Implementing ISO 13485:2016 Training Course

Level Implementation Duration 2 days

Available to book: Instructor led training £1495 + VAT View dates and book now

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Regular list price £1,885+VAT. Book now and save £390. Terms and conditions apply.

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 you 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
Gain a recognized certificate and 16 CPD points

On completion of this training, participants will be able to:
- Define a ISO 13485:2016 QMS
- 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 based quality management system
- Management representatives
- Implementation team members
We are:
- A full scope Notified Body
- A full scope UK Approved Body
- A national Standards Body
- An accredited ISO 13485 Certification Body
- A recognized Auditing Organization under the Medical Device Single Audit Program
- A globally recognized Certification Body
- You will gain 16 CPD points on completing the course
- Certificate
- Training course notes

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