ISO 13485:2016 Requirements On-demand course

Level Requirements Duration 4 hour

Available to book: Virtual classroom Book your place

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.

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

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
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.

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