ISO 13485:2016 Senior Management Briefing

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.


Who should attend?

Senior managers of organizations implementing or running an ISO 13485:2016 QMS.

Learn about your role in the transition to ISO 13485:2016

What will I learn?

You will learn about:

  • ISO 13485:2016
  • ISO 13485 Quality Management System and top management
  • Overview of key changes
  • Transition process and timings
  • Developing a plan for transition

How will my company benefit?

  • 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's included?

  • Course Notes
  • Certificate of attendance