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CLSI brings together the worldwide laboratory community to advance a common cause.
CLSI is excited to share a new report, entitled “The FDA Ruling on Laboratory Developed Tests: Taking Control of What’s in Your Control.” This free resource aggregates helpful CLSI guidance and materials that can also serve as an “LDT Toolkit” for the laboratory community.
CLSI EP Webinar: What's New in Method Evaluation?
Date: 12 November 2024 | 1:00 PM ET
Participate in this CLSI webinar to gain knowledge about the latest method evaluation standards, get a preview of EP47, and engage in a Q&A session addressing important topics in the industry.
CLSI and CAP 2024 Webinar: Identification and Methicillin Resistance Testing for Staphylococci other than S. aureus (SOSA) – What to Do Now?
Date: Thursday, 5 December 2024 | 1:00 – 2:30 PM ET
Learning Objectives:
CLSI QMS14 presents concepts and information to assist a laboratory in meeting leadership requirements for its quality management system. Guidance is provided for leaders to effectively design, implement, and maintain the cultural, structural, and functional aspects of their laboratory that are critical to managing and sustaining quality.
CLSI AUTO11 provides a framework for communication of information technology security issues between the in vitro diagnostic system vendor and the health care organization.
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
CLSI EP47 provides guidance for planning, performing, evaluating, and documenting reagent carryover experiments and guidance for ensuring that no significant reagent carryover occurs.
CLSI C38 provides guidelines for patient preparation, specimen collection, transport, and processing for the measurement of trace elements in a variety of biological matrixes.
This document provides information to help material manufacturers in the production and characterization of commutable reference materials, as well as to assist assay manufacturers and laboratorians in the appropriate use of these materials for calibration and trueness assessment of in vitro diagnostic medical devices.
CLSI and our volunteer members actively identify and develop new guidance on standards that raise laboratory testing quality, safety, and efficiency. We are setting the bar for how that guidance is delivered.
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