This course can be provided at request to groups of 6 to 12 participants and can be organized onsite anywhere in the world.

Every laboratory needs some degree of assistance from an external expert who has experience with ISO 15189 implementation to answer questions, be a sparring partner, proofread documents, provide training to the staff and perform audits.

Programme

This 5-day postgraduate course prepares participants to assist other medical and public health laboratories with the implementation of a quality management system in compliance with ISO 15189:2022 international standard for quality and competence in the medical laboratory.

This course includes the following elements:

• The concept of quality and introducing the principles of quality management in the health laboratory from a mentor’s perspective
• Technical mentoring skills
• Soft skills of a mentor
• Managing the change process in the laboratory you are mentoring
• Implementing the planning and management review cycle in the laboratory you are mentoring
• Implementing the internal audit system iin the laboratory you are mentoring
• Corrective Actions and Preventive Actions: implementing the CAPA* system

*CAPA: Corrective Actions and Preventive Actions

Learning objectives

This course will provide the necessary knowledge, attitude and skills needed to assist health laboratories with the implementation of an

ISO 15189:2022 based quality management system and adequately manage laboratory improvement processes.

After this course participants will be able to:

• Explain the role of a mentor
• Guide a laboratory with implementation of the ISO 15189 quality management system
• Consciously use technical and soft skills to adequately support a laboratory
• Recognize the different phases of a change process in a laboratory that implements a quality management system and tactically manage this process
• Assist laboratories with establishment of the continuous improvement cycle through proper planning and review activities
• Assist laboratories with establishment of the internal audit system
• Assist laboratories with establishment of the CAPA* system required by ISO 15189

*CAPA: Corrective Actions and Preventive Actions

At the end of the course participants will receive a certificate of attendance.

Who should participate?

Experienced quality officers and laboratory managers from a (nearly) ISO 15189 accredited laboratories that wish or have to assist other laboratories with the implementation of a quality management system.

Prequalification

• This course is designed for quality officers and laboratory managers from (nearly) ISO 15189 accredited laboratories. Experience in working with the ISO 15189 quality management system is required.
• Participants have preferably attended the Introduction to Laboratory Quality Management course.
• The course language is English. English speaking and writing ability is required.

Length of the course

The course has a duration of 5 days with face-to-face sessions plus evening homework, and an initial assignment to be completed in advance of the course. This amounts to a total workload of 48 hours.

Course fee

Request an offer.

The course fee includes:

• Course participation
• Binder with handouts
• USB/Flash drive with training materials

The training will be facilitated by two trainers with extensive experience in mentoring laboratories with the implementation of an ISO 15189 based quality management systems in medical/public health laboratories worldwide.