品质管理系统要求内容

1、Quality management systems - Requirements品質管理系統要求1 Scope1.1 GeneralThis International Standard specifies requirements for a quality management system where an organizationa) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, a

2、ndb) aims to enhance customer satisfaction throughthe effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicableregulatoryrequirements.NOTE In this International Standard, the term“product ” applies to t

3、he product intended for, or required by, a customer.1.2 ApplicationAll requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.Were any requirement(s) of this international Standard cannot be applie

4、d due to the nature of an organization and its product, this can be considered for exclusion.Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the or

5、ganization 's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.2 Normative referenceThe following normative document contains provisions which, through reference in this text, constitute provisions of this International Standard. For dated

6、 references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the normative1 範圍1.1 通則當組織有下列要求時，本國際標準界定其品質管理 系統的需求

7、：a) 需要展現其能力足以穩定地提供符合客戶及適用法規要求之產品，和b) 透過系統的有效運用，包括持續改善系統之過程 與保證符合客戶及適當法規要求 ，以增進客戶滿 意。備註 在本國際標準中，”產品”一詞適用於預期 提供予顧客或其所需要之產品。1.2 應用此國際標準的所有要求乃通用性要求且期望能適 用於所有組織，無論其行業、規模及所提供的產品 本國際標準的任何要求若因組織或產品之特性而 無法適用時可考慮予以排除。當本國際標準的任何要求被排除時，則組織不得宣 稱其符合本國際標準，除非所排除的要求侷限於本 國際標準的第七節且不影響組織提供符合客戶及 適當法規要求產品的能力或責任。2 引用標準本國際標

8、準引用下列標準的內容以構成本國際標準的條款。所引用的標準如具日期版次，則其後之修訂或改版均不適用於本國際標準。然而依據本國際標準達成共識之各團體仍應探求使用下列 引用標準最新版次的可能。引用的標準如未指定 日期版次，則應使用最新的引用標準。ISO及IEC 會員皆維持有最新有效國際標準的登錄清單。document indicated below. For undated references, the latest edition of the normative document referred to applies. Membersof ISO and IEC maintain regis

9、ters of currently valid International Standards.ISO 9000:2000, Qualitymanagement systems -Fun dame ntals and vocabulary.3 Terms and definitionsFor the purposes of this International Standard, the terms and definitions given in ISO 9000 apply.The following items, used in this edition of ISO9001 to de

10、scribe the supply chain, have been changed to reflect the vocabulary currently used:supplier t organization t customerThe term “organization ” replaces the term “supplier ” used in ISO 9001:1994, and refers tothe unit to which this International Standard applies. Also, the term“supplier ” now replac

11、esthe term“subcontractor ” .Throughout the text of this International Standard, wherever the term aproduct ” occurs, it can also mean “service ”.4 Quality management system4.1 General requirementsThe organization shall establish, document, implement and maintain a quality management system and conti

12、nuallyimprove its effectiveness inaccordance with the requirements of this International Standard.The organization shalla) identify the processes needed for the quality management system and their application throughout the organization (see 1.2),b) determine the sequence and interaction of these pr

13、ocesses,c) determine criteria and methods needed to ensurethat both the operationand control of theseprocesses are effective,d) ensure the availability of resources and information necessary to support the operationand monitoring of these processes,ISO 9000:2000品質管理系統-綱要與辭彙3名詞與定義ISO 9000 （2000）中之名詞與

14、定義均適用於本國際 標準。本國際標準（ISO 9001 ）用來描述供應鏈之名詞改 變如下，以反映目前的用語習慣：供應商t組織t顧客本版次以“組織”取代先前 ISO 9001 : 1994版次 使用的”供應商”，以表示採用本國際標準的單 位。而”供應商”則用來取代之前版次的”分包 商”。本國際標準全文之中，”產品”一詞可表示為”服 務”的意思。4品質管理系統4.1 一般要求組織應遵照本國際標準的要求建立、文件化、執 行、維持品質管理系統並持續改善其有效性。組織應：a）鑑別品質管理系統所需的過程及其在組織中之 運用（見1.2）,b）決定這些過程的順序及相互關係，c）決定確保這些過程有效運作及管制的

15、必要的準 則及方法，d）確保提供支援這些過程的運作及監督必要的資 源與資訊，e）監控、量測及分析這些過程，和f）採取必要行動以達成這些過程的預期結果及持 續改善。e) monitor, measure and analyze these processes, and組織應遵照本國際標準的要求管理這些過程。f) implement actions necessary to achieve planned results and continual improvement of these processes.These processes shall be managed by the orga

