Clinical and Laboratory Standards Institute Products & Reviews

A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures, 2nd ed.

Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters. 5th ed

M100 - Performance Standards for Antimicrobial Susceptibility Testing, 33rd Edition is currently available for preorder on the manufacturer’s website. Performance Standards for Antimicrobial Susceptibility Testing. 32nd Edition.

Collection of Diagnostic Venous Blood Specimens

Laboratory Quality Control Based on Risk Management, 1st Edition

Colistin Breakpoints for Pseudomonas aeruginosa and Acinetobacter spp. 

Essential Elements of a Phlebotomy Training Program

A Quality Management System Model for Laboratory Services

Next-Generation In Vitro Diagnostic Instrument Interface

Laboratory Support for Pain Management Programs, 1st Edition 

Harmonization of Symbology and Equations, 1st Edition

This document provides both manufacturers and users of quantitative measurement procedures with an economical and user-friendly method of validating and verifying the linearity interval. EP06 can also be used to determine the extent to which a quantitative measurement procedure meets medical requirements or the manufacturer’s linearity interval claims.

This document provides both manufacturers and users of quantitative measurement procedures with an economical and user-friendly method of validating and verifying the linearity interval. EP06 can also be used to determine the extent to which a quantitative measurement procedure meets medical requirements or the manufacturer’s linearity interval claims.

This guideline describes the design, development, and validation of quantitative assays for proteins and peptides by mass spectrometry.

This white paper covers public health emergencies in general, the ways in which emergency use authorizations (EUAs) may be used, and the ramifications of EUAs for medical laboratories and other testing sites.

User Evaluation of Acceptability of a Reagent Lot Change Implementation Guide, 1st Edition

Method Navigator is an online subscription product that provides users with quick and easy access to specific guidance from CLSI documents. Method Navigator was designed to help test developers—whether they are test manufacturers or laboratories developing tests—fulfill FDA, CLIA, ISO, and other requirements.

Learn how to perform a gap analysis of laboratory quality activities to help your laboratory meet minimum QMS requirements.