ISO 13485:2016 Implementation

Level Implementation Duration 2 days

Available to book: Virtual classroom View dates and book now

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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.

On completing the course you’ll gain a certificate and 16 CPD points. The training helps you to generate your own comprehensive course notes and will leave you with a thorough understanding of how to implement the ISO 13485:2016 standard.

How will I benefit?

This course will help you:

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, you should gain the knowledge and skills to:
- Define a quality management system
- Identify the steps for defining, planning, organizing and scheduling necessary activities
- Implement an effective quality management system
- Conduct a base line review of an organization's current position with regard to ISO 13485:2016
Anyone involved in defining, planning, or implementing an ISO 13485:2016 QMS, as well as management representatives and implementation team members.
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 Introduction course.
This training course is HRD Corp claimable programme.
On completion, you will be awarded an internationally recognized BSI Training Academy certificate.

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