This training program will discuss changes from ISO 13485: 2003 to ISO 13485: 2016. Attendees will learn how to apply additional supplier controls and understand how improvement and corrective action clauses are strengthened.
In this webinar, learn about the changes made in the new version, the impact these changes will have on the industry, and the timeline for implementing the new requirements. After attending this overview, attendees will be one step closer to creating a comprehensive quality plan for your organization’s update.
Why Should You Attend:
With the much anticipated release of ISO 13485: 2016, medical device manufacturers are faced with another major regulatory change to their quality management systems. The revisions in this new version range from relatively minor to significant shifts in application.In this webinar, learn about the changes made in the new version, the impact these changes will have on the industry, and the timeline for implementing the new requirements. After attending this overview, attendees will be one step closer to creating a comprehensive quality plan for your organization’s update.
Learning Objectives:
- Gain an understanding of the new risk-based approach
- Get clarification on management review requirements
- Understand how to apply additional supplier controls
- Learn how improvement and corrective action clauses are strengthened
Areas Covered in the Webinar:
- Changes from ISO 13485: 2003 to ISO 13485: 2016
- Intent of the revised standard
- Transition period for implementing the changes
Who Will Benefit:
- Quality System Associates and Managers
- Regulatory Affairs Associates and Managers
- Supply Chain Professionals
Course Provider
Lena Cordie Bancroft,
