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The page below is a sample from the LabCE course The Basics of Non-Conforming Event Management for Clinical Laboratory Services. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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Requirements for Management

While the upfront quality planning of a laboratory’s services is certainly a better use of time and resources, there are requirements for the CAPA process to exist as part of an organization’s QMS.
Regulating and accrediting agencies require that laboratories create, implement, and continually assess their QMS, and each agency specifically points to a requirement for a system that identifies, monitors, and corrects systematic errors.