16、nization in accordance with the requirements of this International Standard.當組織選擇將會影響產品符合要求的部分過程委 外時，組織應確保其管制亦及於此等委外之過程, 且在品質管理系統中界定其管制方式。Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processe

17、s. Control of such outsourced processes shall be identified within the quality management system.備註：上述品質管理系統所須之過程包括管理活 動、資源提供、產品實現與量測等過程。NOTEProcesses needed for the quality management system referredto above should includeprocesses formanagement activities,provision of resources, product realizatio

18、n and measurement.4.2文件化要求4.2.1 通則品質管理系統文件化應包括:4.2 Documentation requirements4.2.1 GeneralThe quality management system documentation shall includea) documented statements of a quality policy and quality objectives,b) a quality manual,c) documented procedures required by this International Standard,

19、d) documents needed by the organization to ensurethe effective planning, operation and control of its processes, ande) records required by this International Standard (see 4.2.4)NOTE 1 Where the term “documented procedure ” appears within this International Standard, this means that the procedure is

20、 established, documented, implemented and maintained.NOTE 2 The extent of the quality management system documentation can differ from one organization to another due toa）品質政策與品質目標，b）品質手冊，c）本國際標準要求的文件化程序，d）組織為確保其過程有效規劃、運作及管制所需要 的文件，及e）本國際標準要求之紀錄（見4.2.4）備註1本國際標準中岀現”文件化程序”之處，係 要求該程序須被建立、文件化、實施及維持。備註2各組

21、織其品質管理系統文件化的程度或有 差別，端賴下列而定a）組織的規模及活動的型態，b）過程的複雜性及相互關係，c）員工的能力。a) the size of the organization and type of activities,b) the complexity of processes and their interactions, andc) the competencies of personnel.NOTE3 The documentation can be in any form or type of medium.4.2.2 Quality manualThe organiz

22、ation shall establish and maintain a quality manual that includesa) the scope of the quality management system, including details of and justification for anyexclusions (see1.2.),b) the documented procedures established for the quality management system, or reference to them, andc) a description of

23、the interaction between the processes of the quality management system.4.2.3 Control of documentsDocuments required by the quality managementsystem shall be controlled. Records are a special typeofdocument and shall be controlled according to the requirements given in 4.2.4.A documented procedure sh

24、all be established to define the controls neededa) 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 current version status of documents are identified,d) to ensure that relevant versions of applicable doc

25、uments are available at points of use,e) to ensure that documents remain legible and readily identifiable,f) to ensure that documents of external origin are identified and their distribution controlled,and備註3文件可能為任何形式或種類的媒體。品質手冊組織應建立與維護品質手冊，其內容包含a）品質管理系統的範圍，包括對排除部份的細節與 理由（見1.2），b）品質管理系統所建立的文件化程序，或參考

26、該 等程序，及c）描述品質管理系統各過程的順序及其彼此間之相 互關係。文件管制品質管理系統運作所要求之文件應加以管制，紀錄 為一特殊型態之文件應依據條文之要求加以管制。應建立文件化之程序用以管制a）文件發行前，核准其正確性，b）審查、必要的更新與再次核准文件，c）確保文件的改變及目前版次狀態被標明，d）確保使用文件各場所，持有相對應版次的適當文 件，e）確保維持文件易於閱讀及容易識別，f）確保外來原始文件被識別及管制其分發，和g）防止作廢文件被誤用，如因任何目的而留存時， 應被適當的識別。記錄管制g) to prevent the unintended use of obsolete docu

27、ments, and to apply suitable identification to them if they are retained for any purpose.4.2.4 Control of recordsRecords shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the qualitymanagement system. Records shall remain legible,

28、 readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and di s p o s i t i on o f records.5 Management responsibility5.1 Management commitmentTop management shall provide

29、 evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness bya) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,b) establishing the quality policy

30、,c) ensuring that quality objectives are established,d) conducting management reviews, ande) ensuring the availability of resources.5.2 Customer focusTop management !shallensure;thatcustomerrequirements are determined and met withthe aim ofenhancing customersatisfaction(see7.2.1 and8.2.1).5.3 Qualit

