COURSE OVERVIEW:

ISO 15189 is the international standard that specifies requirements for quality and competence in medical laboratories. This internal auditor course is designed to provide laboratory professionals with the necessary skills to evaluate the technical competence and management systems of clinical testing facilities. Participants will learn how to move beyond simple checklists to perform deep-dive audits that ensure patient safety and the reliability of diagnostic results.

The scope of this training covers both the management requirements and the technical requirements of the standard. Attendees will explore the nuances of auditing pre-analytical, analytical, and post-analytical phases of laboratory testing. The curriculum emphasizes the importance of measurement uncertainty, traceability, and the validation of examination procedures. By mastering these auditing techniques, participants will help their laboratories maintain accreditation and provide clinicians with highly accurate data for patient care.

Coverage includes the audit of laboratory personnel competence, equipment calibration, and the management of reagents and consumables. The course addresses the unique risks associated with medical laboratories, such as biological hazards and patient confidentiality. Participants will practice writing technical non-conformity reports and evaluating the effectiveness of corrective actions in a clinical setting. The training ensures that internal audits become a proactive tool for identifying risks to result integrity and driving laboratory excellence.

COURSE OBJECTIVES:

After completion of this course, the participants will be able to:

• Interpret the requirements of ISO 15189 for medical laboratories.
• Plan and schedule internal audits based on laboratory risk and importance.
• Evaluate the technical competence of laboratory personnel and trainers.
• Audit the pre-analytical phase: Sample collection, transport, and receipt.
• Verify the validation and verification of examination procedures.
• Audit the analytical phase: Quality control and equipment performance.
• Assess the post-analytical phase: Reporting and clinical interpretation.
• Evaluate the laboratory's process for determining measurement uncertainty.
• Audit the management of reagents, consumables, and external services.
• Identify technical and management non-conformities during an audit.
• Facilitate root cause analysis for laboratory-specific errors.
• Monitor the effectiveness of laboratory improvement initiatives.

TARGET AUDIENCE:

Laboratory Managers, Quality Coordinators, Pathologists, Medical Technologists, Biomedical Scientists, and Laboratory Accreditation Consultants.

TRAINING COURSE METHODOLOGY:

A highly interactive combination of lectures, discussion sessions, and case studies will be employed to maximize the transfer of information, knowledge, and experience. The course will be intensive, practical, and highly interactive. The sessions will start by raising the most relevant questions and motivating everybody to find the right answers. The attendants will also be encouraged to raise more of their questions and to share in developing the right answers using their analysis and experience. There will also be some indoor experiential activities to enhance the learning experience. Course material will be provided in PowerPoint, with necessary animations, learning videos, and general discussions.

The course participants shall be evaluated before, during, and at the end of the course.

COURSE CERTIFICATE:

National Consultant Centre for Training LLC (NCC) will issue an Attendance Certificate to all participants completing a minimum of 80% of the total attendance time requirement.