Quality management systems for medical laboratory
Journal Title: Journal of Analytical Bio-Science - Year 2011, Vol 34, Issue 4
Abstract
The quality management systems (QMS) specified in ISO 9001, 14001, and 15189 enable medical laboratory to standardize business processes and improve customer satisfaction and product quality. However, the real benefits of QMS are realized only when the quality of QMS is maximized by the use of plan-do-study-act cycles and through continuous improvement. Thus, the outcome of QMS depends largely on how each laboratory implements them. One advantage of QMS is that continuity is maintained through surveillance and via an annual renewal audit conducted by a third party. ISO 15189 specifies QMS requirements particular to medical laboratory. Since this is the only globally recognized accreditation used to assess the ability of individual medical laboratory, the demand for ISO 15189 accreditation is anticipated to increase.
Authors and Affiliations
Kiyotada Nakamura
Keywords
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