Quality system for test laboratories

Phillips, P. K.; Lane, Betty; Voak, D.

doi:10.1046/j.1537-2995.1996.36496226159.x

Cited by 1 publication

(2 citation statements)

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“…In tracing thc "path of workflow" from thc patient, to specimen collcction, transpörtation, analysis and reporting, there are numcrous "opportunities for error" [20]. These differences are significant when one considers that EN 45 001 and Guide 25 have been used to support accrcditation in the clinical laboratory environmcnt and have stimulated some debate in the laboralory litcrature [21][22][23][24][25]. The identified differences, howevcr, may be only temporary.…”

Section: Total Process Controlmentioning

confidence: 99%

“…Although this premise was questioned in relation to the testing function [23], ISO 9000 Standards were intended to apply to management of the entire production process and therefore do apply to blood banking [25]. Because the applicability of the blood bank quality System to the medical laboratory has already been shown, it is acceptable to infer that ISO Standards can also be applied to a medical laboratory.…”

Section: Comparison Of the Laboratory Quality System And European Labmentioning

confidence: 99%

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Laboratory Management

1997

LaboratoriumsMedizin

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The hcalth-carc industry has lagged .far beliind husiness and manufacturing in adapting to a quality systcm cnvironment. However, the pressures to improvc scr\ r ices while reducing costs are no different for healthcare than for manufacturing. Thus, isolated aspects of health care are currently exploring the implications of qualiiy Systems such äs that described in the ISO 9000 quality Standards. The authors describe one such application of a quality System for medical laboratories that was built upon current US laboratory regulations, accreditation Standards and quality management principles and compare it to current European laboratory testing Standards. The authors further compare and contrast the US and European Systems to ISO 9002.Zusammenfassung: Das Gesundheitswesen ist hinsichtlich der Orientierung auf ein Qualitätsmanagementsystem gegenüber dem Geschäfts-und Industriebereich weit zurückgeblieben, obwohl der Druck zur Verbesserung der Dienstleistungen bei gleichzeitiger Kostenreduktion in Gesundheitswesen und Industrie ähnlich ist. Um der Entwicklung Rechnung zu tragen, werden derzeit in einzelnen Bereichen des Gesundheitswesens Qualitätssysteme, wie sie beispielsweise in den ISO 9000 Normen niedergelegt sind, erprobt. Die Autoren beschreiben für den Bereich des medizinischen Laboratoriums die Anwendung eines Qualitätssystems, das auf US-amerikanischen Gesetzen für das Laboratorium, Akkreditierungsnormen und Prinzipien für das Qualitätsmanagement aufbaut und vergleichen dieses mit der geltenden europäischen Norm für Prüflaboratorien. Weiterhin werden die USamerikanischen und die europäischen Systeme mit der ISO-Norm 9002 verglichen und ihr gegenübergestellt.

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Section: Total Process Controlmentioning

confidence: 99%

Section: Comparison Of the Laboratory Quality System And European Labmentioning

confidence: 99%