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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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Information Technology Security of In Vitro Diagnostic Instruments and Software Systems, 3rd Edition

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Quality System Regulations for Laboratory-Developed Tests: A Practical Guide for the Laboratory, 2nd Edition

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Evaluation of Reagent Carryover Effects on Test Results, 1st Edition

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Control of Preexamination Variation in Trace Element Determinations, 2nd Edition

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Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine, 2nd Edition

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Preliminary Evaluation of Quantitative Medical Laboratory Measurement Procedures, 4th Edition

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Cancer Molecular Testing: Principles of Oncology Test Interpretation, Laboratory and Assay Design, and Clinical Consultation, 1st Edition

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Processes for the Collection of Urine Specimens, 1st Edition

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Competence Requirements for Biorisk Management Advisors, 1st Edition
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Medical laboratories — Guidance on application of ISO 15189 in anatomic pathology
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