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.
Quality Management Systems | Standards
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 guideline describes five requirements for managing laboratory processes and provides suggestions for effectively meeting regulatory and accreditation requirements, assessing process risks, optimizing efficient use of resources, and contributing to patient safety and positive outcomes.
This guideline provides recommendations for establishing a laboratory internal audit program to enhance the quality of laboratory services through continual improvement. An audit program defines the “who,” “what,” “when,” “where,” and “how” of meeting requirements for internal auditing, and the audit process describes the details of conducting individual laboratory internal audits.