Nccls Quality Manual
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Quick Links.Specialty Areas.Quality Management Systems StandardsAn effective quality management system is the cornerstone for delivery of superior patient care and high-quality test results in the lab. CLSI’s quality management systems 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. Featured Products.
Contents.History In 1968, 31 and scientists representing 15 organizations met to develop a formal consensus process for standardization. In 1977, CLSI was accredited by the American National Standards Institute as a voluntary consensus standards organization. At about the same time, CLSI became the home of the National Reference System for the Clinical Laboratory (NRSCL), a collection of broadly understood reference systems intended to improve the comparability of test results, consistent with the needs of medical practice.CLSI is a global association of 1,500+ member organizations and individual members, as well as more than 2,000 volunteers. Until 2005, CLSI was called the National Committee for Clinical Laboratory Standards ( NCCLS).Committees CLSI documents are developed by committees composed of experts in or ancillary aspects of these activities.
Development of CLSI standards is a dynamic process. Each CLSI committee produces consensus documents related to a specific discipline.The consensus process CLSI's core business is the development of globally applicable voluntary consensus and for the. CLSI develops consensus documents through an accredited consensus process.Volunteers CLSI relies on more than 2,000 volunteers. Volunteers and mentors also work with CLSI's Global Health Partnerships to help establish laboratory quality management systems in resource-limited countries.Global health partnerships CLSI provides direct assistance in Sub-Saharan Africa to combat HIV/AIDS and other infectious diseases. With grants from the US-based (President's Emergency Plan for AIDS Relief) program administered by a cooperative agreement from the (CDC) and the (NIAID), CLSI has been directly engaged in essential laboratory services improvement. During the past several years, CLSI mentors, volunteers, and staff have provided technical assistance in, and.International Organization for Standardization (ISO) CLSI participates in the development of international standards as the Secretariat of Technical Committee (TC) 212, clinical laboratory testing and in vitro diagnostic test systems, a responsibility that was delegated to CLSI by the (ANSI), which is an member body.
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CLSI also serves as the administrator for the US Technical Advisory Committee (TAG) for ISO/TC 212.See also.References.