Quality and biosafety

Laboratory quality

Reliable and timely laboratory investigation results are fundamental to decision-making in almost all aspects of health services: approximately 60–70% of medical decisions are based on laboratory results (Kessel, 2014). The quality of laboratory services thus not only directly affects the quality of health care for individual patients – it is also crucial to a nation’s health security, to its effective allocation of resources and to its ability to meet obligations such as the International Health Regulations (2005).

Consequently, part of WHO’s 2008 global vision, according to the Maputo Declaration on Strengthening of Laboratory Systems, is to base laboratory strengthening on the implementation of national laboratory quality standards.

Implementation of these standards requires trained staff and appropriate infrastructure, equipment, reagents and consumables. WHO has therefore developed several tools and offers training courses to assess national laboratory systems and individual laboratories, and to train all levels of laboratory personnel in the use of quality management systems as a step towards obtaining international accreditation, such as ISO 15189.

WHO/Europe also assists in the training and implementation of quality systems through mentoring. Regular mentoring visits provide opportunities for hands-on training and development of plans, and allow laboratory staff to get answers to questions and assistance with implementing action plans for quality management and international accreditation.


A comprehensive quality management system ensures that laboratories comply with recognized standards as well as biosafety and biosecurity regulations. WHO has therefore also developed several tools and training courses in these areas, including:

  • a WHO laboratory biosafety manual;
  • a training for trainers in biorisk management;
  • an infectious substances shipping training; and
  • a video demonstrating safe practices in different laboratory settings.