【正文】 ISO/TS 16949:2023 標準講解 Quality system documentation progression Key Words 關(guān)鍵詞語 ? Shall – mandatory requirements 應(yīng) – 強制性要求 ? Should – remendation 應(yīng)該 – 建議 ? Note – guidance for understanding 注 – 指南以便明白 ? Such as – for guidance 例如 – 指導(dǎo)性 ? Documented procedure – must have documented system procedure 文件化程序 – 必須有文件化的體系程序 Process An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Process Approach The application of a system of processes within an anization, together with the identification and interactions of these processes, and their management, can be referred to as the “process approach”. 過程 通過使用資源和管理 ,將輸入轉(zhuǎn)化為輸出的活動可視為過程。 過程方法 組織內(nèi)諸過程的系統(tǒng)的應(yīng)用，連同這些過程的識別和相互作用及其管理，可稱之為“過程方法”。 質(zhì)量管理體系的持續(xù)改進 管理職責 測量，分析，改進 產(chǎn)品實現(xiàn) 資源管理 客 戶 滿 意 客 戶 要 求 產(chǎn)品 增值的過程 信息傳遞的途徑 質(zhì)量管理體系 8大原則 ? 以客戶為關(guān)注焦點 Customer Focus ? 領(lǐng)導(dǎo)作用 Leadership ? 全員參與 Involvement of People ? 過程方法 Process Approach ? 系統(tǒng)化管理 System Approach to Management ? 持續(xù)改進 Continual Improvement ? 基于事實的決策方法 Factual approach to Decision Making ? 與供方互利的關(guān)系 Mutually Beneficial Supplier Relationships 4 Quality management system 質(zhì)量管理體系 General requirements The anization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this international Standards. The anization shall: a) identify the processes needed for the quality management system and their application throughout the anization (see ), b) determine the sequence and interaction of these processes, c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, ? 4 Quality management system 4 質(zhì)量管理體系 總要求 組織 應(yīng) 按本標準的要求建立質(zhì)量管理體系 ,形成文件 ,加以實施和保持 ,并持續(xù)改進其有效性 . 組織 應(yīng) : a) 識別質(zhì)量管理體系所需的過程及其在組織中的應(yīng)用 (見 ), b) 確定這些過程的順序和相互作用 , c) 確定為確保這些過程的有效運行和控制所需的準則和方法 , ? 4 Quality management system 4 質(zhì)量管理體系 General requirements d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes, e) monitor, measure and analyse these processes, and f) implement actions necessary to achieve planned results and continual improvement of these processes. These processes shall be managed by the anization in accordance with the requirements of this international Standard. 總要求 d) 確?？梢垣@得必要的資源和信息 ,以支持這些過程的運行和對這些過程的監(jiān)視 , e) 監(jiān)視 ,測量和分析這些過程 f) 實施必要的措施 ,以實現(xiàn)對這些過程策劃的結(jié)果和對這些過程的持續(xù)改進 . 組織 應(yīng) 按本標準的要求管理這些過程 . ? 4 Quality management system 4 質(zhì)量管理體系 Where an anization chooses to outsource any process that affects product conformity with requirements, the anization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system. Note: Process needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement. 針對組織所選擇的任何影響產(chǎn)品符合要求的外包過程 ,組織 應(yīng) 確保對其實施控制 .對此類外包過程的控制 應(yīng) 在質(zhì)量管理體系中加以識別 . 注 :上述質(zhì)量管理體系所需的過程應(yīng)當包括與管理活動 ,資源提供 ,產(chǎn)品實現(xiàn)和測量有關(guān)的過程 . ? 4 Quality management system 4 質(zhì)量管理體系 General requirements Supplemental Ensuring control over outsourced processes shall not absolve the anization of the responsibility of conformity to all customers requirements. NOTE See also and 總則 補充 確?？刂仆獍^程 不應(yīng) 免除組織對符合所有客戶要求的職責。 注：見 和 ? 4 Quality management system 4 質(zhì)量管理體系 Documentation requirements General The quality management system documentation shall include: a) documented statements of a quality policy and quality objectives, b) a quality manual, c) documented procedures required by this international Standard, d) documents needed by the anization to ensure the effective planning, operation and control of its processes, and e) records required by this International Standard (see ) Documentation requirements 總則 質(zhì)量管理體系文件 應(yīng) 包括 : a) 形成文件的質(zhì)量方針和質(zhì)量目標 b) 質(zhì)量手冊 c) 本標準所要求的形成文件的程序 d) 組織為確保其過程的有效策劃 ,運 行和控制所需的文件 e) 本標準所要求的記錄 (見 ) ? 4 Quality management system 4 質(zhì)量管理體系 NOTE 1: Where the term documented procedure appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. NOTE 2: The extent of the quality management system documentation can differ from one anization to another due to: a) the size of anization and type of activities, b) the plexity of processes and their interactions, and c) the petence of personnel NOTE 3: The documentation can be in any form or type of medium. 注 1: 本標準出現(xiàn)“形成文件的程序”之處 ,即要求建立該程序 ,形成文件 ,并加以實施和保持 . 注 2: 不同組織的質(zhì)量管理體系文件的多少于詳略程度取決于 : a) 組織的規(guī)模和活動的類型 , b) 過程及其相互作用的復(fù)雜程度 , c) 人員的能力 . 注 3: 文件可采用任何形式或類型的媒體 . ? 4 Quality management system 4 質(zhì)量管理體系 Quality manual The anization shall establish and maintain a quality manual that includes: a) the scope of the quality management system, including details of and justification for any exclusions (see ). b) the documented procedures established for the quality management system, or referenc