Introduction

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This tool helps national tuberculosis laboratories to implement an ISO 15189 quality management system, which can lead to accreditation.

Why was this tool developed?

Until recently, laboratory services were amongst the weakest components of tuberculosis (TB) treatment and control efforts in high-burden, resource-limited countries. Strengthening laboratory services and systems is essential for universal access to TB laboratory diagnostic services. A first step is to strengthen national laboratories by implementing a quality management system. This will enable them to better support the rest of the national laboratory network. Read more.

Who can use this tool?

National TB laboratories, primarily in low- and middle income countries. The tool is currently used by laboratories in Sub-Saharan Africa, South America, and Central Asia.

How does this tool work?

This tool is a stepwise implementation plan for implementing a quality management system. Each step consists of an activity (one sentence stating what should be done), a description with an explanation on why, what, how, and by whom an activity must be completed, and links to additional support material.

How is this tool organized?

This tool contains two frameworks:

  1. A roadmap with all steps in an ideal order for day-to-day implementation
  2. A framework providing all steps per Quality System Essential (QSE), showing what should be done on each aspect of the laboratory

In the directives section a more detailed explanation can be found of how this tool works.

Who developed this tool?

This tool was developed by the Royal Tropical Institute (Netherlands), Global Laboratory Initiative (Switzerland), Centers for Disease Control and Prevention (U.S.A.), the International Union against Tuberculosis and Lung Disease and the KNCV Tuberculosis Foundation (Netherlands) for the TB CARE I project of USAID.

Email the developers of this tool for more information.