April 24, 2024
This fast-paced virtual instructor-led one-day course covers the basic concepts of planning, conducting and reporting a medical device quality management system (QMS) audit in accordance with ISO 19011:2018. It is a must for auditors at all levels of the organization, as well audit program managers.
This course covers how to apply fundamental auditing strategies to any QMS scheme, as well as how to identify and grade nonconformities and prepare a medical device audit report in accordance with the identified criteria. The course also focuses on applying these fundamental principles when auditing a medical device manufacturer’s quality management system.
This course pairs well as a prerequisite to CQI IRCA-certified QMS Lead Auditor based on ISO 13485 2016 and MDSAP Requirements, EU MDR Internal Auditor (2 day), EU IVDR Internal Auditor (2 day), and MDSAP Internal Auditor Training (2 day).
Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.
Who Should Attend
This class is helpful for all auditors and all management personnel with responsibility for medical device regulatory lifecycles, including involvement with the design and implementation of quality management systems or oversight of an internal or supplier auditing program.