第4部分质量管理系统方案

《第4部分质量管理系统方案》由会员分享，可在线阅读，更多相关《第4部分质量管理系统方案（26页珍藏版）》请在装配图网上搜索。

1、 Section 4 Quality management system第四章 质量管理体系4.1 General requirements一般要求4.2 Documentation requirements文件要求4.2.1 General总则4.2.2 Quality manual质量手册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.客户提供文件与数据控制 组织将建立并

3、且维护文件化程序以控制所有客户提供的文件和数据（例如，网络体系结构，布局，容量，安装结束任务与数据库）如果这些文件和数据影响设计，验证，确认，检查与测试，或服务于产品。4.2.4 Control of records记录控制Section 5 Management responsibility第五章管理职责5.1 Management commitment管理承诺5.2 Customer focus 以顾客为关注焦点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发展顾客关系最高管理者应积极参与建立并维护组织与顾客之间的相互受益的关系。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:顾客沟通程序组织应建立并维护文件化的程序以确保与特定顾客之间的沟通。该程序文件应包括：a) a strategy and criteria for customer selection,选择顾客的策略与标准b) a method for the organization and its customers to share joint expectations and improve the quality ofproducts, and组织和顾客共同参与策划与提高产品质量的方法，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会同顾客安既定的时间间隔评审期望目标的状况，并且应有可以追踪决定流转的方法。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：众所周知，组织不可能对所有顾客提供同样级别的沟通。所提供的级别应依据与顾客的生意数量、历史问题、顾客期望值，以与其它因素（参见附录

8、F，“顾客沟通指导”）5.3 Quality policy质量方针5.4 Planning策划5.4.1 Quality objectives质量目标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.质量目标质量目标应包括在TL9000 质量管理体系计算手册中为TL9000定义的对象。5.4.2 Qua

9、lity management system planning质量管理体系策划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.长期和短期质量策划组织的质量策划行为应包括以提高质量和顾客满意度为目标的长期策划和短期策划。Performance to these g

10、oals shall be monitored and reported. These plans shall address:实现这些目标需要监控和汇报。这些策划应注明：a) cycle time, 循环时间b) customer service, 顾客服务c) training, 培训d) cost, 成本e) delivery commitments, and 交货承诺，等f) product reliability. 产品可靠性5.4.2.C.1-NOTE 1: Top Management should demonstrate their active involvement in

11、long- and short-termquality planning.注解1：最高管理者应积极参与到长期和短期质量策划中。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顾客输入 组织应

12、将顾客输入纳入质量策划中。组织应会同顾客建立质量改进程序。5.4.2.C.3 Supplier Input The organization shall implement methods for soliciting and using supplierinput for quality planning activities. 4供应商输入组织应将供应商输入纳入质量策划中。5.5 Responsibility, authority and communication职责、权限与沟通5.5.1 Responsibility and authority职责和权限5.5.2 Management

13、 representative管理者代表5.5.3 Internal communication部沟通5.5.3.C.1 Organization Performance Feedback The organization shall inform employees of its qualityperformance and the level of customer satisfaction. 4组织成绩反馈组织应通知其员工关于质量成绩以与顾客满意程度。5.6 Management review管理评审5.6.1 General总则5.6.2 Review input评审输入5.6.3 R

14、eview output评审输出Section 6 Resource management第六章 资源管理6.1 Provision of resources资源提供6.2 Human resources人力资源6.2.1 General总则6.2.2 Competence, awareness and training能力、意识和培训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部课程开展当组织开展部培训课程时应当建立并维护一个程序以确保课程的计划、开展与实现。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质量改进观念包括最高管理者在的所有对产品质量有直接影响的员工应当接受持续改进、解决问题与顾客满意等基本观念的培训。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培训需求和意识培训需求应针对所有对产品质量有直接影响的职位。员工应该知晓培训的机会。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 培训所有包括操作、仓储、包装、保存与运输ESD敏感产品的员工都应接受静电放电培训，以确保他们开展工作。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高级质量培训组织应体统适当更高层次的质量培训。高级质量培训可以包括统计技术、过程能力、统计取样、数据收集与分析、问题判断、问题分析积极纠正预防措施等。56.2.2.C.6 Training Content Where the potential for hazardous conditions exists, training content shouldinclude

20、the following:培训容有潜在危险的地方，培训容应包括：a) task execution, 作业执行b) personal safety, 个人安全c) awareness of hazardous environment, and 危险意识，等d) equipment protection. 设备保护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 操作员资格组织应当为所有必要过程建立操作员资格与要求条件。这些要求应注明员工教育背景、工作经历、培训与技能。组织应将该信息通知所有相关职工。6.3 Infrastructure基础设施

22、6.4 Work environment工作环境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 工作区用于操作、储存与包装产品的区域应保持干净、安全并且有序，以确保不会对质量或个人造成负面影响。Section 7 Product realizat

