ISO 13485:2016 Update Workshop.

• 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

• 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

• Some knowledge of the current ISO 13485:2003 (or EN ISO 13485:2012) requirements
• Some knowledge of ISO 9001:2008

Half day

This course can be delivered as an in-company event.