第4部分質(zhì)量管理系統(tǒng)

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(cè)4.2.3 Control of documents文件控制4.2.3. C.1 Con trol of Customer-Supplied Docume nts and Data-The orga ni zati on shallestablish and maintain a documented pr

2、ocedure(s) to control all customer-supplied documents and data (e.g., network architecture, topology, capacity, installation termination assignments, and database) if these documents and data influence the design, verification, validation, inspection and testing, or servicing the product.客戶提供文件及數(shù)據(jù)控制

3、 組織將建立并且維護(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)及數(shù)據(jù)庫(kù))如果這些文件和數(shù)據(jù)影響 設(shè)計(jì)，驗(yàn)證，確認(rèn)，檢查及測(cè)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 Relati on ship Developme nt-Top man ageme nt shall dem on strat

4、e activeinvolvementin establishing and maintaining mutually-beneficial relationships between the organization and its customers. 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 w

5、ith selected customers. 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, 選擇顧客的策略及標(biāo)準(zhǔn)b) a method for the organization and its customers to share joint expectations and improve the quality of products, and組織和顧客共同參與

6、策劃及提高產(chǎn)品質(zhì)量的方法，和c) a joint review with the customer at defined intervals covering the status of shared expectations and including a method to track the resolution of issues. 4 會(huì)同顧客安既定的時(shí)間間隔評(píng)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

7、the same levelof communication with all its customers. The level provided may depend on the amount of business with the customer, 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(duì)所有顧客提供同樣級(jí)別的溝通。所提供的級(jí)別應(yīng)依據(jù)與顧客的

8、 生意數(shù)量、歷史問(wèn)題、顧客期望值，以及其它因素(參見(jiàn)附錄 F ，“顧客溝通指導(dǎo)”)5.3 Quality policy 質(zhì)量方針5.4.1 Quality objectives 質(zhì)量目標(biāo)5.4.1.C.1 Quality Objectives measurements defined in the 質(zhì)量目標(biāo)質(zhì)量目標(biāo)應(yīng)包括在5.4 Planning 策劃-Objectives for quality shall include targets for the TL 9000TL 9000 Quality Management System Measurements Handbook.TL9000

9、 質(zhì)量管理體系計(jì)算手冊(cè)中為 TL9000 定義的對(duì)象。5.4.2 Quality management system planning 質(zhì)量管理體系策劃5.4.2. C.1 Long- and Short-Term Quality PlanningThe organization' s quality planningactivities shall include long- and short-term plans with goals for improving quality and customer satisfaction.長(zhǎng)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)

10、量和顧客滿意度為目標(biāo)的長(zhǎng)期策劃和短 期策劃。Performance to these goals 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(wàn)) product reliability.產(chǎn)品可靠性5.4.2. C.1-NOTE 1:Top Management should d

11、emonstrate their active involvement in long- andshort-term quality planning.注解 1 ：最高管理者應(yīng)積極參與到長(zhǎng)期和短期質(zhì)量策劃中。5.4.2. C.2 Customer In put-The orga ni zati on shall impleme nt methods for solicit ing andconsidering customer input for quality planning activities. The organization should establish joint quali

12、ty improvement programs with customers. 4顧客輸入 組織應(yīng)將顧客輸入納入質(zhì)量策劃中。組織應(yīng)會(huì)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 supplier input 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

13、.5.1 Responsibility and authority 職責(zé)和權(quán)限5.5.2 Management representative 管理者代表5.5.3 Internal communication 內(nèi)部溝通5.5.3. C.1 Organization Performance Feedback-The organization shall inform employees of itsquality performance and the level of customer satisfaction.4組織成績(jī)反饋組織應(yīng)通知其員工關(guān)于質(zhì)量成績(jī)以及顧客滿意程度。5.6 Managem

14、ent review 管理評(píng)審5.6.1 General 總則5.6.2 Review input 評(píng)審輸入5.6.3 Review output 評(píng)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(shí)和培訓(xùn)6.2.2. C.1 In ter nal Course Developme nt Whe n the orga ni zati

15、 on develops in ternal trai ningcourses, it shall establish and maintain a process for planning, developing, and implementing these courses. 4內(nèi)部課程開(kāi)展當(dāng)組織開(kāi)展內(nèi)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(kāi)展及實(shí) 現(xiàn)。 46.2.2. C.2 Quality Improvement ConceptsThose employees that have a direct impact on thequality of the product,

16、including top management, shall be trained in the fundamental concepts of continual improvement, problem solving, and customer satisfaction. 4 質(zhì)量改進(jìn)觀念包括最高管理者在內(nèi)的所有對(duì)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(wèn)題及顧客滿意等基本觀念的培訓(xùn)。 46.2.2. C.3 Training Requirements and AwarenessTraining requirements shall be defined forall posi