31、y policyTop managementshallensure thatthe quality policya) isappropriateto thepurposeof theorganization,品質管理系統所須之記錄應被建立與維持，以證明 符合品質管理系統的要求及有效運作。品質紀錄應 易於閱讀、識別及取用。應建立文件化程序以定義 記錄的識別、儲存、取用、保護、保存期限與處置 方式。5管理責任5.1管理承諾高階管理者應透過下列方式，以證明對其品質管理 系統的發展、實施與持續改善系統有效性之承諾：a）於組織內部傳達-符合客戶及法令、法規要求 的重要性，b）建立品質政策，c）確保品質目

32、標被建立，d）執行管理審查，和e）確保提供必要的資源。5.2顧客為重高階管理者應確保顧客之需求已被決定且滿足，以 達到增進客戶滿意為目的（見及8.2.1）。5.3品質政策高階管理者應確保其品質政策a）適合於組織的目的，b）包括符合品質管理系統需求及持續改善系統有 效性之承諾，c）提供一個建立及審查品質目標之體制，d）於組織中被傳達及瞭解，e）審查其持續的適切性。b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality manageme

33、nt system,c) provides a framework for establishing and reviewing quality objectives,d) is communicated and understood within the organization, ande) is reviewed for continuing suitability.5.4 Planning5.4.1 Quality objectivesTop management shall ensure that quality objectives, including those needed

34、to meet requirements for product see 7.1a), areestablished at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.5.4.2 Quality management system planningTop management shall ensure thata) the planning of the qualit

35、ymanagement system iscarried out in order to meet the requirementsgiven in 4.1, as well as the quality objectives, andb) the integrity of the quality management systemis maintained when changes to the quality management system are planned and implemented.5.5 Responsibility, authority and communicati

36、on5.5.1 Responsibility and authorityTop management shall ensure that the responsibilities,authorities are defined andcommunicated within the organization.5.5.2 Management representativeTop managementshall appoint a memberof management who, irrespective of other responsibilities, shall have responsib

37、ility and authority that includes5.4規劃品質目標高階管理者應確保組織內各相關機能及各層級之 品質目標被建立，品質目標包含符合產品要求之各 項需求（見7.1.a）。品質目標應可被量測，且必須 與品質政策相一致。品質管理系統規劃高階管理者應確保：a）規劃品質管理系統以符合條文4.1及品質目標之要求，和b）當品質管理系統計劃將有或已有變化時，仍得以 維持品質管理系統之完整性。5.5責任、授權與溝通責任與授權高階管理者應確保組織內之責任、授權已被定義及 溝通。管理代表高階管理者應指派管理階層中之一員，不受其他責任影響下，明定其責任與授權包含a）確保品質管理系統中所需

38、之過程被建立、實施與維持；b）向高階管理者報告品質管理系統執行之成效及 任何必要之改善；c）確保組織全員對客戶需求認知的提昇。備註管理代表的責任可以包括與外部機構對品 質管理系統有關事務的聯繫。a) ensuring that processes needed for the quality management system are established, implemented and maintained,b) reporting to top management on the performanceof the quality managementsystem and any ne

39、ed for improvement, andc) ensuring the promotion of awareness of customer requirements throughout the organization.NOTE The responsibilityof a managementrepresentative can include liaison with external parties on matters relating to the quality management system.5.5.3 Internal communicationTop manag

40、ement shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.5.6 Management review5.6.1 GeneralTop management s hall review the organization ' s quality manageme

41、ntsystem, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness.This review shall include assessingopportunitiesfor improvement and the need forchanges to the quality managementsystem, including the quality policy and quality objectives.Records from management review

42、 shall be maintained (see 4.2.4).5.6.2 Review inputThe input to management review shall include information ona) results of audits,內部溝通高階管理者應確保組織內之溝通過程已被建立，並 且對於品質管理系統的有效性進行溝通。5.6管理審查5.6.1 通則高階管理者應於事先計劃的間隔期間審查組織的 品質管理系統，以確保其持續的適切性、正確性與 有效性。管理審查應包括評估改善的機會與品質管 理系統修正的必要性，包括品質政策與目標。管理審查的紀錄需加以維持（見4.2.4）。

43、管理審查的輸入管理審查的輸入應涵蓋下列資訊a）稽核的結果，b）客戶的回饋，c）過程的績效及產品的符合性，d）各項矯正與預防措施的狀態，e）前次管理審查決議事項的跟催，f）可能影響品質管理系統的變化，和b) customer feedback,c) process performance and product conformity,d) status of preventive and corrective actions,e) follow-up actions from previous management reviews,管理審查的輸出管理審查的輸岀應包括下列各項的決議與行動a）品質管

