ISO 13485:2016 Transition Training

Duration 3 days

Available to book: In-house Request a quote

Are you already familiar with ISO 13485:2003/EN 13485:2012 and want to find out about ISO 13485:2016? This comprehensive course introduces you to the new requirements and explores the changes between ISO 13485:2003/EN 13485:2012 and the latest standard.

With greater attention on the organization’s ability to meet applicable customer and regulatory requirements, ISO 13485:2016 focuses on the entire supply chain of the medical device industry, with added emphasis on risk management.

By attending, you’ll be able to identify the gaps in your current Quality Management System (QMS) and start planning your transition and certification to comply with ISO 13485:2016.

How will my company benefit?

Recognize the key changes between ISO 13485:2003/EN 13485:2012
Understand how these changes may impact your current QMS
Explore the relationship between ISO 9001:2015 High level structure and ISO13485:2016
Consider transition timelines and what resources may be required.

You will learn about:
- Key changes between ISO 13485:2003/EN 13485:2012 and ISO 13485:2016
- Revised terms and definitions
- Relationship between ISO 9001:2015 high level structure and ISO 13485:2016
- Transition timelines and what resources may be required.
Anyone involved in planning, implementing, auditing or supervising an ISO 13485:2016 QMS transition.
- You will gain 3 CPD points on completing the course
- Course Notes
- Certificate of attendance
Download the ISO 13485:2016 Transition course guide (PDF)

Let's shape your organization's future together

Reach out and see how we can help guide you on your path to sustainable operational success.

Get in touch