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 and maintain a documented procedure(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.
客户提供文件及数据控制－ 组织将建立并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，安装结束任务及数据库）如果这些文件和数据影响设计，验证，确认，检查及测试，或服务于产品。
4.2.4 Control of records
记录控制
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汽车基地 http://www.qcbase.com 主机厂与供应商的信息、服务、交流中心! 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 involvement
in establishing and maintaining mutually-beneficial relationships between the organization and its customers. [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 a documented procedure(s) for communicating with selected customers. 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,
选择顾客的策略及标准
b) a method for the organization and its customers to share joint expectations and improve the quality of products, and
组织和顾客共同参与策划及提高产品质量的方法，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]
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 of 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, “Guidance for 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，以及其它因素（参见附录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
measurements defined 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 Quality management system planning 质量管理体系策划
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汽车基地 http://www.qcbase.com 主机厂与供应商的信息、服务、交流中心! 5.4.2.C.1 Long- and Short-Term Quality Planning – The organization’s quality planning
activities shall include 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 goals 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 long- and short-term quality 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
considering customer input for quality planning activities. The organization should establish joint quality improvement programs with customers. [4]
顾客输入－ 组织应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 supplier input 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 representative
管理者代表
5.5.3 Internal communication
内部沟通
5.5.3.C.1 Organization Performance Feedback – The organization shall inform employees of its quality performance 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及顾客满意程度。
5.6 Management review
管理评审
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汽车基地 http://www.qcbase.com 主机厂与供应商的信息、服务、交流中心! 5.6.1 General
总则
5.6.2 Review input
评审输入
5.6.3 Review output
评审输出
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汽车基地 http://www.qcbase.com 主机厂与供应商的信息、服务、交流中心!
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, it shall establish and maintain a process for planning, developing, and implementing these courses. [4]
内部课程开展－当组织开展内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、开展及实现。[4]
6.2.2.C.2 Quality Improvement Concepts – Those employees that have a direct impact on the quality of the product, including top management, shall be trained in the fundamental concepts of continual improvement, problem solving, and customer satisfaction. [4]
质量改进观念－包括最高管理者在内的所有对产品质量有直接影响的员工应当接受持续改进、解决问题及顾客满意等基本观念的培训。[4]
6.2.2.C.3 Training Requirements and Awareness – Training requirements shall be defined for all positions that have a direct impact on the quality of products. Employees shall be made aware of training opportunities. [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 performing their jobs.
ESD 培训－所有包括操作、仓储、包装、保存及运输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 advanced quality training. Examples of advanced quality training may include statistical techniques, process capability, statistical sampling, data collection and analysis, problem identification, problem analysis, and corrective 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、数据收集及分析、问题判断、问题分析积极纠正预防措施等。[5]
6.2.2.C.6 Training Content – Where the potential for hazardous conditions exists, training content should
include the following:
培训内容－有潜在危险的地方，培训内容应包括：
a) task execution,
作业执行 个人安全
b) personal safety,
c) awareness of hazardous environment, and
危险意识，等
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汽车基地 http://www.qcbase.com 主机厂与供应商的信息、服务、交流中心! d) equipment protection.
设备保护
6.2.2.HV.1 Operator Qualification – The organization shall establish operator qualification and requalification 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. [4]
HV.1 操作员资格－组织应当为所有必要过程建立操作员资格及要求条件。这些要求应注明员工教育背景、工作经历、培训及技能。组织应将该信息通知所有相关职工。
6.3 Infrastructure 基础设施
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. [5]
6.4.C.1 工作区－用于操作、储存及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。
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汽车基地 http://www.qcbase.com 主机厂与供应商的信息、服务、交流中心!
Section 7 Product realization 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 guidelines that covers the life cycle of its products. This framework shall 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、以及观念、定义、发展、产品、操作、维护，以及产品的处理（如果必要），跨度产品的生命周期。
7.1.C.2 New Product Introduction – The organization shall establish and maintain a documented procedure(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 and capacity studies, sales and service personnel training, and new product post-introduction evaluations.
