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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 .
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.
This guideline provides recommendations for establishing and maintaining a process to assist the laboratory in achieving a continuous state of readiness for assessment by an external organization. This includes selecting and evaluating an external assessment organization, preparing for and undergoing a successful assessment, and sustaining ongoing readiness for assessment.
Gap Analysis is an online subscription product that provides users with performing a quick and easy gap analysis and can track progress toward achieving complete compliance.
