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1、品质管理系统要求1资料内容仅供参考，如有不当或者侵权，请联系本人改正或者删除。Quality management systemsRequirements品質管理系統 - 要求1 Scope1 範圍1.1 General1.1 通則This International Standard specifies requirements for當組織有下列要求時 , 本國際標準界定其品質管理a quality management system where an organization系統的需求 :a) needs todemonstrateits abilityto consistentlya)
2、需要展現其能力足以穩定地提供符合客戶及適provideproductthatmeetscustomerand用法規要求之產品 , 和applicable regulatory requirements, andb) aims to enhance customer satisfaction through theb)透過系統的有效運用 , 包括持續改进系統之過程effectiveapplicationofthe system, including與保證符合客戶及適當法規要求, 以增進客戶滿processes for continual improvement of the system意。an
3、d the assuranceofconformityto customerandapplicable regulatory requirements.NOTE InthisInternationalStandard,the備註 在本國際標準中 , ”產品 ”一詞適用於預期提供term” product ” applies to the product intended予顧客或其所需要之產品。for, or required by, a customer.1.2 ApplicationAll requirements of this International Standard are gen
4、eric 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 applied due to the nature of an organization and its product, this can be considered for exclusion.Where exclusions are made, cl
5、aims 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 organization ability,s or responsibility, to provide product that meets customer and applicable regulatory requirements.1.2
6、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 Normative referenceThe following normative document contains provisions which, through reference in this text, constitute provision
7、s of this International Standard. For dated 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 possibilityof applying the most recent edition of the norma
8、tive document indicated below. For undated references, the latest edition of the normative document referredto applies. Members of ISO and IEC maintain registers of currently valid International Standards.2 引用標準本國際標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
9、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。2资料内容仅供参考，如有不当或者侵权，请联系本人改正或者删除。ISO 9000: , Quality management systems Fundamentals and vocabulary.3 Terms and definitionsFor the purposes of this International Standard, the terms and definitions given in ISO 9000 apply.The followin
10、g items,used in this edition ofISO 9001to describethe supplychain,have beenchangedtoreflect the vocabulary currently used:ISO 9000:品質管理系統綱要與辭彙3 名詞與定義ISO 9000( ) 中之名詞與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 , 以反映当前的用語習慣 :supplier organization customer供應商 組織 顧客The term” organizationreplaces”the t
11、erm” supplier”usedinISO 9001:1994,and refers tothe unitto本版次以 ”組織 ”取代先前 ISO 9001: 1994版次使whichthisInternationalStandardapplies.Also,the用的 ”供應商 ”,以表示採用本國際標準的單位。而 ”term” supplier” now replaces the term供應商 ”則用來取代之前版次的 ”分包商 ”。” subcontractor ” .Throughoutthetextofthis InternationalStandard,whereverthete
12、rm” product ”occurs,itcan also本國際標準全文之中 , ”產品 ”一詞可表示為 ”服務 ”的mean ” service”.意思。4 Quality management system4.1 General requirementsThe organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requiremen
13、ts of this International Standard.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进其有效性。The organization shalla) identify the processes needed for the qualitymanagement system and their application throughout the organization (see 1.2),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) determine the se
14、quence and interaction of these b) 決定這些過程的順序及相互關係 , processes,c) determine criteria and methods needed to ensurethat both the operation and control of these processes are effective,d) ensure the availability of resources and information necessary to support the operation and monitoring of these proc
15、esses,c) 決定確保這些過程有效運作及管制的必要的準則及方法 ,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) monitor,measureandanalyzetheseprocesses,e) 監控、 量測及分析這些過程, 和andf) implementactionsnecessaryto achieveplannedf) 採取必要行動以達成這些過程的預期結果及持3资料内容仅供参考，如有不当或者侵权，请联系本人改正或者删除。results and continual improvement of these processes.These processes sha
16、ll be managed by the organization in accordance with the requirements of this International Standard.續改进。組織應遵照本國際標準的要求管理這些過程。Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of
17、 such outsourced processes shall be identified within the quality management system.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。NOTE Processes needed for the quality management system referred to above should includeprocesses for management activities, provision of resources, pro
18、duct realization and measurement.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。4.2 Documentation requirements4.2 文件化要求4.2.1 General4.2.1 通則The quality management system documentation shall品質管理系統文件化應包括:includea) documentedstatementsofa qualitypolicyanda) 品質政策與品質目標 ,quality objectives,b) a quality manual,
19、b) 品質手冊 ,c) documentedproceduresrequiredbythisc) 本國際標準要求的文件化程序,International Standard,d) documentsneeded bytheorganization to ensured) 組織為確保其過程有效規劃、運作及管制所需the effectiveplanning, operation andcontrolof its要的文件 , 及processes, ande) records required by this International Standard (seee) 本國際標準要求之紀錄(見 4.2
20、.4)4.2.4)NOTE 1 Where the term” documented procedure ”備註 1 本國際標準中出現”文件化程序 ”之處 , 係要appears within this International Standard, this means求該程序須被建立、 文件化、 實施及維持。that the procedure isestablished,documented,implemented and maintained.NOTE2Theextentofthequalitymanagementsystem documentation can differ from
