《質量管理體系文件》ISO9001_2015_中英文對照

1、 1 secretariat of iso/tc 176/sc 2 date: 3 june 2013 to the members of iso/tc 176/sc 2 - quality management and quality assurance/ quality systems iso/cd 9001 目錄目錄 1 scope 范圍 2 normative references 規(guī)范性引用文件 3 terms and definitions 術語和定義 4 context of the organization 組織的背景 4.1 understanding the organiz

2、ation and its context 理解組織及其背景 4.2 understanding the needs and expectations of interested parties 理解相關方的需求和期望 4.3 determining the scope of the quality management system 質量管理體系范圍的確定 4.4 quality management system 質量管理體系 5 leadership 領導作用 5.1 leadership and commitment 領導作用和承諾 5.2 quality policy 質量方針 5.

3、3 organizational roles, responsibilities and authorities 組織的作用、職責和權限 6 planning 策劃 6.1 actions to address risks and opportunities 風險和機遇的應對措施 6.2 quality objectives and planning to achieve them 質量目標及其實施的策劃 6.3 planning of changes 變更的策劃 7 support 支持 7.1 resources 資源 7.2 competence 能力 7.3 awareness 意識

4、7.4 communication 溝通 7.5 documented information 形成文件的信息 8 operation 運行 8.1 operational planning and control 運行的策劃和控制 8.2 determination of market needs and interactions with customers 市場需求的確定和顧客溝通 8.3 operational planning process 運行策劃過程 28.4 control of external provision of goods and services 外部供應產品和

5、服務的控制 8.5 development of goods and services 產品和服務開發(fā) 8.6 production of goods and provision of services 產品生產和服務提供 8.7 release of goods and services 產品和服務放行 8.8 nonconforming goods and services 不合格產品和服務 9 performance evaluation 績效評價 9.1 monitoring, measurement, analysis and evaluation 監(jiān)視、測量、分析和評價 9.2 i

6、nternal audit 內部審核 9.3 management review 管理評審 10 continual improvement 持續(xù)改進 10.1 nonconformity and corrective action 不符合和糾正措施 10.2 improvement 改進附錄 a annex a quality management principles (informative)質量管理原則文獻 1scope 范圍范圍 this international standard specifies requirements for a quality management sy

7、stem where an 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 goods and services that meet customer and applicable statutory and regulatory requirements, and 需要證實其具有穩(wěn)定地提供滿足顧客要求和適用法律法規(guī)要求的產品和服務的能力； b）aims to enhance customer satisfaction through the eff

8、ective 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 通過體系的的有效應用， 包括體系持續(xù)改進的過程，以及保證符合顧客和適用的法律法規(guī)要求，旨在增強顧客滿意。 注 1：in this international standard, the term “product” o

9、nly applies to 在本標準一中，術語“產品”僅適用于： a) goods and services intended for, or required by, a customer, and 預期提供給顧客或顧客所要求的商品和服務； b) any intended output resulting from the operational processes 運行過程所產生的任何預期輸出。 注 2：statutory and regulatory requirements can be expressed as legal requirements 法律法規(guī)要求可稱作為法定要求。

10、2 normative references 規(guī)范性引用文件規(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 document (including any amendments) applies 下列文件中的條款通過本標

11、準的引用而構成本標準的條款。凡是注日期的引用文件，只有引用的版本適用。凡是不注日期的引用文件，其最新版本（包括任何修訂）適用于本標準。 iso 9000:2015, quality management systems fundamentals and vocabulary gb/t19000- 2015 質量管理體系 基礎和術語 3 3 term and definitions 術語和定義術語和定義 for the purposes of this document, the terms and definitions given in iso 9000 apply 本標準采用 gb/t19

12、000 中所確立的術語和定義。 4 context of the organization 組織的背景環(huán)境組織的背景環(huán)境 4.1 understanding the organization and its context 理解組織及其背景環(huán)境理解組織及其背景環(huán)境 the organization shall determine external and internal issues, that are relevant to its purpose and its strategic direction and that affect its ability to achieve the