17、tions that have a direct impact on the quality of products. Employees shall be made awareof training opportunities. 4 培訓(xùn)需求和意識(shí)培訓(xùn)需求應(yīng)針對(duì)所有對(duì)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(huì)。6.2.2. C.4 ESD Training All employees with functions that involve any handling, storage, packaging,preservation, or delivery of ESD-sensitiv

18、e products shall receive training in electrostatic discharge (ESD) protection prior to performing their jobs.ESD培訓(xùn)-所有包括操作、倉(cāng)儲(chǔ)、包裝、保存及運(yùn)輸ES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(kāi)展工作。6.2.2. C.5 Advanced Quality TrainingThe organization shall offer appropriate levels ofadvanced quality training. Examples of advanced qua

19、lity training may include statistical techniques, process capability, statistical sampling, data collection and analysis, problem identification, problem analysis, and corrective and preventive action.5高級(jí)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(jí)質(zhì)量培訓(xùn)可以包括統(tǒng)計(jì)技術(shù)、過(guò)程 能力、統(tǒng)計(jì)取樣、數(shù)據(jù)收集及分析、問(wèn)題判斷、問(wèn)題分析積極糾正預(yù)防措施等。56.2.2. C.6 Training C

20、ontent Where the potential for hazardous conditions exists, training content shouldinclude the following:培訓(xùn)內(nèi)容有潛在危險(xiǎn)的地方，培訓(xùn)內(nèi)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(shí)，等d) equipment protection. 設(shè)備保護(hù)6.2.2. HV.1 Operator Qualificati onThe orga ni zati

21、on shall establish operator qualificati on andrequalification requirements for all applicable processes. These requirements, at a minimum, shall address employee education, experience, training, and demonstrated skills. The organization shall communicate this information to all affected employees.4H

22、V.1 操作員資格組織應(yīng)當(dāng)為所有必要過(guò)程建立操作員資格及要求條件。這些要求應(yīng)注明員 工教育背景、工作經(jīng)歷、培訓(xùn)及技能。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6.4 Work environment 工作環(huán)境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 performanc e. 5工

23、作區(qū)用于操作、儲(chǔ)存及包裝產(chǎn)品的區(qū)域應(yīng)保持干凈、安全并且有序，以確保不會(huì)對(duì)質(zhì) 量或個(gè)人造成負(fù)面影響。Section 7 Product realization 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 orga ni zati on shall establish and maintain an in tegrated set ofguidelines that covers the life cycle of its products. This framework shal

24、l contain, as appropriate, the processes, activities, and tasks involved in the concept, 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(cè)。該框架應(yīng)盡可 能包括國(guó)過(guò)程、功能、以及觀念、定義、發(fā)展、產(chǎn)品、操作、維護(hù)，以及

25、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 establish and maintain adocumented procedure(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

26、 such programs as: quality and reliability prediction studies, pilot production, demand and capacity studies, sales and service personnel 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)量及可靠性預(yù)測(cè)計(jì)劃，試制產(chǎn)品，需求及產(chǎn)量計(jì) 劃，銷售及服務(wù)人員培訓(xùn)，新產(chǎn)品定位估計(jì)。7.1. C.3 Disaster Recovery-The organization

27、shall establish and maintain methods for disasterrecovery to ensure the organization' s ability to recreate and service the product throughout its lifecycle. 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內(nèi)進(jìn)行維修和服務(wù)。7.1. C.4 End of Life Planning-The organization shall establish and maintain a documentedproced

28、ure(s) for the discontinuance of manufacturing and/or support of a product by the operation and service 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

29、) archiving product documentation and software,保存產(chǎn)品文檔及軟件，c) responsibility for any future residual support issues,對(duì)任何殘留問(wèn)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.1 Configuration Management Plan-The organiza

30、tion 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)一配置管理策劃，其內(nèi)容應(yīng)包括：a) identification and scope of the configuration management activities, 配置管理活動(dòng)的定義及范圍b) schedule for performing these activities,執(zhí)行這些活動(dòng)的進(jìn)度表c) configuration management tools,配置管理工具d) con

31、figuration management methods and documented procedure(s), 配置管理方法及程序文件e) organizations and responsibilities assigned to them, 組織及分派給它的責(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(jí)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范圍

32、。 107.1. HS.1-NOTE 1: General work instructions defining general configuration management tasks and responsibilities 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。7.1.5.1 Estimati onThe orga ni zati on shall establish

