iso17025中英文对照

iso17025中英文对照 ISO/IEC 17025:2005中英文对照版 特别声明:若对本版本有疑义，请以英文版本为准。 4 管理要求 Management requirements 4.1 组织 Organization 4.1.1 实验室或其所在的组织应是一个能够承担法律责任的实体。 The laboratory or the organization of which it is part shall be an entity that can be held legally responsible. 4.1.2 实验室的职责是以符合本的要求的方式从事检测和校准，并能满足客户、法定管 理机构或提供认可的组织的需求。 It is the responsibility of the laboratory to carry out its testing and calibration activities in such a way as to meet the requirements of this International Standard and to satisfy the needs of the customer, the regulatory authorities or organizations providing recognition. 4.1.3 实验室的应覆盖实验室在固定设施内、开其固定设施的场所，或在相关的临 时或移动设施中进行的工作。 The management system shall cover work carried out in the laboratory’s permanent facilities, at sites away from its permanent facilities, or in associated temporary or mobile facilities. 4.1.4 如果实验室所在的组织还从事检测和(或)校准以外的活动，为了鉴别潜在的利益冲 实，应界定该驵织中参与检测和(或)校准或对检测和(或)校准有影响的关键人员的职责。 If the laboratory is part of an organization performing activities other than testing and/or calibration, the responsibilities of key personnel in the organization that have an involvement or influence on the testing and/or calibration activities of the laboratory shall be defined in order to identify potential conflicts of interest. 注1: 如果实验室是某个较大组织的一部分，该组织应使其有利益冲突的部门，如生产、 商贸营销或财务部门，不对实验室满足本标准的要求产生不良影响。 NOTE 1 Where a laboratory is part of a larger organization, the organizational arrangements should be such that departments having conflicting interests, such as production, commercial marketing or financing do not adversely influence the laboratory's compliance with the requirements of this International Standard. 注2: 如果实验室希望作为第三方实验室得到认可，应能证明其公正性。并且实验室及其 员工能够扺御任何可能影响其技术判断的、不正当的商业、财务和其分方面的压力。第三方 检测或校准实验室不应参与任何损害其判断独立性和检测或校准诚信度的活动。 NOTE 2 If the laboratory wishes to be recognized as a third-party laboratory, it should be able to demonstrate that it is impartial and that it and its personnel are free from any undue commercial, financial and other pressures which might influence their technical judgement. The third-party 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. 4.1.5 实验室应: The laboratory shall a) 有管理人员和技术人员，不考虑他们的其他职责为何，他们应具有所需的权力和资源来 履行包括实施、保持和改进管理体系的职责，识别对管理体系或检测和(或)校准程序的偏离， 以及采取措施预防或减少这种偏离(见5.2); 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 5.2); b) 有措施保证管理层和员工不受任何对工作质量有不良影响的、来自内外部的不正当的商 业、财务和其他方面的压力和影响; have arrangements to ensure that its management and personnel are free from any undue internal and external commercial, financial and other pressures and influences that m ay adversely affect the quality of their work; c) 有保护客户的机密信息和所有权的政策和程序，包括保护电子存储和传输结果的程序; c) have policies and procedures to ensure the protection of its customers' confidential information and proprietary rights, including procedures for protecting the electronic storage and transmission of results; d) 有政策和程序以避免卷入任何可能会降低其能力、公正性、判断或运作诚实性的可信程 度的活动; have policies and procedures to avoid involvement in any activities that would diminish confidence in its competence, impartiality, judgement or operational integrity; e) 确定实验室的组织和管理结构、其在母体组织中的地位，以及质量管理、技术运作和支 持服务之间的关系; define the organization and management structure of the laboratory, its place in any parent organization, and the relationships between quality management, technical operations and support services; f) 规定所有对检测和(或)校准质量有影响的所有管理、操作和核查人员的职责、权力和相互 关系; specify the responsibility, authority and interrelationships of all personnel who manage, perform or verify work affecting the quality of the tests and/or calibrations; g) 由熟悉各项检测和(或)校准的、程序、目的和结果的人员对检测和校准人员包 括在培员工进行足够的监督; provide adequate supervision of testing and calibration staff, including trainees, by persons familiar with methods and procedures, purpose of each test and/or calibration, and with the assessment of the test or calibration results; h) 有技术管理层，全面负责技术运作和确保实验室运作质量所需的资源; 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; i) 指定一名人员作为质量主管(不论如何称谓)，不管现有的其他职责，应赋予其在任何时候 都能保证质量体系得到实施和遵循的责任和权力。