ISO 19011:2018 - Applying Principles to Medical Device QMS Audits
This fast-paced instructor-led 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.
Learning Outcomes
By the end of this training, learners will be able to:
- Describe the purpose of:
- A quality management system
- Quality system standards
- Quality Management system audits
- Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011:2018
- Plan, conduct, report and follow up 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 or supplier auditing program.
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