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)絡體系結(jié)構(gòu)，布局，容量，安裝結(jié)束任務與數(shù)據(jù)庫）如果這些文件和數(shù)據(jù)影響設計，驗證，確認，檢查與測試，或服務于產(chǎn)品。4.2.4 Control of records記錄控制Section 5 Management responsibility第五章管理職責5.1 Management commitment管理承諾5.2 Customer focus 以顧客為關注焦點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)展顧客關系最高管理者應積極參與建立并維護組織與顧客之間的相互受益的關系。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建立并維護文件化的程序以確保與特定顧客之間的溝通。該程序文件應包括：a) a strategy and criteria for customer selection,選擇顧客的策略與標準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間間隔評審期望目標的狀況，并且應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”）5.3 Quality policy質(zhì)量方針5.4 Planning策劃5.4.1 Quality objectives質(zhì)量目標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)量目標質(zhì)量目標應包括在TL9000 質(zhì)量管理體系計算手冊中為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)量策劃行為應包括以提高質(zhì)量和顧客滿意度為目標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:實現(xiàn)這些目標需要監(jiān)控和匯報。這些策劃應注明：a) cycle time, 循環(huán)時間b) customer service, 顧客服務c) training, 培訓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

12、將顧客輸入納入質(zhì)量策劃中。組織應會同顧客建立質(zhì)量改進程序。5.4.2.C.3 Supplier Input The organization shall implement methods for soliciting and using supplierinput for quality planning activities. 4供應商輸入組織應將供應商輸入納入質(zhì)量策劃中。5.5 Responsibility, authority and communication職責、權(quán)限與溝通5.5.1 Responsibility and authority職責和權(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通知其員工關于質(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部課程開展當組織開展部培訓課程時應當建立并維護一個程序以確保課程的計劃、開展與實現(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當接受持續(xù)改進、解決問題與顧客滿意等基本觀念的培訓。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培訓需求和意識培訓需求應針對所有對產(chǎn)品質(zhì)量有直接影響的職位。員工應該知曉培訓的機會。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 培訓所有包括操作、倉儲、包裝、保存與運輸ESD敏感產(chǎn)品的員工都應接受靜電放電培訓，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)量培訓組織應體統(tǒng)適當更高層次的質(zhì)量培訓。高級質(zhì)量培訓可以包括統(tǒng)計技術、過程能力、統(tǒng)計取樣、數(shù)據(jù)收集與分析、問題判斷、問題分析積極糾正預防措施等。56.2.2.C.6 Training Content Where the potential for hazardous conditions exists, training content shouldinclude

20、the following:培訓容有潛在危險的地方，培訓容應包括：a) task execution, 作業(yè)執(zhí)行b) personal safety, 個人安全c) awareness of hazardous environment, and 危險意識，等d) equipment protection. 設備保護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 操作員資格組織應當為所有必要過程建立操作員資格與要求條件。這些要求應注明員工教育背景、工作經(jīng)歷、培訓與技能。組織應將該信息通知所有相關職工。6.3 Infrastructure基礎設施

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)域應保持干凈、安全并且有序，以確保不會對質(zhì)量或個人造成負面影響。Section 7 Product realizat

23、ion第七章 產(chǎn)品實現(xiàn)7.1 Planning of product realization 產(chǎn)品實現(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)模式組織應當建立并維護一套覆蓋產(chǎn)品生命循環(huán)的完整的指導手冊。該框架應盡可能包括國過程、功能、以與觀念、定義、發(fā)展、產(chǎn)品、操作、維護，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)品介紹組織應建立并維護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)品介紹程序應包括以下程序：質(zhì)量與可靠性預測計劃，試制產(chǎn)品，需求與產(chǎn)量計劃，銷售與服務人員培訓，新產(chǎn)品定位估計。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事故處理組織應建立并維護事故處理的方法以確保組織有能力在生命周期進行維修和服務。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:最終策劃組織應為保質(zhì)期和服務組織終止生產(chǎn)或支持產(chǎn)品建立并維護一套文件化的程序。該程序文件應包括：a) cessation of full or partial support after a certain period of time, 一定時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建立并維護一

30、配置管理策劃，其容應包括：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任，f) level of required control for each configuration item, and 每個配置項目需要控制的級別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并且責任不必轉(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評估組織應建立并維護一種方法用以在方案策劃、實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：方案因素應包括產(chǎn)品尺寸，復雜性，成就，員工，進度，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計算機資源組織應建立并維護一種方法用以評估和追蹤目標計算

35、機的重要資源，計算機中的軟件是否預期運行。這些資源包括存儲器的效用、吞吐量、適時執(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產(chǎn)品生命周期中的質(zhì)量。應當考慮的工具包括：設計開發(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.服務交付策劃 廠商有責任交貨或提供服務，但是對服務的設計與發(fā)展不負責任，應符合7.3.1.C.1條方案策劃要求。7.2 Customer-related processes與顧客有關的過程7.2.1 Determination of requirements related to the product 與產(chǎn)品有關的要求的確定7.2.2 Review of

38、requirements related to the product與產(chǎn)品有關的要求的評審7.2.2.C-NOTE 1: The contract review process should include:注解1：合同評審過程應包括：a) product acceptance planning and review, 產(chǎn)品驗收策劃和評審b) handling of problems detected after product acceptance, including customer complaints and claims,and 產(chǎn)品驗收后發(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任刪除和/或修正不符合項目。97.2.2.C-NOTE 2: The product acceptance plan should include as appropriate:注解2：產(chǎn)品驗收策劃應當包括以下容作為補充：a) acceptance review process,

40、 驗收評審過程，b) acceptance criteria, 驗收標準c) documented test procedure(s), 文件化的檢測程序d) test environment, 檢測環(huán)境e) test cases, 檢測實例f) test data, 檢測數(shù)據(jù)g) resources involved, 相關資源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 必要的檢驗報告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關于問題的通知 組織應建立并維護一套程序文件以通知可能受已報告的服務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問題嚴重性組織應根據(jù)對顧客的影響向顧客指明問題的嚴重程度，根據(jù)手冊中的術語可分為嚴重，重大，一般問題。組織根據(jù)嚴重程度確定答復時間。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 組織應建立并維護一套程序文件解決升級的顧客報告問題。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.顧客反饋組織應建立并維護一套程序文件與時處理顧客問題反饋。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建立并維護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設計和開發(fā)7.3.1 Design and

46、 development planning 設計和開發(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 組織應依據(jù)定義的產(chǎn)品生命周期模式建立并維護一個方案計劃。該計劃應包括：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, 計劃進度、跟蹤、問題決定與報告的方式e) budgets, staffing, and schedules associated with project activities, 與方案活動相關的預算、人員、進度f) method(s), standards, documented procedure(s),

48、 and tools to be used, 方法，標準，程序文件以應用工具g) references to related plans (e.g., development, testing, configuration management, and quality), 策劃相關的參考資料（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）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), 風險管理與意外事故策劃（例如：技術，成本以與進度）l) performance, safety, security, and other critical requirements, 執(zhí)行、保險、安全以與其它緊急需求m) project-specific training requirements, 方案詳細培訓需求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策劃可能是獨立的文件，其它文件的由部分或由幾個文件組成。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)方案都有效的任務和職則不必再在方案策劃中重復引用。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、織應建立并維護一種方法對設計和測試過程的文件進行必要的追蹤。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：組織應建立一種聯(lián)系方法來貫徹產(chǎn)品的要求并改進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形成文件并對結(jié)果加以記錄。檢測策劃應包括：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（驗證產(chǎn)品功能的程度，有時表現(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