【正文】 anual shall include or make reference to the supporting procedures including technical procedures. It shall outline the structure of the documentation used in the management system. 質(zhì)量手冊(cè)中應(yīng) 界定技術(shù)管理層和質(zhì)量主管的作用和責(zé)任包括確保遵循本標(biāo)準(zhǔn)的責(zé)任 . The roles and responsibilities of technical management and the quality manager, including their responsibility for ensuring pliance with this International Standard, shall be defined in the quality manual. 當(dāng)策劃和實(shí)施 管理體系的變更時(shí) ,最高管理者應(yīng)確保維持管理體系的完整性 . Top management shall ensure that the integrity of the management system is maintained when changes to the management system are planned and implemented. 文件控制 Document control 總則 General 實(shí)驗(yàn)室應(yīng)建立和維持程序來(lái)控制構(gòu) 成其質(zhì)量體系的所有文件 (內(nèi)部制定或來(lái)自外部的 ),諸如規(guī)章、標(biāo)準(zhǔn)、其他規(guī)範(fàn)化文件、檢測(cè)和 (或 )校準(zhǔn)方法 ,以及圖紙、軟件、規(guī)範(fàn)、指導(dǎo)書(shū)和手冊(cè) . The laboratory shall establish and maintain procedures to control all documents that form part of its management system (internally generated or from external sources), such as regulations, standards, other normative documents, test and/or calibration methods, as well as drawings, software, specifications, instructions and manuals. 注 1:本文中的 “文件 ”可以是方針聲明、程序、規(guī)範(fàn)、校準(zhǔn)表格、圖表、教科書(shū)、張貼品、備忘錄、軟件、圖紙、計(jì)劃等 . 這些文件可能承載在各種載體上 ,進(jìn)化論是硬拷貝或是電子媒體 ,並且可以是數(shù)字的、模擬的、攝影的或書(shū)面的形 式 . NOTE 1 In this context “document” could be policy statements, procedures, specifications, calibration tables, charts, text books, posters, notices, memoranda, software, drawings, plans, etc. These may be on various media, whether hard copy or electronic, and they may be digital, analog, photographic or written. 注 2:有關(guān)檢測(cè)和校準(zhǔn)數(shù)據(jù)的控制在 條中規(guī)定 .記錄的控制在 條中規(guī)定 . NOTE 2 The control of data related to testing and calibration is covered in . The control of records is covered in . 文件的批準(zhǔn)和發(fā)布 Document approval and issue 凡作爲(wèi)質(zhì)量體系組成部分發(fā)給實(shí)驗(yàn)室人員的所有文件 ,在發(fā)佈之前應(yīng)由授權(quán)人員審查並批準(zhǔn)使用 .應(yīng)建立識(shí)別質(zhì)量體系中文件當(dāng)前的修訂狀態(tài)和分發(fā)的控制清單或等同的文件控制程序並易於查閱 ,以防止使用無(wú)效和 (或 )作廢的文件 . All documents issued to personnel in the laboratory as part of the management system shall be reviewed and approved for use by authorized personnel prior to issue. A master list or an equivalent document control procedure identifying the current revision status and distribution of documents in the management system shall be established and shall be readily available to preclude the use of invalid and/or obsolete documents. 所用程序應(yīng)確保 : The procedure(s) adopted shall ensure that: a) 在對(duì)實(shí)驗(yàn)室有效運(yùn)作起重要作用的所有作業(yè)場(chǎng)所 ,都能得到相應(yīng)文件的授權(quán)版本 。 and e) 實(shí)驗(yàn)室管理層對(duì)遵循本標(biāo)準(zhǔn)及持續(xù)改進(jìn)管理體系的承諾 . the laboratory management39。 d) 要求實(shí)驗(yàn) 室所有與檢測(cè)和校準(zhǔn)活動(dòng)有關(guān)的人員熟悉與之相關(guān)的質(zhì)量文件 ,並在工作中執(zhí)行這些政策和程序 。 c) 與質(zhì)量有關(guān)的管理體系的目的 。 the management’s statement of the laboratory39。s mitment to good professional practice and to the quality of its testing and calibration in servicing its customers。