ISO 13485:2016 Introduction - International

Level Understanding Duration 1 day

Available to book: On-demand elearning View dates, locations and prices

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

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
Senior management, quality managers, regulatory affairs managers, internal and external auditors, consultants and anyone involved with the implementation of the standard.
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

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