质量主管应有直接渠道接触决定实验室政 策和资源的最高管理层; 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; the quality manager shall have direct access to the highest level of management at which decisions are made on laboratory policy or resources; j) 指定关键管人员的代理人(见注)。 appoint deputies for key managerial personnel (see Note); k) 确保实验室人员理解他们所从事的活动的相互关系和重要性，以及如何为管理体系质量 目标的实现做出贡献。 ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the objectives of the management system. 注: 个别人可能有多项职能，对每项职责都指定代理人可能是不现实的。 NOTE Individuals may have more than one function and it may be impractical to appoint deputies for every function. 4.1.6 最高管理者应确保在实验室内部建立适宜的沟通机制，并就与管理体系有效性的事宜 进行沟通。 Top management shall ensure that appropriate communication processes are established within the laboratory and that communication takes place regarding the effectiveness of the management system. 4.2 管理體系 Management system 4.2.1 實驗室建立、實施和維持與活動范圍相適應的管理體系.應將其政策、、計劃、程 序和指導書制定成文件,並達到確保實驗室檢測和(或)校准結果質量所需的程度.體系文件應 傳達至有關人員,並被其理解、獲取和執行. The laboratory shall establish, implement and maintain a management system appropriate to the scope of its activities. The laboratory shall document its policies, systems, programmes, procedures and instructions to the extent necessary to assure the quality of the test and/or calibration results. The system’s documentation shall be communicated to, understood by, available to, and implemented by the appropriate personnel. 4.2.2 實驗室管理體系中與質量有關的政策,包括質量方針聲明,應在質量手冊(不論如何稱 謂)中闡明.應制定總體目標並在管理評審時加以評審. 質量方針聲明應在最高管理者的授權 下發佈,至少包括下列內容: The laboratory'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) 實驗室管理層對良好職業行爲和爲客戶提供檢測和校準服務質量的承諾; the laboratory management's commitment to good professional practice and to the quality of its testing and calibration in servicing its customers; b) 管理層關於實驗室服務標準的聲明; the management’s statement of the laboratory's standard of service; c) 與質量有關的管理體系的目的; the purpose of the management system related to quality; d) 要求實驗室所有與檢測和校準活動有關的人員熟悉與之相關的質量文件,並在工作中執 行這些政策和程序; a requirement that all personnel concerned with testing and calibration activities within the laboratory familiarize themselves with the quality documentation and implement the policies and procedures in their work; and e) 實驗室管理層對遵循本標準及持續改進管理體系的承諾. the laboratory management's commitment to comply with this International Standard and to continually improve the effectiveness of the management system. 注:質量方針聲明宜簡明,可包括應始終按照規定的方法和客戶的需要來進行檢測和(或)校準 的要求.當檢測和(或)校準實驗室是某個較大組織的一部分時,某些質量方針要素可以列以其 他文件之中. NOTE The quality policy statement should be concise and may include the requirement that tests and/or calibrations shall always be carried out in accordance with stated methods and customers' requirements. When the test and/or calibration laboratory is part of a larger organization, some quality policy elements may be in other documents. 4.2.3 最高管理者應提供建立和實施管理體系以及持續改進其有效性承諾的證據. Top management shall provide evidence of commitment to the development and implementation of the management system and to continually improving its effectiveness. 4.2.4 最高管理者應將滿足客戶要求和法定要求的重要性傳達到組織. Top management shall communicate to the organization the importance of meeting customer requirements as well as statutory and regulatory requirements. 4.2.5 質量手冊應包括或指明含技術程序在內的支持性程序,並概述質量體系中所用文件的 架構. The quality manual 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. 4.2.6 質量手冊中應界定技術管理層和質量主管的作用和責任包括確保遵循本標準的責任. The roles and responsibilities of technical management and the quality manager, including their responsibility for ensuring compliance with this International Standard, shall be defined in the quality manual. 