ISO15189认可流程 ISO15189认证流程 医学实验室认可流程 发布时间: 2015-02-03 00:03 点击:
The ISO15189 approval process ISO15189 certification process of medical laboratory accreditation process
1、实验室调查研究阶段。
Investigation of phase 1, laboratory.
实验室相关工作人员查阅资料,了解背景、理解认可带来的意义和好处,以及认可所需的投入包括资金、人力和物力。
Laboratory staff access to information, understand the background, significance and benefits brought about by the understanding of recognition, and investment approval required including funds, manpower and material resources.
经过充分酝酿和讨论,实验室管理层研究决定申请认可,加入国家实验室认可体系。
After full deliberation and discussion, the laboratory management research decided to apply for accreditation, joined the National Laboratory Accreditation system.
这一阶段不是可以缺少的,只有经过了解背景知识, 机构管理层的研究讨论,形成决议后,才能在申请认可过程中,克服各种困难,集合机构所有的资源,特别是人力资源,才能真正作到通过实验室认可这个途径,提高实验室的管理水平和技术能力。
This stage can not be missing, only after understanding the background knowledge, research institutions, management's discussion, after forming the resolution, in order to apply for accreditation process, overcome various difficulties, all resource collection agencies, especially the human resource, can really do this way through the laboratory accreditation, improve the management level and technical ability of laboratory.
2、质量体系建立阶段,在这个阶段,实验室初步建立质量体系
2, the quality system establishment stage, at this stage, the preliminary establishing quality system of laboratory.
在此阶段,实验室管理层指定技术负责人、质量负责人和联系人,组织相关人员培训,包括派人员出去学习或者请认可专家来本机构进行讲课,在技术能力建设上,购买仪器和设备,进行量值溯源。将实验室运行状况文字化,形成文件,制订质量手册和程序文件。
At this stage, the laboratory management specified technical responsible person, the person in charge of quality and contacts, organize the related staff training, including sending people out or ask the experts to the recognition of learning institutions in lectures, technical ability on construction, the purchase of instruments and equipment, the value of quantity traceability. The operation status of laboratory words, form a file, make the quality handbook and procedure document.
对有些方法、仪器设备使用编写作业指导书,形成下一层次的文件。这样,初步建立了质量体系
The use of written instructions to some methods, instruments and equipment, the formation of a hierarchical file. So, initially established a quality system.
体系建立后,试运行,进行一次内部评审,将内审结果作为输出,进行一次全要素的管理评审,以评价质量体系的有效性。
System is established, the trial operation, carry out an internal review, the audit results as output, a total factor of management review, in order to evaluate the effectiveness of the quality system.
对内审和管理评审的结果,按照 PDCA 的工作思路,即 P(Plan) 计划、 D(Do) 执行、 (Check) 检查和A(Action) 实施改进,以便对质量体系不断完善和持续改进。
On the internal audit and management review results, work in accordance with the idea of PDCA, namely P (Plan), D (Do) implementation plan, (Check) examination and A (Action) implementation of improvement, so that the quality system of continuous improvement and continuous improvement.
3、填写申请书阶段。
3, filling out the application stage.
按照认可机构的相关要求,填写申请书和附表,全面描述实验室的检测、校准能力,以及提供证明其能力的依据。这段时间是实验室管理层学习 ISO 15189,真正理解和掌握标准。
In accordance with the relevant requirements of accreditation bodies, fill out the application form and the schedule, a comprehensive description of laboratory testing, calibration capability, and provides a basis to prove its ability. This time is the management of the laboratory study of ISO 15189, to understand and master the standard.
以质量手册为依据,将实际工作过程形成文件,制订程序 (Plan);运行程序 (Do),发现实际状况与程序不符合 (Check),不符合项越多,进步越快,理会越深入;采取纠正措施,解决不合适的地方 (Action), 进行跟踪审核等。
To the quality manual as the basis, the actual work process documented, procedures (Plan); operation procedure (Do), finds the actual condition and the program doesn't fit (Check), do not accord with the more progress sooner, ignore, more thorough; take corrective measures, to solve the wrong place (Action), tracking audit etc..
只有如此,实验室才能了解到标准的精髓,真正掌握标准,才能将标准为我所用,全面提高实验室的管理水平和技术能力,真正做到与国际接轨。
Only so, can understand the essence of the laboratory standard, truly grasp the standard can be used, standard, comprehensively improve the management level and technical ability of laboratory, truly and international standards.