject matter experts, they contain the same high-quality content you will find in our tutor-led training, but with the added benefit of being able to learn at your own pace and at any time

Course aim

This course will help you understand what ISO 13485 is, why it’s important and how you can contribute to helping maintain patient safety in your organization.

How will I benefit?

This course will help you: 

• Understand what an ISO 13485 quality management system is
• Appreciate why ISO 13485 is important to your organization
• Recognize the importance of ISO 13485 and patient safety
• Identify how your activities play a role in ensuring safe medical devices

What will I learn?

Upon completion of this course, you will be able to:

• Understand why ISO 13485 quality management systems are important 
• Appreciate how your role is relevant to the ISO13485 QMS 
• Recognize the benefits of an ISO13485 QMS for your organisation 
• Describe why ISO 13485 is important in helping ensure patient safet

Who should attend?

All staff especially those who are within scope of an ISO 13485 management system

Modules

• ISO 13485 Quality Management Systems - Requirements for Regulatory Purposes Awareness On-demand Training Course