ISO 13485:2016 Transition Training

This course covers changes from ISO 13485:2003 to the ISO 13485:2016 standard and their impact on a company’s Quality Management System (QMS). Topics include the Annex SL framework, methods for meeting and auditing new requirements, and the business approach on how to use your ISO 13485-based QMS to benefit company performance.

TCIE’s business-centric approach prepares participants to not only assist their companies in becoming ISO compliant, but in driving efficiencies, error reduction and increased profitability through proper use and management of the ISO system. 

Hours: 16

Learning Outcomes

  • Identify and assess gaps in a company’s current QMS
  • Be prepared to plan the transition to the ISO 13485:2016 revision

Intended Audience

Individuals who are already familiar with the ISO 13485:2003 Standard for the medical device industry and are involved in transitioning their company to ISO 13485:2016, including planning, implementation and supervisory activities. It is also ideal for auditors who will audit to the new standard.


Substantial knowledge of ISO 13485:2003 and key principles of a QMS