13、intended outcome(s) of its quality management system 組織應確定外部和內部那些與組織的宗旨、戰(zhàn)略方向有關、影響質量管理體系實現預期結果的能力的事務。 the organization shall update such determinations when needed 需要時，組織應更新這些信息。 when determining relevant external and internal issues, the organization shall consider those arising from:在確定這些相關的內部和外部事宜

14、時，組織應考慮以下方面： a) changes and trends which can have an impact on the objectives of the organization可能對組織的目標造成影響的變更和趨勢； b) relationships with, and perceptions and values of relevant interested parties 與相關方的關系，以及相關方的理念、價值觀； c) governance issues, strategic priorities, internal policies and commitments; a

15、nd 組織管理、 戰(zhàn)略優(yōu)先、內部政策和承諾； d) resource availability and priorities and technological change 資源的獲得和優(yōu)先供給、技術變更。 注 1：understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, cultural, social, economic and natural environment, whether interna

16、tional, national, regional or local.外部的環(huán)境，可以考慮法律、技術、競爭、文化、社會、經濟和自然環(huán)境方面，不管是國際、國家、地區(qū)或本地。 注 2：when understanding the internal context the organization could consider those related to perceptions, values and culture of the organization.內部環(huán)境， 可以組織的理念、 價值觀和文化。 4.2 understanding the needs and expectations

17、of interested parties 理解相關方的需求和期望理解相關方的需求和期望 the organization shall determine 組織應確定： a) the interested parties that are relevant to the quality management system, and 與質量管理體系有關的相關方 b) the requirements of these interested parties 相關方的要求 the organization shall update such determinations in order to un

18、derstand and anticipate needs or expectations affecting customer requirements and customer satisfaction 組織應更新以上確定的結果，以便于理解和滿足影響顧客要求和顧客滿意度的需求和期望。 the organization shall consider the following relevant interested parties 組織應考慮以下相關方： a) direct customers 直接顧客 4b) end users 最終使用者 c) suppliers, distributo

19、rs, retailers or others involved in the supply chain 供應鏈中的供方、分銷商、零售商及其他 d) regulators; and 立法機構 e) any other relevant interested parties 其他 注：note addressing current and anticipated future needs can lead to the identification of improvement and innovation opportunities應對當前的和預期的未來需求可導致改進和變革機會的識別。 4.3

20、 determining the scope of the quality management system 確定質量管理體系的范圍確定質量管理體系的范圍 the organization shall determine the boundaries and applicability of the quality management system to establish its scope 組織應界定質量管理體系的邊界和應用，以確定其范圍。 when determining this scope, the organization shall consider 在確定質量管理體系范圍時

21、， 組織應考慮： a) the external and internal issues referred to in 4.1, and 標準 4.1 條款中提到的內部和外部事宜 b) the requirements referred to in 4.2 標準 4.2 條款的要求 the scope shall be stated in terms of goods and services, the main processes to deliver them and the sites of the organization included 質量管理體系的范圍應描述為組織所包含的產品、

22、服務、主要過程和地點。 when stating the scope, the organization shall document and justify any decision not to apply a requirement of this international standard and to exclude it from the scope of the quality management system. any such exclusion shall be limited to clause 7.1. 4 and 8 and shall not affect th

23、e organizations ability or responsibility to assure conformity of goods and services and customer satisfaction, nor can an exclusion be justified on the basis of a decision to arrange for an external provider to perform a function or process of the organization.描述質量管理體系的范圍時，對不適用的標準條款，應將質量管理體系的刪減及其理由

24、形成文件。刪減應僅限于標準第 7.1、 4 和 8 章節(jié)， 且不影響組織確保產品和服務滿足要求和顧客滿意的能力和責任。過程外包不是正當的刪減理由。 注：an external provider can be a supplier or a sister organization (such as a headquarters or alternate site location) that is outside of the organizations quality management system.外部供應商可以是組織質量管理體系之外的供方或兄弟組織。 the scope shall b

