Laboratory Quality Standards and their Implementation
(2011; 74 pages)


The objective of this document on Laboratory Quality Standards is for it to be used as a guideline for evaluation, development and implementation of quality systems and standards for health laboratory services. The internationally accepted standards of the International Standards Organization (ISO) 15189 and ISO 17025 have stringent requirements and can usually be met only by laboratories either at the national level or by specialized reference laboratories. They are often very resource-intensive and many countries find it difficult to implement them. Since laboratories in developing Member States are at different levels with respect to quality, the standards outlined in this document, while based on the ISO standards, have been simplified to encourage Member States to follow them. A flexible step-wise approach is encouraged so that these guidelines become a stepping-stone to achieving the ISO standards. Establishing and maintaining laboratory quality standards are essential.

This document presents a minimum set of standards that can be readily adapted by countries and applied to laboratories at every level of the health-care system. Suggestions are also provided on ways to implement them. They are important for several reasons, including ensuring the quality and traceability of patients' results; supporting clinical and public health decision-making; procuring equipment; use of standard techniques and reagents; for sharing documentation; training programmes; quality assurance; meeting requirements for reimbursement for national insurance schemes; and compliance with national or international accreditation and licensing systems.

This document will be of help to national policy-makers as well as regulators in developing national laboratory quality standards. It provides a simple approach to meet the minimum requirements set, and it is hoped that eventually laboratories can improve their systems and aspire to meet ISO 15189 in a logical and step-by-step manner.

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