Applying ISO 19011:2018 Principles to Medical Device Quality Management System Audits
March 17, 2022
This training course is 8 hours. Students will learn the basic concepts of planning, conducting, and report writing for a QMS audit in accordance with ISO 19011:2018.This fast-paced 1-day course is a must for auditors at all levels of the organization. During the course, students will learn how to apply fundamental auditing strategies essential for auditing to any QMS scheme.They will also learn to identify and grade nonconformities and prepare an audit report in accordance the identified criteria.The course will focus on applying these fundamental auditing principles when auditing to medical devices quality management systems.
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 auditing program.