You need this course if...
- You are responsible for managing an ISO 13485:2003/EN ISO 13485:2012 based Quality Management System
- You own or manage Quality Management System processes in your organisation
- You are an Internal Auditor of an ISO 13485:2003 / 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 organisation.
You will learn...
- The principal changes introduced in ISO 13485:2016, together with the new and enhanced requirements, in order to recognise to what extent your Quality Management System requires adapting
- The differences between ISO 13485:2003/EN ISO 13485:2012 and ISO 13485:2016;
How long a transition period you have before the changes become mandatory.
You will need...
- To possess some knowledge of the current ISO 13485:2003/EN ISO 13485:2012 requirements
- To possess some knowledge of ISO 9001:2008.
Half day in-house only.