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.
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
For information on the process after applying for on-demand training, how to take the training, etc., please refer to Accessing BSI E-learning Courses.
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
To benefit from the expertise of a tutor, and interaction with other delegates, choose the virtual online or classroom version of this course (in Japanese).
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
- This is an online, eLearning course.
- You’ll have access to the course for 30 days.
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
Course Duration Hours
- 4 Hours
We will send you an invoice (PDF) by e-mail within 5 business days after your application. Please make payment by bank transfer by the due date as indicated on the invoice.
We will send you a paid invoice (PDF) by e-mail approximately 5 business days after your application. Discounts other than promotional codes are not eligible for card payment.
In the event of cancellation after registration, a cancellation fee of 100% of the full amount of the course fee will be charged.