Course description
Applying ISO 19011:2018 Principles to Medical Device Quality Management System Audits
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.
Upcoming start dates
Suitability - 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.
Outcome / Qualification etc.
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)
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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Expenses
General Registration $600.00