iso17025中英文对照内容摘要:

(或 )修訂標識、頁碼、總頁數或表示文件結束的標記和發佈機構 . Management system documents generated by the laboratory shall be uniquely identified. Such identification shall include the date of issue and/or revision identification, page numbering, the total number of pages or a mark to signify the end of the document, and the issuing authority(ies). 文件變更 Document changes 除非另有特別指定 , 文件的變更應由原審查責任人進行審查和批准 .被指定的人員應獲得進行審查和批准所依據的有關背景資料 . Changes to documents shall be reviewed and approved by the same function that performed the original review unless specifically designated otherwise. The designated personnel shall have access to pertinent background information upon which to base their review and approval. 若可行 ,更改的或新的內容應在文件或適當的附件中標明 . Where practicable, the altered or new text shall be identified in the document or the appropriate attachments. 如果實驗室的文件控制度允許在文件再版之前對文件進行手寫修改 ,則應確定修改的程序和權限 .修改之處應有清晰的標注、簽名縮寫並注明日期 .修訂的文件應儘快地正式發佈 . If the laboratory39。 s document control system allows for the amendment of documents by hand pending the reissue of the documents, the procedures and authorities for such amendments shall be defined. Amendments shall be clearly marked, initialled and dated. A revised document shall be formally reissued as soon as practicable. 應制定程序來描述如何更改和控制保存在計算機系統中的文件 . Procedures shall be established to describe how changes in documents maintained in puterized systems are made and controlled. 要求、標書和合同的評審 Review of requests, tenders and contracts 實驗室應建立和維持評審客戶要求、標書和合同的程序 .這些爲簽訂檢測和 (或 )校準合同而進行評審的政策和程序應確保 : The laboratory shall establish and maintain procedures for the review of requests, tenders and contracts. The policies and procedures for these reviews leading to a contract for testing and/or calibration shall ensure that: a) 對包括所用方法在內的要求應予適當規定 ,形成文件 ,並易於理解 (見 )。 the requirements, including the methods to be used, are adequately defined, documented and understood (see )。 b) 實驗室有能力和資源滿足這些要求。 the laboratory has the capability and resources to meet the requirements。 c) 選擇適當的、能滿足客戶要求的檢測和 (或 )校準方法 (見 )。 the appropriate test and/or calibration method is selected and is capable of meeting the customers39。 requirements (see ). 客戶要求或標書與合同之間的任何差異 ,應在工作開始之前得到解決 .每項合同應得到實驗室和客戶雙方的接受 . Any differences between the request or tender and the contract shall be resolved before any work mences. Each contract shall be acceptable both to the laboratory and the customer. 注 1: 對要求、標書和合同的評審需以可行和有效的方式進行 ,並考慮財務、法律和時間安排等方面的影響 .對內部客戶的要求、標書和合同的審查可用簡化方式進行 . NOTE 1 The request, tender and contract review should be conducted in a practical and efficient manner, and the effect of financial, legal and time schedule aspects should be taken into account. For internal customers, reviews of requests, tenders and contracts can be performed in a simplified way. 注 2: 對實驗室能力的評審 ,應證實實驗室具備了必要的物力、人力和信息資源 ,且實驗室人員對所從事的檢測和 (或 )校準具有必要的技能和專業技術 .該評審也可包括以前參加的實驗室間比對或能力驗證的結果和 (或 )爲確定測量不確定度、檢出限、置信限等而使用的已知值樣品或物品所做的試驗性檢測或校準計劃的結果 . NOTE 2 The review of capability should establish that the laboratory possesses the necessary physical, personnel and information resources, and that the laboratory39。 s personnel have the skills and expertise necessary for the performance of the tests and/or calibrations in question. The review may also enpass results of earlier participation in interlaboratory parisons or proficiency testing and/or the running of trial test or calibration programmes using samples or items of known value in order to determine uncertainties of measurement, limits of detection, confidence limits, etc. 注 3:合同可以是爲客房提供檢測和 (或 )校準服務的任何書面的或口頭的協議 . NOTE 3 A contract may be any written or oral agreement to provide a customer with testing and/or calibration services. 應保存包括任何重大變化在內的評審記錄 .在執行合同期間 ,就客戶的要求或工作結果與客戶進行討論的有關記錄 ,也應予保存 . Records of reviews, including any significant changes, shall be maintained. Records shall also be maintained of pertinent discussions with a customer relating to the customer39。 s requirements or the results of the work during the period of execution of the contract. 注 :對例行的和其他簡單任務的評審 ,由實驗室中 負責合同工作的人員注明日期並加以標識(如簽名縮寫 )即寫 .對於重復性的例行工作 ,如果客戶要求不變 ,僅需在初期調查階段 ,或在與客戶的總協議下對持續進行的例行工作合同批准時進行評審 .對於新的、複雜的或先進的檢測和 (或 )校準任務 ,則需保存較全面的記錄 . NOTE For review of routine and other simple tasks, the date and the identification (. the initials) of the person in the laboratory responsible for carrying out the contracted work are considered adequate. For repetitive routine tasks, the review need be made only at the initial enquiry stage or on granting of the contract for on going routine work performed under a general agreement with the customer, provided that the customer39。 s requirements remain unchanged. For new, plex or advanced testing and/or calibration tasks, a more prehensive record should be maintained. 評審的內容應包括被實驗室分包出去的所有工作 . The review shall also cover any work that is subcontracted by the laboratory. 對合同的任何偏離均應通知客戶 . The customer shall be informed of any deviation from the contract. 工作開始後如果需要修改合同 ,應重復進行同樣的合同評審過程 ,並將所有修改內容通知所有受到影響的人員 . If a contract needs to be amended after work has menced, the same contract review process shall be repeated and any amendments shall be municated to all affected personnel. 檢測和校準的分包 Subcontracting of tests and calibrations 當實驗室由於未預料的原因 (如工作量 、需要更多專業技術或暫不具備能力 )或持續性的原因 (如通過長期分包、代理或特殊協議 )需將工作分包時 ,應分包給合格的分包方 ,例如能夠遵照本標準要求進行工作的分包方 . When a laboratory subcontracts work, whether because of unforeseen reasons (. workload, need for further expertise or temporary incapacity) or on a continuing basis (. through permanent subcontracting, agency or franchising arrangements), this work shall be placed with a petent subcontractor. A petent subcontractor is one that, for example, plies with this International Standard for the work in question. 實驗室應將分包安排以書面形式通知客戶 ,適當時應得到客。
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