企業(yè)質(zhì)量管理體系

1、 Section 4 Quality management system第四章 質(zhì)量管理體系4.1 General requirements一般要求4.2 Documentation requirements文件要求4.2.1 General總則4.2.2 Quality manual質(zhì)量手冊4.2.3 Control of documents文件控制4.2.3.C.1 Control of Customer-Supplied Documents and Data The organization shall establish andmaintain a documented procedu

2、re(s) to control all customer-supplied documents and data (e.g., networkarchitecture, topology, capacity, installation termination assignments, and database) if these documentsand data influence the design, verification, validation, inspection and testing, or servicing the product.客戶提供文件與數(shù)據(jù)控制 組織將建立并

3、且維護(hù)文件化程序以控制所有客戶提供的文件和數(shù)據(jù)（例如，網(wǎng)絡(luò)體系結(jié)構(gòu)，布局，容量，安裝結(jié)束任務(wù)與數(shù)據(jù)庫）如果這些文件和數(shù)據(jù)影響設(shè)計(jì)，驗(yàn)證，確認(rèn)，檢查與測試，或服務(wù)于產(chǎn)品。4.2.4 Control of records記錄控制Section 5 Management responsibility第五章管理職責(zé)5.1 Management commitment管理承諾5.2 Customer focus 以顧客為關(guān)注焦點(diǎn)5.2.C.1 Customer Relationship Development Top management shall demonstrate active involvem

4、entin establishing and maintaining mutually-beneficial relationships between the organization and itscustomers. 4發(fā)展顧客關(guān)系最高管理者應(yīng)積極參與建立并維護(hù)組織與顧客之間的相互受益的關(guān)系。5.2.C.2 Customer Communication Procedures The organization shall establish and maintain adocumented procedure(s) for communicating with selected custo

5、mers. The documented procedure(s)shall include:顧客溝通程序組織應(yīng)建立并維護(hù)文件化的程序以確保與特定顧客之間的溝通。該程序文件應(yīng)包括：a) a strategy and criteria for customer selection,選擇顧客的策略與標(biāo)準(zhǔn)b) a method for the organization and its customers to share joint expectations and improve the quality ofproducts, and組織和顧客共同參與策劃與提高產(chǎn)品質(zhì)量的方法，和c) a join

6、t review with the customer at defined intervals covering the status of shared expectations andincluding a method to track the resolution of issues. 4會同顧客安既定的時(shí)間間隔評審期望目標(biāo)的狀況，并且應(yīng)有可以追蹤決定流轉(zhuǎn)的方法。5.2.C.2-NOTE 1: It is recognized that it is not possible for an organization to provide the same level ofcommunic

7、ation with all its customers. The level provided may depend on the amount of business with thecustomer, the history of problems, customer expectations, and other factors (see Appendix F, “Guidancefor Communication with Customers”).注解1：眾所周知，組織不可能對所有顧客提供同樣級別的溝通。所提供的級別應(yīng)依據(jù)與顧客的生意數(shù)量、歷史問題、顧客期望值，以與其它因素（參見附錄

8、F，“顧客溝通指導(dǎo)”）5.3 Quality policy質(zhì)量方針5.4 Planning策劃5.4.1 Quality objectives質(zhì)量目標(biāo)5.4.1.C.1 Quality Objectives Objectives for quality shall include targets for the TL 9000 measurementsdefined in the TL 9000 Quality Management System Measurements Handbook.質(zhì)量目標(biāo)質(zhì)量目標(biāo)應(yīng)包括在TL9000 質(zhì)量管理體系計(jì)算手冊中為TL9000定義的對象。5.4.2 Qua

9、lity management system planning質(zhì)量管理體系策劃5.4.2.C.1 Long- and Short-Term Quality Planning The organizations quality planning activities shallinclude long- and short-term plans with goals for improving quality and customer satisfaction.長期和短期質(zhì)量策劃組織的質(zhì)量策劃行為應(yīng)包括以提高質(zhì)量和顧客滿意度為目標(biāo)的長期策劃和短期策劃。Performance to these g

