1、1 / 206,ISO/TS 16949:2002 標(biāo)準(zhǔn)講解,ISO/TS16949 STANDARD INTERPRETATION,2 / 206,Quality system documentation progression,3 / 206,Key Words 關(guān)鍵詞語,Shall mandatory requirements 應(yīng) 強制性要求 Should recommendation 應(yīng)該 建議 Note guidance for understanding 注 指南以便明白 Such as for guidance 例如 指導(dǎo)性 Documented procedure must h

2、ave documented system procedure 文件化程序 必須有文件化的體系程序,4 / 206,Process An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Process Approach The application of a system of processes within an organization, together with the

3、 identification and interactions of these processes, and their management, can be referred to as the “process approach”.,過程 通過使用資源和管理,將輸入轉(zhuǎn)化為輸出的活動可視為過程。 過程方法 組織內(nèi)諸過程的系統(tǒng)的應(yīng)用，連同這些過程的識別和相互作用及其管理，可稱之為“過程方法”。,5 / 206,6 / 206,質(zhì)量管理體系8大原則,以客戶為關(guān)注焦點 Customer Focus 領(lǐng)導(dǎo)作用 Leadership 全員參與 Involvement of People 過程方法

4、Process Approach 系統(tǒng)化管理 System Approach to Management 持續(xù)改進(jìn) Continual Improvement 基于事實的決策方法 Factual approach to Decision Making 與供方互利的關(guān)系 Mutually Beneficial Supplier Relationships,7 / 206,4 Quality management system 質(zhì)量管理體系,8 / 206,4.1 General requirements The organization shall establish, document, im

5、plement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this international Standards. The organization shall: a) identify the processes needed for the quality management system and their application throughout the organization

6、 (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,4 Quality management system 4 質(zhì)量管理體系,4.1 總要求 組織應(yīng)按本標(biāo)準(zhǔn)的要求建立質(zhì)量管理體系,形成文件,加以實施和保持,并持續(xù)改進(jìn)其有效性. 組織應(yīng): a) 識別質(zhì)量管理體系所需

7、的過程及其在組織中的應(yīng)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行和控制所需的準(zhǔn)則和方法,9 / 206,4 Quality management system 4 質(zhì)量管理體系,4.1 General requirements d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes, e) monitor, measure and analyse thes

8、e processes, and f) implement actions necessary to achieve planned results and continual improvement of these processes. These processes shall be managed by the organization in accordance with the requirements of this international Standard.,4.1 總要求 d) 確?？梢垣@得必要的資源和信息,以支持這些過程的運行和對這些過程的監(jiān)視 , e) 監(jiān)視 ,測量和

9、分析這些過程 f) 實施必要的措施,以實現(xiàn)對這些過程策劃的結(jié)果和對這些過程的持續(xù)改進(jìn). 組織應(yīng)按本標(biāo)準(zhǔn)的要求管理這些過程.,10 / 206,4 Quality management system 4 質(zhì)量管理體系,Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced

10、processes shall be identified within the quality management system. Note: Process needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.,針對組織所選擇的任何影響產(chǎn)品符合要求的外包過程,組織應(yīng)確保對其實施控制.對此類外包過程的控制

11、應(yīng)在質(zhì)量管理體系中加以識別. 注:上述質(zhì)量管理體系所需的過程應(yīng)當(dāng)包括與管理活動,資源提供,產(chǎn)品實現(xiàn)和測量有關(guān)的過程.,11 / 206,4 Quality management system 4 質(zhì)量管理體系,4.1.1 General requirements - Supplemental Ensuring control over outsourced processes shall not absolve the organization of the responsibility of conformity to all customers requirements. NOTE See

12、 also 7.4.1 and 7.4.1.3,4.1.1 總則 - 補充 確?？刂仆獍^程不應(yīng) 免除組織對符合所有客戶要求的職責(zé)。 注：見7.4.1 和7.4.1.3,12 / 206,4 Quality management system 4 質(zhì)量管理體系,4.2 Documentation requirements 4.2.1 General The quality management system documentation shall include: a) documented statements of a quality policy and quality objectiv

13、es, b) a quality manual, c) documented procedures required by this international Standard, d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and e) records required by this International Standard (see 4.2.4),4.2 Documentation requiremen

