ISO 13485 Transition Training Course (from ISO 13485:2003 to ISO 13485:2016)

Level Specialist Duration 4 hours

Available to book: Public classroom HK$1500 Book Now

This course is now available online

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.

Our high impact accelerated learning approach increases learning by improving knowledge retention and skill application. This course is activity-based, resulting in a deeper understanding of the material and a greater impact on job performance.

How will I benefit?

This course will help you:

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 8 CPD hours
- Training course notes
- Lunch
- Refreshments
- An internationally recognized BSI Training Academy certificate

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.

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