iso9001-28中英文29共33頁.

1、ISO 9001:2008En glish -Ch in ese Bili ngualQuality man ageme nt system- Requireme nt質量管理體系 -要求Copyright reserved, for reference to Intertek systems certification customers onlyISO 9001:2008 Introduction引言0.1 General 總則The adoption of a quality management system should be a strategic decision of an o

2、rganization. The design and implementation of an organizations quality management system is influenced bya) its organizational environment, changes in that environment, and the risks associated with that environment,b) its varying needs,c) its particular objectives,d) the products it provides,e) the

3、 processes it employs,f) its size and organizational structure. 采用質量管理體系應當是組織的一項戰(zhàn)略性決策。 一個組織質量管理體系的設計 和實施受下列因素的影響：a) 組織的業(yè)務環(huán)境、該環(huán)境的變化或與該環(huán)境有關的風險，b) 組織的不同需求，c) 組織的特定目標，d) 所提供的產品，e) 所采用的過程，f) 組織的規(guī)模和組織結構。It is not the intent of this International Standard to imply uniformity in the structure of quality man

4、agement systems or uniformity of documentation. 統(tǒng)一質量管理體系的結構或文件不是本標準的目的。The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “ NOT E” is for guidance inunderstanding or clarifying the associated requirem

5、ent.本標準所規(guī)定的質量管理體系要求是對產品要求的補充。 “注”是幫助理解、澄 清有關要求的參考性信息。This International Standard can be used by internal and external parties, including certificaten bodies, to assess the organizations ability to meet customer, statutory and regulatory requireme nts applicable to the product, and the orga ni zati o

6、ns own requireme nts.本標準能用于內部和外部各方（包括認證機構）評定組織滿足顧客要求、適用的 產品的法律法規(guī)要求和組織自身要求的能力。The quality ma nageme nt prin ciples stated in ISO 9000 and ISO 9004 have bee n take n in to con siderati on duri ng the developme nt of this Intern ati onal Sta ndard.本標準的制定已經考慮了 ISO 9000和ISO 9004中所闡明的質量管理原則。0.2 Process ap

7、proach 過程方法This Intern ati onal Sta ndard promotes the adopti on of a process approach whe n develop in g,impleme nting and impro ving the effective ness of a quality man ageme nt system, to enhance customer satisfact ion by meet ing customer requireme nts.本標準鼓勵在建立、實施質量管理體系以及改進其有效性時采用過程方法，旨在通過滿足顧客要求

8、，增強顧客滿意。For an orga ni zatio n to fun ctio n effectively, it has to determ ine and man age numerous linked activities. An activity or set of activities using resources, and man aged in order to en able the tran sformati on of in puts into outputs, can be con sidered as a process. Ofte n the output f

9、rom one process directly forms the in put to the n ext.為使組織有效運行，需確定和管理眾多相互關聯(lián)的活動。通過使用資源和實施管 理，將輸入轉化為輸出的一項或一組活動，可以視為一個過程。通常，一個過程 的輸出可直接形成下一個過程的輸入。The applicati on of a system of processes with in an orga ni zatio n, together with the ide ntificati on and in teracti ons of these processes, and their ma

10、n ageme nt to produce the desired outcome , can be referred to as the“ process approach為了產生期望的結果，組織內諸過程組成的系統(tǒng)的應用，連同這些過程的識別和 相互作用，以及對這些過程的管理，可稱之為“過程方法”。An adva ntage of the process approach is the ongoing con trol that it provides over the lin kage betwee n the in dividual processes with in the system

11、 of processes, as well as over their comb in ati on and in teract ion.過程方法的一個優(yōu)點就是實現了對過程系統(tǒng)中單個過程之間的聯(lián)系以及過程的 組合和相互作用進行連續(xù)的控制。When used within a quality man ageme nt system, such an approach emphasizes the importa nee ofa）un dersta nding and meeti ng requireme nts,b）the n eed to con sider processes in ter

12、ms of added value,c）obta ining results of process performa nee and effective ness, andd）con ti nual improveme nt of processes based on objective measureme nt.在質量管理體系中應用過程方法時，該方法強調以下方面的重要性：a）理解和滿足要求；b）需要從增值的角度考慮過程；c）獲得過程績效和有效性的結果；d）基于客觀的測量，持續(xù)改進過程。The model of a process-based quality man ageme nt syst

13、em show n in Figure 1 illustrates the process linkages presented in Clauses 4 to 8. This illustration shows that customers play a sig nifica nt role in defi ning requireme nts as in puts. Mon itori ng of customer satisfacti on requires the evaluati on of in formatio n relati ng to customer percepti