14、ts 4.2.1 總則 質(zhì)量管理體系文件應(yīng)包括: a) 形成文件的質(zhì)量方針和質(zhì)量目標(biāo) b) 質(zhì)量手冊 c) 本標(biāo)準(zhǔn)所要求的形成文件的程序 d) 組織為確保其過程的有效策劃,運 行和控制所需的文件 e) 本標(biāo)準(zhǔn)所要求的記錄(見4.2.4),13 / 206,4 Quality management system 4 質(zhì)量管理體系,NOTE 1: Where the term appears within this International Standard, this means that the procedure is established, documented, implemente

15、d and maintained. NOTE 2: The extent of the quality management system documentation can differ from one organization to another due to: a) the size of organization and type of activities, b) the complexity of processes and their interactions, and c) the competence of personnel NOTE 3: The documentat

16、ion can be in any form or type of medium.,注 1: 本標(biāo)準(zhǔn)出現(xiàn)“形成文件的程序”之處,即要求建立該程序,形成文件,并加以實施和保持. 注 2: 不同組織的質(zhì)量管理體系文件的多少于詳略程度取決于: a) 組織的規(guī)模和活動的類型 , b) 過程及其相互作用的復(fù)雜程度, c) 人員的能力. 注 3: 文件可采用任何形式或類型的媒體.,14 / 206,4 Quality management system 4 質(zhì)量管理體系,4.2.2 Quality manual The organization shall establish and maintain a

17、 quality manual that includes: a) the scope of 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, and c) a description of the interaction between the pro

18、cesses of the quality management system.,4.2.2 質(zhì)量手冊 組織應(yīng)編制和保持質(zhì)量手冊,質(zhì)量手冊包括: 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1.2) b) 為質(zhì)量管理體系編制的形成文件的程序或?qū)ζ湟?c) 質(zhì)量管理體系過程之間的相互作用的表述 .,15 / 206,4 Quality management system 4 質(zhì)量管理體系,4.2.3 Control of documents Documents required by the quality management system shall be controlled

19、. Quality records are a special type of document and shall be controlled according to the requirements given in 4.2.4. A documented procedure shall be established to define the controls needed a) to approve documents for adequacy prior to issue, b) to review and update as necessary and re- approve d

20、ocuments, c) to ensure that changes and the current revision status of documents are identified,4.2.3 文件控制 質(zhì)量管理體系所要求的文件應(yīng)予以控制.記錄是一種特殊類型的文件,應(yīng)按照4.2.4的要求進(jìn)行控制. 應(yīng)編制形成文件的程序,以規(guī)定以下方面所需的控制: a) 文件發(fā)布前得到批準(zhǔn),以確保文件是充分與適宜的, b) 必要時對文件進(jìn)行評審與更新,并再次批準(zhǔn), c) 確保文件的更改和現(xiàn)行修訂狀態(tài)得到識別,16 / 206,4 Quality management system 4 質(zhì)量管理體系,d

21、) 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 are identified and their distribution controlled, and g) to prevent the unintended use of obs

22、olete document, and to apply suitable identification to them if they are retained for any purpose.,d) 確保在使用處可獲得適用文件的有關(guān)版本 e) 確保文件保持清晰,易于識別, f) 確保外來文件得到識別,并控制其分發(fā), g) 防止作廢文件的非預(yù)期使用,若因任何原因而保留作廢文件時,對這些文件進(jìn)行適當(dāng)?shù)臉?biāo)識.,17 / 206,4 Quality management system 4 質(zhì)量管理體系,4.2.3.1 Engineering specifications The organizat

23、ion shall have a process to assure the timely review, distribution and implementation of all customer engineering standards/specifications and changes based on customer required schedule. Timely review should be as soon as possible, and shall not exceed two working weeks. The organization shall main

24、tain a record of the date on which each change is implemented in production. Implementation shall include updates documents.,4.2.3.1 工程規(guī)范 組織應(yīng)有一過程以確保對所有客戶的工程標(biāo)準(zhǔn)/規(guī)范和更改和在客戶要求的時間表的基礎(chǔ)上進(jìn)行及時的評審，發(fā)放和實施。進(jìn)行及時的評審應(yīng)該盡早，并且不應(yīng)超過2個工作周。 組織應(yīng)保持在生產(chǎn)中的每一個更改實施日期的記錄。實施應(yīng)包括更新文件。,18 / 206,4 Quality management system 4 質(zhì)量管理體系,NOT

25、E: A change in these standards / specifications requires an updated record of customer production part approval when these specifications are referenced on the design record or if they affect documents of production part approval process, such as control plan, FMEAs, etc.,注：當(dāng)這些規(guī)范指向設(shè)計記錄或他們影響到生產(chǎn)零件審批過程

