INTERNAL AUDITS ACCORDING TO ISO 13485/MDR/ISO 19011 TRAINING – upon request

The Auditing Management Systems allow economic operators of medical devices to drive an activity across the entire audit workflow from planning to reporting. In this training, the background of the Auditing Management System including the principles of auditing, managing an audit program, conducting management system audits, and evaluation of competence of the individuals involved in the audit process will be introduced to you.
Within 8 hours, you will receive a comprehensive summary concerning the fundamentals of the Auditing Management and the potential advantages of adhering to the program. Furthermore, you will receive practical examples of how to write the audit report and of typical ISO 13485:2016 and Medical Device Regulation (MDR) nonconformities.

• Opening remarks
• Introduction
• Types of Audits
• Auditing Principles
• Managing and Audit Program
• Conducting an Audit
• Competence and Evaluation of Auditors
• Audit Sampling and Non-conformity identification
• Practical examples
• Q&A session
• Closing remarks

• Start 08:30 AM – End 05:30 PM. Attendees are recommended to login 15 min in advance.

In order to keep the training interactive, the exact content schedule cannot be provided.