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

Pre Requisite

You should have an understanding of the Plan-Do-Check-Act cycle and the process used in the quality cycle management.