23、ion第七章 产品实现7.1 Planning of product realization 产品实现的策划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生命循环模式组织应当建立并维护一套覆盖产品生命循环的完整的指导手册。该框架应尽可能包括国过程、功能、以与观念、定义、发展、产品、操作、维护，以与产品的处理（如果必要），跨度产品的生命周期。7.1.C.2 New Product Introduction The organization shall establ

25、ish and maintain adocumentedprocedure(s) for introducing new products for General Availability.新产品介绍组织应建立并维护一套文件化的程序用以介绍新产品的一般性能。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新产品介绍程序应包括以下程序：质量与可靠性预测计划，试制产品，需求与产量计划，销售与服务人员培训，新产品定位估计。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事故处理组织应建立并维护事故处理的方法以确保组织有能力在生命周期进行维修和服务。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:最终策划组织应为保质期和服务组织终止生产或支持产品建立并维护一套文件化的程序。该程序文件应包括：a) cessation of full or partial support after a certain period of time, 一定时间后停止全部或部分支持，b) archiving product documentation and software, 保存产品文档与软件，c) responsibility for any future residual suppo

29、rt issues, 对任何残留问题支持的责任，d) transition to the new product, if applicable, and 如果适用，转化为新产品，等e) accessibility of archive copies of data. 10 数据拷贝存档的可达性7.1.HS.1Configuration Management Plan The organization shall establish and maintain aconfiguration management plan, which should include: 配置管理策划组织应建立并维护一

30、配置管理策划，其容应包括：a) identification and scope of the configuration management activities, 配置管理活动的定义与围b) schedule for performing these activities, 执行这些活动的进度表c) configuration management tools, 配置管理工具d) configuration management methods and documented procedure(s), 配置管理方法与程序文件e) organizations and responsibil

31、ities assigned to them, 组织与分派给它的责任，f) level of required control for each configuration item, and 每个配置项目需要控制的级别g) point at which items are brought under configuration management. 10指明哪些条款置于配置管理的管辖围。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：总的工作指令规定总的配置管理任务并且责任不必转述为配置管理策划的部分文件。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评估组织应建立并维护一种方法用以在方案策划、实施与更改过程中评估和跟踪方案因素7.1.S.1-NOTE 1: Project factors should include product size, complexity, effort, staffing, schedules, cost,quality, reliability, and productivity.注解1：方案因素应包括产品尺寸，复杂性，成就，员工，进度，成本，质量，可靠性与生产能力。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计算机资源组织应建立并维护一种方法用以评估和追踪目标计算

35、机的重要资源，计算机中的软件是否预期运行。这些资源包括存储器的效用、吞吐量、适时执行以与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支持软件与工具管理组织应该保证用在产品中的部开发的支持软件与工具在整个产品生命周期中的质量。应当考虑的工具包括：设计开发工具、测试工具、配置管理工具，以与文件工具。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.服务交付策划 厂商有责任交货或提供服务，但是对服务的设计与发展不负责任，应符合7.3.1.C.1条方案策划要求。7.2 Customer-related processes与顾客有关的过程7.2.1 Determination of requirements related to the product 与产品有关的要求的确定7.2.2 Review of

38、requirements related to the product与产品有关的要求的评审7.2.2.C-NOTE 1: The contract review process should include:注解1：合同评审过程应包括：a) product acceptance planning and review, 产品验收策划和评审b) handling of problems detected after product acceptance, including customer complaints and claims,and 产品验收后发现问题的处理，包括客户投诉与要求，等c

39、) responsibility of removal and/or correction of nonconformities after applicable warranty period orduring product maintenance contract period. 9在保证期或维修合约有效期间有责任删除和/或修正不符合项目。97.2.2.C-NOTE 2: The product acceptance plan should include as appropriate:注解2：产品验收策划应当包括以下容作为补充：a) acceptance review process,

40、 验收评审过程，b) acceptance criteria, 验收标准c) documented test procedure(s), 文件化的检测程序d) test environment, 检测环境e) test cases, 检测实例f) test data, 检测数据g) resources involved, 相关资源h) method(s) for problem tracking and resolution, and 问题追踪与解决方法，等i) required acceptance test reports. 10 必要的检验报告7.2.3 Customer communi

41、cation 顾客沟通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关于问题的通知 组织应建立并维护一套程序文件以通知可能受已报告的服务问题影响的所有顾客。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问题严重性组织应根据对顾客的影响向顾客指明问题的严重程度，根据手册中的术语可分为严重，重大，一般问题。组织根据严重程度确定答复时间。7.2.3.C.2-NOTE 1: The customer and the organization should jointly determine the priority for resolvingcustomer-reported problems.注解1：顾客和组织共同确定解决顾客报告问题的优先程度。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问题升级 组织应建立并维护一套程序文件解决升级的顾客报告问题。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.顾客反馈组织应建立并维护一套程序文件与时处理顾客问题反馈。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.组织的回收过程组织应建立并维护一套程序文件以鉴定和回收不适合维修的产品。7.3 Design and development设计和开发7.3.1 Design and

46、 development planning 设计和开发策划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:方案策划 组织应依据定义的产品生命周期模式建立并维护一个方案计划。该计划应包括：a) project organizational structure, 方案组织结构b) project roles and responsibilit

