ISO 13485:2016 Implementation

Level Implementation Duration 2 days

Available to book: Virtual classroom $1895 View dates and book now

This two-day course gives you the knowledge and steps to implement a quality management system (QMS) in line with ISO 13485:2016. It’s suitable for managers or members of an implementation team.

Choose to take this stage of your learning journey in-person or live online in a classroom environment. You’ll learn how to plan, organize and schedule everything needed to define an ISO 13485: 2016 QMS, as well as how to implement it. You’ll also carry out a baseline review, specific to your own organization.

How will I benefit?

Understand and plan ISO 13485:2016 implementation
Find ways to increase efficiency, add value and monitor supply chains effectively
Take the first steps towards ISO 13485:2016 certification

On completion of this training, participants will be able to:
- Describe the fundamentals of quality management systems
- Explain the purpose, structure and requirements of ISO 13485:2016
- Apply a process of implementing a quality management system that meets the requirements of ISO 13485:2016
- Prepare for ISO 13485:2016 certification
- Anyone involved in defining, planning, or implementing an ISO 13485:2016 based quality management system
- Management representatives
- Implementation team members
- Gain 16 CPD points on completion and comprehensive training notes
- A thorough understanding of how to implement the ISO 13485:2016 standard.
You should have a good knowledge of ISO I3485:2016 and the key principles of a QMS. If not, we strongly recommend you attend our ISO 13485:2016 Clause by Clause course.

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