4.2.7 當策劃和實施管理體系的變更時,最高管理者應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. 4.3 4.3 文件控制 Document control 4.3.1 總則 General 實驗室應建立和維持程序來控制構成其質量體系的所有文件(內部制定或來自外部的),諸如 規章、標準、其他規範化文件、檢測和(或)校準方法,以及圖紙、軟件、規範、指導書和手冊. 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、規範、校準表格、圖表、教科書、張貼品、備 忘錄、軟件、圖紙、計劃等. 這些文件可能承載在各種載體上,進化論是硬拷貝或是電子媒 體,並且可以是數字的、模擬的、攝影的或書面的形式. 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:有關檢測和校準數據的控制在 5.4.7 條中規定.記錄的控制在 4.13 條中規定. NOTE 2 The control of data related to testing and calibration is covered in 5.4.7. The control of records is covered in 4.13. 4.3.2 文件的批准和發布 Document approval and issue 4.3.2.1 凡作爲質量體系組成部分發給實驗室人員的所有文件,在發佈之前應由授權人員審 查並批准使用.應建立識別質量體系中文件當前的修訂狀態和分發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. 4.3.2.2 所用程序應確保: The procedure(s) adopted shall ensure that: a) 在對實驗室有效運作起重要作用的所有作業場所,都能得到相應文件的授權版本; authorized editions of appropriate documents are available at all locations where operations essential to the effective functioning of the laboratory are performed; b) 定期審查文件,必要時進行修訂,以保證持續適用和滿足使用的要求; documents are periodically reviewed and, where necessary, revised to ensure continuing suitability and compliance with applicable requirements; c) 及時地從所有使用和發佈處撤除無效或作廢的文件,或用其他方法確保防止誤用; invalid or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use; d) 出於法律或知識保存目的的而保留的和廢文件,應有適當的標記. obsolete documents retained for either legal or knowledge preservation purposes are suitably marked. 4.3.2.3 實驗室制定的管理體系文件應有唯一性標識.該標識應包括發佈日期和(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). 4.3.3 文件變更 Document changes 4.3.3.1 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. 4.3.3.2 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. 4.3.3.3 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 laboratory's document control system allows for the amendment of documents by hand pending the re-issue 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 re-issued as soon as practicable. 4.3.3.4 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 computerized systems are made and controlled. 4.4 要求、標書和合同的評審 Review of requests, tenders and contracts 4.4.1 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5.4.2); the requirements, including the methods to be used, are adequately defined, documented and understood (see 5.4.2); 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5.4.2); the appropriate test and/or calibration method is selected and is capable of meeting the customers' requirements (see 5.4.2). 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 commences. 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 laboratory's personnel have the skills and expertise necessary for the performance of the tests and/or calibrations in question. The review may also encompass results of earlier participation in interlaboratory comparisons 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. 4.4.2 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 customer'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 (e.g. 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 customer's requirements remain unchanged. For new, complex or advanced testing and/or calibration tasks, a more comprehensive record should be maintained. 4.4.3 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. 4.4.4 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. 4.4.5 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 commenced, the same contract review process shall be repeated and any amendments shall be communicated to all affected personnel. 