25、e available as documented information 質量管理管理體系范圍應形成文件。 4.4 quality management system 質量管理體系質量管理體系 4.4.1 general 總則總則 the organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with th

26、e requirements of this international standard.組織應按本標準的要求建立質量管理體系、過程及其相互作用，加以實施和保持，并持續(xù)改進。 4.4.2 process approach 過程方法過程方法 the organization shall apply a process approach to its quality management system. the 5organization shall:組織應將過程方法應用于質量管理體系。組織應： a) determine the processes needed for the quality

27、management system and their application throughout the organization;確定質量管理體系所需的過程及其在整個組織中的應用; b) determine the inputs required and the outputs expected from each process;確定每個過程所需的輸入和期望的輸出； c) determine the sequence and interaction of these processes;確定這些過程的順序和相互作用； d) determine the risks to conformi

28、ty of goods and services and customer satisfaction if unintended outputs are delivered or process interaction is ineffective;確定產生非預期的輸出或過程失效對產品、服務和顧客滿意帶來的風險； e) determine criteria, methods, measurements, and related performance indicators needed to ensure that both the operation and control of these

29、 processes are effective 確定所需的準則、方法、測量及相關的績效指標，以確保這些過程的有效運行和控制； f) determine the resources and ensure their availability 確定和提供資源； g) assign responsibilities and authorities for processes 規(guī)定職責和權限； h) implement actions necessary to achieve planned results 實施所需的措施以實現策劃的結果； i) monitor, analyse and chang

30、e, if needed, these processes ensuring that they continue to deliver the intended outputs; and 監(jiān)測、分析這些過程，必要時變更，以確保過程持續(xù)產生期望的結果； j) ensure continual improvement of these processes.確保持續(xù)改進這些過程。 5 leadership 領導作用領導作用 5.1leadership and commitment 領導作用與承諾領導作用與承諾 5.1.1 leadership and commitment with respect

31、 to the quality management system 針對質量管針對質量管理體系的領導作用與承諾理體系的領導作用與承諾 top management shall demonstrate leadership and commitment with respect to the quality management system by 最高管理者應通過以下方面證實其對質量管理體系的領導作用與承諾： a) ensuring that quality policies and quality objectives are established for the quality mana

32、gement system and are compatible with the strategic direction of the organization;確保質量方針和質量目標得到建立，并與組織的戰(zhàn)略方向保持一致； b) ensuring the quality policy is understood and followed within the organization;確保質量方針在組織內得到理解和實施； c) ensuring the integration of the quality management system requirements into the org

33、anizations business processes;確保質量管理體系要求納入組織的業(yè)務運作； d) promoting awareness of the process approach;提高過程方法的意識； e) ensuring that the resources needed for the quality management system are available;確保質量管理體系所需資源的獲得； f) communicating the importance of effective quality management and of conforming to the

34、 quality management system requirements and the requirements of goods and services;傳達有效的質量管理以及滿足質量管理體系、產品和服務要求的重要性； g) ensuring that the quality management system achieves its intended outcomes outputs;確保質量管理體系實現預期的輸出； h) engaging, directing and supporting persons to contribute to the effectiveness

35、of the quality 6management system 吸納、指導和支持員工參與對質量管理體系的有效性作出貢獻； i) promoting continual improvement and innovation; and 增強持續(xù)改進和創(chuàng)新； j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.支持其他的管理者在其負責的領域證實其領導作用。 5.1.2leadership and co

36、mmitment with respect to the needs and expectations of customers 針針對顧客需求和期望的領導作用與承諾對顧客需求和期望的領導作用與承諾 top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that 最高管理者應通過以下方面， 證實其針對以顧客為關注焦點的領導作用和承諾： a) the risks which can affect conformity of goods and se

37、rvices and customer satisfaction are identified and addressed;可能影響產品和服務符合性、顧客滿意的風險得到識別和應對； b) customer requirements are determined and met;顧客要求得到確定和滿足； c) the focus on consistently providing goods and services that meet customer and applicable statutory and regulatory requirements is maintained;保持以穩(wěn)