注解1－新产品介绍程序应包括以下程序：质量及可靠性预测计划，试制产品，需求及产量计划，销售及服务人员培训，新产品定位估计。
7.1.C.3 Disaster Recovery – The organization shall establish and maintain methods for disaster recovery to ensure the organization’s ability 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内进行维修和服务。
7.1.C.4 End of Life Planning – The organization shall establish and maintain a documented
procedure(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, 保存产品文档及软件，
c) responsibility for any future residual support 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.1 Configuration Management Plan – The organization shall establish and maintain a configuration management plan, which should include:
配置管理策划－组织应建立并维护一配置管理策划，其内容应包括： a) identification and scope of the configuration management activities, 配置管理活动的定义及范围
b) schedule for performing these activities, 执行这些活动的进度表
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汽车基地 http://www.qcbase.com 主机厂与供应商的信息、服务、交流中心! c) configuration management tools, 配置管理工具
d) configuration management methods and documented procedure(s), 配置管理方法及程序文件
e) organizations and responsibilities assigned to them, 组织及分派给它的责任，
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范围。[10]
7.1.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：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 tracking project factors during project planning, execution, and change management. [11] 评估－组织应建立并维护一种方法用以在方案策划、实施及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，可靠性及生产能力。
7.1.S.2 Computer Resources – The organization shall establish and maintain methods for estimating 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]
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、适时执行以及I/O通道。[11]
7.1.S.3 Support Software and Tools Management – The organization shall ensure that
internally 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, testing tools, configuration management tools, and documentation tools. [11]
支持软件及工具管理－组织应该保证用在产品中的内部开发的支持软件及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，以及文件工具。[11]
7.1.V.1 Service Delivery Plan – Suppliers that are responsible for the delivery or implementation of a service, and are not responsible for the design and development of that service, shall comply with the Project 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，但是对服务的设计及发展不负责任，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 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
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汽车基地 http://www.qcbase.com 主机厂与供应商的信息、服务、交流中心! 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。[9]
7.2.2.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内容作为补充： a) acceptance review process, 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 问题追踪及解决方法，等
i) required acceptance test reports. [10] 必要的检验报告
7.2.3 Customer communication 顾客沟通
7.2.3.C.1 Notification About Problems – The organization shall establish and maintain a
documented procedure(s) to notify all customers who may be affected by a reported problem that is service affecting. [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 shall assign severity levels to customer reported problems based on the impact to the customer in accordance with the definitions of critical, major, and minor problem reports contained in the glossary of this handbook. The severity level shall be used in determining the timeliness of the organization’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 resolving customer-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 and maintain a documented escalation procedure(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。[11]
7.2.3.C.4 Customer Feedback – The organization shall establish and maintain a documented procedure(s) to provide the customer with feedback on their problem reports in a timely manner. 顾客反馈－组织应建立并维护一套程序文件及时处理顾客问题反馈。
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汽车基地 http://www.qcbase.com 主机厂与供应商的信息、服务、交流中心! 7.2.3.H.1 Organization’s Recall Process – The organization shall establish and maintain a
documented procedure(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 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 the defined 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 responsibilities, 方案角色及职责
c) interfaces with internal and external organizations, 与内部或外部组织交流
d) means for scheduling, tracking, issue resolution, and reporting, 计划进度、跟踪、问题决定及报告的方式
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), 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，及质量）
h) project-specific environment and physical resource considerations (e.g., development, user documentation, testing, and operation),
方案详细考虑的环境及物质资源（例如：发展，用户证书，测试及操作）
i) customer, user, and supplier involvement during the product life cycle (e.g., joint reviews, informal meetings, and approvals),
产品生命周期内顾客，用户及厂商（例如：联合评审，非正式会议，以及批准） j) management of project quality, 方案质量管理