4.5 檢測和校準的分包 Subcontracting of tests and calibrations 4.5.1 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 (e.g. workload, need for further expertise or temporary incapacity) or on a continuing basis (e.g. through permanent subcontracting, agency or franchising arrangements), this work shall be placed with a competent subcontractor. A competent subcontractor is one that, for example, complies with this International Standard for the work in question. 4.5.2 實驗室應將分包安排以書面形式通知客戶,適當時應得到客戶的准許,最好是書面的同 意. The laboratory shall advise the customer of the arrangement in writing and, when appropriate, gain the approval of the customer, preferably in writing. 4.5.3 實驗室應就其分包方的工作對客戶負責,由客戶或法定管理機構指定的分包方除外. The laboratory is responsible to the customer for the subcontractor’s work, except in the case where the customer or a regulatory authority specifies which subcontractor is to be used. 4.5.4 實驗室應保存檢測和(或)校準中使用的所有分包方的註冊資料,並保存其工作符合本 標準的證明記錄. The laboratory shall maintain a register of all subcontractors that it uses for tests and/or calibrations and a record of the evidence of compliance with this International Standard for the work in question. 4.6 服務和供應品的採購 Purchasing services and supplies 4.6.1 實驗室應有選擇和購買對檢測和(或)校準質量有影響的服務和供應商品的政策和程序. 還應有與檢測和校準有關的試劑和消耗材料的購買、驗收和存儲的程序. The laboratory shall have a policy and procedure(s) for the selection and purchasing of services and supplies it uses that affect the quality of the tests and/or calibrations. Procedures shall exist for the purchase, reception and storage of reagents and laboratory consumable materials relevant for the tests and calibrations. 4.6.2 實驗室應確保所購買的、影響檢測和(或)校準質量的供應品、試劑和消耗材料,只有在 經檢查或證實符合有關檢測和(或)校準方法中規定標準規範或要求之後才投入使用.所使用 的服務和供應品應符合規定的要求.應保存採取的符合性檢查活動的記錄. The laboratory shall ensure that purchased supplies and reagents and consumable materials that affect the quality of tests and/or calibrations are not used until they have been inspected or otherwise verified as complying with standard specifications or requirements defined in the methods for the tests and/or calibrations concerned. These services and supplies used shall comply with specified requirements. Records of actions taken to check compliance shall be maintained. 4.6.3 影響實驗室輸出質量的物品採購文件中,應包含描述所購服務和供應品的資料.這些採 購文件在發出之前,其技術內容經過審查和批准. Purchasing documents for items affecting the quality of laboratory output shall contain data describing the services and supplies ordered. These purchasing documents shall be reviewed and approved for technical content prior to release. 注:該描述可包括型式、類別、等級、精確的標識、規格、圖紙、檢查說明、包括檢測結果 批准在內的其他技術資料、質量要求和進行這些工作所依據的質量體系標準. NOTE The description may include type, class, grade, precise identification, specifications, drawings, inspection instructions, other technical data including approval of test results, the quality required and the management system standard under which they were made. 4.6.4 實驗室應對影響檢測和校準質量的重要的消耗品、供應品和服務的供應商進行評價, 並保存這些評價的記錄和獲批准的供應商名單. The laboratory shall evaluate suppliers of critical consumables, supplies and services which affect the quality of testing and calibration, and shall maintain records of these evaluations and list those approved. 4.7 服務客戶 Service to the customer 4.7.1 實驗室應與客戶或其代表合作,以明確客戶的要求,並在確保其他客戶機密的前提下, 允許客戶到實驗室監視與其工作有關的操作. The laboratory shall be willing to cooperate with customers or their representatives in clarifying the customer's request and in monitoring the laboratory’s performance in relation to The work performed, provided that the laboratory ensures confidentiality to other customers. 注1:這種合作可包括: NOTE 1 Such cooperation may include: a) 允許客戶或其代表合理進入實驗室的相關區域直接觀察爲其進行的檢測和(或)校準; providing the customer or the customer's representative reasonable access to relevant areas of the laboratory for the witnessing of tests and/or calibrations performed for the customer; b) 客戶爲驗證目的所需的檢測和(或)校準物品的準備、包裝和發送. preparation, packaging, and dispatch of test and/or calibration items needed by the customer for verification purposes. 