Achieving, maintaining and improving accuracy, timeliness and reliability are major
challenges for health laboratories. Countries worldwide committed themselves
to build national capacities for the detection of, and response to, public health
events of international concern when they decided to engage in the International
Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency.
This handbook was developed through collaboration between the WHO Lyon
Office for National Epidemic Preparedness and Response, the United States
of America Centers for Disease Control and Prevention (CDC) Division of
Laboratory Systems, and the Clinical and Laboratory Standards Institute (CLSI).
It is based on training sessions and modules provided by the CDC and WHO in
more than 25 countries, and on guidelines for implementation of ISO 15189 in
diagnostic laboratories, developed by CLSI.
This handbook is intended to provide a comprehensive reference on Laboratory
Quality Management System for all stakeholders in health laboratory processes,
from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents. Each topic is discussed in a separate chapter. The chapters follow the framework developed by CLSI and are organized as the "12 Quality System Essentials".