k) risk management and contingency plans (e.g., technical, cost and schedules), 风险管理及意外事故策划（例如：技术，成本以及进度）
l) performance, safety, security, and other critical requirements, 执行、保险、安全以及其它紧急需求 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) post-project analysis. [10] 方案定位分析. [10]
7.3.1.C.1-NOTE 1: The project plan and any related plans may be an independent document, a part of another 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 responsibilities common to all development 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 trace documented requirements through design and test. [11]
7.3.1.C.2 必要的可追踪性－组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。[11]
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汽车基地 http://www.qcbase.com 主机厂与供应商的信息、服务、交流中心! 7.3.1.C.2-NOTE 1: The organization should establish communication methods for dissemination of product 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 Planning – Test plans shall be documented and results recorded. Test plans should include:
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) 检测范围（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, performance, regression, interoperability),
b) 检测的执行形式（如：功能、范围、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 product’s functions, sometimes expressed as a percent 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) 数据分类及必要的数据库
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），及检测程序文件， i) use of external testing, and i) 外部检测方法，等
j) method of reporting and resolving defects. [11] l) 报告方法及纠正措施. [11]
7.3.1.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 the software components into 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, and c) 综合进度，等
d) test requirements. [10] d)必要的检测。[10]
7.3.1.S.2 Migration Planning – The organization shall develop and document a migration plan when a system or software product is planned to be migrated from an old to a new environment. The plan should include 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。该策划应包括如下内容：
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b) development of migration tools, b) 迁移工具的建立
c) conversion of product and data, c) 产品及数据的转换 d) migration execution, d)迁移执行
e) migration verification, and e) 迁移验证，等
f) support for the old environment in the future. [10] f) 将来对旧环境的支持. [10]
7.3.2 Design and development inputs 设计和开发输入
7.3.2.C.1 Customer and Supplier Input – The organization shall establish and maintain
methods for soliciting and using customer and supplier input during the development of new or revised product requirements. [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 be defined 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、组织或用户要求
d) safety, environmental, and security requirements, 安全、环境和可靠性要求
e) installability, usability, and maintainability requirements, 安装性能，使用性能及维护性能要求 f) design constraints, and 设计约束，等
g) testing requirements. [10] 检测要求. [10]
7.3.2.H.1 Content of Requirements – The product requirements shall include, but are not limited to:
7.3.2.H.1 容量要求－产品要求应包括，但不局限于： a) nominal values and tolerances, 名称数据及耐性
b) maintainability needs, and 可维修性，必须，等
c) end-item packaging requirements. [5] 最终包装要求. [5]
7.3.2.S.1 Identification of Software Requirements – The organization shall determine, analyze, and document the software component requirements of the system. [10] 7.3.2.S.1 软件要求鉴定－组织应确定、分析、证明系统软件组建的要求。
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7.3.2.S.2 Requirements Allocation – The organization shall document the allocation of the product requirements to the product architecture. [9]
7.3.2.s.2 要求分配－组织应编制文件将产品的要求分配到产品结构。[9]
7.3.3 Design and development outputs 设计和开发输出
7.3.3.S.1 Software Design and Development Output – Software design and development outputs should include, but are not limited to: a) system architecture, b) system detailed design, c) source code, and
d) user documentation. [9]
7.3.3.S.1 软件设计和开发输出－软件设计和开发输出应包括（但不限于）： a) 体系结构
b) 系统详细设计 c) 源代码，和 d) 用户文件〔9〕
7.3.3.V.1 Services Design and Development Output – The required output from the services design and development shall contain a complete and precise statement of the service to be provided. Design and development outputs shall include, but are not limited to: a) service delivery procedures, b) resource and skill requirements, c) reliance on suppliers,
d) service characteristics subject to customer evaluation, and e) standards of acceptability for each service characteristic. [13]
7.3.3.V.1 服务设计和开发输出－服务设计和开发的输出应包含完整的和精确的提供服务的阐述。设计和开发输出应包括（但不限于）： a) 服务传递程序 b) 资源和能力要求 c) 对供应商的信任
d) 服从于客户评估的服务特征 e) 每个服务特征可接受性的标准 f)
7.3.4 Design and development review 设计和开发检讨
7.3.5 Design and development verification 设计和开发确认
7.3.6 Design and development validation 设计和开发确认
7.3.6.C-NOTE 1: Organizations should include customer(s) or a third party during various validation stages, as appropriate.
