WHO laboratory strengthening tools

Laboratory quality management system handbook

This handbook is intended to provide a comprehensive reference for all stakeholders in health laboratory processes, from management to administration to bench-work laboratorians. It covers essential topics for quality management of a public health or clinical laboratory, based on both International Organization for Standardization (ISO) 15189 and Clinical and Laboratory Standards Institute (CLSI) GP26-A3 documents. It is also linked to the Laboratory quality management system training toolkit.

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Laboratory Quality Stepwise Implementation tool

This web-based tool provides a stepwise plan to guide medical laboratories towards implementing a quality management system in accordance with the requirements of ISO 15189. The Royal Tropical Institute (the Netherlands) developed the tool for WHO. Laboratory staff can use it to implement, step by step, a quality management system, either by working through phases and activities sequentially or by working on one essential subject area at a time. Checklists can be created for phases or for subject areas according to need.

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Developing national laboratory policies and strategies

Part of WHO’s global vision, according to the 2008 Maputo Declaration on Strengthening of Laboratory Systems, is for laboratory strengthening to be based on the implementation of national laboratory quality standards. Implementation of these standards requires trained staff, appropriate infrastructure, equipment, reagents and consumables. All these components should be provided and coordinated by the national authority, and informed and driven by national policies and strategies for health laboratory services.

In recognition of this, WHO/Europe developed a methodology to assist Member States in the development of their national laboratory policies and strategies.

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Laboratory assessment tool

This tool offers guidance to assess laboratories and national laboratory systems. Its target audience is any stakeholder performing laboratory assessments, such as national health authorities, multilateral agencies, nongovernmental organizations, laboratory managers, etc. The tool describes a general process for assessing laboratories and provides 2 questionnaires to help assess national laboratory systems (Annex 1) and individual laboratories (Annex 2). Assessors can use it as such, or customize the available materials to meet local requirements or specificities to better fit the assessment context.

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Laboratory biosafety manual

This manual provides practical guidance on biosafety techniques for use in laboratories at all levels. It covers risk assessment and safe use of recombinant DNA technology, and provides guidelines for the commissioning and certification of laboratories. It introduces laboratory biosecurity concepts and reflects the latest regulations for the transport of infectious substances. It also incorporates material on safety in health-care laboratories previously published by WHO.

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Guidance on regulations for the transport of infectious substances

This publication provides information for identifying, classifying, marking, labelling, packaging, documenting and refrigerating infectious substances for transportation, and ensuring their safe delivery. It provides practical guidance to facilitate compliance with applicable international regulations for the transport of infectious substances by all modes of transport, both nationally and internationally, and includes the changes that apply from 1 January 2015.

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