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M100 and M27M44S Free
With these read-only web versions of M100 and M27M44S, you can now quickly reference the most trusted AST and antifungal breakpoints from anywhere with an Internet connection. Available online as a convenient companion to our M100 document and M27M44S document.
M23S
This document describes the necessary technical steps for establishing the optimal disk content (potency) for single antimicrobial agents without the addition of enhancing or inhibiting substances.
This document is intended for use with M23.
VET01S Free
Quickly reference the most trusted AST veterinary breakpoint tables as a convenient, complimentary supplement to the AST VET01 document.
AST Rationale Documents
Providing the scientific reasons behind breakpoint decisions.
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EP19-Ed2
This report uses the “measurement procedure lifecycle” framework to aid users of CLSI evaluation protocols documents during establishment and implementation of measurement procedures developed by both commercial manufacturers and clinical laboratories, ie, for laboratory-developed tests.
EP36-Ed1
This report provides a standardized symbology for use throughout CLSI documents. Use of these standardized symbols is expected to be of great benefit to the CLSI readership, volunteers participating in CLSI committees, and the scientific community in general.
MM14-A2
This document provides guidelines for a quality proficiency testing/external quality assessment program, including reliable databases; design control in the choice of materials and measurands; good manufacturing processes; documentation procedures; complaint handling; corrective and preventive action plans; and responsive timing of reports.
MM22-A3
This document provides guidance for the laboratory development and use of qualitative nucleic acid microarray methods for the diagnosis and monitoring of infectious diseases. It also presents recommendations for validation and verification, quality control, and interpretation of results.
POCT07-A
This document presents the core infrastructure for a standardized error tracking system with the primary goals of reducing risk and increasing quality of point-of-care testing, while accumulating standardized data for benchmarking use.
GP36-A
This document provides guidance for laboratory and health care leadership for development, implementation, and sustainment of effective emergency preparedness plans (all hazards) supporting nonanalytical components of clinical and public health laboratory services that may pertain to various natural and manmade disasters.
Quality System Regulations for Laboratory Developed Tests: A Practical Guide for the Laboratory
This practical guide, compiled with the help of experts from the in vitro diagnostics industry, is intended for the laboratory that is creating laboratory developed tests that may be subject to the US Food and Drug Administration (FDA) regulations, specifically the Quality System Regulation (QSReg), 21 CFR Part 820.