7.3.6.C－注1：恰当地说，在不同的确认阶段组织应该包括客户或第三方。
7.3.6.S.1 Release Management – The organization shall establish and maintain a documented procedure(s) to control the release and delivery of software products and documentation. The documented procedure(s) should include methods to provide for the following:
a) release planning information delivered to the customer sufficiently in advance of the release,
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c) detailed descriptions of product features delivered and changes incorporated in new software products or releases, and
d) advising the customer of current or planned changes. [11]
7.3.6.S.1 发行管理－组织应建立和维护一个程序文件去控制软件产品和文件的发行和分发。这个程序文件应包括下文提供的方法：
a) 发行规划信息（在发行之前充分发给客户的） b) 给客户的产品介绍和发行进度表
c) 产品特征的详细说明和新软件或发行中的变化 d) 建议客户目前的或计划的变化
7.3.7 Control of design and development changes 设计和开发变化的控制
7.3.7.C.1 Change Management Process – The organization shall establish and maintain a process to ensure that all requirements and design changes, which may arise at any time during the product life cycle, are managed and tracked in a systematic and timely manner and do not adversely affect quality, reliability, and design intent. Management of changes should include: a) impact analysis, b) planning,
c) implementation, d) testing,
e) documentation, f) communication, and g) review and approval. [5]
7.3.7.C.1 变更管理制程－组织应建立和维持一个制程以确保所有的需求和设计变更（在产品生命周期任何时候能出现的）被以一个系统的和即时的方式管理和追踪，不影响质量，可靠度和设计目的。变化的管理应包括： a) 影响分析 b) 规划 c) 实施 d) 试验 e) 文件 f) 信息，和 g) 检讨和批准
7.3.7.C.2 Informing Customers – The organization shall establish and maintain a documented procedure(s) to ensure that customers are informed when design changes affect contractual commitments. [5]
7.3.7.C.2 通知客户－组织应建立和维持一个程序文件以确保当设计变更影响合同承诺时通知客户。〔5〕
7.3.7.HS.1 Problem Resolution Configuration Management – The organization shall establish an interface between problem resolution and configuration management to ensure that fixes to problems are incorporated in future revisions. [11]
7.3.7.HS.1 问题解决配置管理－组织应建立一个问题解决和配置管理之间的接口，以确保问题整理合并成将来的版本。
7.3.7.H.1 Component Changes – The organization shall have a documented procedure(s) in place to ensure that material or component substitutions or changes do not adversely affect product quality or performance. The documented procedure(s) should include: a) functional testing, b) qualification testing, c) stress testing,
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7.3.7.H.1 组成变化－组织应有一个适当的程序文件去确保材料或成分替代或变化不反过来影响产品质量或性能。这个程序文件包括： a) 功能试验 b) 资格试验 c) 压力试验
d) 所列被批准的部分，和/或 e) 所列关键部分
7.4 Purchasing 购买
7.4.1 Purchasing process 购买过程
7.4.1.C.1 Purchasing Procedure(s) – The documented purchasing procedure(s) shall include: a) product requirements definition, b) risk analysis and management, c) qualification criteria, d) contract definition,
e) proprietary, usage, ownership, warranty, and licensing rights are satisfied, f) future support for the product is planned,
g) ongoing supply-base management and monitoring, h) supplier selection criteria, i) supplier re-evaluation, and
k) feedback to key suppliers based on data analysis of supplier performance. [10] 7.4.1.C.1 购买程序－购买程序文件包括： a) 产品需求定义 b) 风险分析和管理 c) 资格标准 d) 合同定义
e) 所有权，使用权，保证，和许可权被满足 f) 对产品未来的支持被计划
g) 正在进行的基本供应管理和监控 h) 供应商选择标准 i) 供应商再评估，和
j) 根据供应商绩效的数据分析反馈给关键供应商
7.4.1.C.1-NOTE 1: The documented procedure(s) should be applicable to off-the-shelf product. This typically includes original equipment manufacturer (OEM) products used in manufacturing and commercial off-the-shelf (COTS) products used in software systems.
