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CLSI Standards: Guidelines for Health Care Excellence

Developed by our members for use by the global laboratory community, CLSI’s consensus-based medical laboratory standards are the most widely recognized resources for continually improving testing quality, safety, and efficiency.

Browse our collection of consensus-based medical laboratory standards documents. Choose from print or electronic versions of CLSI standards and guidelines.

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Effective 04 January 2024, CLSI is pleased to offer Country-Based Pricing for customers who meet established economic criteria. Visit our Country-Based Pricing page for more information about this new program. Note: Discounted pricing is available only when a customer is logged in to his/her CLSI account.

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Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma
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Newborn Screening for Preterm, Low Birth Weight, and Sick Newborns, 2nd Edition

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Medical laboratories — Practical guidance for the estimation of measurement uncertainty
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General Laboratory Equipment Performance Qualification, Use, and Maintenance, 2nd Edition

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A Quality Management System Model for Laboratory Services, 5th Edition

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Un Modelo de Sistema de Gestión de Calidad Para Servicios de Laboratorio, 5ta Edición

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Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices -- Part 1, 2nd Edition
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In vitro diagnostic medical devices -- Clinical performance studies using specimens from human subjects -- Good study practice
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Next-Generation In Vitro Diagnostic Instrument Interface, 1st Edition

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Developing and Using Quality Indicators for Laboratory Improvement, 2nd Edition

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