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An effective quality management system is the cornerstone for the delivery of superior patient care and high-quality test results in the lab. CLSI’s quality management system standards can help your lab with easy to understand and use documents that show you how to implement a quality management system. Our standards documents cover a range of subjects, including management of laboratory documents, training and competence assessment, laboratory design, and nonconforming event management .
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
Earn P.A.C.E.® credits with this self-paced online learning program that will give you the knowledge and skills necessary for successful implementation and sustainment of a quality management system in your lab.
CLSI QMS02 provides guidance on the processes needed for documents management, including creating, controlling, changing, and retiring a laboratory’s policy, process, procedure, and form documents in both paper and electronic environments.
Provides the “Ten Rules for Laboratory Document Management” on one page for quick reference.
CLSI QMS29 provides information about the management review process, including the intent of management review, who should be involved in the review, and how the review can be conducted.
