As a leader, your commitment and support is crucial to the success of your organization's ISO 13485:2016 Medical Devices Quality Management System (QMS). This interactive briefing has been designed around the requirements of the standard and highlights your responsibilities in terms of leadership and commitment.
The focus is on helping senior management migrate their system from ISO 13485:2003 to ISO 13485:2016. You will gain a better understanding of your organization's obligations and develop action plans for managing the transition.
How will I benefit?
This course will help you:
- Demonstrate your organization's commitment to medical devices quality
- Ensure quality objectives are established at all levels and functions
- Allocate resources for the implementation or development of your ISO 13485:2016 QMS
- Participate in improvement projects and show support by leading by example
- Communicate the importance of meeting customer and regulatory requirements
What will I learn about?
You will learn about:
- ISO 13485:2016
- ISO 9001:2015 and HLS
- ISO 13485 QMS and top management
- Overview of key changes
- Transition process and timings
- Developing a plan
Who should attend?
Senior managers of organizations implementing or running an ISO 13485:2016 QMS.