47、ies, 方案角色与职责c) interfaces with internal and external organizations, 与部或外部组织交流d) means for scheduling, tracking, issue resolution, and reporting, 计划进度、跟踪、问题决定与报告的方式e) budgets, staffing, and schedules associated with project activities, 与方案活动相关的预算、人员、进度f) method(s), standards, documented procedure(s),

48、 and tools to be used, 方法，标准，程序文件以应用工具g) references to related plans (e.g., development, testing, configuration management, and quality), 策划相关的参考资料（例如：发展，测试，配置管理，与质量）h) project-specific environment and physical resource considerations (e.g., development, userdocumentation, testing, and operation), 方

49、案详细考虑的环境与物质资源（例如：发展，用户证书，测试与操作）i) customer, user, and supplier involvement during the product life cycle (e.g., joint reviews, informalmeetings, and approvals), 产品生命周期顾客，用户与厂商（例如：联合评审，非正式会议，以与批准）j) management of project quality, 方案质量管理k) risk management and contingency plans (e.g., technical, cost a

50、nd schedules), 风险管理与意外事故策划（例如：技术，成本以与进度）l) performance, safety, security, and other critical requirements, 执行、保险、安全以与其它紧急需求m) project-specific training requirements, 方案详细培训需求n) required certifications, 必须的证明，o) proprietary, usage, ownership, warranty, licensing rights, and 所有者，用法，所有权，授权，许可权力，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：方案策划或其它相关策划可能是独立的文件，其它文件的由部分或由几个文件组成。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：总的工作指令定义的对于所有的开发方案都有效的任务和职则不必再在方案策划中重复引用。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 必要的可追踪性组

53、织应建立并维护一种方法对设计和测试过程的文件进行必要的追踪。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：组织应建立一种联系方法来贯彻产品的要求并改进各种要求以符合方案策划的定义。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 检测策划检测策划应形成文件并对结果加以记录。检测策划应包括：a) scope of testing (e.g., unit, feature, integration, system, acceptance),a) 检测围（例如：单位、特性、综合性能、系统、验收）b) types of tests to be performed (e.g., functional, boundary, usability, p

55、erformance, regression,interoperability),b) 检测的执行形式（如：功能、围、用途、性能、退步、协同工作能力）c) traceability to requirements,c) 必要的可追踪性d) test environment (e.g., relevancy to customer environment, operational use),d) 检测环境（例如：相关顾客环境，操作效用）e) test coverage (degree to which a test verifies a products functions, sometimes

56、 expressed as apercent of functions tested),e) 检测规模（验证产品功能的程度，有时表现为功能测试的百分比）f) expected results,f) 期望结果，g) data definition and database requirements,g) 数据分类与必要的数据库h) set of tests, test cases (inputs, outputs, test criteria), and documented test procedure(s),h) 检测装置，检测实例（输入，输出，检测标准），与检测程序文件，i) use of

57、 external testing, andi) 外部检测方法，等j) method of reporting and resolving defects. 11l) 报告方法与纠正措施. 117.3.1.C.3-NOTE 1: Testing may be covered at several levels.7.3.1.C.3 注解1：检测可能覆盖几个级别。7.3.1.S.1 Integration Planning The organization shall develop and document a plan to integrate thesoftware components i

58、nto the product to ensure they interact as designed. The plan shall include:7.3.1.S.1 综合策划组织应建立计划将软件的部分组装到产品中以确保其象设计的一样相互作用，该计划要形成文件。该计划应包括：a) methods and documented procedure(s),a) 方法和程序文件b) responsibilities,b) 职责c) schedule for integration, andc) 综合进度，等d) test requirements. 10d)必要的检测。107.3.1.S.2 M

59、igration Planning The organization shall develop and document a migration plan when asystem or software product is planned to be migrated from an old to a new environment. The plan shouldinclude the following:7.3.1.S.2 迁移策划组织应建立迁移策划并形成文件，该策划适用于当一个系统或软件产品计划从旧的环境中迁移到新的环境中。该策划应包括如下容：a) requirements ana

60、lysis and definition of migration,a)必要的分析与迁移定义b) development of migration tools,b) 迁移工具的建立c) conversion of product and data,c) 产品与数据的转换d) migration execution,d)迁移执行e) migration verification, ande) 迁移验证，等f) support for the old environment in the future. 10f) 将来对旧环境的支持. 107.3.2 Design and development

61、inputs 设计和开发输入7.3.2.C.1 Customer and Supplier Input The organization shall establish and maintain methods forsoliciting and using customer and supplier input during the development of new or revised productrequirements. 4顾客和厂商输入组织应建立并维护将顾客和厂商要求纳入新产品开发或修改的方法。7.3.2.C.2 Design and Development Requirements Design and development requirements shall bedefined and documented, and should include:设计和开发要求设计和开发需求应定义并形成文件，并且应包括：a) quality and reliability requirements,质量和可靠性要求b) functions and capabilities of the product, 产品的功能和性能c) business, organizational, and user requirements, 商业、组织或用户要