The objective of the ISO 13485:2016 internal auditor training course is to help you learn how to audit the processes of an ISO 13485:2016 Quality Management System (QMS). This course provides guidance and practical experience in planning, executing, reporting, and auditing follow-up of an internal audit while maintaining the effectiveness and conformity of an ISO 13485:2016 compliant QMS. In the course, we will cover the general principles of ISO 13485:2016 auditing and walk through all the clauses in this standard, to provide a holistic picture of how audits can be performed.
What You Will Learn?
The ISO 13485:2016 Internal Auditor Training will help you:
- • Know ISO 13485:2016 structure and scope, as well as how it pertains to organizations seeking regulatory compliance.
- • Recognize essential auditing principles and auditor responsibilities.
- • Plan for an internal audit.
- • Know about general concepts and principles of auditing.
- • Post-audit activities and CAPA planning.
What You Will Gain Through This Course?
- • Know the ISO 13485:2016 requirements and the quality system requirements of Directives 93/42/EEC and 98/79/EC.
- • Have a good understanding of how to conduct internal quality system audits.
- • Plan and prepare for an internal audit by understanding the function of internal audits in the maintenance and enhancement of management systems.
- • Collecting information through observation, questioning, and sampling.
- • Conduct a thorough audit based on identifying, sampling, and questioning processes.
- • Check to see if corrective action has been taken effectively.
Who Can Attend the ISO 13485:2016 Internal Auditor Training course?
- • Internal auditors
- • Consultants
- • Individuals interested in performing first-party or second-party audits
- • Management representatives
- • Medical device quality professionals with expertise in quality management systems and ISO 13485:2016
You should have an understanding of the Plan-Do-Check-Act cycle and the process used in the quality cycle management.