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标准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 实验室的管理体系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)校准的方法、程序、目的和结果评价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、制度、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.
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