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 QMS and start planning your transition and certification to comply with ISO 13485:2016.
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 ISO 13485:2016
- Consider transition timelines and what resources may be required
What will I learn?
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 HLS and ISO 13485:2016
- Transition timelines and what resources may be required
Who should attend?
Anyone involved in planning, implementing, auditing or supervising an ISO 13485:2016 QMS transition.