【正文】 已經(jīng)進(jìn)行提供證據(jù)的特殊類型的文件。 NOTE2 The extent of the quality management system documentation can differ from one anization to another due to: 注 2 不同組織的質(zhì)量管理體系文件的多少與詳略程度取決于： a)the size of anization and type of activities, a)組織的規(guī)模和活動(dòng)的類型， b)the plexity of processes and their interactions, and b)過程及其相互作用的復(fù)雜程度， 和 c)the petence of personnel. c)人員的能力。記錄是一種特殊類型的文件，必18 18 Records are a special type of document and shall be controlled according to the requirements given in . 須依據(jù) 的要求進(jìn)行控制 . A documented procedure shall be established to define the controls needed: 必須編制形成文件的程序，以規(guī)定以下方面所需的控制： a)to approve documents for adequacy prior to issue, a)文件發(fā)布前得到批準(zhǔn)， 以確保文件是充分的， b)to review and update as necessary and reapprove documents, b)必要時(shí)對(duì)文件進(jìn)行評(píng)審與更新，并再次批準(zhǔn)， c)to ensure that changes and the current revision status of documents are identified, c)確保文件的更改和現(xiàn)行修訂狀態(tài)得到識(shí)別， d)to ensure that relevant versions of applicable documents are available at points of use, d)確保在使用處可獲得適用文件的有關(guān)版本， e)to ensure that documents remain legible and readily identifiable, e)確保文件保持清晰、易于識(shí)別， f)to ensure that documents of external origin are identified and their distribution controlled, and f)確保外 來文件得到識(shí)別，并控制其分發(fā)，和 g)to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retailed of any purpose. g)防止作廢文件的非預(yù)期使用，若因任何原因而保留作廢文件時(shí)，對(duì)這些文件進(jìn)行適當(dāng)?shù)臉?biāo)識(shí)。實(shí)施必須包括對(duì)文件的更新。必須編制形成文件的程序，以規(guī)定記錄的標(biāo)識(shí)、貯存、保護(hù)、檢索、保存期限和處置所需的控制。 efficiency 過程效率 Top management shall review the product realization processes and the support processes to assure their effectiveness and efficiency. 最高管理者必須評(píng)審產(chǎn)品實(shí)現(xiàn)過程和支持過程，以確保它們的有效性和效率。 Customer focus 以顧客為關(guān)注焦點(diǎn) ISO9001:2020, Quality management systemRequirements ISO9001： 2020，質(zhì)量管理體系 — 要求 Customer focus 以顧客為關(guān)注焦點(diǎn) Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see and ). 最高管理者必須以增進(jìn)顧客滿意為目的，確保顧客的要求得到確定并予以滿足（見 和 ） policy 質(zhì)量方針 ISO9001:2020, Quality management systemRequirements ISO9001： 2020，質(zhì)量管理體系 — 要求 Quality policy 質(zhì)量方針 Top management shall ensure that the quality policy 最高管理者必須確保質(zhì)量方針： 22 22 a)is appropriate to the purpose of the anization, a)與組織的宗旨相適應(yīng)， b)include a mitment to ply with requirements and continually improve the effectiveness of the quality management system. b)包括對(duì)滿足要求和持續(xù)改進(jìn)質(zhì)量管理體系有效性的承諾， c)provides a framework for establishing and reviewing quality objectives, c)提供制定和評(píng)審質(zhì)量目標(biāo)的框架， d)is municated and understood within the anization, and d)在組織內(nèi)得到溝通和理解，和 e)is reviewed for continuing suitability. e)在持續(xù)適宜性方面得到評(píng)審。 NOTE Quality objective should address customer expectations and be achievable within a defined time period. 注 質(zhì)量目標(biāo)應(yīng)該考慮顧客期望并在規(guī)定的時(shí)間內(nèi)達(dá)到。 目標(biāo)應(yīng)該是： ? 