【導(dǎo)讀】實(shí)驗(yàn)室或其所在的組織應(yīng)是一個(gè)能夠承擔(dān)法律責(zé)任的實(shí)體。理機(jī)構(gòu)或提供認(rèn)可的組織的需求。時(shí)或移動(dòng)設(shè)施中進(jìn)行的工作。實(shí)，應(yīng)界定該駔織中參與檢測和(或)校準(zhǔn)或?qū)z測和(或)校準(zhǔn)有影響的關(guān)鍵人員的職責(zé)。商貿(mào)營銷或財(cái)務(wù)部門，不對(duì)實(shí)驗(yàn)室滿足本標(biāo)準(zhǔn)的要求產(chǎn)生不良影響。注2：如果實(shí)驗(yàn)室希望作為第三方實(shí)驗(yàn)室得到認(rèn)可，應(yīng)能證明其公正性。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。檢測或校準(zhǔn)實(shí)驗(yàn)室不應(yīng)參與任何損害其判斷獨(dú)立性和檢測或校準(zhǔn)誠信度的活動(dòng)。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)；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；

　　

【正文】 work。 d) 必要時(shí) ,通知客戶並取消工作 。 where necessary, the customer is notified and work is recalled。 e) 確定批準(zhǔn)恢復(fù)工作的職責(zé) . the responsibility for authorizing the resumption of work is defined. 注 : 對(duì)質(zhì)量體系或檢測和 (或 )校準(zhǔn)活動(dòng)的不符合工作或問題的鑒別 ,可能在質(zhì)量體系和技術(shù)運(yùn)作的各個(gè)環(huán)節(jié)進(jìn)行 ,例如客戶抱怨、質(zhì)量控制、儀器校準(zhǔn)、消耗材料的核查、對(duì)員工的考察或監(jiān)督、檢測報(bào)告和校準(zhǔn)證書的核查 、管理評(píng)審和內(nèi)部或外部審核 . NOTE Identification of nonconforming work or problems with the management system or with testing and/or calibration activities can occur at various places within the management system and technical operations. Examples are customer plaints, quality control, instrument calibration, checking of consumable materials, staff observations or supervision, test report and calibration certificate checking, management reviews and internal or external audits. 當(dāng)評(píng)價(jià)表明不符合工作可能再度發(fā)生 ,或?qū)?shí)驗(yàn)室的運(yùn)作對(duì)其政策和程序的 符合性産生懷疑時(shí) , 應(yīng)立即執(zhí)行 中規(guī)定的糾正措施程序 . Where the evaluation indicates that the nonconforming work could recur or that there is doubt about the pliance of the laboratory39。s operations with its own policies and procedures, the corrective action procedures given in shall be promptly followed. 改進(jìn) Improvement 實(shí)驗(yàn)室應(yīng)通過實(shí)施質(zhì)量方針和目檔、應(yīng)用審核結(jié)果、數(shù)據(jù)分析、糾正措施和預(yù)防措施以及管理評(píng)審來持續(xù)改進(jìn)管理體系的有效性 . The laboratory shall continually improve the effectiveness of its management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. 記錄控制 Control of records 總則 General 實(shí)驗(yàn)室應(yīng)建立和維持識(shí)別、收集、索引、存取、存檔、存放、維護(hù)和清理質(zhì)量記錄和技術(shù)記錄的程序 . 質(zhì)量記錄應(yīng)包括來自內(nèi)部審核和管理評(píng)審的報(bào)告及糾正和預(yù)防措施的記錄 . The laboratory shall establish and maintain procedures for identification, collection, indexing, access, filing, storage, maintenance and disposal of quality and technical records. Quality records shall include reports from internal audits and management reviews as well as records of corrective and preventive actions. 所有記錄應(yīng)清晰明瞭 ,並以便於存取的方式存放和保存在具有防止損壞、變質(zhì)、丟失等適宜環(huán)境的設(shè)施中 .應(yīng)規(guī)定記錄的保存期 . All records shall be legible and shall be stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss. Retention times of records shall be established. 注 :記錄可存放於任何形式的載體上 ,例如硬拷貝或電子媒體 . NOTE Records may be in any media, such as hard copy or electronic media. 所有記錄應(yīng)予以安全保護(hù)和保密 . All records shall be held secure and in confidence. 實(shí)驗(yàn)室應(yīng)有程序來保護(hù)和備份以上形式存儲(chǔ)的記錄 ,並防止未經(jīng)授予權(quán)的侵入或修改 . The laboratory shall have procedures to protect and backup records stored electronically and to prevent unauthorized access to or amendment of these records. 技術(shù)記錄 Technical records 實(shí)驗(yàn)室應(yīng)將原始觀察記錄、導(dǎo)出數(shù)據(jù)、開展跟蹤審核的足夠信息、校準(zhǔn)記錄、員工記錄以及發(fā)出的每份檢測報(bào)告或校準(zhǔn)證書的副本規(guī)定的時(shí)間保存 .如可能 ,每項(xiàng)檢測或校準(zhǔn)的記錄應(yīng)包含足夠的信息 ,以便識(shí)別不確定度的影響因素 ,並保證該檢測或校準(zhǔn)在盡可能接近原條件的情況下能夠複現(xiàn) .