This 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.
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
Please Note
- The course features interactive elements, knowledge checks, and comprehension tests. While we provide an estimated duration on the website, the actual completion time may vary based on your progress.
- You'll have access to this course lasting 90 days from activation, allowing you to revisit and review materials whenever and wherever it suits your schedule.
Who should attend?
Senior management, quality managers, regulatory affairs managers, internal and external auditors, consultants and anyone involved with the implementation of the standard.
What will I learn?
You will 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
What will I gain?
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
Prerequisites
There are no formal prerequisites, however it will be useful for delegates to read the standard before attending the course.
Enrollment and Access
- Once you've completed your registration and payment, you'll receive a system-generated activation email with password set up instructions.
- The course content can be accessed and reviewed multiple times within 90 days of receiving the activation email.
- For course-related questions or technical issues, please contact:
- Ms. Maggie Chiang: 02-26560333 ext. 139
- Ms. Winnie Tsai: 02-26560333 ext. 145
, or email us at Maggie.chiang@bsigroup.com / Winnie.tsai@bsigroup.com
- BSI reserves the right to make final interpretations of course-related policies.
- To learn more about our On-Demand Courses, please visit our website.