26、，諸如控制計劃，F(xiàn)MEA等時，這些標(biāo)準(zhǔn)/規(guī)范中的每一個更改都要求客戶生產(chǎn)零件審批的更新記錄。,19 / 206,4 Quality management system 4 質(zhì)量管理體系,4.2.4 Control of records 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 le

27、gible, 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.,4.2.4 記錄控制 應(yīng)建立并保持記錄,以提供符合要求和質(zhì)量管理體系有效運行的證據(jù).記錄應(yīng)保持清晰,易于識別和檢索.應(yīng)編制形成文件的程序,以規(guī)定記錄的標(biāo)識,貯存,保

28、護(hù),檢索,保存期限和處置所需的控制.,20 / 206,4 Quality management system 4 質(zhì)量管理體系,NOTE 1: “Disposition” above includes disposal. NOTE 2: “Records” also include customer-specified records. 4.2.4.1 Records retention The control of records shall satisfy regulatory and customer requirement.,注1：上述的“處置”包括處理。 注2：“記錄”也包括客戶指

29、定的記錄。 4.2.4.1 記錄的保持 記錄控制應(yīng)滿足法規(guī)和客戶要求。,21 / 206,5 Management responsibility 管理層職責(zé),22 / 206,5 Management responsibility 5 管理層職責(zé),5.1 Management commitment Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improvi

30、ng its effectiveness by: a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements, b) establishing the quality policy, c) ensuring that quality objectives are established, d) conducting management reviews, and e) ensuring the availabili

31、ty of resources.,5.1 管理承諾 最高管理者應(yīng)通過以下活動,對其建立,實施質(zhì)量管理體系并持續(xù)改進(jìn)其有效性的承諾提供證據(jù): a)向組織傳達(dá)滿足顧客和法律法規(guī)要求的重要性, b) 制定質(zhì)量方針, c) 確保質(zhì)量目標(biāo)的制定, d) 進(jìn)行管理評審, e) 確保資源的獲得,23 / 206,5 Management responsibility 5 管理層職責(zé),5.1.1 Process efficiency Top management shall review the product realization processes and the support processes t

32、o assure their effectiveness and efficiency.,5.1.1 過程有效性 最高管理層應(yīng)評審產(chǎn)品的實現(xiàn)過程和支持過程以確保它們的有效性和效率。,24 / 206,5 Management responsibility 5 管理層職責(zé),5.2 Customer focus Top management shall ensure that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction (see 7.2.1 an

33、d 8.2.1).,5.2 以顧客為關(guān)注焦點 最高管理者應(yīng)以增強顧客滿意為目的,確保顧客的要求得到確定并予以滿足(見7.2.1和8.2.1).,25 / 206,5 Management responsibility 5 管理層職責(zé),5.3 Quality policy Top management shall ensure that the quality policy. a) is appropriate to the purpose of the organization, b) includes a commitment to comply with requirements and

34、continually improve the effectiveness of the quality management system, c) provides a framework for establishing and reviewing quality objectives, d) is communicated and understood within the organization, and e) is reviewed for continuing suitability.,5.3 質(zhì)量方針 最高管理者應(yīng)確保質(zhì)量方針: a) 與組織的宗旨相適應(yīng), b) 包括對滿足要求

35、和持續(xù)改進(jìn)質(zhì)量管理體系有效性的承諾, c) 提供制定和評審質(zhì)量目標(biāo)的框架, d) 在組織內(nèi)得到溝通和理解 e) 在持續(xù)適宜性方面得到評審.,26 / 206,5 Management responsibility 5 管理層職責(zé),5.4 Planning 5.4.1 Quality objectives Top management shall ensure that quality objectives, including those needed to meet requirements for product (see 7.1) are established at relevant

36、functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.,5.4 策劃 5.4.1 質(zhì)量目標(biāo) 最高管理者應(yīng)確保在組織的相關(guān)職能和層次上建立質(zhì)量目標(biāo),質(zhì)量目標(biāo)包括滿足產(chǎn)品要求所需的內(nèi)容(見7.1).質(zhì)量目標(biāo)應(yīng)是可測量的,并與質(zhì)量方針保持一致.,27 / 206,5 Management responsibility 5 管理層職責(zé),5.4.1.1 Quality objectives - suppl

37、emental Top management shall define quality objectives and measurements that shall be included in the business plan and used to deploy the quality policy. NOTE: Quality objectives should address customer expectations and be achievable within a defined time period.,5.4.1.1 質(zhì)量目標(biāo) - 補充 最高管理層應(yīng)確定質(zhì)量目標(biāo)和度量指標(biāo)