10、oals shall be monitored and reported. These plans shall address:實(shí)現(xiàn)這些目標(biāo)需要監(jiān)控和匯報(bào)。這些策劃應(yīng)注明：a) cycle time, 循環(huán)時(shí)間b) customer service, 顧客服務(wù)c) training, 培訓(xùn)d) cost, 成本e) delivery commitments, and 交貨承諾，等f) product reliability. 產(chǎn)品可靠性5.4.2.C.1-NOTE 1: Top Management should demonstrate their active involvement in

11、long- and short-termquality planning.注解1：最高管理者應(yīng)積極參與到長期和短期質(zhì)量策劃中。5.4.2.C.2 Customer Input The organization shall implement methods for soliciting and consideringcustomer input for quality planning activities. The organization should establish joint quality improvementprograms with customers. 4顧客輸入 組織應(yīng)

12、將顧客輸入納入質(zhì)量策劃中。組織應(yīng)會同顧客建立質(zhì)量改進(jìn)程序。5.4.2.C.3 Supplier Input The organization shall implement methods for soliciting and using supplierinput for quality planning activities. 4供應(yīng)商輸入組織應(yīng)將供應(yīng)商輸入納入質(zhì)量策劃中。5.5 Responsibility, authority and communication職責(zé)、權(quán)限與溝通5.5.1 Responsibility and authority職責(zé)和權(quán)限5.5.2 Management

13、 representative管理者代表5.5.3 Internal communication部溝通5.5.3.C.1 Organization Performance Feedback The organization shall inform employees of its qualityperformance and the level of customer satisfaction. 4組織成績反饋組織應(yīng)通知其員工關(guān)于質(zhì)量成績以與顧客滿意程度。5.6 Management review管理評審5.6.1 General總則5.6.2 Review input評審輸入5.6.3 R

14、eview output評審輸出Section 6 Resource management第六章 資源管理6.1 Provision of resources資源提供6.2 Human resources人力資源6.2.1 General總則6.2.2 Competence, awareness and training能力、意識和培訓(xùn)6.2.2.C.1 Internal Course Development When the organization develops internal training courses, itshall establish and maintain a pr

15、ocess for planning, developing, and implementing these courses. 4部課程開展當(dāng)組織開展部培訓(xùn)課程時(shí)應(yīng)當(dāng)建立并維護(hù)一個(gè)程序以確保課程的計(jì)劃、開展與實(shí)現(xiàn)。46.2.2.C.2 Quality Improvement Concepts Those employees that have a direct impact on the quality ofthe product, including top management, shall be trained in the fundamental concepts of continu

16、alimprovement, problem solving, and customer satisfaction. 4質(zhì)量改進(jìn)觀念包括最高管理者在的所有對產(chǎn)品質(zhì)量有直接影響的員工應(yīng)當(dāng)接受持續(xù)改進(jìn)、解決問題與顧客滿意等基本觀念的培訓(xùn)。46.2.2.C.3 Training Requirements and Awareness Training requirements shall be defined for allpositions that have a direct impact on the quality of products. Employees shall be made aw

17、are of trainingopportunities. 4培訓(xùn)需求和意識培訓(xùn)需求應(yīng)針對所有對產(chǎn)品質(zhì)量有直接影響的職位。員工應(yīng)該知曉培訓(xùn)的機(jī)會。6.2.2.C.4 ESD Training All employees with functions that involve any handling, storage, packaging,preservation, or delivery of ESD-sensitive products shall receive training in electrostatic discharge (ESD)protection prior to pe

18、rforming their jobs.ESD 培訓(xùn)所有包括操作、倉儲、包裝、保存與運(yùn)輸ESD敏感產(chǎn)品的員工都應(yīng)接受靜電放電培訓(xùn)，以確保他們開展工作。6.2.2.C.5 Advanced Quality Training The organization shall offer appropriate levels of advancedquality training. Examples of advanced quality training may include statistical techniques, processcapability, statistical samplin

19、g, data collection and analysis, problem identification, problem analysis, andcorrective and preventive action. 5高級質(zhì)量培訓(xùn)組織應(yīng)體統(tǒng)適當(dāng)更高層次的質(zhì)量培訓(xùn)。高級質(zhì)量培訓(xùn)可以包括統(tǒng)計(jì)技術(shù)、過程能力、統(tǒng)計(jì)取樣、數(shù)據(jù)收集與分析、問題判斷、問題分析積極糾正預(yù)防措施等。56.2.2.C.6 Training Content Where the potential for hazardous conditions exists, training content shouldinclude

