The objective of the ISO 13485 internal auditor training course is to help you learn how to audit the processes of an ISO 13485 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 compliant QMS. In the course, we will cover the general principles of ISO 13485 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 Internal Auditor Training will help you:
- • Know ISO 13485 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 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 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
You should have an understanding of the Plan-Do-Check-Act cycle and the process used in the quality cycle management.