iso15189認(rèn)可和cap認(rèn)證的流程和體會(huì)(ppt44頁(yè))-wenkub.com
2025-01-14 17:54 本頁(yè)面
【正文】 。 24 ISO 15189 人員能力評(píng)價(jià) Competency Assessment Phase II The petency of each person to perform his/her assigned duties is assessed. NOTE: during the first year of an individual39。沒(méi)有通過(guò)評(píng)審的人員需經(jīng)再培訓(xùn)和再評(píng)審，合格后才可繼續(xù)上崗，并記錄。s degree (or beyond) in chemical, physical or biological science or medical technology and at least 4 years experience (one of which must be in clinical chemistry) 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 in toxicology、 blood gas testing (or certified or registered respiratory therapist ） Testing Personnel Qualifications Phase II All testing personnel meet the following requirements. 1. Personnel performing high plexity testing must have at a minimum an earned associate degree in a laboratory science or medical laboratory technology from an accredited institution, or equivalent laboratory training 2. Personnel performing moderate plexity testing must have at a minimum an earned high school diploma or equivalent and documented training Evidence of Compliance: ? Records of qualifications including degree or transcript, certification/registration, current license (if required) and work history in related field 22 CAP 普通員工資質(zhì)要求很具體 所有員工的資質(zhì)證明 23 對(duì)比舉例二、人員能力評(píng)價(jià) 5.1.11 應(yīng)在培訓(xùn)后評(píng)審每個(gè)員工執(zhí)行指定工作的能力 ， 之后定期評(píng)審 。 .5 血液 h) 應(yīng)至少有 1名具有副高以上專業(yè)技術(shù)職務(wù)任職資格，從事醫(yī)學(xué)檢驗(yàn)工作至少 5年以上的人員負(fù)責(zé)技術(shù)管理工作。國(guó)際實(shí)驗(yàn)室認(rèn)可合作組織（ ILAC）要求各國(guó)認(rèn)可組織于 2023年 3月 1日前完成標(biāo)準(zhǔn)轉(zhuǎn)換工作。 ISO15189:《 醫(yī)學(xué)實(shí)驗(yàn)室 — 質(zhì)量和能力的專用要求 》 CLIA 88（美國(guó)臨床實(shí)驗(yàn)室改進(jìn)修正法規(guī)’ 88 ） CLSI（美國(guó)臨床和實(shí)驗(yàn)室標(biāo)準(zhǔn)協(xié)會(huì)） 11 二、認(rèn)證認(rèn)可差別 Certification ＆ Accreditation 認(rèn)證 認(rèn)可 中華人民共和國(guó)國(guó)務(wù)院令(第 390號(hào) ) 《 中華人民共和國(guó)認(rèn)證認(rèn)可條例 》 2023年１１月１日起施行。ISO15189認(rèn)可和 CAP認(rèn)證的流程和體會(huì) 浙江大學(xué)醫(yī)學(xué)院附屬第二醫(yī)院 譚運(yùn)年 1 一、為什么要做？ 二、認(rèn)證認(rèn)可差別 三、體系建立和檢查手段 四、申請(qǐng)流程和體會(huì) 3 一、為什么要做？ 為什么不想做？據(jù)說(shuō) 聽(tīng)說(shuō) 傳說(shuō) ?文件工作多 ?學(xué)習(xí)任務(wù)重 ?硬件達(dá)不到要求 ?軟件達(dá)不到要求 ?只按部分要求做，不評(píng) 4 推動(dòng)的因素 ?外部： 國(guó)內(nèi)：優(yōu)質(zhì)醫(yī)院、等級(jí)醫(yī)院、衛(wèi)生部重點(diǎn)?？圃u(píng)審。 總理 溫家寶 第一章 總 則 第二條 本條例所稱 認(rèn)證 ，是指由認(rèn)證機(jī)構(gòu)證明產(chǎn)品、服務(wù)、管理體系符合相關(guān)技術(shù)規(guī)范、相關(guān)技術(shù)規(guī)范的強(qiáng)制性要求或者標(biāo)準(zhǔn)的合格評(píng)定活動(dòng)。 ? 準(zhǔn)則核查表 ? 的專業(yè)組核查表 15 三、體系建立和檢查手段 CAP 實(shí)驗(yàn)室文件體系 QMP Policy Standard Operation Procedure,SOP Records CLIA 88美國(guó)臨床實(shí)驗(yàn)室改進(jìn)修正法規(guī)’ 88 Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. 2023 CDC and CMS modified CLSI美國(guó)臨床和實(shí)驗(yàn)室標(biāo)準(zhǔn)協(xié)會(huì) Clinical and Laboratory Standards Institute is a volunteer driven, membership supported, nonprofit, standards aniza
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