38、定提供滿足顧客和相關法規(guī)要求的產品和服務為焦點； d) the focus on enhancing customer satisfaction is maintained;保持以增強顧客滿意為焦點； 注：reference to “business” in this international standard should be interpreted broadly to mean those activities that are core to the purposes of the organizations existence.本標準中的“業(yè)務”可以廣泛地理解為對組織存在的目的很

39、重要的活動。 5.2quality policy 質量方針質量方針 top management shall establish a quality policy that:最高管理者應制定質量方針，方針應： a) is appropriate to the purpose of the organization;與組織的宗旨相適應； b) provides a framework for setting quality objectives;提供制定質量目標的框架； c) includes a commitment to satisfy applicable requirements, an

40、d 包括對滿足適用要求的承諾； d) includes a commitment to continual improvement of the quality management system.包括對持續(xù)改進質量管理體系的承諾。 the quality policy shall:質量方針應： a) be available as documented information;形成文件； b) be communicated within the organization;在組織內得到溝通； c) be available to interested parties, as appropri

41、ate; and 適用時，可為相關方所獲取； d) be reviewed for continuing suitability.在持續(xù)適宜性方面得到評審。 注：quality management principles can be used as the basis for the quality policy.質量管理原則可作為質量方針的基礎。 5.3 organizational roles, responsibilities and authorities 組織的作用、職責和權限組織的作用、職責和權限 top management shall ensure that the resp

42、onsibilities and authorities for relevant roles are assigned and communicated within the organization.最高管理者應確保組織內相關的職責、權限得到規(guī)定和溝通。 7 top management shall be accountable for the effectiveness of the quality management system and shall assign the responsibility and authority for:最高管理者應對質量管理體系的有效性負責，并規(guī)定

43、職責和權限以便： a) ensuring that the quality management system conforms to the requirements of this international standard and,確保質量管理體系符合本標準的要求； b) ensuring that the processes interact and are delivering their intended outputs;確保過程相互作用并產生期望的結果； c) reporting on the performance of the quality management syst

44、em to top management and any need for improvement, and 向最高管理者報告質量管理體系的績效和任何改進的需求； d) ensuring the promotion of awareness of customer requirements throughout the organization.確保在整個組織內提高滿足顧客要求的意識。 6 planning 策劃策劃 6.1actions to address risks and opportunities 風險和機遇的應對措施風險和機遇的應對措施 when planning for the

45、quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to 策劃質量管理體系時，組織應考慮 4.1 和 4.2 的要求，確定需應對的風險和機遇，以便： a) assure the quality management system can achieve it

46、s intended outcome(s);確保質量管理體系實現期望的結果； b) assure that the organization can consistently achieve conformity of goods and services and customer satisfaction;確保組織能穩(wěn)定地實現產品、服務符合要求和顧客滿意； c) prevent, or reduce, undesired effects, and 預防或減少非預期的影響； d) achieve continual improvement.實現持續(xù)改進。 the organization sh

47、all plan:組織應策劃： a) actions to address these risks and opportunities, and 風險和機遇的應對措施； b) how to 如何 1) integrate and implement the actions into its quality management system processes (see 4.4), and 在質量管理體系過程中納入和應用這些措施（見 4.4） 2) evaluate the effectiveness of these actions.評價這些措施的有效性 any actions taken

48、to address risks and opportunities shall be proportionate to the potential effects on conformity of goods and services and customer satisfaction.采取的任何風險和機遇的應對措施都應與其對產品、服務的符合性和顧客滿意的潛在影響相適應。 注：options to address risks can include for example risk avoidance, risk mitigation or risk acceptance可選的風險應對措施包

49、括風險規(guī)避、風險降低、風險接受等。 6.2quality objectives and planning to achieve them 質量目標及其實施的策劃質量目標及其實施的策劃 the organization shall establish quality objectives at relevant functions, levels and processes. the quality objectives shall:組織應在相關職能、層次、過程上建立質量目標。質量目標應： a) be consistent with the quality policy;與質量方針保持一致 b)

