Get an understanding of the concepts, key principles, and clauses of the ISO 13485:2016 standard and how the requirements impact the day-to-day operations of organizations in the medical device industry.

This two-day course has been designed to increase your knowledge on how to effectively implement a Quality Management System according to ISO 13485:2016 requirements. The course introduces key concepts to understand, develop and implement an effective QMS.

This intensive three-day course is intended for medical device quality professionals aiming to increase their knowledge on ISO 13485:2016 to increase effectiveness of their organization QMS for internal auditing purposes. Learn best practices to improve your QMS audit process compliance to ISO 13485:2016 and ISO 19011:2018.

The course focuses on key principles and practices for effective Quality Management System audits according to ISO 13485:2016 and ISO 19011:2018. Experienced instructors will guide you throughout the audit process, from its management to results reporting. Increase your knowledge and develop additional skills to plan, conduct, report and follow-up a compliant QMS audit.

Increase your understanding of ISO 13485:2016 and its relevance for medical devices manufacturers QMS implementation. The course explores ISO 13485:2016 requirements by discussing key principles and its interaction with ISO 9001:2015 and with European Regulations (MDR and IVDR).

Bring world-class quality standards to your business with our introduction to ISO 9001 quality management training course. 

Look for a more flexible way to learn? This course is also available on-demand