Length of training: 3 days

Price: 10 000,- CZK

The ISO 15189:2022 Quality Manager Training is designed for staff in the position of quality manager of a medical laboratory according to the requirements of ISO 15189:2022 Medical Laboratories - Quality and Competence Requirements. The course is designed for beginners as well as for quality managers familiar with the requirements of a quality management system.

The basis is a discussion of the individual requirements of ISO 15189:2022 Healthcare Laboratories - Quality and Competence Requirements and ISO 19011:2018 Guidelines for auditing management systems and their interrelationship to the operation of a healthcare laboratory.

The content of the course covers basic and advanced knowledge and skills of the quality manager, his/her responsibilities and duties, supplemented by practical training, including possible variants of documentation. An important contribution of the training is the practical experience of the lecturers, highlighting the most common mistakes and ways of finding opportunities for improvement..

Training programme:

Day 1

• Quality management systems - basic principle
• Terminology in the field of quality management system
• Requirements of ISO 15189:2022 - Part 1

Day 2

• Requirements of ISO 15189:2022 - Part 2
• Methods of implementing the requirements of the standard
• Accreditation process

Day 3

• 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

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