50、 be relevant to conformity of goods and services and customer satisfaction;與產品、服務的 8符合性和顧客滿意相關 c) be measurable (if practicable);可測量（可行時） d) take into account applicable requirements,考慮適用的要求 e) be monitored,得到監(jiān)測 f) be communicated, and 得到溝通 g) be updated as appropriate.適當時進行更新 the organization shall

51、 retain documented information on the quality objectives.組織應將質量目標形成文件。 when planning how to achieve its quality objectives, the organization shall determine:在策劃目標的實現時，組織應確定： a) what will be done;做什么； b) what resources will be required (see 7.1)所需的資源（見 7.1） ； c) who will be responsible;責任人； d) when i

52、t will be completed, and 完成的時間表； e) how the results will be evaluated.結果如何評價。 6.3planning of changes 變更的策劃變更的策劃 the organization shall determine the needs and opportunities for change to maintain and improve the performance of the quality management system.組織應確定變更的需求和機會， 以保持和改進質量管理體系績效。 the organiza

53、tion shall undertake change in a planned and systematic manner, identifying risks and opportunities and reviewing the potential consequences of change.組織應有計劃、 系統(tǒng)地進行變更，識別風險和機遇，并評價變更的潛在后果。 注：specific requirements on control of changes are included in clause 8.變更控制的特定要求在第 8 條規(guī)定。 7 support 支持支持 7.1resou

54、rces 資源資源 7.1.1 general 總則總則 the organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system.組織應確定、提供為建立、實施、保持和改進質量管理體系所需的資源。 the organization shall consider 組織應考慮： a) what are existing in

55、ternal resources, capabilities and limitations, and 現有的資源、 能力、 局限 b) which goods and services are to be sourced externally.外包的產品和服務 7.1.2 infrastructure 基礎設施基礎設施 the organization shall determine, provide and maintain the infrastructure necessary for its 9operations and to assure conformity of goods

56、and services and customer satisfaction.組織應確定、提供和維護其運行和確保產品、服務符合性和顧客滿意所需的基礎設施。 注：note infrastructure can include:基礎設施可包括： a) buildings and associated utilities;建筑物和相關的設施 b) equipment including hardware and software, and設備（包括硬件和軟件） c) transportation, communication and information systems.運輸、通訊和信息系統(tǒng) 7.

57、1.3 process environment 過程環(huán)境過程環(huán)境 the organization shall determine, provide and maintain the process environment necessary for its operations and to assure conformity of goods and services and customer satisfaction.組織應確定、提供和維護其運行和確保產品、服務符合性和顧客滿意所需的過程環(huán)境。 注：process environment can include physical, soc

58、ial, psychological and environmental factors (such as temperature, recognition schemes, ergonomics and atmospheric composition).過程環(huán)境可包括物理的、社會的、心理的和環(huán)境的因素（例如：溫度、承認方式、人因工效、大氣成分） 。 7.1.4 monitoring and measuring devices 監(jiān)視和測量設備監(jiān)視和測量設備 the organization shall determine, provide and maintain the monitoring

59、 and measuring devices needed to verify conformity to product requirements and shall ensure that the devices are fit for purpose.組織應確定、 提供和維護用于驗證產品符合性所需的監(jiān)視和測量設備， 并確保監(jiān)視和測量設備滿足使用要求。 the organization shall retain appropriate documented information as evidence of fitness for purpose of monitoring and me

60、asuring devices.組織應保持適當的文件信息， 以提供監(jiān)視和測量設備滿足使用要求的證據。 注 1：monitoring and measurement devices can include measuring equipment and assessment methods such as surveys.監(jiān)視和測量設備可包括測量設備和評價方法（例如：調查問卷） 。 注 2：monitoring and measurement devices can be calibrated or verified, or both, at specified intervals, or pr