Quality Management Systems | Standards

An 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 .

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QMS01 | A Quality Management System Model for Laboratory Services, 5th Edition

This guideline provides a model for medical laboratories to organize the implementation and management of an effective quality management system.

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QMS23 | General Laboratory Equipment Performance Qualification, Use, and Maintenance, 2nd Edition

This guideline reflects requirements and provides recommendations for use in planning, recording, and monitoring performance qualification, function checks, calibration verification, and preventive maintenance activities for general laboratory equipment. Examples are included to provide insight and enhance comprehension.

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