You need this course if...
- You are responsible for managing an ISO 13485:2003 (or EN ISO 13485:2012) based Quality Management System
- You own or manage Quality Management System processes in your organization
- You are an Internal Auditor of an ISO 13485:2003 (or EN ISO 13485:2012) based Quality Management System
- You require an understanding of the extent and nature of the changes in this revision of ISO 13485:2016 in order to facilitate a smooth transition and raise awareness of the changes and the preparation needed within your organization
You will learn...
- The principal changes introduced in ISO 13485:2016, together with the new and enhanced requirements, in order to recognize to what extent your Quality Management System requires adapting
- The differences between ISO 13485:2003 (or EN ISO 13485:2012) and ISO 13485:2016
- How long a transition period you have before the changes become mandatory
You will need
- Some knowledge of the current ISO 13485:2003 (or EN ISO 13485:2012) requirements
- Some knowledge of ISO 9001:2008