20、the following:培訓(xùn)容有潛在危險(xiǎn)的地方，培訓(xùn)容應(yīng)包括：a) task execution, 作業(yè)執(zhí)行b) personal safety, 個(gè)人安全c) awareness of hazardous environment, and 危險(xiǎn)意識，等d) equipment protection. 設(shè)備保護(hù)6.2.2.HV.1 Operator Qualification The organization shall establish operator qualification andrequalification requirements for all applicable p

21、rocesses. These requirements, at a minimum, shalladdress employee education, experience, training, and demonstrated skills. The organization shallcommunicate this information to all affected employees. 4HV.1 操作員資格組織應(yīng)當(dāng)為所有必要過程建立操作員資格與要求條件。這些要求應(yīng)注明員工教育背景、工作經(jīng)歷、培訓(xùn)與技能。組織應(yīng)將該信息通知所有相關(guān)職工。6.3 Infrastructure基礎(chǔ)設(shè)施

22、6.4 Work environment工作環(huán)境6.4.C.1 Work Areas Areas used for handling, storage, and packaging of products shall be clean, safe,and organized to ensure that they do not adversely affect quality or personnel performance. 56.4.C.1 工作區(qū)用于操作、儲存與包裝產(chǎn)品的區(qū)域應(yīng)保持干凈、安全并且有序，以確保不會對質(zhì)量或個(gè)人造成負(fù)面影響。Section 7 Product realizat

23、ion第七章 產(chǎn)品實(shí)現(xiàn)7.1 Planning of product realization 產(chǎn)品實(shí)現(xiàn)的策劃7.1.C.1 Life Cycle Model The organization shall establish and maintain an integrated set of guidelinesthat covers the life cycle of its products. This framework shall contain, as appropriate, the processes,activities, and tasks involved in the co

24、ncept, definition, development, production, operation, maintenance,and (if required) disposal of products, spanning the life of the products. 10生命循環(huán)模式組織應(yīng)當(dāng)建立并維護(hù)一套覆蓋產(chǎn)品生命循環(huán)的完整的指導(dǎo)手冊。該框架應(yīng)盡可能包括國過程、功能、以與觀念、定義、發(fā)展、產(chǎn)品、操作、維護(hù)，以與產(chǎn)品的處理（如果必要），跨度產(chǎn)品的生命周期。7.1.C.2 New Product Introduction The organization shall establ

25、ish and maintain adocumentedprocedure(s) for introducing new products for General Availability.新產(chǎn)品介紹組織應(yīng)建立并維護(hù)一套文件化的程序用以介紹新產(chǎn)品的一般性能。7.1.C.2-NOTE 1: The new product introduction program should include provisions for such programs as:quality and reliability prediction studies, pilot production, demand an

26、d capacity studies, sales and servicepersonnel training, and new product post-introduction evaluations.注解1新產(chǎn)品介紹程序應(yīng)包括以下程序：質(zhì)量與可靠性預(yù)測計(jì)劃，試制產(chǎn)品，需求與產(chǎn)量計(jì)劃，銷售與服務(wù)人員培訓(xùn)，新產(chǎn)品定位估計(jì)。7.1.C.3 Disaster Recovery The organization shall establish and maintain methods for disasterrecovery to ensure the organizations ability

27、to recreate and service the product throughout its life cycle. 10事故處理組織應(yīng)建立并維護(hù)事故處理的方法以確保組織有能力在生命周期進(jìn)行維修和服務(wù)。7.1.C.4 End of Life Planning The organization shall establish and maintain a documentedprocedure(s) for the discontinuance of manufacturing and/or support of a product by the operation andservice

28、 organizations. The documented procedure(s) should include:最終策劃組織應(yīng)為保質(zhì)期和服務(wù)組織終止生產(chǎn)或支持產(chǎn)品建立并維護(hù)一套文件化的程序。該程序文件應(yīng)包括：a) cessation of full or partial support after a certain period of time, 一定時(shí)間后停止全部或部分支持，b) archiving product documentation and software, 保存產(chǎn)品文檔與軟件，c) responsibility for any future residual suppo