14、on as to whether the orga ni zatio n has met the customer requireme nts. The model show n in Figure 1 covers all the requireme nts of this Intern ati onal Stan dard, but does not show processes at a detailed level.圖1所反映的以過程為基礎的質量管理體系模式展示了 4 8章中所提出的過程聯(lián) 系。該展示反映了在規(guī)定輸入要求時， 顧客起著重要的作用。對顧客滿意的監(jiān)視 要求對顧客關于組織是否

15、已滿足其要求的感受的信息進行評價。該模式雖覆蓋了本標準的所有要求，但卻未詳細地反映各過程。NOTE In addition, the methodology known as-DP-Check- Act ”（PDCA）can be applied to all processes. PDCA can be briefly described as follows.Pla n: establish the objectives and processes n ecessary to deliver results in accorda nee with customer requireme nt

16、s and the orga ni zati ons policies. Do: impleme nt the processes.Check: mon itor and measure processes and product aga inst policies, objectives and requireme nts for the product and report the results.Act: take acti ons to con ti nu ally improve process performa nee.注：此外，稱之為“ PDCA的方法可適用于所有過程。PDCA模

17、式可簡述如下： P-策劃：根據顧客的要求和組織的方針，建立實現結果所必需的目標和過程； D-做：實施過程；C-檢查：根據方針、目標和產品要求，對過程和產品進行監(jiān)視和測量，并報告 結果；A-處置：采取措施，以持續(xù)改進過程績效。Continual improvement of the quality niarmgement system應出譽理饒樂的!準:盤丄Customer 顧客Customer 客戶R$quiremnitsResourceManjement資黑管理Product1 z-Product.嚴品實現Jly-A _rirernenl analysts and Irrfvcvfnwnt(

18、!，井析相茂追j_”t；:TT1SatisfactionManagementResponsibilityValue-adding activities - f ；.譏習.Informabon flowFigure 1 Model of a proces$*based quality management system 團1 it i靈為基掘URj町量蒼！ r itsfe i.0.3 Relatio nship with ISO 9004與ISO 9004的關系ISO 9001 and ISO 9004 are quality man ageme nt system sta ndards whi

19、ch have bee n desig ned to compleme nt each other, but can also be used in depe nden tly.ISO 9001和ISO 9004都是質量管理體系標準，這兩項標準相互補充，但也可單 獨使用。ISO 9001 specifies requireme nts for a quality man ageme nt system that can be used for internal application by organizations, or for certification, or for con trac

20、tual purposes. It focuses on the effective ness of the quality man ageme nt system in meet ing customer requireme nts.ISO 9001規(guī)定了質量管理體系要求，可供組織內部使用，也可用于認證或合同 目的。ISO 9001所關注的是質量管理體系在滿足顧客要求方面的有效性。At the time of publication of this International Standard, ISO 9004 is under revisi on. Therevised editi on

21、 of ISO 9004 will provide guida nee to man ageme nt for achiev ing susta ined success for any orga ni zati on in a complex, dema nding, and ever changing, environment. ISO 9004 provides a wider focus on quality management than ISO 9001; it addresses the needs and expectations of all in terested part

22、ies and their satisfact ion, by the systematic and con ti nual improvement of the organization s performanee. However, it is not intended for certification, regulatory or contractual use.與ISO 9001相比，ISO 9004對質量管理體系更寬范圍的目標提供了指南，除了有效性，該標準還特別關注持續(xù)改進一個組織的總體績效與效率。 對于最高管理 者希望超越 ISO 9001 要求，追求績效持續(xù)改進的那些組織，推薦

23、 ISO 9004 作為 指南。然而，用于認證或合同不是 ISO 9004 的目的。Continual improvement of the quality management system 質量管理體系的不斷改進Customer 顧客Customer 客戶Requirements 要求Satisfaction 滿意測量、分析和改進Management Responsibility 管理職責 Resource Management 資源管理 Measurement, analysis and Improvement Product Realization 產品實現 Product 產品Out

24、put 輸出Input 輸入0.4 Compatibility with other management systems 與其他管理體系的相容性During the development of this International Standard, due consideration was given to the provisions of ISO 14001:2004 to enhance the compatibility of the two standards for the benefit of the user community. Annex A shows the c

25、orrespondence between ISO 9001:2008 and ISO 14001:2004. 為了使用者的便利，本標準在制定過程中適當考慮了 ISO 14001:2004 標準的內 容，以增強兩個標準的相容性。附錄 A表明了 ISO 9001:2008與ISO 14001:2004 之間的對應關系。This International Standard does not include requirements specific to other management systems, such as those particular to environmental man

