The Clinical and Laboratory Standards Institute (CLSI) recently published Quality Management System: A Model for Laboratory Services; Approved Guideline-Fourth Edition (GP26-A4). This document provides a practical model for medical laboratories that will assist with implementation and maintenance of an effective quality management system (QMS).
To facilitate this objective, GP26 offers a structure for a comprehensive, systematic approach to build quality into the laboratory's processes, assess the laboratory's performance, and implement quality improvements, and can be used along with other quality-related documents to design the system foundation necessary to achieve total quality management. This document combines and replaces the previous edition of the approved guideline, GP26-A3, published in 2004, and the second edition of CLSI document HS01, also published in 2004.
This guideline is intended for use by laboratory directors, managers, supervisors, quality managers, and others responsible for implementing, maintaining, and evaluating the laboratory's QMS. The QMS model described in GP26 can be used in laboratories around the world including, but not limited to, medical laboratories, public health laboratories, research laboratories, veterinary laboratories, food laboratories, and environmental laboratories. By applying the recommendations of GP26, the laboratory can implement a QMS that incorporates international, national, accreditation, local, and organizational requirements, and meets customer expectations.
Keywords : Clinical and Laboratory Standards Institute CLSI GP26-A4 QMS Quality Management System Standard
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