Medical Laboratory Quality Management Programs

To assure the quality of test results, a medical laboratory needs to implement a sound quality management system. ISO 15189-2022 describes the quality management system (QMS) for medical laboratories.  Implementing effective, QMS not only guarantees patient safety but also ensures need of various users of laboratory services are met.

Of particular interest to organizations considering embarking on their accreditation journey, this course will equip the participants with deeper understanding of ISO 15189:2022 relating to the competence and quality of Medical Laboratories.

Participants will gain a practical understanding of the standard, including how this relates to their roles in a laboratory setting.

• Knowledge of QMS, document  and  record  control  with  information management;
• Establishing structural, organizational and personnel requirements including roles and responsibilities management;
• Understanding   of   management of   nonconformities, evaluation, and preventive/corrective activities to ensure the effectiveness of the QMS
• Practical skills on actions to address risks, opportunities and improvement
• Knowledge of maintenance of laboratory environment, equipment and, reagents;
• Knowledge of the key processes including pre-examination, examination, and post-examination processes

By the end of this course, participants will:

• Understand how ISO 15189 standard is used as a framework for business processes, management systems and conformance to quality requirements
• Understand the purpose, as well as the benefits of a quality management system
• Have insight into the key areas of management systems and how they impact patient safety
• Understand how to introduce quality culture in their organizations

This course is designed for any individuals responsible for, and involved in, the quality and/or technical support activities relating to biological sample examination and result generation activities within their organization.

This could include:

• Laboratory technical staff;
• Laboratory non-technical including administrators, biomedical engineers, and support staffs;
• Laboratory managers;
• Users of laboratory services (clinicians and other clinical personnel);
• Researchers;
• Laboratory auditors/assessors.

• Organization & Management Structure
•  Impartiality & Confidentiality
• Management Requirements
• Technical requirements