Length of training: 16 hrs.

Price: 6 300,- CZK

The course is intended for internal auditors or quality managers who are beginners in auditing according to ISO 13485.

It is based on an interpretation of the requirements of ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes from the perspective of an internal auditor. The actual auditing procedure also includes the requirements of ISO 19011:2018 Guidelines for auditing management systems and their interdependence with the organization's operations.

The course includes training in the preparation and implementation of an internal audit, including conducting audit communications and preparing an audit report.

The aim is to inform the participants about the principles and principles of auditing and to share the experience of auditing practice.

Training programme:

Day 1

• Quality management systems - a basic overview for the auditor
• Requirements of ISO 13485:2016 - Part 1

Day 2

• Requirements of ISO 13485:2016 - Part 2
• Requirements ISO 19011:2018 Guidelines for auditing management systems
• Audit terminology
• Setting up an audit programme
• Step-by-step audit process
• Practical audit training
• Managing audit non-conformities, corrective and preventive actions
• Audit records - audit report and non-conformity record
• Auditor evaluation

The training ends with a final test.

Upon completion of the course, the participant will receive a Certificate of Completion.