實驗室認(rèn)可和質(zhì)量體系認(rèn)證(已修改)
2025-01-16 18:14 本頁面
【正文】 實驗室認(rèn)可和質(zhì)量體系認(rèn)證楊振華2023年 11月 24曰l 現(xiàn)場檢查l l 質(zhì)量控制 (QC),室間質(zhì)評 (EQA)l l 質(zhì)量保證 (QA)l (美國實驗室認(rèn)可， CLIA 88)l 質(zhì)量改進 (QI,CQI)l l 質(zhì)量體系 (QS)l (ISO 9OO2， 17025， 15189)l 質(zhì)量管理 (QM， TQM) Quality Standards for Medical Laboratories Dr. Pharm. JeanClaude LibeerIPH Brussels醫(yī)院質(zhì)量體系認(rèn)證n1995: n1999Pace standards (NL)King Fund (UK)JCHA (US)ANAES (Fr)ISO 9000HACCP= EMAS, ISO 14000= BS 1799Certification/accreditation in Health Care Institutionsn歐共體傾向使用 ISO文件 一些國家使用自巳的標(biāo)準(zhǔn) ,如美國的 JCHO中國一些醫(yī)院，血站在用 ISO 9002防疫站，檢驗室在用 ISO 25認(rèn)可 (證 )的花費n實驗室為認(rèn)可進行內(nèi)部質(zhì)量工作的花費n請外部耒認(rèn)可的花費COSTS FOR ACCREDITATIONMean investment : 3 manyearMaintenance of the system: manyearHospital facilitieslHotel acmodationlNursing DepartmentlLaundrylKitchenl?..ISO 9002醫(yī)學(xué) 專業(yè) 部門lIntensive Care UnitlMedium Care UnitlSurgeryl?.需要其它特定的標(biāo)準(zhǔn)Hospital interrelations臨床實驗室認(rèn)可標(biāo)準(zhǔn)l1995:l1999: CCKL? GBEA? KBMAL,? ISO 9000? EN 45000? GLP? ISO 25? CPA? CAP?Accreditation procedure for reference laboratorieslISO 17025(25)是校正或參考實驗室認(rèn)可的標(biāo)準(zhǔn)臨床或常規(guī)實驗室的認(rèn)可標(biāo)準(zhǔn)l ISO 17025 as normative accreditation standard+l ISO 15189 as sector specific document and additional requirementslISO 15189 as normative accreditation standard二個文件合并認(rèn)可的優(yōu)缺點l優(yōu)點lUniform approach for all types of laboratorieslSame quality mitment is emphasized
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