iso15189認(rèn)可和cap認(rèn)證的流程和體會(huì)(ppt44頁(yè))-wenkub
2023-02-04 17:54:21 本頁(yè)面
【正文】 tion. CLSI promotes the development and use of voluntary laboratory consensus standards and guidelines within the health care munity. CAP 3000 Checklist 16 評(píng)審依據(jù)的內(nèi)容 ISO 15189 CAP (LAP) 依據(jù) ? CNASCL02準(zhǔn)則 《醫(yī)學(xué)實(shí)驗(yàn)室質(zhì)量和能力認(rèn)可準(zhǔn)則》自查 /核查表 ? （ LIS…) 3000 條 Checklist 內(nèi)容 4 管理要求 組織和管理 質(zhì)量管理體系 文件控制 合同的評(píng)審 委托實(shí)驗(yàn)室的檢驗(yàn) 外部服務(wù)和供給 咨詢服務(wù) 投訴的處理 不符合項(xiàng)的識(shí)別和控制 糾正措施 預(yù)防措施 持續(xù)改進(jìn) 質(zhì)量和技術(shù)記錄 內(nèi)部審核 管理評(píng)審 5 技術(shù)要求 人員 設(shè)施和環(huán)境條件 實(shí)驗(yàn)室設(shè)備 檢驗(yàn)前程序 檢驗(yàn)程序 檢驗(yàn)程序的質(zhì)量保證 檢驗(yàn)后程序 結(jié)果報(bào)告 17 .5 實(shí)驗(yàn)室管理層應(yīng)負(fù)責(zé)質(zhì)量管理體系的設(shè)計(jì) 、 實(shí)施 、 維持及改進(jìn) ， 包括： a) 管理層為實(shí)驗(yàn)室所有人員提供履行其職責(zé)所需的適當(dāng)權(quán)力和資源； e) 明確實(shí)驗(yàn)室的組織和管理結(jié)構(gòu) ， 以及實(shí)驗(yàn)室與其他相關(guān)機(jī)構(gòu)的關(guān)系； f) 規(guī)定所有人員的職責(zé) 、 權(quán)力和相互關(guān)系； h) 技術(shù)管理層 全面負(fù)責(zé)技術(shù)運(yùn)作 ，并提供資源以確保滿足實(shí)驗(yàn)室程序規(guī)定的質(zhì)量要求； i) 指定一名質(zhì)量主管 （ 或其他稱謂 ） ，賦予其職責(zé)和權(quán)力以監(jiān)督所有活動(dòng)遵守質(zhì)量管理體系的要求 。 ISO 15189 組織和管理 18 對(duì)比舉例一、組織和管理 注：包括實(shí)驗(yàn)室負(fù)責(zé)人和普通員工要求（ ISO中 未見(jiàn)一般員工要求 ） CAP PERSONNEL REQUIREMENT BY TESTNG COMPLEXITY ?DIRECTORS（ MD or DO） ?SECTION DIRECTORS/TECHNICAL SUPERVISORS （ MD or DO） ?SUPERVISORS/GENERAL SUPERVISORS ?ALL PERSONNEL 19 CAP 組織和管理 **REVISED** 07/31/2023 Laboratory Director Qualifications Phase II The laboratory director satisfies the personnel requirements of the College of American Pathologists. … The director must: a. Be an MD or DO licensed to practice (if required) in the jurisdiction where the laboratory is located, and b. Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or American Osteopathic Board of Pathology, or possess qualifications equivalent to those required for certification OR a. Be an MD, DO or DPM licensed to practice (if required) in the jurisdiction where the laboratory is located, and b. Have at least one year of laboratory training during residency, or at least two years of experience supervising high plexity testing OR a. Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution, and b. Be certified and continue to be certified by a board approved by HHS** (or, for nonUS laboratories, by an equivalent board) OR, for nonUS laboratories (not subject to US regulations) only a. Laboratory Director shall be an MD, DO, PhD or shall have mensurate education 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 p
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