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实验室仪器设备管理注意事项汇总建立设备质量管理体系 Establishing the system of equipment quality management ⑴ 建立设备管理组织 The establishment of equipment management organization 设备管理组织有质量管理部门、技术部门和支持服务部门构成。根据设备管理工作的特点、范围和工作量，确定管理人员、核查人员、操作人员和服务人员的职责、权力与相互关系，使各项管理职能分解落实到相关部门、相关岗位，尽量做到职责清晰，分工明确。 The equipment management organization is composed of the quality management department, the technical department and the support service department. According to the characteristics of equipment management, the scope of work and work, determine the managers, inspectors, operators and service personnel responsibilities, powers and mutual relations, so that the management function decomposition to the relevant departments, the relevant posts, try to make clear responsibility, clear division of labor. ⑵ 制定设备管理程序 The development of equipment management program 设备管理程序是检测机构实行设备管理的途径。通过建立相应的程序文件，明确设备管理活动的过程、步骤、内容和所有环节，使各项工作都有章可循。 The equipment management program is the way to implement the equipment management of the inspection organization. Through the establishment of the corresponding procedures, clear equipment management process, steps, contents and all the links, so that the work of rule-based. ⑶ 编写设备作业指导书 The preparation of equipment operating instructions 设备作业指导书是指导检测人员操作设备的规范性文件。一般设备可按照说明书操作，大型、复杂的仪器或操作人员流动性大、性能不稳定的设备需编写作业指导书或操作规程。 The equipment work instruction is a standard document that guides the inspectors' operating equipment. General equipment can operate in accordance with instructions. Large and complex instruments or operators with large fluidity and unstable performance need to write operation instructions or operation rules. 健全设备质量管理制度 Improving the system of equipment quality management ⑴ 评审制度 The evaluation system 评审是添置或处置设备的一项前期工作，主要从设备的适应性、可靠性、经济性、安全性、维护性等方面综合分析，目的是为了合理配置设备资源，发挥设备的最佳效益。对于大型、贵重、精密的仪器需进行可行性认证，达到技术上先进，性能上可靠，工作上需要，经济上合理;对于租借、维修、淘汰的设备，以及小型或辅助设备，应进行必要的评审。 Review is a preliminary work for acquiring or disposing equipment, mainly from the aspects of adaptability, reliability, economy, safety and maintainability of equipment, so as to rationally configure equipment resources and give full play to the best benefits of equipment. For large, valuable and precise instruments, we need to carry out feasibility certification, which is technically advanced, reliable in performance, and economically reasonable in operation. For rental, repair and elimination of equipment, and small or auxiliary equipment, we should make necessary reviews. ⑵ 验收制度 The approval system 验收是保证添置或维修的设备正常运行的一个重要手段。仪器设备的开箱拆封应在设备管理员、操作人员、供应人员等有关人员都在场时进行，验收过程中，应对设备评审要求、订货合同和装箱清单，逐一清点，并做好记录。对于大型、精密的仪器设备，安装调试后，还应通过一定时期(合同期内)的试运行，根据实际运行效果和各项指标测试结论，确认无质量问题方可验收。仪器设备经验收后方可办理移交手续，交付使用。 Acceptance is an important means to ensure the normal operation of the equipment that has been added or maintained. Instrument and equipment out of the box should be opened in the presence of all the equipment administrator and operator, supply personnel and other relevant personnel, approval process, deal with equipment requirements, contract review and packing list, one by one count, and record. For large and precise instruments and equipment, after installation and commissioning, it is also necessary to confirm that no quality problems can be checked according to the actual operation results and the test results of various indicators through a trial run in a certain period (within the contract period). After acceptance of the instrument and equipment, the handover procedure can be handled and the equipment can be delivered and used. ⑶ 使用制度 The use of the system 为延长设备的使用寿命，充分发挥其作用，必须建立设备使用制度，对人员、工作环境、设施条件、维修、保养等提出明确要求做作出规定。 In order to extend the service life of the equipment and give full play to its role, we must establish a system for the use of equipment, and make clear rules for personnel, working environment, facilities, maintenance and so on. ⑷ 记录制度 The recording system 记录是建立完整的设备档案，保证设备正常运销的一项基础工作，对设备管理的责任落实、制度执行及管理程序的运行和完善都很重要。每台设备从计划选购到淘汰都应保持完整的记录，内容除一般性设备档案外，还应设备购置、检定、维护的计划，论证意见或报告，调试验收报告，设备使用和校准记录，仪器故障和维修记录，运行状况，性能变化，异常现象及整改情况等。 Record is a basic work for establishing complete equipment archives and ensuring the normal operation and sale of equipment. It is very important for the implementation of the responsibility of equipment management, the implementation of system and the operation and improvement of management procedures. Each device should be eliminated from the purchase plan to maintain the integrity of the records, in addition to the general equipment archives, should also be the purchase of equipment, test, maintenance plans, opinions or reports, commissioning acceptance report, equipment use and calibration records, equipment failure and maintenance records, operation status, performance changes, and abnormal phenomenon rectification etc.. ⑸ 核查制度 The verification system 核查是证实设备符合技术规范，避免影响检测结果的一项重要举措。操作人员在使用仪器前后，应按照技术规程和说明书，采取自校、比对等方法，校准主要性能参数，保证仪器的准确度和量程范围符合要求。质量管理组应定期检查设备的使用、记录等情况，对新购置或租借的设备、现场检测使用的设备、使用频繁或漂移较大的设备，应制定核查程序，使设备保持良好的工作状态。 Verification is an important measure to verify that the equipment meets the technical specifications and avoids the impact of the test results. Before and after using the instrument, the operator should calibrate the main performance parameters according to the technical regulations and instructions, and calibrate the main performance parameters, so as to ensure the accuracy and range of the instrument meet the requirements. The quality management group should regularly check the use and record of equipment. The verification procedures should be made for new purchased or leased equipment, on-site testing equipment and frequent or drifting equipment, so that the equipment can maintain good working condition. |
