ISO 13485:2016 Transition & Auditor Refresher
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).
Who should attend?
Anyone involved in planning, implementing, auditing or supervising an ISO 13485:2016 QMS transition.
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.
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.
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.
- Course Notes
- Certificate of attendance
- Loan copy of the standard (to be returned after the course)