建立設備質量管理體系

Establishing the system of equipment quality management

⑴ 建立設備管理組織

The establishment of equipment management organization

設備管理組織有質量管理部門、技術部門和支持服務部門構成。根據設備管理工作的特點、范圍和工作量，確定管理人員、核查人員、操作人員和服務人員的職責、權力與相互關系，使各項管理職能分解落實到相關部門、相關崗位，盡量做到職責清晰，分工明確。

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 制定設備管理程序

The development of equipment management program

設備管理程序是檢測機構實行設備管理的途徑。通過建立相應的程序文件，明確設備管理活動的過程、步驟、內容和所有環節，使各項工作都有章可循。

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 編寫設備作業指導書

The preparation of equipment operating instructions

設備作業指導書是指導檢測人員操作設備的規范性文件。一般設備可按照說明書操作，大型、復雜的儀器或操作人員流動性大、性能不穩定的設備需編寫作業指導書或操作規程。

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.

健全設備質量管理制度

Improving the system of equipment quality management

⑴ 評審制度

The evaluation system

評審是添置或處置設備的一項前期工作，主要從設備的適應性、可靠性、經濟性、安全性、維護性等方面綜合分析，目的是為了合理配置設備資源，發揮設備的最佳效益。對于大型、貴重、精密的儀器需進行可行性認證，達到技術上先進，性能上可靠，工作上需要，經濟上合理;對于租借、維修、淘汰的設備，以及小型或輔助設備，應進行必要的評審。

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 驗收制度

The approval system

驗收是保證添置或維修的設備正常運行的一個重要手段。儀器設備的開箱拆封應在設備管理員、操作人員、供應人員等有關人員都在場時進行，驗收過程中，應對設備評審要求、訂貨合同和裝箱清單，逐一清點，并做好記錄。對于大型、精密的儀器設備，安裝調試后，還應通過一定時期(合同期內)的試運行，根據實際運行效果和各項指標測試結論，確認無質量問題方可驗收。儀器設備經驗收后方可辦理移交手續，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

為延長設備的使用壽命，充分發揮其作用，必須建立設備使用制度，對人員、工作環境、設施條件、維修、保養等提出明確要求做作出規定。

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 記錄制度

The recording system

記錄是建立完整的設備檔案，保證設備正常運銷的一項基礎工作，對設備管理的責任落實、制度執行及管理程序的運行和完善都很重要。每臺設備從計劃選購到淘汰都應保持完整的記錄，內容除一般性設備檔案外，還應設備購置、檢定、維護的計劃，論證意見或報告，調試驗收報告，設備使用和校準記錄，儀器故障和維修記錄，運行狀況，性能變化，異常現象及整改情況等。

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

核查是證實設備符合技術規范，避免影響檢測結果的一項重要舉措。操作人員在使用儀器前后，應按照技術規程和說明書，采取自校、比對等方法，校準主要性能參數，保證儀器的準確度和量程范圍符合要求。質量管理組應定期檢查設備的使用、記錄等情況，對新購置或租借的設備、現場檢測使用的設備、使用頻繁或漂移較大的設備，應制定核查程序，使設備保持良好的工作狀態。

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.