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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 how it serves to facilitate global alignment for Medical Device quality management systems.
From consultants to senior managers, this course is suitable for anyone who needs to implement the standard. You’ll learn to use ISO 13485:2016 as the basis for regulatory requirements worldwide and recognize the key clauses.
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.
This course will help you:
You'll learn about:
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
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
Explore our BSI Academy knowledge bundles, giving you great savings across multiple courses and an opportunity to maximize your training budget.
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