With greater attention on the organization’s ability to meet applicable customer and regulatory requirements, the new ISO 13485:2016 focuses on the entire supply chain of the medical device industry, with added emphasis on risk management.
Discover the latest requirements and explore the changes since ISO 13485:2003 and EN 13485:2012. You’ll refresh your auditing techniques and be able to identify the gaps in your current Quality Management System (QMS).
How will my company benefit?
This course will help you:
- Recognize the key changes between ISO 13485:2003/EN 13485:2012 and ISO 13485:2016 and identify how these may impact your organization
- Update your knowledge of audit principles, practices and terminology
- Refresh your skills to prepare for an ISO 13485:2016 audit
- Explore the relationship between ISO 9001:2015 High level structure and ISO13485:2016
- Make a smooth transition to ISO 13485:2016 and understand what resources may be required
- Participate in audit workshop scenarios to apply the skills you’ve learnt
Who should attend?
Anyone involved in planning, implementing, auditing or supervising an ISO 13485:2016 QMS transition.
What will I learn?
You will learn about:
- Key changes and auditing techniques
- How these changes may impact your current QMS
- Revised terms, definitions and audit principles
- Impact of changes from an auditing perspective
- Developing an internal audit schedule and plan
- Relationship between ISO 9001:2015 high level structure and ISO 13485:2016
- Transition timelines and what resources may be required.
What's included?
You will gain
- Course Notes
- Certificate of attendance
Discover the key changes between ISO 13485:2003/EN 13485:2012 and ISO 13485:2016 and refresh your auditing skills in line with the new standard.