29、rt issues, 對任何殘留問題支持的責(zé)任，d) transition to the new product, if applicable, and 如果適用，轉(zhuǎn)化為新產(chǎn)品，等e) accessibility of archive copies of data. 10 數(shù)據(jù)拷貝存檔的可達(dá)性7.1.HS.1Configuration Management Plan The organization shall establish and maintain aconfiguration management plan, which should include: 配置管理策劃組織應(yīng)建立并維護(hù)一

30、配置管理策劃，其容應(yīng)包括：a) identification and scope of the configuration management activities, 配置管理活動的定義與圍b) schedule for performing these activities, 執(zhí)行這些活動的進(jìn)度表c) configuration management tools, 配置管理工具d) configuration management methods and documented procedure(s), 配置管理方法與程序文件e) organizations and responsibil

31、ities assigned to them, 組織與分派給它的責(zé)任，f) level of required control for each configuration item, and 每個(gè)配置項(xiàng)目需要控制的級別g) point at which items are brought under configuration management. 10指明哪些條款置于配置管理的管轄圍。107.1.HS.1-NOTE 1: General work instructions defining general configuration management tasks andrespons

32、ibilities need not be replicated as part of a specific documented configuration management plan.注解1：總的工作指令規(guī)定總的配置管理任務(wù)并且責(zé)任不必轉(zhuǎn)述為配置管理策劃的部分文件。7.1.S.1 Estimation The organization shall establish and maintain a method for estimating and trackingproject factors during project planning, execution, and change

33、 management. 11評估組織應(yīng)建立并維護(hù)一種方法用以在方案策劃、實(shí)施與更改過程中評估和跟蹤方案因素7.1.S.1-NOTE 1: Project factors should include product size, complexity, effort, staffing, schedules, cost,quality, reliability, and productivity.注解1：方案因素應(yīng)包括產(chǎn)品尺寸，復(fù)雜性，成就，員工，進(jìn)度，成本，質(zhì)量，可靠性與生產(chǎn)能力。7.1.S.2 Computer Resources The organization shall establ

34、ish and maintain methods for estimatingand tracking critical computer resources for the target computer, the computer on which the software isintended to operate. Examples of these resources are utilization of memory, throughput, real timeperformance, and I/O channels. 11計(jì)算機(jī)資源組織應(yīng)建立并維護(hù)一種方法用以評估和追蹤目標(biāo)計(jì)算

35、機(jī)的重要資源，計(jì)算機(jī)中的軟件是否預(yù)期運(yùn)行。這些資源包括存儲器的效用、吞吐量、適時(shí)執(zhí)行以與I/O通道。117.1.S.3 Support Software and Tools Management The organization shall ensure that internallydeveloped support software and tools used in the product life cycle are subject to the appropriate qualitymethod(s). Tools to be considered include: design a

36、nd development tools, testing tools, configurationmanagement tools, and documentation tools. 11支持軟件與工具管理組織應(yīng)該保證用在產(chǎn)品中的部開發(fā)的支持軟件與工具在整個(gè)產(chǎn)品生命周期中的質(zhì)量。應(yīng)當(dāng)考慮的工具包括：設(shè)計(jì)開發(fā)工具、測試工具、配置管理工具，以與文件工具。117.1.V.1 Service Delivery Plan Suppliers that are responsible for the delivery or implementation of aservice, and are not

37、responsible for the design and development of that service, shall comply with theProject Plan requirements of 7.3.1.C.1.服務(wù)交付策劃 廠商有責(zé)任交貨或提供服務(wù)，但是對服務(wù)的設(shè)計(jì)與發(fā)展不負(fù)責(zé)任，應(yīng)符合7.3.1.C.1條方案策劃要求。7.2 Customer-related processes與顧客有關(guān)的過程7.2.1 Determination of requirements related to the product 與產(chǎn)品有關(guān)的要求的確定7.2.2 Review of

