1 Day, 6.5 Instructional Hours
6.5 Engineering Professional Development Hours (PDHs)
Learn what you need to know to transition to the new ISO 13485:2016 Quality Management System (QMS) standard in this one-day overview.
Prerequisites: Understanding of ISO 13485:2003 is required.
This course will provide participants an understanding of the key changes and how they will impact their organization. Our experienced instructor will discuss the new requirements, facilitate hands-on exercises, and provide guidance on how to transition to ISO 13485:2016. Upon completion of this course, you will be able to:
- Explain the reason for the changes to ISO 13485:2016
- Explain the requirements, and purpose of ISO 13485:2016
- Identify and understand the key changes between ISO 13485:2003 and ISO 13485:2016
- Explain how regulatory requirements have been imbedded into ISO 13485:2016
- Identify the gaps between ISO 13485:2016 and your current QMS
- Assess the overall impact the new requirements will have on your current quality management system
- Contribute to the development of a transition plan to ISO 13485:2016
- Determine key strategies and actions to ensure an effective transition
- Understand the transition timeline
Each participant will receive a training manual and a copy of the ISO 13485:2016 standard.
Who Should Attend:
Participants finding this course beneficial include those in organizations that are currently certified to ISO 13485:2003 and looking to transition to ISO 13485:2016. In addition, this course would be essential to:
- Senior management responsible for the effectiveness of the QMS
- Employees assisting organizations with their transition to ISO 13485:2016
- Management representatives, operations managers, process owners, and consultants responsible for ensuring the requirements are met