26、agement, occupational health and safety management, financial management or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible for an organization to adapt i

27、ts existing management system(s) in order to establish a quality management system that complies with the requirements of this International Standard. 本標準不包括針對其他管理體系的特定要求， 例如環(huán)境管理、 職業(yè)健康與安全管 理、財務管理或風險管理有關的特定要求。 然而本標準使組織能夠將自身的質量 管理體系與相關的管理體系要求結合或一體化。 組織為了建立符合本標準要求的 質量管理體系，可能會改變現行的管理體系。.Quality manageme

28、nt systems Requirements 質量管理體系 要求1 Scope 范圍1.1 General 總則This International Standard specifies requirements for a quality management system wherean organization 本標準為有下列需求的組織規(guī)定了質量管理體系要求：a) needs to demonstrate its ability to consistently provide product that meets customer andapplicable statutory and

29、 regulatory requirements, andb) aims to enhance customer satisfaction through the effective application of the system,including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.a) 需要證實其有能力穩(wěn)定地提供滿足顧客和適用的法

30、律法規(guī)要求的產品；b) 通過體系的有效應用，包括體系持續(xù)改進的過程以及保證符合顧客與適用的 法律法規(guī)要求，旨在增強顧客滿意。NOTE 1 In this International Standard, the term“ product ” only applies toa) product intended for, or required by, a customer,b) any intended output resulting from the product realization processes. 注1：在本標準中，術語“產品”僅適用于a) 預期提供給顧客或顧客所要求的產品，

31、b) 產品實現過程所產生的任何預期輸出。NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.注2：法律法規(guī)要求可稱作法定要求。1.2 Application 應用All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided

32、.本標準規(guī)定的所有要求是通用的， 旨在適用于各種類型、 不同規(guī)模和提供不同產 品的組織。Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion. 當本標準的任何要求由于組織及其產品的特點不適用時，可以考慮對其進行刪 減。Where exclusions are made, claims of conformity to th

33、is International Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organizations ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements. 如果進行了刪減，而且這些刪

34、減僅限于本標準第 7 章的要求，同時不影響組織提 供滿足顧客和適用法律法規(guī)要求的產品的能力或責任 , 方可聲稱符合本標準。2 Normative references 規(guī)范性引用文件The following referenced documents are indispensable for the application of this document.For dated references, only the edition cited applies. For undated references, the latest edition of the referenced docu

35、ment (including any amendments) applies. 下列文件中的條款通過本標準的引用而成為本標準的條款。 凡是注日期的引用文 件，其隨后所有的修改單(不包括勘誤的內容)或修訂版均不適用于本標準，然 而，鼓勵根據本標準達成協(xié)議的各方研究是否可使用這些文件的最新版本。 凡是 不注日期的引用文件，其最新版本適用于本標準。ISO 9000:2005, Quality management systems Fundamentals and vocabularyISO9000:2005 質量管理體系基礎和術語3 Terms and definitions 術語和定義For t

36、he purposes of this document, the terms and definitions given in ISO 9000 apply.本標準采用 ISO 9000 中所確立的術語和定義。Throughout the text of this International Stan dard, wherever the term “ product II“”occurs, it can also mean “ service ”. 本標準中所出現的術語“產品”，也可指“服務”。4 Quality management system 質量管理體系4.1 General re

37、quirements 總要求The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard. 組織應按本標準的要求建立質量管理體系， 形成文件，加以實施和保持，并持續(xù) 改進其有效性。The organization shalla) determine th

38、e processes needed for the quality management system and their application throughout the organization (see 1.2),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,d) ens

39、ure the availability of resources and information necessary to support the operation and monitoring of these processes,e) monitor, measure where applicable, and analyse these processes, andf) implement actions necessary to achieve planned results and continual improvement of these processes.組織應：a) 確

40、定質量管理體系所需的過程及其在整個組織中的應用(見 1.2 )；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作和控制所需的準則和方法；d) 確保可以獲得必要的資源和信息，以支持這些過程的運作和監(jiān)視；e) 監(jiān)視、測量 ( 適用時) 和分析這些過程；f) 實施必要的措施， 以實現對這些過程所策劃的結果和對這些過程的持續(xù)改進。These processes shall be managed by the organization in accordance with the requirements of this International Standard. 組織應按本標

41、準的要求管理這些過程。Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management syst

42、em. 針對組織所選擇的任何影響產品符合要求的外包過程，組織應確保對其實施控 制。對此類外包過程控制的類型和程度應在質量管理體系中加以規(guī)定。NOTE 1 Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, measurement, analysis and improvement. 注1：上述質量管理體系所需的過程包括與管理活動、資