注2:客戶非常重視與實驗室保持技術方面的良好溝通並獲得建議和指導,以及根據結果得出 的意見和解釋.實驗室在整個過程中,宜與客戶尤其是大宗業務的客戶保持聯繫.實驗室應將 檢測和(或)校準過程中的任何延誤和主要偏離通知客戶. NOTE 2 Customers value the maintenance of good communication, advice and guidance in technical matters, and opinions and interpretations based on results. Communication with the customer, especially in large assignments, should be maintained throughout the work. The laboratory should inform the customer of any delays or major deviations in the performance of the tests and/or calibrations. 4.7.2 實驗室應向客戶處征求反饋意見,無論是正面的還是負面的.應使 用和分析這些意見 並應用於改進管理體系、檢測和校準活動及對客戶的服務. The laboratory shall seek feedback, both positive and negative, from its customers. The feedback shall be used and analysed to improve the management system, testing and calibration activities and customer service. 注: 反饋意見的類型例如: 客戶滿意度調查、與客戶一起評價檢測或校准報告. NOTE Examples of the types of feedback include customer satisfaction surveys and review of test or calibration reports with customers. 4.8 抱怨 Complaints 實驗室應有政策和程序處理來自客戶或其他方面的抱怨. 應保存所有抱怨的記錄,以及實驗 室針對抱怨所開展的調查和糾正措施的記錄(見4.11). The laboratory shall have a policy and procedure for the resolution of complaints received from customers or other parties. Records shall be maintained of all complaints and of the investigations and corrective actions taken by the laboratory (see also 4.11). 4.9 不符合檢測和(或)校準工作的控制 Control of nonconforming testing and/or calibration work 4.9.1 當檢測和(或)校準工作的任何方面,或該工作的結果不符合其程序或客戶同意的要求 時,實驗室應實施既定的政策和程序.該政策和程序應保證: The laboratory shall have a policy and procedures that shall be implemented when any aspect of its testing and/or calibration work, or the results of this work, do not conform to its own procedures or the agreed requirements of the customer. The policy and procedures shall ensure that: a) 確定對不符合工作進行管理的責任和權力,規定當不符合工作被確定時所採取的措施(包 括必要時暫停工作,扣發檢測報告和校準證書); the responsibilities and authorities for the management of nonconforming work are designated and actions (including halting of work and withholding of test reports and calibration certificates, as necessary) are defined and taken when nonconforming work is identified; b) 對不符合工作的嚴重性進行評價; an evaluation of the significance of the nonconforming work is made; c) 立即進行糾正,同時對不符合工作的可接受性作出決定; correction is taken immediately, together with any decision about the acceptability of the nonconforming work; d) 必要時,通知客戶並取消工作; where necessary, the customer is notified and work is recalled; e) 確定批准恢復工作的職責. the responsibility for authorizing the resumption of work is defined. 注: 對質量體系或檢測和(或)校準活動的不符合工作或問題的鑒別,可能在質量體系和技術 運作的各個環節進行,例如客戶抱怨、質量控制、儀器校準、消耗材料的核查、對員工的考 察或監督、檢測報告和校準證書的核查、管理評審和內部或外部審核. 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 complaints, 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. 4.9.2 當評價表明不符合工作可能再度發生,或對實驗室的運作對其政策和程序的符合性産 生懷疑時, 應立即執行4.11 中規定的糾正措施程序. Where the evaluation indicates that the nonconforming work could recur or that there is doubt about the compliance of the laboratory's operations with its own policies and procedures, the corrective action procedures given in 4.11 shall be promptly followed. 4.10 改進 Improvement 實驗室應通過實施質量方針和目檔、應用審核結果、數據分析、糾正措施和預防措施以及管 理評審來持續改進管理體系的有效性. 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. 4.13 記錄控制 Control of records 4.13.1 總則 General 4.13.1.1 實驗室應建立和維持識別、收集、索引、存取、存檔、存放、維護和清理質量記 錄和技術記錄的程序. 質量記錄應包括來自內部審核和管理評審的報告及糾正和預防措施 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. 4.13.1.2 所有記錄應清晰明瞭,並以便於存取的方式存放和保存在具有防止損壞、變質、丟 失等適宜環境的設施中.應規定記錄的保存期. 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. 4.13.1.3 所有記錄應予以安全保護和保密. All records shall be held secure and in confidence. 4.13.1.4 實驗室應有程序來保護和備份以上形式存儲的記錄,並防止未經授予權的侵入或修 改. The laboratory shall have procedures to protect and back-up records stored electronically and to prevent unauthorized access to or amendment of these records. 