iso15189認可和cap認證的流程和體會-免費閱讀
【正文】 and specimen collection, handling, processing and testing 2. Monitoring the recording and reporting of test results, including, as applicable, reporting critical results 3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records 4. Direct observation of performance of instrument maintenance and function checks 5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples。生化 ： 應(yīng)制定員工能力評審的內(nèi)容和方法，每年評審員工的工作能力；對新進員工在最初 2個月內(nèi)應(yīng)至少進行 2次能力評審（間隔為 30天），并記錄。 質(zhì)量主管應(yīng)直接向?qū)嶒炇艺吆唾Y源決策的實驗室管理層報告； j) 指定所有關(guān)鍵職能的代理人 ， 但需認識到 ， 在小型實驗室一人可能會同時承擔多項職責 ， 對每項職責指定一位代理人不切實際 。 國外： JCI (Joint Commission on Accreditation of Healthcare Organizations ,JCAHO) ， CAP（ College of American Pathologist） ?內(nèi)部： 自身發(fā)展的需要、自重、自尊。 ISO/IEC 導則 2 一個 第三方 （認證機構(gòu)）對（一個組織的）產(chǎn)品、過程或服務(wù)符合規(guī)定的要求給出書面保證的過程 是 權(quán)威機構(gòu) 對某一組織或個人有能力完成特定任務(wù)做出正式承認的程序 12 發(fā)個證先，你們符合結(jié)婚的條件 13 區(qū)分重點 ?誰組織檢查：第三方還是權(quán)威機構(gòu)？ ?檢查是體系要求符合性認定還是能力的認定？ ?區(qū)別是建立在有一定內(nèi)涵聯(lián)系基礎(chǔ)上 ?CAP 英文中稱 Accreditation 14 ISO I5189 實驗室文件體系 質(zhì)量手冊 程序文件 項目操作指南（ SOP) 各種記錄 ISO15189:2023《 醫(yī)學實驗室質(zhì)量和能力的要求 》 CNASCL02： 2023《 醫(yī)學實驗室質(zhì)量和能力認可準則 》 ISO15189:2023《 醫(yī)學實驗室質(zhì)量和能力的要求 》 于 2023年 11月 1日發(fā)布。s degree (or beyond) in a chemical, physical or biological science or medical technology and at least 4 years experience (one of which is in clinical hematology) under a qualified director. Evidence of Compliance: ? Records of qualifications including degree or transcript, certification/registration, current license (if required) and work history in related field Personnel Bench Testing Phase II The person in charge of bench testing in chemistry has education equivalent to an associate39。沒有通過評審的人員應(yīng)經(jīng)再培訓和再評審，合格后才可繼續(xù)上崗，并記錄。 25 CAP 人員能力評價 (誰來評估？怎樣評估？明確間隔時間？） 比 ISO15189 要求更細 ISO 15189 ?未對 PT 做出規(guī)定 ?整合在準則核查表條款 糾正措施 預防措施 CAP ?對 PT 有非常具體規(guī)定 ?有非常多的 Checkllist 舉例三、 PT數(shù)據(jù)的上報、分析、強制要求 28 PT Evaluation Phase II There is ongoing evaluation of PT and alternative assessment results, with prompt corrective action taken for unacceptable results. Primary records are retained for two years These include all instrument tapes, work cards, puter pri ntouts, evaluation reports, evidence of review, and documentation of followup/corrective action. Evidence of Compliance: ? Records of ongoing, timely review of all PT reports and alternative assessment results by the laboratory director or designee AND ? Records of investigation of unacceptable PT and alternative assessment results including records of corrective action that is appropriate to the natu
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