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Six Sigma-based quality control

1 SIX Sigma-based quality CONTROLDIAGNOSTICSL earning Guide seriesSix Sigma-based quality control2 SIX SIGMAfiBASED quality control DIAGNOSTICSTO TABLE OF CONTENTSACKNOWLEDGEMENTSDR. JAMES O. WESTGARDDr. James O. Westgard is president of Westgard QC, Inc., a small business providing education and training for laboratory quality management. He is an emeritus professor in the Department of Pathology and Laboratory Medicine at the University of Wisconsin Medical School. He spent many years as faculty director of quality Management Services for the Clinical Laboratories at the University of Wisconsin Hospital and Clinics. A native of North Dakota, Dr. Westgard obtained a bachelor s degree in chemistry from Concordia College in Moorhead, Minnesota, and master s and doctorate degrees in analytical chemistry from the University of Wisconsin, Madison.

is described as an Individualized Quality Control Plan (IQCP), which consists of three components: a risk assessment, a QC plan and a quality assessment program. In comparison, ISO 15189 provides the global standard of practice for accreditation8 by stating: “The laboratory shall design quality control

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