記錄應(yīng)包括負(fù)責(zé)抽樣的人員、從事各項(xiàng)檢測和 (或 )校準(zhǔn)的人員和結(jié)果校核人員的標(biāo)識(shí) . The laboratory shall retain records of original observations, derived data and sufficient information to establish an audit trail, calibration records, staff records and a copy of each test report or calibration certificate issued, for a defined period. The records for each test or calibration shall contain sufficient information to facilitate, if possible, identification of factors affecting the uncertainty and to enable the test or calibration to be repeated under conditions as close as possible to the original. The records shall include the identity of personnel responsible for the sampling, performance of each test and/or calibration and checking of results. 注 1:在某些領(lǐng)域 ,保留所有的原始觀察記錄也許是不可能或不實(shí)際的 . NOTE 1 In certain fields it may be impossible or impractical to retain records of all original observations. 注 2: 技術(shù)記錄是進(jìn)行檢測和 (或 )校準(zhǔn)所得數(shù)據(jù) (見 )和信息的累積 ,它們表明檢測和 (或 )校準(zhǔn)是否達(dá)到了規(guī)定的質(zhì)量或規(guī)定的過程參數(shù) .技術(shù)記錄可包括表格、合同、工作單、工作手冊(cè)、核查表、工作筆記、控制圖、外部和內(nèi)部的檢測報(bào)告及校準(zhǔn)證書、客戶信函、文件和反饋 . NOTE 2 Technical records are accumulations of data (see ) and information which result from carrying out tests and/or calibrations and which indicate whether specified quality or process parameters are achieved. They may include forms, contracts, work sheets, work books, check sheets, work notes, control graphs, external and internal test reports and calibration certificates, customers39。 notes, papers and feedback. 觀察結(jié)果、數(shù)據(jù)和計(jì)算應(yīng)在工作時(shí)予以記錄 ,並能的按照特定任務(wù)分類識(shí)別 . Observations, data and calculations shall be recorded at the time they are made and shall be identifiable to the specific task. 當(dāng)記錄中出現(xiàn)錯(cuò)誤時(shí) ,每一錯(cuò)誤應(yīng)劃改 ,不可擦塗 掉 ,以免字跡模糊或消失 ,並將正確值填寫在其旁邊 .對(duì)記錄的所有改動(dòng)應(yīng)有改動(dòng)人的簽名或簽名縮寫 .對(duì)電子存儲(chǔ)的記錄也應(yīng)採取同等措施 ,以避免原始數(shù)據(jù)的丟失或改動(dòng) . When mistakes occur in records, each mistake s hall be crossed out, not erased, made illegible or deleted, and The correct value entered alongside. All such alterations to records s hall be signed or initialled by the person making the correction. In the case of records stored electronically, equivalent measures shall be taken to avoid loss or change of original data. 內(nèi)部審核 Internal audits 實(shí)驗(yàn)室應(yīng)根據(jù)預(yù)定的日程表和程序 ,定期地對(duì)其活動(dòng)進(jìn)行內(nèi) 部審核 ,以驗(yàn)證其運(yùn)作持續(xù)符合質(zhì)量體系和本標(biāo)準(zhǔn)的要求 .內(nèi)部審核計(jì)劃應(yīng)涉及質(zhì)量體系的全部要素 ,包括檢測和 (或 )校準(zhǔn)活動(dòng) .質(zhì)量主管負(fù)責(zé)按照日程表的要求和管理層的需要策劃和組織內(nèi)部審核 .審核應(yīng)由經(jīng)過培訓(xùn)和具備資格的人員來執(zhí)行 ,只要資源允許 ,審核人員應(yīng)獨(dú)立于被審核的活動(dòng) . The laboratory shall periodically, and in accordance with a predetermined schedule and procedure, conduct internal audits of its activities to verify that its operations continue to ply with the requirements of the management system and this International Standard. The internal audit programme shall address all elements of the management system, including the testing and/or calibration activities. It is the responsibility of the quality manager to plan and anize audits as required by the schedule and requested by management. Such audits shall be carried out by trained and qualified personnel who are, wherever resources permit, independent of the activity to be audited. 注 : 內(nèi)部審核的周期通常爲(wèi)一年 . NOTE The cycle for internal auditing should normally be pleted in one year. 總則 General 決定實(shí)驗(yàn)室檢測和 (或 )