21、 one organization to another due toa) the size of the organization and type of activities,b) the complexity of processes and their interactions, and備註 2 各組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 ,4资料内容仅供参考，如有不当或者侵权，请联系本人改正或者删除。c) the competencies of personnel.c) 員工的能力。NOTE3 The doc
22、umentationcan be in any formor備註 3 文件可能為任何形式或種類的媒體。type of medium.4.2.2 Quality manual4.2.2 品質手冊The organization shall establish and maintain a quality組織應建立與維護品質手冊, 其內容包含manual that includesa) thescopeofthequalitymanagementsystem,a) 品質管理系統的範圍, 包括對排除部份的細節與includingdetailsofandjustificationforany理由 (見
23、 1.2),exclusions (see1.2.),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.4.2.3 Control of documentsDocuments required by the quality management system shal
24、l be controlled. Records are a special typeof document and shall be controlled according to the requirements given in 4.2.4.b) 品質管理系統所建立的文件化程序 , 或參考該 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。4.2.3 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 4.2.4 之要求加以管制。A documented procedure shallbeestablishedto應建立文件化之程序
25、用以管制define the controls neededa) to approve documents for adequacy prior to issue,a) 文件發行前 , 核准其正確性 ,b) to review and update as necessary and re-approveb) 審查、 必要的更新與再次核准文件,documents,c) to ensurethat changes andthecurrent versionc) 確保文件的改變及当前版次狀態被標明,status of documents are identified,d) to ensurethat
26、relevant versionsofapplicabled) 確保使用文件各場所 , 持有相對應版次的適當文documents are available at points of use,件 ,e) to ensurethatdocumentsremain legibleande) 確保維持文件易於閱讀及容易識別 ,readily identifiable,f) to ensurethat documents ofexternaloriginaref) 確保外來原始文件被識別及管制其分發, 和identified and their distribution controlled, and
27、g) to preventtheunintendeduse ofobsoleteg) 防止作廢文件被誤用 , 如因任何目的而留存時, 應documents,andto apply suitableidentificationto被適當的識別。them if they are retained for any purpose.4.2.4 Control of records4.2.4 記錄管制5资料内容仅供参考，如有不当或者侵权，请联系本人改正或者删除。Recordsshallbeestablishedandmaintained toprovide evidence of conformity
28、to requirements and oftheeffectiveoperationofthequalitymanagementsystem.Recordsshallremain legible,readilyidentifiableand retrievable.A documentedprocedureshall be established to define the controls needed fortheidentification,storage,protection,retrieval,r e t e n t i o nt i m ea n dd i s p o s it
29、io n o f re c o rd s.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 Management responsibility5 管理責任5.1 Management commitment5.1 管理承諾Topmanagementshallprovideevidenceofits高階管理者應透過下列方式, 以證明對其品質管理commitmentto the developmentand implementation系統的發展、實施
30、與持續改进系統有效性之承諾:ofthequalitymanagementsystemandcontinuallyimproving its effectiveness bya) 於組織內部傳達- 符合客戶及法令、法規要求a) communicatingto the organizationthe importance的重要性 ,ofmeetingcustomeraswellasstatutoryandregulatory requirements,b) 建立品質政策 ,b) establishing the quality policy,c) ensuring that quality obj
31、ectives are established,d) conducting management reviews, ande) ensuring the availability of resources.5.2 Customer focusTop management shall ensure that customer requirements are determined and met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1).5.3 Quality policyTop managemen
32、t shall ensure that the quality policya) is appropriate to the purpose of the organization,c) 確保品質目標被建立 ,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 7.2.1 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进系統有效性之承諾 ,b) includesacommitmenttocomplywithrequiremen
33、tsandcontinuallyimprovetheeffectiveness of the quality management system,c) 提供一個建立及審查品質目標之體制,c) providesaframeworkforestablishingandreviewing quality objectives,d) 於組織中被傳達及瞭解,d) iscommunicatedandunderstoodwithintheorganization, ande) 審查其持續的適切性。6资料内容仅供参考，如有不当或者侵权，请联系本人改正或者删除。e) is reviewed for contin
34、uing suitability. 5.4 Planning5.4.1 Quality objectivesTop management shall ensure that quality objectives, including those needed to meet requirements for product see 7.1 a), are established at relevant functions and levels within the organization. The quality objectives shall be measurable and cons
35、istentwith the quality policy.5.4.2 Quality management system planningTop management shall ensure thata) the planning of the quality management system is carried out in order to meet the requirements givenin 4.1, as well as the quality objectives, andb) the integrity of the quality management system
36、 ismaintainedwhen changesto the qualitymanagement system are planned and implemented.5.5 Responsibility, authority and communication5.5.1 Responsibility and authorityTopmanagementshallensurethattheresponsibilities, authorities are defined and communicated within the organization.5.5.2 Management rep
37、resentativeTopmanagementshallappointamemberofmanagement who, irrespective of other responsibilities, shall have responsibility and authoritythat includesa) ensuring that processes needed for the qualitymanagement system are established, implemented and maintained,b) reportingto top managementon the
38、performanceof the qualitymanagementsystemand any needfor improvement, andc) ensuring the promotion of awareness of customer requirements throughout the organization.5.4 規劃5.4.1 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。5.4.2 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5.5.1 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。5.5.2 管理代表高階管理者應指派管理階層中之一員 , 不受其它責任影響下 , 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进 ;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能够包括與外部機構對品質7