33、and maintain a method for estimati ng andtracking project factors during project planning, execution, and change management.11評(píng)估組織應(yīng)建立并維護(hù)一種方法用以在方案策劃、實(shí)施及更改過(guò)程中評(píng)估和跟蹤方案因素注解 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，可靠性及生產(chǎn)能 力。7.1.5.2 Computer Resources-The orga ni zati on shall establish and maintain methods fore

34、stimating and tracking critical computer resources for the target computer, the computer on which the software is intended to operate. Examples of these resources are utilization of memory, throughput, real time performance, 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(píng)估和追蹤目標(biāo)計(jì)算機(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

35、存儲(chǔ)器的效用、吞吐量、適時(shí)執(zhí)行以及 I/O 通道。 117.1.5.3 Support Software and Tools Management-The organization shall ensure thatinternally developed support software and tools used in the product life cycle are subject to the appropriate quality method(s). Tools to be considered include: design and development tools, t

36、esting tools, configuration management tools, and documentation tools.1111支持軟件及工具管理組織應(yīng)該保證用在產(chǎn)品中的內(nèi)部開(kāi)發(fā)的支持軟件及工具在整個(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(kāi)發(fā)工具、測(cè)試工具、配置管理工具，以及文件工具。7.1. V.1 Service Delivery Plan-Suppliers that are responsible for the delivery or implementation服務(wù)交付策劃 廠商有責(zé)任交貨或提供服務(wù)，但是對(duì)服務(wù)的設(shè)計(jì)及發(fā)展不負(fù)責(zé)任，應(yīng)符合7.3.1.

37、C.1 條方案策劃要求。7.2 Customer-related processes 與顧客有關(guān)的過(guò)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 requirements related to the product 與產(chǎn)品有關(guān)的要求的評(píng)審7.2.2. C-NOTE 1: The contract review process should include:注解 1 ：合同評(píng)審過(guò)程應(yīng)包括：a) product acceptance planning and revie

38、w,產(chǎn)品驗(yàn)收策劃和評(píng)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(wèn)題的處理，包括客戶投訴及要求，等c) responsibility of removal and/or correction of nonconformities after applicable warranty period or during product maintenance contract period. 9 在保證期或維修合約有效期間

39、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)包括以下內(nèi)容作為補(bǔ)充：a) acceptance review process,驗(yàn)收評(píng)審過(guò)程，b) acceptance criteria,驗(yàn)收標(biāo)準(zhǔn)c) documented test procedure(s),文件化的檢測(cè)程序d) test environment,檢測(cè)環(huán)境e) test cases,檢測(cè)實(shí)例f) test data,檢測(cè)數(shù)據(jù)g) resources involve

40、d,相關(guān)資源h) method(s) for problem tracking and resolution, and問(wèn)題追蹤及解決方法，等i) required acceptance test reports. 10必要的檢驗(yàn)報(bào)告7.2.3 Customer communication顧客溝通7.2.3. C.1 Notificati on About ProblemsThe orga ni zati on shall establish and maintain adocumented procedure(s) to notify all customers who may be affe

41、cted by a reported problem that is service affecting. 5關(guān)于問(wèn)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(wèn)題影響的所有顧 客。7.2.3. C.2 Problem Severity The orga ni zati on shall assig n severity levels to customer reportedproblems based on the impact to the customer in accordance with the definitions of critical, major, an

42、d minor problem reports contained in the glossary of this handbook. The severity level shall be used in determining the timeliness of the organization's resp11onse.問(wèn)題嚴(yán)重性組織應(yīng)根據(jù)對(duì)顧客的影響向顧客指明問(wèn)題的嚴(yán)重程度，根據(jù)手冊(cè)中的術(shù)語(yǔ)可分為嚴(yán) 重，重大，一般問(wèn)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 jointl

43、y determine the priority forresolving customer-reported problems.注解 1 ：顧客和組織共同確定解決顧客報(bào)告問(wèn)題的優(yōu)先程度。7.2.3. C.3 Problem Escalati onThe orga ni zati on shall establish and main tain a docume ntedescalation procedure(s) to resolve customer-reported problems.11問(wèn)題升級(jí) 組織應(yīng)建立并維護(hù)一套程序文件解決升級(jí)的顧客報(bào)告問(wèn)題。 117.2.3. C.4 Cust

44、omer FeedbackThe orga ni zati on shall establish and mai ntain a docume ntedprocedure(s) to provide the customer with feedback on their problem reports in a timely manner. 顧客反饋組織應(yīng)建立并維護(hù)一套程序文件及時(shí)處理顧客問(wèn)題反饋。7.2.3. H.1 Organization' s Recall Process The organization shall establish and maintain adocume

