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 and the European MDR/IVDR. The relationship with ISO 14971 ‘Application of Risk Management to Medical Devices’ is also explored during the course.
Gain a better insight into the use of ISO 13485:2016 as the basis for a Quality Management System (QMS) implemented by medical device organizations.
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?
On completion, you will be able to:
- Explain the use of ISO 13485:2016, as the basis for a quality management system for medical device organizations
- Define the overall structure of ISO 13485:2016
- Apply the process approach concept of the standard
- Recognize the key clauses of the ISO 13485:2016 standard
What is included?
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