43、源提供、產品實現和測 量、分析和改進有關的過程。NOTE 2 An “ outsourced process ” is a process that the organizationeeds for its quality management system and which the organization chooses to have performed by an external party.注2：外包過程是經組織識別為質量管理體系所需的，但選擇由組織的外部方實 施的過程。NOTE 3 Ensuring control over outsourced processes does

44、not absolve the organization of theresponsibility of conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such asa) the potential impact of the outsourced process on the organizations ca

45、pability to provide product that conforms to requirements,b) the degree to which the control for the process is shared,c) the capability of achieving the necessary control through the application of7.4. 注3：確保對外包過程的控制并不免除組織滿足顧客和法律法規(guī)要求的責任。對 外包過程控制的類型和程度可受下列因素影響：a) 外包過程對組織提供滿足要求的產品的能力的潛在影響；b) 對外包過程控制的分

46、擔程度；c) 通過應用 7.4 條款實現所需控制的能力。4.2 Documentation requirements 文件要求4.2.1 General 總則The quality management system documentation shall includea) documented statements of a quality policy and quality objectives,b) a quality manual,c) documented procedures and records required by this International Standard

47、, andd) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.質量管理體系文件應包括：a) 形成文件的質量方針和質量目標；b) 質量手冊；c) 本標準所要求的形成文件的程序和記錄；d) 組織確定的為確保其過程有效策劃、運作和控制所需的文件，包括記錄。NOTE 1 Where the term “ documented procedure ” a

48、ppears within this International Standard, this means that the procedure is established, documented, implemented and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.注 1：本標準出現 “形成文

49、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。 一個文件可包括一個或多個程序的要求。 一個形成文件的程序 的要求可以被包含在多個文件中。NOTE 2 The extent of the quality management system documentation can differ from one organization to another due toa) the size of organization and type of activities,b) the complexity of processes and their interactions, an

50、dc) the competence of personnel. 注2：不同組織的質量管理體系文件的多少與詳略程度取決于：a) 組織的規(guī)模和活動的類型；b) 過程及其相互作用的復雜程度；c) 人員的能力。NOTE 3 The documentation can be in any form or type of medium. 注3文件可采用任何形式或類型的媒體。4.2.2 Quality manual 質量手冊The organization shall establish and maintain a quality manual that includesa) the scope of

51、the quality management system, including details of and justification for any exclusions (see 1.2),b) the documented procedures established for the quality management system, or reference to them, andc) a description of the interaction between the processes of the quality management system.組織應編制和保持質

52、量手冊，質量手冊包括：a) 質量管理體系的范圍，包括任何刪減的細節(jié)與理由(見 1.2 )；b) 為質量管理體系建立的形成文件的程序或對其引用；c) 質量管理體系過程之間的相互作用的表述。4.2.3 Control of documents 文件控制Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4

53、.2.4.質量管理體系所要求的文件應予以控制。記錄是一種特殊類型的文件，應依據4.2.4 的要求進行控制。A documented procedure shall be established to define the controls needed 應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,b) to review and update as necessary and re-approve documents,c) to ensure that changes and the c

54、urrent revision status of documents are identified,d) to ensure that relevant versions of applicable documents are available at points of use,e) to ensure that documents remain legible and readily identifiable,f) to ensure that documents of external origin determined by the organization to be necess

55、ary for the planning and operation of the quality management system are identified and their distribution controlled, andg) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.a) 文件發(fā)布前得到批準，以確保文件是充分與適宜的；為文件的充分性與適宜 性，在文

56、件發(fā)布前進行批準。b) 必要時對文件進行評審與更新，并再次批準；c) 確保文件的更改和現行修訂狀態(tài)得到識別；d) 確保在使用處可獲得有關版本的適用文件；e) 確保文件保持清晰、易于識別；f) 確保組織所確定的策劃和運行質量管理體系所需的外來文件得到識別，并控 制其分發(fā)；g) 防止作廢文件的非預期使用，若因任何原因而保留作廢文件時，對這些文件 進行適當的標識。4.2.4 Control of records 記錄的控制Records established to provide evidence of conformity to requirements and of the effective

57、 operation of the quality management system shall be controlled. 為符合要求和質量管理體系有效運行提供證據而建立的記錄，應予以控制。The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records. 組織應編制形成文件的程序，以規(guī)定記錄的標識、

58、貯存、保護、檢索、保存和處 置所需的控制。Records shall remain legible, readily identifiable and retrievable. 記錄應保持清晰、易于識別和檢索。5 Management responsibility管理職責5.1 Management commitment管理承諾Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness bya) communicating to the organiza