4.13.2 技術記錄 Technical records 4.13.2.1 實驗室應將原始觀察記錄、導出數據、開展跟蹤審核的足夠信息、校準記錄、員 工記錄以及發出的每份檢測報告或校準證書的副本規定的時間保存.如可能,每項檢測或校 準的記錄應包含足夠的信息,以便識別不確定度的影響因素,並保證該檢測或校準在盡可能 接近原條件的情況下能夠複現.記錄應包括負責抽樣的人員、從事各項檢測和(或)校準的人員 和結果校核人員的標識. 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:在某些領域,保留所有的原始觀察記錄也許是不可能或不實際的. NOTE 1 In certain fields it may be impossible or impractical to retain records of all original observations. 注2: 技術記錄是進行檢測和(或)校準所得數據(見5.4.7)和信息的累積,它們表明檢測和(或) 校準是否達到了規定的質量或規定的過程參數.技術記錄可包括表格、合同、工作單、工作 手冊、核查表、工作筆記、控制圖、外部和內部的檢測報告及校準證書、客戶信函、文件和 反饋. NOTE 2 Technical records are accumulations of data (see 5.4.7) 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, customers' notes, papers and feedback. 4.13.2.2 觀察結果、數據和計算應在工作時予以記錄,並能的按照特定任務分類識別. Observations, data and calculations shall be recorded at the time they are made and shall be identifiable to the specific task. 4.13.2.3 當記錄中出現錯誤時,每一錯誤應劃改,不可擦塗掉,以免字迹模糊或消失,並將正確 值填寫在其旁邊.對記錄的所有改動應有改動人的簽名或簽名縮寫.對電子存儲的記錄也應 採取同等措施,以避免原始數據的丟失或改動. 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. 4.14 內部審核 Internal audits 4.14.1 實驗室應根據預定的日程表和程序,定期地對其活動進行內部審核,以驗證其運作持 續符合質量體系和本標準的要求.內部審核計劃應涉及質量體系的全部要素,包括檢測和(或) 校準活動.質量主管負責按照日程表的要求和管理層的需要策劃和組織內部審核.審核應由 經過培訓和具備資格的人員來執行,只要資源允許,審核人員應獨立于被審核的活動. 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 comply 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 organize 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: 內部審核的周期通常爲一年. NOTE The cycle for internal auditing should normally be completed in one year. 5.1 總則 General 5.1.1 決定實驗室檢測和(或)校準的正確性和可靠性的因素有很多,包括: Many factors determine the correctness and reliability of the tests and/or calibrations performed by a laboratory. These factors include contributions from: — 人員(5.2); human factors (5.2); — 設施和環境條件(5.3); accommodation and environmental conditions (5.3); — 檢測和校準方法及方法的確認(5.4); test and calibration methods and method validation (5.4); — 設備(5.5); equipment (5.5); — 測量的溯源性(5.6); measurement traceability (5.6); — 抽樣(5.7); sampling (5.7); — 檢測和校準物品的處置(5.8); the handling of test and calibration items (5.8). 5.1.2 上述因素對總的測量不確定度的影響,在(各類)檢測之間和(各類)校準之間明顯不同. 實驗室在制定檢測和校準的方法和程序、培訓和考核人員、選擇和校準所用設備時,應考慮 到這些因素. The extent to which The factors contribute to the total uncertainty of measurement differs considerably between (types of) tests and between (types of) calibrations. The laboratory shall take account of these factors in developing test and calibration methods and procedures, in the training and qualification of personnel, and in the selection and calibration of the equipment it uses. 5.2 人員 Personnel 5.2.1 實驗室管理層應確保所有操作專門設備、從事檢測和(或)校準以及評價結果和簽署檢 測報告和校準證書的人員的能力.當使用在培員工時,應對其安排適當的監督.對從事特定工 作的人員,應按要求根據相應的教育、培訓、經驗和(或)可證明的技能進行資格確認. The laboratory management shall ensure the competence of all who operate specific equipment, perform tests and/or calibrations, evaluate results, and sign test reports and calibration certificates. When using staff who are undergoing training, appropriate supervision shall be provided. Personnel performing specific tasks shall be qualified on the basis of appropriate education, training, experience and/or demonstrated skills, as required. 注1:某些技術領域(如無損檢測)可能要求從事某些工作的人員持有個人資格證書,實驗室有 責任滿足這些專門人員持證上崗的要求.人員資格證書的要求可能是法定的、特殊技術領域 標準包含的,或是客戶要求的. NOTE 1 In some technical areas (e.g. non-destructive testing) it may be required that the personnel performing certain tasks hold personnel certification. The laboratory is responsible for fulfilling specified personnel certification requirements. The requirements for personnel certification might be regulatory, included in the standards for the specific technical field, or required by the customer. 