Applying ISO 19011:2018 Principles to Medical Device Quality Management System Audits
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About This Course
Students will learn the basic concepts of planning, conducting and report writing for a medical device QMS audit in accordance with ISO 19011:2018. This fast-paced one-day course is a must for auditors at all levels of the organization. You will learn 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 will focus on applying these fundamental principles when auditing medical devices’ quality management systems.
Key Learning Objectives
By the end of this training, you will be able to:
- Describe the purpose of a quality management system, quality system standards and quality management system audits
- Explain the role of an auditor in planning, conducting, reporting and following up on a quality management system audit in accordance with ISO 19011:2018
- Plan, conduct, report and follow up on an audit of a quality management system to establish conformity (or otherwise) with audit criteria (e.g., ISO 13485:2016)
Who Should Attend
This ISO 19011:2018 audit training is helpful for all auditors and all management personnel with responsibility for medical device regulatory life cycles, including involvement with the design and implementation of quality management systems or oversight of an internal auditing program.
Robert Ruff - Rob has over 30 years’ experience in the medical device and public health sectors, including completing a long, distinguished career with the U.S. FDA. His extensive regulatory experience includes co-authoring the MDSAP Audit Model and the Quality System Inspection Technique (QSIT). He also developed the FDA’s computer-based training for QSIT, the Quality System Regulation and the Medical Device Reporting Regulation.