38、requirements related to the product與產(chǎn)品有關(guān)的要求的評審7.2.2.C-NOTE 1: The contract review process should include:注解1：合同評審過程應(yīng)包括：a) product acceptance planning and review, 產(chǎn)品驗(yàn)收策劃和評審b) handling of problems detected after product acceptance, including customer complaints and claims,and 產(chǎn)品驗(yàn)收后發(fā)現(xiàn)問題的處理，包括客戶投訴與要求，等c

39、) responsibility of removal and/or correction of nonconformities after applicable warranty period orduring product maintenance contract period. 9在保證期或維修合約有效期間有責(zé)任刪除和/或修正不符合項(xiàng)目。97.2.2.C-NOTE 2: The product acceptance plan should include as appropriate:注解2：產(chǎn)品驗(yàn)收策劃應(yīng)當(dāng)包括以下容作為補(bǔ)充：a) acceptance review process,

40、 驗(yàn)收評審過程，b) acceptance criteria, 驗(yàn)收標(biāo)準(zhǔn)c) documented test procedure(s), 文件化的檢測程序d) test environment, 檢測環(huán)境e) test cases, 檢測實(shí)例f) test data, 檢測數(shù)據(jù)g) resources involved, 相關(guān)資源h) method(s) for problem tracking and resolution, and 問題追蹤與解決方法，等i) required acceptance test reports. 10 必要的檢驗(yàn)報(bào)告7.2.3 Customer communi

41、cation 顧客溝通7.2.3.C.1 Notification About Problems The organization shall establish and maintain a documentedprocedure(s) to notify all customers who may be affected by a reported problem that is serviceaffecting. 5關(guān)于問題的通知 組織應(yīng)建立并維護(hù)一套程序文件以通知可能受已報(bào)告的服務(wù)問題影響的所有顧客。7.2.3.C.2 Problem Severity The organization

42、 shall assign severity levels to customer reportedproblems based on the impact to the customer in accordance with the definitions of critical, major, andminor problem reports contained in the glossary of this handbook. The severity level shall be used indetermining the timeliness of the organization

43、s response. 11問題嚴(yán)重性組織應(yīng)根據(jù)對顧客的影響向顧客指明問題的嚴(yán)重程度，根據(jù)手冊中的術(shù)語可分為嚴(yán)重，重大，一般問題。組織根據(jù)嚴(yán)重程度確定答復(fù)時(shí)間。7.2.3.C.2-NOTE 1: The customer and the organization should jointly determine the priority for resolvingcustomer-reported problems.注解1：顧客和組織共同確定解決顧客報(bào)告問題的優(yōu)先程度。7.2.3.C.3 Problem Escalation The organization shall establish a

44、nd maintain a documented escalationprocedure(s) to resolve customer-reported problems. 11問題升級 組織應(yīng)建立并維護(hù)一套程序文件解決升級的顧客報(bào)告問題。117.2.3.C.4 Customer Feedback The organization shall establish and maintain a documentedprocedure(s) to provide the customer with feedback on their problem reports in a timely mann

45、er.顧客反饋組織應(yīng)建立并維護(hù)一套程序文件與時(shí)處理顧客問題反饋。7.2.3.H.1 Organizations Recall Process The organization shall establish and maintain a documentedprocedure(s) for identifying and recalling products that are unfit to remain in service.組織的回收過程組織應(yīng)建立并維護(hù)一套程序文件以鑒定和回收不適合維修的產(chǎn)品。7.3 Design and development設(shè)計(jì)和開發(fā)7.3.1 Design and

46、 development planning 設(shè)計(jì)和開發(fā)策劃7.3.1.C.1 Project Plan The organization shall establish and maintain a project plan based on thedefined product life cycle model. The plan should include:方案策劃 組織應(yīng)依據(jù)定義的產(chǎn)品生命周期模式建立并維護(hù)一個(gè)方案計(jì)劃。該計(jì)劃應(yīng)包括：a) project organizational structure, 方案組織結(jié)構(gòu)b) project roles and responsibilit

47、ies, 方案角色與職責(zé)c) interfaces with internal and external organizations, 與部或外部組織交流d) means for scheduling, tracking, issue resolution, and reporting, 計(jì)劃進(jìn)度、跟蹤、問題決定與報(bào)告的方式e) budgets, staffing, and schedules associated with project activities, 與方案活動相關(guān)的預(yù)算、人員、進(jìn)度f) method(s), standards, documented procedure(s),

