ISO 13485:2016 Medical Devices Quality Management Implementation Training

Level Implementation Duration 2 days

Available to book: Public classroom 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.

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?

Full understanding of ISO 13485:2016 requirements.
Able to explain and interpret requirements, relevant to your organization
Learn how a quality management system provides a framework for safer medical devices.
Comprehensive training notes and 14 CPD points on completion

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 based quality management system
- Management representatives
- Implementation team members
- Training course notes for delegates
- Lunch & Refreshments
- On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate
- Loan copy of the standard (to be returned after the course)
If you have any enquiries, let us know how can we help you.
Call: +91 80815 80815
Email us: info.in@bsigroup.com

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