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
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 is included?
- This is an online, interactive eLearning course.
- You’ll have access to the course for 12 months.
On completion, you'll be awarded an internationally recognized BSI Training Academy certificate
Exam Registration
Click here to register for ISO 13485:2015 Introduction Exam only.