48、 and tools to be used, 方法，標(biāo)準(zhǔn)，程序文件以應(yīng)用工具g) references to related plans (e.g., development, testing, configuration management, and quality), 策劃相關(guān)的參考資料（例如：發(fā)展，測試，配置管理，與質(zhì)量）h) project-specific environment and physical resource considerations (e.g., development, userdocumentation, testing, and operation), 方

49、案詳細(xì)考慮的環(huán)境與物質(zhì)資源（例如：發(fā)展，用戶證書，測試與操作）i) customer, user, and supplier involvement during the product life cycle (e.g., joint reviews, informalmeetings, and approvals), 產(chǎn)品生命周期顧客，用戶與廠商（例如：聯(lián)合評審，非正式會議，以與批準(zhǔn)）j) management of project quality, 方案質(zhì)量管理k) risk management and contingency plans (e.g., technical, cost a

50、nd schedules), 風(fēng)險(xiǎn)管理與意外事故策劃（例如：技術(shù)，成本以與進(jìn)度）l) performance, safety, security, and other critical requirements, 執(zhí)行、保險(xiǎn)、安全以與其它緊急需求m) project-specific training requirements, 方案詳細(xì)培訓(xùn)需求n) required certifications, 必須的證明，o) proprietary, usage, ownership, warranty, licensing rights, and 所有者，用法，所有權(quán)，授權(quán)，許可權(quán)力，等p) pos

51、t-project analysis. 10 方案定位分析. 107.3.1.C.1-NOTE 1: The project plan and any related plans may be an independent document, a part ofanother document, or comprised of several documents.注解1：方案策劃或其它相關(guān)策劃可能是獨(dú)立的文件，其它文件的由部分或由幾個(gè)文件組成。7.3.1.C.1-NOTE 2: General work instructions defining tasks and responsibilit

52、ies common to alldevelopment projects need not be replicated as part of a project plan.注解2：總的工作指令定義的對于所有的開發(fā)方案都有效的任務(wù)和職則不必再在方案策劃中重復(fù)引用。7.3.1.C.2 Requirements Traceability The organization shall establish and maintain a method to tracedocumented requirements through design and test. 117.3.1.C.2 必要的可追蹤性組

53、織應(yīng)建立并維護(hù)一種方法對設(shè)計(jì)和測試過程的文件進(jìn)行必要的追蹤。117.3.1.C.2-NOTE 1: The organization should establish communication methods for dissemination ofproduct requirements and changes to requirements to all impacted parties identified in the project plan.7.3.1.C.2 注解1：組織應(yīng)建立一種聯(lián)系方法來貫徹產(chǎn)品的要求并改進(jìn)各種要求以符合方案策劃的定義。7.3.1.C.3 Test Plan

54、ning Test plans shall be documented and results recorded. Test plans shouldinclude:7.3.1.C.3 檢測策劃檢測策劃應(yīng)形成文件并對結(jié)果加以記錄。檢測策劃應(yīng)包括：a) scope of testing (e.g., unit, feature, integration, system, acceptance),a) 檢測圍（例如：單位、特性、綜合性能、系統(tǒng)、驗(yàn)收）b) types of tests to be performed (e.g., functional, boundary, usability, p

55、erformance, regression,interoperability),b) 檢測的執(zhí)行形式（如：功能、圍、用途、性能、退步、協(xié)同工作能力）c) traceability to requirements,c) 必要的可追蹤性d) test environment (e.g., relevancy to customer environment, operational use),d) 檢測環(huán)境（例如：相關(guān)顧客環(huán)境，操作效用）e) test coverage (degree to which a test verifies a products functions, sometimes expressed as apercent of functions tested),e) 檢測規(guī)模（驗(yàn)證產(chǎn)品功能的程度，有時(shí)表現(xiàn)為功能測試的百分比）f) expected results,f) 期望結(jié)果，g) data definition and database requirements,g) 數(shù)據(jù)分類與必要的數(shù)據(jù)庫h) set of tests, test cases (inputs, outputs, tes