Abstract
The changing landscape of the clinical laboratory is necessitating that the field of clinical microbiology evolve beyond quality control and quality assurance and adopt a quality management system (QMS). QMS standards exceed those required to achieve Clinical Laboratory Improvement Amendments compliance or College of American Pathologists accreditation. Laboratories that adhere to the requirements for a QMS as described by the International Organization of Standards (ISO) ensure that quality is planned, documented, and continually sought. The Clinical and Laboratory Standards Institute (CLSI) has categorized the technical and management ISO standards into 12 quality system essentials that cover the total testing process in the laboratory. The CLSI quality system essentials serve as a checklist when implementing a new test or acquiring new equipment to prevent overlooking a critical step in the process. A laboratory QMS provides the evidence that the laboratory is a valued partner providing a quality outcome for patients and meeting the quality goals and objectives of the organization.
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