s management system policies related to quality, including a quality policy statement, shall be defined in a quality manual (however named). The overall objectives shall be established, and shall be reviewed during management review. The quality policy statement shall be issued under the authority of top management. It shall include at least the following: a) 實(shí)驗(yàn)室管理層對(duì)良好職業(yè)行爲(wèi)和爲(wèi)客戶提供檢測(cè)和校準(zhǔn)服務(wù)質(zhì)量的承諾 。 NOTE Individuals may have more than one function and it may be impractical to appoint deputies for every function. 最高管理者應(yīng)確保在實(shí)驗(yàn)室內(nèi)部建立適宜的溝通機(jī)制，并就與管理體系有效性的事宜進(jìn)行溝通。 k) 確保實(shí)驗(yàn)室人員理解他們所從事的活動(dòng)的相互關(guān)系和重要性，以及如何為管理體系質(zhì)量目標(biāo)的實(shí)現(xiàn)做出貢獻(xiàn)。 j) 指定關(guān)鍵管人員的代理人 (見(jiàn)注 )。質(zhì)量主管應(yīng)有直接渠道接觸決定實(shí)驗(yàn)室政策和資源的最高管理層； appoint a member of staff as quality manager (however named) who, irrespective of other duties and responsibilities, shall have defined responsibility and authority for ensuring that the management system related to quality is implemented and followed at all times。 h) 有技術(shù)管理層，全面負(fù)責(zé)技術(shù)運(yùn)作和確保實(shí)驗(yàn)室運(yùn)作 質(zhì)量所需的資源； have technical management which has overall responsibility for the technical operations and the provision of the resources needed to ensure the required quality of laboratory operations。 f) 規(guī)定所有對(duì)檢測(cè)和 (或 )校準(zhǔn)質(zhì)量有影響的所 有管理、操作和核查人員的職責(zé)、權(quán)力和相互關(guān)系； specify the responsibility, authority and interrelationships of all personnel who manage, perform or verify work affecting the quality of the tests and/or calibrations。 d) 有政策和程序以避免卷入任何可能會(huì)降低其能力、公正性、判斷或運(yùn)作誠(chéng)實(shí)性的可信程度的活動(dòng)； have policies and procedures to avoid involvement in any activities that would diminish confidence in its petence, impartiality, judgement or operational integrity。 c) 有保護(hù)客戶的機(jī)密信息和所有權(quán)的政策和程序，包括保護(hù)電子存儲(chǔ)和傳輸結(jié)果的程序； c) have policies and procedures to ensure the protection of its customers39。 NOTE 2 If the laboratory wishes to be recognized as a thirdparty laboratory, it should be able to demonstrate that it is impartial and that it and its personnel are free from any undue mercial, financial and other pressures which might influence their technical judgement. The thirdparty testing or calibration laboratory should not engage in any activities that may endanger the trust in its independence of judgement and integrity in relation to its testing or calibration activities. 實(shí)驗(yàn)室應(yīng)： The laboratory shall a) 有管理人員和技術(shù)人員，不考慮他們的其他職責(zé)為何，他們應(yīng)具有所需的權(quán)力和資源來(lái)履行包括實(shí)施、保持和改進(jìn)管理體系的職責(zé)，識(shí)別對(duì)管理體系或檢測(cè)和 (或 )校準(zhǔn)程序的偏離，以及采取措施預(yù)防或減少這種偏離 (見(jiàn) )； have managerial and technical personnel who, irrespective of other responsibilities, have the authority and resources needed to carry out their duties, including the implementation, maintenance and improvement of the management system, and to identify the occurrence of departures from the management system or from the procedures for performing tests and/or calibrations, and to initiate actions to prevent or minimize such departures (see also )。并且實(shí) 驗(yàn)室及其員工能夠扺御任何可能影響其技術(shù)判斷的、不正當(dāng)?shù)纳虡I(yè)、財(cái)務(wù)和其分方面的壓力。 NOTE 1 Where a laboratory is part of a larger anization, the anizational arrangements should be such that departments having conflicting interests, such as production, mercial marketing or financing do not adversely influence the laboratory39。 The management system shall