Length of training: 16 hrs.

Price: 7 000,- CZK

The course is designed for internal auditors and quality managers in a medical laboratory who have experience in auditing and maintaining a management system, or who need training in changes from the original version of the ISO standard.

The basis of the training is an interpretation of the requirements of ISO 15189:2022 Medical Laboratories - Quality and Competence Requirements from the perspective of the internal auditor and highlighting critical points in the implementation of internal audits. A significant benefit of the training is the practical experience of the trainers, highlighting the most common mistakes in auditing and how to look for opportunities for improvement that give added value to internal audits. The training also includes a reiteration of the requirements of ISO 19011:2018 Guidelines for auditing management systems and their interrelationship to the organization's operations.

The course includes training on preparing and conducting 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 15189:2022 - Part 1

Day 2

• Requirements of ISO 15189:2022 - Part 2
• Requirements of Methodological Guideline for Accreditation No. MPA 10-02-xx
• 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.