Historical
CLSI C24-A3
Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline- Third Edition
Clinical and Laboratory Standards Institute document C24-A3-Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline-Third Edition addresses the principles of statistical quality control (QC), with particular attention to the planning of a QC strategy, the definition of an analytical run, and the application of statistical QC in a healthcare laboratory. While these principles are of interest to manufacturers, this guideline is intended for use by a healthcare laboratory to provide a QC procedure that employs control materials that are independent and external to a reagent kit, an instrument, or analytical system. This guideline is a revision of an earlier guideline and includes the original definition for user-defined run length. Changes in the second edition included a strong emphasis on defining quality up front to guide the selection of control rules and the number of control measurements. The third edition adds example applications that make use of a simple sigma-metrics QC planning tool.
Clinical And Laboratory Standards Institute [clsi]