實驗室品質管理與ISO 15189對管理要求之作業指引

醫學實驗室的品質要求符合國際認可的標準作業規範，可證明實驗室分析的數據具醫療價值。臨床實驗室標準國際委員會所制定的實驗室品質系統，可作爲實驗室運作的基礎及品質改善的原動力，以提升醫療品質及檢驗品質，也是我國醫療法對醫療及醫事檢驗機構的品質要求。ISO 15189爲國際問醫學實驗室認證之標準統範，包括品質要求與技術要求，主要是實驗室制定分析前、分析中、分析後的各項標準作業流程(SOP)，在品質系統的管理與運作下，可提昇實驗室的效率與功能。通過ISO 15189實驗室認證爲目前國內臨床檢驗室提昇品質所追求的目標與未來之趨勢。建立實驗室ISO 15189品質要求之作業指引，包括：組織與管理、品質管理系統、文件管制、合約審查、委外檢驗、外部服務與供應、諮詢服務、解決抱怨、不符合性事物的鑑別與管制、矯正措施、預防措施、持續改善、品質與技術紀錄、內部稽核、及管理審查等15要項之標準程序，可做爲醫學實驗室準備認證之基本要求與參考。

關鍵字

品質系統； ISO 15189 ；實驗室認證

並列摘要

A good quality system is essential for a medical laboratory. Reports from an accredited medical laboratory are reliable for medical application. The quality system essential (QSE), described by the National Committee for Clinical Laboratory Standards (NCCLS), is current official requirement for the medical laboratory. In addition, ISO 15189 is the major standard in the laboratory accreditation and it provides quality and technical requisitions. In accordance with the guideline of ISO 15189, a laboratory should set up the standard operation protocol (SOP) for the pre-assay, intra-assay, and post-assay. This can become a driving force for continue quality improvement of the laboratory. In this article, we want to describe the essential criteria based on ISO 15189 for laboratory quality requirements. There are 15 items, which includes organization and management, quality system, document control, review of contracts, examination by referral laboratories, external services and supplies, advisory services, complaints, identification and control of nonconformities, corrective actions, preventive actions, continual improvement, quality and technical records, internal audits, and management review, prospectively. These could be the fundamental for the preparing of laboratory accreditation.

並列關鍵字

quality system ； ISO 15189 ； laboratory accreditation

國際替代計量

實驗室品質管理與ISO 15189對管理要求之作業指引

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