44、理系統及其過程有效性的改善，g）改善的建議。f) changes that could affect the quality management system, andg) recommendations for improvement.5.6.3 Review outputThe output from the managementreview shall include any decisions and actions relate toa) improvement of the effectiveness of the quality management system and it

45、s processes,b) improvement of product related to customer requirements, andc) resource needs.6 Resource management6.1 Provision of resourcesThe organization shall determine and provide the resources neededa) to implement and maintain the quality management system and continually improve its effectiv

46、eness, andb) to enhance customer satisfaction by meeting customer requirements.6.2 Human resources6.2.1 GeneralPersonnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.6.2.2 Competence, awareness and trainingThe org

47、anization shalla) determine the necessary competency for personnel performing work affecting product quality,b) provide training or take other actions to satisfy these needs,b）與客戶需求有關的產品改善，c）資源的需求。6.資源管理6.1資源的提供組織應決定與提供必要的資源以a）執行和維護品質管理系統及持續改善其有效性，和b）藉由符合客戶需求以增進客戶滿意。6.2人力資源通則人員從事足以影響產品品質之工作，必須依其適當 教

48、育、訓練、技能和經歷以勝任其工作。資格、認知與訓練組織應：a）界定從事足以影響產品品質工作者之資格需求，b）提供訓練或其他措施以滿足這些需求，c）評估所採取措施的有效性，d）確保員工認知本身作業的相關性與重要性及其對達成品質目標的貢獻，和e）維持適當的教育、訓練、技能及經驗的紀錄（見4.2.4）。6.3基礎設施組織應決定、提供及維護為達成符合產品需求必要 的基礎設施。基礎設施包括可行的下列c) evaluate the effectiveness of the actions taken,d) ensure thatitspersonnelare aware of therelevance a

49、nd importance of their activitiesandhow they contribute to the achievement of the quality objectives, ande) maintain appropriate records of education, training, skills and experience (see 4.2.4).6.3 InfrastructureThe organization shall determine, provide and maintain the infrastructure needed to ach

50、ieve conformity to product requirements. Infrastructure includes, as applicablea) building, workspace and associated utilities;b) process equipment (both hardware and software), anda）建築物、工作空間及附屬的設施；b）過程設備（包括軟、硬體設備），和c）支援服務（例如運輸、通訊）。6.4工作環境組織應決定和管理為達到符合產品需求必要的工 作環境。7產品實現7.1產品實現的規劃c) supporting servic

51、es (such as transport or communication).組織應規劃與展開針對產品實現所需要的各項過 程，產品實現過程的規劃必須與品質管理系統其他 過程的要求相一致。在規劃產品實現過程時，組織必須適當地決定下列 要項：6.4 Work environmentThe organization shall determine and managethe the work environment needed to achieve conformity to product requirements.a）品質目標及產品的需求；7 Product realizationb）針對產

52、品所需過程、文件及資源的提供;7.1 Planning of product realizationThe organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1).In planning product real

53、ization, the organization shall determine the following, as appropriate:a) quality objectives and requirements for the product;b) the need to establish processes, documents, and provide resources specific to the product;c) required verification, validation, monitoring, inspection and test activities

54、 specific to theproduct and the criteria for product acceptance;c）針對產品必要的驗證、確認、監控、檢驗與測試 的活動及產品的允收標準；d）必要的記錄以證明產品實現過程與最終產品符合要求（見4.2.4）。此項規劃產岀的結果，其格式應適合其組織的運作 方法。備註1針對特定產品、專案或合約用以描述其品 質管理系統所有過程（包括產品實現過程）及所需 資源的書面文件，可被稱為品質計劃。備註2組織亦可運用條文 7.3的要求於產品實現 過程的展開。d) records needed to provide evidence that the r

55、ealization processes and resulting product meet requirements (see 424).The output of this planning shall be in a form suitable for the organization ' s method of operations.NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) a

56、nd the resources to be applied to a specific product, project or contract, can be referred to as a quality plan.NOTE 2 The organization may also apply the requirement given in 7.3 to the development of product realization processes.7.2 Customer-related processes7.2.1 Determination of requirements re

57、lated to the productThe organization shall determinea) requirements specified by the customer,including the requirementsfor deliveryandpost-delivery activities,b) requirementsnot stated by the customer butnecessary for specified or intended use, where known,c) statutory and regulatory requirements relatedto product, andd) any addit