38、，應(yīng)包含于業(yè)務(wù)計劃和用來展開質(zhì)量方針。 注：質(zhì)量目標(biāo)中應(yīng)該注明客戶的期望，并在所定期限內(nèi)可以達(dá)到。,28 / 206,5 Management responsibility 5 管理層職責(zé),5.4.2 Quality management system planning Top management shall ensure that: a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the qua

39、lity objectives, and b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.,5.4.2 質(zhì)量管理體系策劃 最高管理者應(yīng)確保: a) 對質(zhì)量管理體系進(jìn)行策劃,以滿足質(zhì)量目標(biāo)以及4.1的要求, b) 在對質(zhì)量管理體系的變更進(jìn)行策劃和實施時,保持質(zhì)量管理體系的完整性.,29 / 206,5 Management responsibility 5 管理層職責(zé),5

40、.5 Responsibility, authority and communication 5.5.1 Responsibility and authority Top management shall ensure that the responsibilities and authorities are defined and communicated within the organization.,5.5 職責(zé),權(quán)限與溝通 5.5.1 職責(zé)和權(quán)限 最高管理者應(yīng)確保組織內(nèi)的職責(zé),權(quán)限得到規(guī)定和溝通.,30 / 206,5 Management responsibility 5 管理層職

41、責(zé),5.5.1.1 Responsibility for Quality Managers with responsibility and authority for corrective action shall be promptly informed of products or processes which do not conform to requirements. Personnel responsible for product quality shall have the authority to stop production to correct quality pro

42、blems. Production operations across all shifts shall be staffed with personnel in charge of, or delegated responsibility for，ensuring product quality.,5.5.1.1 質(zhì)量職責(zé) 對糾正措施賦有職責(zé)和權(quán)限的管理者應(yīng)被及時通知不符合要求的產(chǎn)品或過程。 賦有產(chǎn)品質(zhì)量職責(zé)的人員應(yīng)有權(quán)限停止生產(chǎn)以糾正質(zhì)量問題。 所有班次的生產(chǎn)運作應(yīng)有人員看管，或委派相關(guān)職責(zé)人員以確保產(chǎn)品質(zhì)量。,31 / 206,5 Management responsibility 5

43、管理層職責(zé),5.5.2 Management representative Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes: a) ensuring that processes needed for the quality management system are established, implemented and maintaine

44、d, b) reporting to top management on the performance of the quality management system and any need for improvement, and c) ensuring the promotion of awareness of customer requirements throughout the organization. NOTE: The responsibility of a management representative can include liaison with extern

45、al parties on matters relating to the quality management system.,5.5.2 管理者代表 最高管理者應(yīng)指定一名管理者,無論該成員在其它方面的職責(zé)如何,應(yīng)具有以下方面的職責(zé)和權(quán)限: a) 確保質(zhì)量管理體系所需的過程得到建立,實施和保持, b) 向最高管理者報告質(zhì)量管理體系的業(yè)績和任何改進(jìn)的需求, c) 確保在整個組織內(nèi)提高滿足顧客要求的意識. 注: 管理者代表的職責(zé)可包括與質(zhì)量管理體系有關(guān)事宜的外部聯(lián)絡(luò).,32 / 206,5 Management responsibility 5 管理層職責(zé),5.5.2.1 Customer re

46、presentative Top management shall designate personnel with responsibility and authority to ensure the customer requirements are addressed. This includes selection of special characteristics, setting quality objectives and related training, corrective and preventive actions, product design and develo

47、pment.,5.5.2.1 客戶代表 最高管理層應(yīng)指派人員擁有職責(zé)和權(quán)限以確保滿足客戶要求。包括選擇特殊特性、建立質(zhì)量目標(biāo)和相關(guān)的培訓(xùn)、糾正和預(yù)防措施、產(chǎn)品設(shè)計和開發(fā)。,33 / 206,5 Management responsibility 5 管理層職責(zé),5.5.3 Internal communication Top management shall ensure that appropriate communication processes are established within the organization and that communication takes pl

48、aces regarding the effectiveness of the quality management system.,5.5.3 內(nèi)部溝通 最高管理者應(yīng)確保在組織內(nèi)建立適當(dāng)?shù)臏贤ㄟ^程,并確保對質(zhì)量管理體系的有效性進(jìn)行溝通 .,34 / 206,5 Management responsibility 5 管理層職責(zé),5.6 Management review 5.6.1 General Top management shall review the organizations quality management system, at planned intervals, to

49、ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records from management reviews shall be maintained (see 4.