注2:對檢測報告所含意見和解釋負責的人員,除了具備相應的資格、培訓、經驗以及所進行 的檢測方面的足夠知識外,還需具有: NOTE 2 The personnel responsible for the opinions and interpretation included in test reports should, in a ddition to the appropriate qualifications, training, experience and satisfactory knowledge of the testing carried out, also have: — 製造被檢測物品、材料、産品等所用的相應技術知識、已使用或擬使用方法的知識,以及 在使用過程中可能出現的缺陷或降級等方面的知識; relevant knowledge of the technology used for the manufacturing of the items, materials, products, etc. tested, or the way they are used or intended to be used, and of the defects or degradations which may occur during or in service; — 法規和標準中闡明的通用要求的知識; knowledge of the general requirements expressed in the legislation and standards; and — 所發現的對有關物品、材料和産品等正常使用的偏離程度的瞭解. an understanding of the significance of deviations found with regard to the normal use of the items, materials, products, etc. concerned. 5.2.2 實驗室管理層制訂實驗室人員的教育、培訓和技能目標.應有確定培訓需求和提供人員 培訓的政策和程序.培訓計劃應與實驗室當前和預期的任務相適應. The management of the laboratory shall formulate the goals with respect to the education, training and skills of the laboratory personnel. The laboratory shall have a policy and procedures for identifying training needs and providing training of personnel. The training programme shall be relevant to the present and anticipated tasks of the laboratory. The effectiveness of the training actions taken shall be evaluated. 5.2.3 實驗室應使用長期雇傭人員或簽約人員.在使用簽約人員和額外技術人員關鍵的支持 人員時,實驗室應確保這些人員是勝任的且受到監督,並依據實驗室的管理體系要求工作. The laboratory shall use personnel who are employed by, or under contract to, the laboratory. Where contracted and additional technical and key support personnel are used, the laboratory shall ensure that such personnel are supervised and competent and that they work in accordance with the laboratory's management system. 5.2.4 對與檢測和(或)校準有關的管理人員、技術人員和關鍵支持人員,實驗室應保留其當前 工作的描述. The laboratory shall maintain current job descriptions for managerial, technical and key support personnel involved in tests and/or calibrations. 注:工作描述可用多種方式表達,但至少需規定以下內容: NOTE Job descriptions can be defined in many ways. As a minimum, the following should be defined: — 從事檢測和(或)校準工作方面的職責; the responsibilities with respect to performing tests and/or calibrations; — 檢測和(或)校準計劃和結果評價方面的職責; the responsibilities with respect to the planning of tests and/or calibrations and evaluation of results; — 提交意見和解釋的職責; the responsibilities for reporting opinions and interpretations; — 方法改進、新方法制定和確認方面的職責; the responsibilities with respect to method modification and development and validation of new methods; — 所需的專業知識和經驗; expertise and experience required; — 資格和培訓計劃; qualifications and training programmes; — 管理職責. managerial duties. 5.2.5 管理層應授權專門人員進行特殊類型的抽樣、檢測和(或)校準、發佈檢測報告和校準 證書、提出意見和解釋以及操作特殊類型的設備.實驗室應保留所有技術人員(包括簽約人員) 的相關授權、能力、教育和專業資格、培訓、技能和經驗的記錄,並包含授權和(或)能力確認 的日期.這些信息應易於獲取. The management shall authorize specific personnel to perform particular types of sampling, test and/or calibration, to issue test reports and calibration certificates, to give opinions and interpretations and to operate particular types of equipment. The laboratory shall maintain records of the relevant authorization(s), competence, educational and professional qualifications, training, skills and experience of all technical personnel, including contracted personnel. This information shall be readily available and shall include the date on which authorization and/or competence is confirmed. 5.3 設施和環境條件 Accommodation and environmental conditions 5.3.1 用於檢測和(或)校準的實驗室設施,包括但不限於能源、照明和環境條件,應有助於檢測 和(或)校準的正確實施. Laboratory facilities for testing and/or calibration, including but not limited to energy sources, lighting and environmental conditions, shall be such as to facilitate correct performance of the tests and/or calibrations. 實驗室應確保其環境條件不會使結果無效,或對所要求的測量質量産生不良影響.在實驗室 固定設施以外的場所進行抽樣、檢測和(或)校準時,應予特別注意.