以顧客為關(guān)注焦點(diǎn)的， ? 源自業(yè)務(wù)計(jì)劃， ? 被規(guī)定并被貫徹， ? 可衡量的， ? 測(cè)量出來的； ? 管理層用于進(jìn)行有效的和有效率的評(píng)審， ? 被用于糾正措施和持續(xù)改進(jìn)。 Personnel responsible for product quality shall have the authority to stop production to correct quality problems. 負(fù)責(zé)產(chǎn)品質(zhì)量的人員，為了糾正質(zhì)量問題，必須有權(quán)停止生產(chǎn)。作為采取措施的結(jié)果，應(yīng)該評(píng)審所有班次。 IATF 的 ISO/TS16949 ： 2020 指南（ 質(zhì)量職責(zé)）： 應(yīng)該把重點(diǎn)放在出現(xiàn)運(yùn)行不良上，進(jìn)行審核以確定進(jìn)行決策的人員、采取的措施并包括時(shí)間安排。 24 24 Responsibility, authority and munication 職責(zé)、權(quán)限和溝通 Responsibility and authority 職責(zé)和權(quán)限 ISO9001:2020, Quality management systemRequirements ISO9001： 2020，質(zhì)量管理體系 — 要求 Responsibility and authority 職責(zé)、權(quán)限和溝通 Responsibility and authority 職責(zé)和權(quán)限 Top management shall ensure that responsibilities and authorities are defined and municated within the anization. 最高管理者必須確保組織內(nèi)的職責(zé)、權(quán)限得到規(guī)定和溝通。 審核應(yīng)該驗(yàn)證這組織擁有為建立、宣導(dǎo)和監(jiān)測(cè)在營運(yùn)計(jì)劃中質(zhì)量的過程。質(zhì)量目標(biāo)必須是可衡量的，并與質(zhì)量方針一致。在組織的認(rèn)證中最高管理者不必須與現(xiàn)場(chǎng)認(rèn)證的相同，但在任何情況下都必須清楚地加以定義。 Records retention 記錄保存 The control of records shall satisfy regulatory and customer requirements. 記錄控制必須滿足法規(guī)和顧客 要求。 Control of records 記錄控制 ISO9001:2020, Quality managements systemRequirements ISO9001： 2020，質(zhì)量管理體系 — 要求 of records 記錄控制 Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. 必須建立并保持記錄，以提供符合要求和質(zhì)量管理體系有效運(yùn)行的證據(jù)。應(yīng)該盡快進(jìn)行及時(shí)的評(píng)審，時(shí)間必須不能超過兩個(gè)工作周。 Quality manual 質(zhì)量手冊(cè) ISO9001:2020, Quality management system— Requirements ISO9001： 2020，質(zhì)量管理體系 — 要求 The anization shall establish and maintain a quality manual that includes: 組織必須編制和保持質(zhì)量手冊(cè)，質(zhì)量手冊(cè)包括： a)the scope of the quality management system, including details of and justification for any exclusions(see ) a) 質(zhì)量管理體系的范圍，包括任何刪減的細(xì)節(jié)與合理性（見 ）， b)the documented procedures established for the quality management system, or reference to them, and b)為質(zhì)量管理體系編制的形成文件的程序或?qū)ζ湟?，? c)a description of the interaction between the processes of the quality management system. c)質(zhì)量管理體系過程之間的相互作用的表述。 總則 ISO9001： 2020，質(zhì)量管理體系 — 要求 Documentation requirements 文件要求 General 總 則 ISO9001:2020,Quality management system— Requirements shall include: 質(zhì)量管理體系文件必須包括： a)documented statements of a quality policy and quality objectives, a)形成文件的質(zhì)量方針和質(zhì)量目標(biāo)， b)a quality manual, b)質(zhì)量手冊(cè)， c)documented procedures required by this International Standard, c)標(biāo)準(zhǔn)所要求的形成文件的程序， d)documents needed by the anization to the ensure the effective planning, operation and control of its processes, and d)組織為確保其過程有效策劃、運(yùn)作和控制所需的文件，和 e)records required by this International Standard(see ). e)本標(biāo)準(zhǔn)所要求的記錄（見 ）。例如：符合顧客零件批準(zhǔn)程序，包括內(nèi)部和外包活動(dòng) ，是組織的職責(zé)。 NOTE Processes needed for the quality management system referred to above should incl