Laboratory quality management

Ensuring accuracy, timeliness and reliability of test results are major challenges for health laboratories. The International Health Regulations (IHR 2005) encourages Member States to build functional laboratory quality management systems into their national laboratory system for the most reliable detection of potential outbreaks and emergencies of international concern. WHO helps Member States to strengthen laboratory quality management through the development of training materials, guidance documents and practical tools with which laboratories can assess their quality system and take necessary steps to improve and sustain this capacity.

WHO also conducts activities which assess the functionality of laboratory quality management systems. These include supporting simulation exercises (SimEx) and the distribution of External Quality Assessment programmes (EQA)and Proficiency Testing (PT) for specific pathogens, such as arboviruses, viral hemorrhagic fevers (VHF) and for general microbiology including antimicrobial resistant organisms (AMR).

Our work

Safeguarding biosafety and biosecurity in laboratories

Safeguarding biosafety and biosecurity in laboratories

© WHO/Ploy Phutpheng - 2020
In biosafety level II laboratory setting, a medical scientist is working on RT-PCR method for the testing of the novel coronavirus at Department of Medical Sciences.
© Credits

Overview

Member States to develop capacities to identify, store and securely handle dangerous biological agents and toxins according to international best practices. 

Although biosafety & biosecurity awareness and expertise has improved greatly in the past few decades through the availability more effective safety equipment and automated diagnostic technologies it remains one of the weakest core capacities of Member States identified by IHR monitoring and evaluation activities. 

WHO helps Member States build their national biosafety and biosecurity capacity through guidance documents, tools, technical assistance, and resource mobilization. This includes supporting trainings on biological risk management; sharing best practices through workshops and meetings; providing regulatory frameworks; and ensuring biological agents are transported safely.  

During disease outbreaks countries also need to have the capacity and expertise to safely transport infectious substances between national, regional or international laboratories as outlined in the International Health Regulations. WHO has developed guidance and training resources on the transport of infectious substances to help shippers and other personnel comply with the United Nations Model Regulations for the transport of infectious substances.

Publications

Laboratory quality management system: handbook

This Laboratory quality management system handbook is intended to provide a comprehensive reference on Laboratory quality management system for all stakeholders...

Policy and procedures of the WHO/NICD microbiology external quality assessment programme in Africa: years 1 to 4, 2002-2006

The WHO/NICD microbiology External Quality Assessment (EQA) programme was established as a result of the Integrated Disease Surveillance and Response (IDSR) strategy;...