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目的研究ISO9000质量管理体系在采供血机构和医疗机构应用的适宜性、必要性和有效性。方法采用前瞻性和回顾性研究方法对9个样本单位进行了调研。结果全部样本调研单位已建立完善的既符合ISO9000标准又符合相关法律法规和本单位实际的质量手册和质量管理的体系文件并有效运行。其中8个单位已通过第3方审核认证。结论血站和医疗机构引进ISO9000质量管理体系是适宜的,必要的和可行的,具推广应用前景。
Objective To study the suitability, necessity and effectiveness of the application of ISO9000 quality management system in blood collection and feeding institutions and medical institutions. Methods A prospective and retrospective study was conducted on 9 sample units. As a result, all sample research units have established a sound system document that meets both the ISO 9000 standard and the relevant laws and regulations, and the actual quality manual and quality management of the unit, and operates effectively. Among them, 8 units have passed the third party audit certification. Conclusion The introduction of ISO9000 quality management system in blood stations and medical institutions is appropriate, necessary and feasible, and has broad application prospects.