45、nted procedure(s) for identifying and recalling products that are unfit to remain in service. 組織的回收過(guò)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(kāi)發(fā)7.3.1 Design and development planning 設(shè)計(jì)和開(kāi)發(fā)策劃7.3.1. C.1 Project Pla n-The orga ni zati on shall establish and maintain a project pla n base

46、d onthe defined 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 responsibilities,方案角色及職責(zé)c) interfaces with internal and external organizations,與內(nèi)部或外部組織交流d) means for scheduling, tracking, issue r

47、esolution, and reporting, 計(jì)劃進(jìn)度、跟蹤、問(wèn)題決定及報(bào)告的方式e) budgets, staffing, and schedules associated with project activities, 與方案活動(dòng)相關(guān)的預(yù)算、人員、進(jìn)度f(wàn)) method(s), standards, documented procedure(s), 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 managem

48、ent, and quality), 策劃相關(guān)的參考資料(例如：發(fā)展，測(cè)試，配置管理，及質(zhì)量)h) project-specific environment and physical resource considerations (e.g., development, user documentation, testing, and operation),方案詳細(xì)考慮的環(huán)境及物質(zhì)資源(例如：發(fā)展，用戶證書(shū)，測(cè)試及操作)i) customer, user, and supplier involvement during the product life cycle (e.g., joint r

49、eviews, informal meetings, and approvals),產(chǎn)品生命周期內(nèi)顧客，用戶及廠商(例如：聯(lián)合評(píng)審，非正式會(huì)議，以及批準(zhǔn))j) management of project quality,方案質(zhì)量管理k) risk management and contingency plans (e.g., technical, cost and schedules), 風(fēng)險(xiǎn)管理及意外事故策劃(例如：技術(shù)，成本以及進(jìn)度)l) performance, safety, security, and other critical requirements, 執(zhí)行、保險(xiǎn)、安全以及其它

50、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) post-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,

51、 apart of another 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 responsibilities 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(duì)于所有的開(kāi)發(fā)方案都有效的任務(wù)和職則

52、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 methodto trace documented requirements through design and test.117.3.1. C.2 必要的可追蹤性組織應(yīng)建立并維護(hù)一種方法對(duì)設(shè)計(jì)和測(cè)試過(guò)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 dis

53、seminationof product 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(lái)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 Pla nning-Test pla ns shall be docume nted and results recorded. Test pla nsshould include:7.3.1. C.3 檢測(cè)策劃?rùn)z測(cè)策劃應(yīng)形

54、成文件并對(duì)結(jié)果加以記錄。檢測(cè)策劃應(yīng)包括：a) scope of testing (e.g., unit, feature, integration, system, acceptance),a) 檢測(cè)范圍(例如：?jiǎn)挝?、特性、綜合性能、系統(tǒng)、驗(yàn)收)b) types of tests to be performed (e.g., functional, boundary, usability, performance, regression, interoperability),b) 檢測(cè)的執(zhí)行形式(如：功能、范圍、用途、性能、退步、協(xié)同工作能力)c) traceability to requir

55、ements,c) 必要的可追蹤性d) test environment (e.g., relevancy to customer environment, operational use),d) 檢測(cè)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 product's functions, sometimes expressed as apercent of functions tested),e) 檢測(cè)規(guī)模(驗(yàn)證產(chǎn)品功能的程度，有時(shí)表現(xiàn)為功能測(cè)試的百分比)f) expected results

56、,f) 期望結(jié)果，g) data definition and database requirements,g) 數(shù)據(jù)分類及必要的數(shù)據(jù)庫(kù)h) set of tests, test cases (inputs, outputs, test criteria), and documented test procedure(s),h) 檢測(cè)裝置，檢測(cè)實(shí)例(輸入，輸出，檢測(cè)標(biāo)準(zhǔn))，及檢測(cè)程序文件，i) use of external testing, andi) 外部檢測(cè)方法，等j) method of reporting and resolving defects. 11l) 報(bào)告方法及糾正措施 .

57、 117.3.1. C.3-NOTE 1:Testing may be covered at several levels.7.3.1. C.3 注解1 ：檢測(cè)可能覆蓋幾個(gè)級(jí)別。7.3.1.S.1 Integration Planning-The organization shall develop and document a plan tointegrate the software components into the product to ensure they interact as designed. The plan shall include:7.3.1.5.1 綜合策劃組織應(yīng)建立計(jì)劃將軟件的部分組裝到產(chǎn)品中以確保其象設(shè)計(jì)的一樣相互作 用，該計(jì)劃要形成文件。該計(jì)劃應(yīng)包括：a) methods and documented procedure(s),a) 方法和程序文件b) responsibilities,b) 職責(zé)c) sch