對影響檢測和校準結果的 設施和環境條件的技術要求應制定成文件. The laboratory shall ensure that the environmental conditions do not invalidate the results or adversely affect the required quality of any measurement. Particular care shall be taken when sampling and tests and/or calibrations are undertaken at sites other than a permanent laboratory facility. The technical requirements for accommodation and environmental conditions that can affect the results of tests and calibrations shall be documented. 5.3.2 相關的規範、方法和程序有要求,或對結果的質量有影響時,實驗室應監測、控制和記 錄環境條件.對諸如生物消毒、灰塵、電磁干擾、輻射、溫度、供電、溫度、聲級和振級等 應予以重視,使其適應於相關的技術活動.當環境條件危及到檢測和(或)校準的結果時,應停止 檢測和校準. The laboratory shall monitor, control and record environmental conditions as required by the relevant specifications, methods and procedures or where they influence the quality of the results. Due attention shall be paid, for example, to biological sterility, dust, electromagnetic disturbances, radiation, humidity, electrical supply, temperature, and sound and vibration levels, as appropriate to the technical activities concerned. Tests and calibrations shall be stopped when the environmental conditions jeopardize the results of the tests and/or calibrations. 5.3.3 應將不相容活動的相鄰區域進行有效隔離.應採取措施以防止交叉污染. There shall be effective separation between neighbouring areas in which there are i ncompatible activities. Measures shall be taken to prevent cross-contamination. 5.3.4 對影響檢測和(或)校準質量的區域的進入和使用,應加以控制.實驗室應根據其特定情 況確定控制的範圍. Access to and use of areas affecting the quality of the tests and/or calibrations shall be controlled. The laboratory shall determine the extent of control based on its particular circumstances. 5.3.5 應採取措施確保實驗室的良好內務,必要時應制訂專門的程序. Measures shall be taken to ensure good housekeeping in the laboratory. Special procedures shall be prepared where necessary. 5.4 檢測和校準的方法及方法的確認 Test and calibration methods and method v alidation 5.4.1 總則 General 實驗室使用適合的的方法和程序進行所有檢測和(或)校準,包括被檢測和(或)校準物品的抽 樣、處理、運輸、存儲和準備,適當進,還應包括測量不確定度的評價和分析檢測和(或)校準 數據的統計技術. The laboratory shall use appropriate methods and procedures for all tests and/or calibrations within its scope. These include sampling, handling, transport, storage and preparation of items to be tested and/or calibrated, and, where appropriate, an estimation of the measurement uncertainty as well as statistical techniques for analysis of test and/or calibration data. 如果缺少指導書可能影響檢測和(或)校準的結果,實驗室應具有所有相關設備的使用和操作 說明書以及處置、準備檢測和(或)校準物品的指導書,或者二者兼有.所有與實驗室工作有關 的指導書、標準、手冊和參考資料應保持現行有效並易於員工取閱(見4.3).對檢測和校準方 法的偏離,僅應在該偏離已被文件規定、經技術判斷、授權和客戶同意的情況下才允許發生. The laboratory shall have instructions on the use and operation of all relevant equipment, and on the handling and preparation of items for testing and/or calibration, or both, where the absence of such instructions could jeopardize the results of tests and/or calibrations. All instructions, standards, manuals and reference data relevant to the work of the laboratory shall be kept up to date and shall be made readily available to personnel (see 4.3). Deviation from test and calibration methods shall occur only if the deviation has been documented, technically justified, authorized, and accepted by the customer. 注:如果國際的、區域的或國家的標準,或其他承認的規範已包含了如何進行檢測和(或)校準 的簡明和足夠信息,並且這些標準是以可被實驗室操作人員作爲公開件使用的方式書寫時, 則不需再進行補充或改寫內部程序.對方法中的可選擇步驟,可能是必要制定附加細則或補 充文件. NOTE International, regional or national standards or other recognized specifications that contain sufficient and concise information on how to perform the tests and/or calibrations do not need to be supplemented or rewritten as internal procedures if these standards are written in a way that they can be used as published by the op erating staff in a laboratory. It may be necessary to provide additional documentatio n for optional steps in the method or additional details.