【文章內(nèi)容簡(jiǎn)介】 (或 )修訂標(biāo)識(shí)、頁(yè)碼、總頁(yè)數(shù)或表示文件結(jié)束的標(biāo)記和發(fā)佈機(jī)構(gòu) . 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(yīng)由原審查責(zé)任人進(jìn)行審查和批準(zhǔn) .被指定的人員應(yīng)獲得進(jìn)行審查和批準(zhǔn)所依據(jù)的有關(guān)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(nèi)容應(yīng)在文件或適當(dāng)?shù)母郊袠?biāo)明 . Where practicable, the altered or new text shall be identified in the document or the appropriate attachments. 如果實(shí)驗(yàn)室的文件控制度允許在文件再版之前對(duì)文件進(jìn)行手寫修改 ,則應(yīng)確定修改的程序和權(quán)限 .修改之處應(yīng)有清晰的標(biāo)注、簽名縮寫並注明日期 .修訂的文件應(yīng)儘快地正式發(fā)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(yīng)制定程序來描述如何更改和控制保存在計(jì)算機(jī)系統(tǒng)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(biāo)書和合同的評(píng)審 Review of requests, tenders and contracts 實(shí)驗(yàn)室應(yīng)建立和維持評(píng)審客戶要求、標(biāo)書和合同的程序 .這些爲(wèi)簽訂檢測(cè)和 (或 )校準(zhǔn)合同而進(jìn)行評(píng)審的政策和程序應(yīng)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(duì)包括所用方法在內(nèi)的要求應(yīng)予適當(dāng)規(guī)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(shí)驗(yàn)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(dāng)?shù)?、能滿足客戶要求的檢測(cè)和 (或 )校準(zhǔn)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(biāo)書與合同之間的任何差異 ,應(yīng)在工作開始之前得到解決 .每項(xiàng)合同應(yīng)得到實(shí)驗(yàn)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(duì)要求、標(biāo)書和合同的評(píng)審需以可行和有效的方式進(jìn)行 ,並考慮財(cái)務(wù)、法律和時(shí)間安排等方面的影響 .對(duì)內(nèi)部客戶的要求、標(biāo)書和合同的審查可用簡(jiǎn)化方式進(jìn)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(duì)實(shí)驗(yàn)室能力的評(píng)審 ,應(yīng)證實(shí)實(shí)驗(yàn)室具備了必要的物力、人力和信息資源 ,且實(shí)驗(yàn)室人員對(duì)所從事的檢測(cè)和 (或 )校準(zhǔn)具有必要的技能和專業(yè)技術(shù) .該評(píng)審也可包括以前參加的實(shí)驗(yàn)室間比對(duì)或能力驗(yàn)證的結(jié)果和 (或 )爲(wèi)確定測(cè)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(yàn)性檢測(cè)或校準(zhǔn)計(jì)劃的結(jié)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(wèi)客房提供檢測(cè)和 (或 )校準(zhǔn)服務(wù)的任何書面的或口頭的協(xié)議 . NOTE 3 A contract may be any written or oral agreement to provide a customer with testing and/or calibration services. 應(yīng)保存包括任何重大變化在內(nèi)的評(píng)審記錄 .在執(zhí)行合同期間 ,就客戶的要求或工作結(jié)果與客戶進(jìn)行討論的有關(guān)記錄 ,也應(yīng)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(duì)例行的和其他簡(jiǎn)單任務(wù)的評(píng)審 ,由實(shí)驗(yàn)室中 負(fù)責(zé)合同工作的人員注明日期並加以標(biāo)識(shí)(如簽名縮寫 )即寫 .對(duì)於重復(fù)性的例行工作 ,如果客戶要求不變 ,僅需在初期調(diào)查階段 ,或在與客戶的總協(xié)議下對(duì)持續(xù)進(jìn)行的例行工作合同批準(zhǔn)時(shí)進(jìn)行評(píng)審 .對(duì)於新的、複雜的或先進(jìn)的檢測(cè)和 (或 )校準(zhǔn)任務(wù) ,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(píng)審的內(nèi)容應(yīng)包括被實(shí)驗(yàn)室分包出去的所有工作 . The review shall also cover any work that is subcontracted by the laboratory. 對(duì)合同的任何偏離均應(yīng)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(yīng)重復(fù)進(jìn)行同樣的合同評(píng)審過程 ,並將所有修改內(nèi)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(cè)和校準(zhǔn)的分包 Subcontracting of tests and calibrations 當(dāng)實(shí)驗(yàn)室由於未預(yù)料的原因 (如工作量 、需要更多專業(yè)技術(shù)或暫不具備能力 )或持續(xù)性的原因 (如通過長(zhǎng)期分包、代理或特殊協(xié)議 )需將工作分包時(shí) ,應(yīng)分包給合格的分包方 ,例如能夠遵照本標(biāo)準(zhǔn)要求進(jìn)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(shí)驗(yàn)室應(yīng)將分包安排以書面形式通知客戶 ,適當(dāng)時(shí)應(yīng)得到客