7.4.1.C.1－注 1：程序文件应适用于现有产品。这特别包括用于制造的原有设备制造商（OEM）产品和用于软件系统的商业性现有（COTS）产品。
7.4.2 Purchasing information 购买信息
7.4.3 Verification of purchased products 所购产品的确认
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7.5.1 Control of production and service provision 产品和服务提供的控制
7.5.1.C.1 Organization’s Support Program – The organization shall ensure that customers are provided support to resolve product related problems. [5]
7.5.1.C.1 组织的支持计划－组织应确保客户被提供解决相关问题产品的支持。〔5〕
7.5.1.C.2 Service Resources – The organization shall provide customer contact employees with appropriate tools, training, and resources necessary to provide effective and timely customer service. [4]
7.5.1.C.2 服务资源－组织应提供客户联系员工，这些员工具有对提供有效的和即时的客户服务的必要的适当的工具，技能和资源。
7.5.1.HS.1 Emergency Service – The organization shall ensure that services and resources are available to support recovery from emergency failures of product in the field throughout its expected life. [4]
7.5.1.HS.1 紧急服务－组织应确保服务和资源能支持产品从整个期望生命中紧急故障恢复。〔4〕
7.5.1.HS.2 Installation Plan – The organization shall establish and maintain a documented installation plan. The installation plan shall identify the resources, the information required, and list the sequence of events. The results associated with the installation sequence shall be documented. [10]
7.5.1.HS.2 安装计划－组织应建立和维持一个文件性的安装计划。安装计划应鉴别资源，所需信息和列出事情的次序。和安装次序有关的结果写在文件中。〔10〕
7.5.1.S.1 Patching Procedure(s) – The organization shall establish and maintain a documented procedure(s) that guide the decision to solve problems by patching.
a) The documented procedure(s) shall address patch development procedures, propagation (forward and backward), and resolution.
b) The documented procedure(s) shall be consistent with customer needs or contractual requirements for maintenance support.
c) The organization shall provide the customer with a statement of impact on the customer's operation for each patch. [11]
7.5.1.S.1 修补程序－组织应建立和维持一个程序文件指导通过修补解决问题的决定 a) 程序文件应写出修补发展程序，发展（向前和向后），和解决方案 b) 程序文件应和用于维护支持的客户需求或合同需求一致。 c) 组织应提供客户每个修补对客户的操作影响的阐述。
7.5.1.S.2 Patch Documentation – The organization shall establish and maintain methods to ensure that all documentation required to describe, test, install, and apply a patch has been verified and delivered with the patch. [11]
7.5.1.S.2 修补文件－组织应建立和维持一些方法，这些方法确保需要描述、试验、安装和使用修补的文件已被修改并分发。
7.5.1.S.3 Replication – The organization shall establish and maintain a documented procedure(s) for replication, which should include the following: a) identification of master copy,
b) identification of replicate copies for delivery, c) quantity of replicates to deliver,
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f) identification of required documentation such as user guides, g) packaging of documentation, and
h) control of environment to ensure repeatable replication. [9]
7.5.1.S.3 复制－组织将建立和维持一个用于复制的程序文件，应包括如下： a) 原版的鉴定
b) 传递的副本的鉴定 c) 传递副本的数量 d) 媒体类型 e) 标签
f) 被要求文件如用户指南的鉴定 g) 文件包装，和
h) 确保可重复的复制的环境控制
7.5.1.V.1 Software Used in Service Delivery – Organizations shall document and implement processes for the maintenance and control of software used in service delivery to ensure continued process capability and integrity.
7.5.1.V.1 用于服务传递的软件－组织应编制和实施用于软件控制和维护的过程，这些软件用在服务传递，以确保持续的制程容量和完整性。
7.5.1.V.2 Tool Changes – The organization shall have a documented procedure(s) in place to ensure that substitutions or changes to tools used in performing the service do not adversely affect the quality of the service.
