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Process management guideline, 5/15

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May 2015—The Clinical and Laboratory Standards Institute has published a new document, “Process Management (QMS18-Ed1).” This guideline describes four requirements for managing laboratory processes and provides suggestions for effectively meeting regulatory and accreditation requirements, optimizing efficient use of resources, and contributing to patient safety and positive outcomes. It describes what laboratories need to do to meet published regulations, accreditation requirements, and international standards for process management and control. It also provides suggestions and examples for fulfilling the requirements. By following the guidance in this document, laboratories can reduce or eliminate errors, meet customer expectations, and increase the effectiveness and efficiency of laboratory operations.

CLSI, 610-688-0100

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