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目的建立和运行同时符合《检测和校准实验室能力的通用要求》(ISO/IEC17025)及《血站实验室质量管理规范》的实验室质量体系。方法通过编写体系文件、人员培训、日常监督,内部审核、管理评审等方法实现实验室质量管理体系的建设和运行。结果建立和运行的实验室质量管理体系通过了我国合格评定国家认可委员会的认可及国家卫生部督导组对实验室的督导验收。结论在血站建立和运行实验室认可质量管理体系是完全可行和必要的,可确保血液质量和安全。
Objective To establish and operate a laboratory quality system that meets the requirements of General Requirements for Testing and Calibration Laboratory Capabilities (ISO / IEC 17025) and Blood Bank Laboratory Quality Management Practices. Methods The construction and operation of the laboratory quality management system were achieved through the preparation of system documents, personnel training, daily supervision, internal audit and management review. The results of the establishment and operation of the laboratory quality management system through the approval of China’s accreditation of national accreditation board and the Ministry of Health Supervision Group supervision and inspection of the laboratory. Conclusion Establishing and operating a laboratory-accredited quality management system at a blood bank is entirely feasible and necessary to ensure blood quality and safety.