Implementing ISO 13485 Training Course

Level Implementation Duration 2 days

Available to book: Virtual classroom Book your place

This two-days course has been designed to provide participants with the knowledge and process steps to enable them to effectively implement a quality management system in line with the requirements for ISO 13485:2003 certification. The course introduces the concepts needed to understand, develop, and implement a quality management system.

How will I benefit?

Understand how to implement a QMS as required by medical device directives
Plan the implementation of ISO13485:2016 within your organization
Take the first steps towards ISO 13485:2016 certification
Identify how you can better meet regulatory requirements
Find ways to increase efficiency and add value through quality management
Monitor supply chains to achieve continuous improvement.

Upon completion of this training, delegates will be able to:
- Describe the fundamentals of quality management systems
- Explain the purpose, structure and requirements of ISO 13485
- Apply a process of implementing a quality management system that meets the requirements of ISO 13485
- Prepare for ISO 13485 certification
Anyone involved in defining, planning, or implementing an ISO 13485:2016 based quality management system

Management representatives

Implementation team members
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

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