50、2.4),5.6 管理評審 5.6.1 總則 最高管理者應(yīng)按策劃的時間間隔評審質(zhì)量管理體系,以確保其持續(xù)的適宜性,充分性和有效性.評審應(yīng)包括評價質(zhì)量管理體系改進(jìn)的機(jī)會和變更的需要,包括質(zhì)量方針和質(zhì)量目標(biāo). 應(yīng)保持管理評審的記錄(見4.2.4).,35 / 206,5 Management responsibility 5 管理層職責(zé),5.6.1.1 Quality management system performance These reviews shall include all requirements of the quality management system and its

51、performance trends as an essential part of the continual improvement process. Part of the management review shall be the monitoring of quality objectives, and the regular reporting and evaluation of the cost of poor quality (see 8.4.1 and 8.5.1),5.6.1.1 質(zhì)量管理體系績效 這些評審應(yīng)包括質(zhì)量管理體系的所有要求，并且將它的績效趨勢作為持續(xù)改進(jìn)過程的

52、實質(zhì)部分。 管理評審的其中部分應(yīng)是質(zhì)量目標(biāo)的監(jiān)控，定期報告和評價不良質(zhì)量成本。,36 / 206,5 Management responsibility 5 管理層職責(zé),These results shall be recorded to provide, as a minimum, evidence of the achievement of: - the quality objectives specified in the business plan, and - customer satisfaction with product supplied.,這些結(jié)果應(yīng)被記錄，至少可提供作為證

53、據(jù)達(dá)到： - 業(yè)務(wù)計劃中規(guī)定的質(zhì)量目標(biāo)，和 - 客戶對產(chǎn)品提供的滿意度。,37 / 206,5 Management responsibility 5 管理層職責(zé),5.6.2 Review input The input to management review shall include information on: a) results of audits, b) customer feedback, c) process performance and product conformity, d) status of preventive and corrective actions,

54、 e) follow-up actions from previous management reviews, f) planned changes that could affect the quality management system, and g) recommendations for improvement.,5.6.2 評審輸入 管理評審的輸入應(yīng)包括以下方面的信息: a) 審核結(jié)果 b) 顧客反饋 c) 過程的業(yè)績和產(chǎn)品的符合性 d) 預(yù)防和糾正措施的狀況 e) 以往管理評審的跟蹤措施 f) 可能影響質(zhì)量管理體系的變更 g) 改進(jìn)的建議,38 / 206,5 Manageme

55、nt responsibility 5 管理層職責(zé),5.6.2.1 Review input - Supplemental Input to management review shall include an analysis of actual and potential field-failures and their impact on quality, safety, or the environment.,5.6.2.1 評審輸入 - 補充 管理評審的輸入應(yīng)包括對實際和潛在使用失效的分析以及它們對質(zhì)量，安全或環(huán)境的影響。,39 / 206,5 Management responsi

56、bility 5 管理層職責(zé),5.6.3 Review output The output from the management review shall include any decisions and actions related to: a) improvement of the effectiveness of the quality management system and its processes, b) improvement of product related to customer requirements, and c) resource needs.,5.6.

57、3 評審輸出 管理評審的輸出應(yīng)包括與以下方面有關(guān)的任何決定和措施: a) 質(zhì)量管理體系及其過程有效性的改進(jìn) b) 與顧客要求有關(guān)的產(chǎn)品的改進(jìn) c) 資源需求.,40 / 206,6 Resource management 資源管理,41 / 206,6 Resource management 6 資源管理,6.1 Provision of resources The organization shall determine and provide the resources needed: a) to implement and maintain the quality management

58、system and continually improve its effectiveness, and b) to enhance customer satisfaction by meeting customer requirements.,6.1 資源提供 組織應(yīng)確定并提供以下方面所需的資源: a) 實施,保持質(zhì)量管理體系并持續(xù)改進(jìn)其有效性, b) 通過滿足顧客要求,增強顧客滿意.,42 / 206,6 Resource management 6 資源管理,6.2 Human resources 6.2.1 General Personnel performing work affec

59、ting product quality shall be competent on the basis of appropriate education, training, skills and experience.,6.2 人力資源 6.2.1 總則 基于適當(dāng)?shù)慕逃?培訓(xùn),技能和經(jīng)驗,從事影響產(chǎn)品質(zhì)量工作的人員應(yīng)是能夠勝任的.,43 / 206,6 Resource management 6 資源管理,6.2.2 Competence, awareness and training The organization shall: a) determine the necessary competence for personnel performing work affecting product quality, b) provide training