iso15189認(rèn)可和cap認(rèn)證的流程和體會-文庫吧在線文庫
【正文】 tion and experience necessary to meet personnel requirements as determined by the CAP ………. **REVISED** 07/31/2023 Section Director/Technical Supervisor Qualifications/Requirements Phase II Section Directors/Technical Supervisors meet defined qualifications and fulfill the expected responsibilities. NOTE: The section director/technical supervisor in each high plexity laboratory section can be a licensed MD or DO with certification in anatomic and/or clinical pathology, or qualifications equivalent to those required for board certification. The section director/technical supervisor responsible for anatomic pathology must be an MD or DO certified in anatomic pathology or possess qualifications equivalent to those required for certification. The section director/technical supervisor responsible for clinical pathology must be an MD or DO certified in clinical pathology or possess qualifications equivalent to those required for certification。 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)范的強制性要求或者標(biāo)準(zhǔn)的合格評定活動。 ISO15189:《 醫(yī)學(xué)實驗室 — 質(zhì)量和能力的專用要求 》 CLIA 88（美國臨床實驗室改進修正法規(guī)’ 88 ） CLSI（美國臨床和實驗室標(biāo)準(zhǔn)協(xié)會） 11 二、認(rèn)證認(rèn)可差別 Certification ＆ Accreditation 認(rèn)證 認(rèn)可 中華人民共和國國務(wù)院令(第 390號 ) 《 中華人民共和國認(rèn)證認(rèn)可條例 》 2023年１１月１日起施行。 .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)檢驗工作至少 5年以上的人員負(fù)責(zé)技術(shù)管理工作。沒有通過評審的人員需經(jīng)再培訓(xùn)和再評審，合格后才可繼續(xù)上崗，并記錄。 。 24 ISO 15189 人員能力評價 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。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 對比舉例二、人
規(guī)章制度相關(guān)推薦
鄂ICP備17016276號-1