7.5.1.V.2 工具变更－组织应适当地有一个程序文件去确保用在服务上的工具的替代或变更不反过来影响服务的质量。
7.5.2 Validation of processes for production and service provision 产品和服务提供的制程的确认
7.5.2.HV.1 Operational Changes – Each time a significant change is made in the established operation (e.g., a new operator, new machine, or new technique), a critical examination shall be made of the first unit(s)/service(s) processed after the change. [5]
7.5.2.HV.1 操作变更－每次一个主要的变更发生在已建立的操作（如： 一个新的操作者，新设备，或新技术），变化之后的第一个元件/服务需经过严格的检验。
7.5.3 Identification and traceability 鉴定和可追溯性
7.5.3.HS.1 Product Identification – The organization shall establish and maintain a process for the identification of each product and the level of required control. For each product and its versions, the following shall be identified where they exist: a) product documentation,
b) development or production tools essential to repeat product creation, c) interfaces to other products, and
d) software and hardware environment. [9]
7.5.3.HS.1 产品鉴定－组织需建立和维持一个每个产品的鉴定方法和所需的控制水平。每个产品及其副本，下面在他们存在处将被鉴定： a) 产品文件
b) 对于重述产品创造必要的开发偶尔生产的工具 c) 与其它产品的接口，和 d) 软硬件环境
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7.5.3.H.1 用于退还的可追溯性－域可替代的单位（FRU）在产品生命周期内应是可追溯的，运用可帮助组织和客户鉴定退还的，需替换或修复的产品的方法。
7.5.3.H.2 Traceability of Design Changes – The organization shall establish and maintain a documented procedure(s) which provides traceability of design changes to identifiable manufacturing dates, lots, or serial numbers.
7.5.3.H.2 设计变更的可追溯性－组织应建立和维持一个程序文件，提供设计变更可追溯性，象制造日期，份额或系列号。
7.5.4 Customer property 客户所有权
The organization shall exercise care with customer property while it is under the organization's control or being used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4).
组织应练习关心客户的所有权，当它在组织的控制下或被组织使用时。组织应鉴定，核查，保护和保卫被用于或合成产品而提供的客户所有权。如果任何客户所有权被丢失，损坏或被发现是不适用的，这将被告知客户并作记录。
NOTE Customer property can include intellectual property. 注：客户所有权可包括知识产权。
7.5.5 Preservation of product 产品的储存
7.5.5.C.1 Anti-Static Protection – Anti-static protection shall be employed, where applicable, for components and products susceptible to electrostatic discharge (ESD) damage. Consider
components and products such as: integrated circuits, printed wiring board assemblies, magnetic tapes and/or disks, and other media used for software or data storage. [5]
7.5.5.C.1 反静态保护－反静态保护适用于易受静电释放（ESD）的影响的成分和产品。这些成分和产品如：集成电路，印刷线路集成板，磁带和/或磁盘和其它的用于软件和数据储存的媒体。〔5〕
7.5.5.HS.1 Packaging and Labeling Audit – The organization shall include a packaging and labeling audit in the quality plan or documented procedure(s). This may include, for example, marking, labeling, kitting, documentation, customer-specific marking, and correct quantities. 7.5.5.HS.1 包装和标签审核－组织应在质量计划或程序文件中包括包装和标签。可包括，如：标记，标签，用具，文件，客户要求的标记和正确的数量。
7.5.5.HS.1-NOTE 1: This audit is normally done on products ready to ship. 7.5.5.HS.1－注 1：审核一般对准备发货的产品进行。
7.5.5.H.1 Deterioration – Where the possibility of deterioration exists, materials in storage shall be controlled (e.g., date stamped/coded) and materials with expired dates shall be deemed non-conforming. [5]
7.5.5.HS.1 变化－存在变化的可能性的地方，存的料要严格控制（如：印字/编码的日期），到期的材料被认为是不合格的。〔5〕
7.5.5.S.1 Software Virus Protection – The organization shall establish and maintain methods for software virus prevention, detection, and removal from the deliverable product. [9]
7.5.5.S.1 软件病毒保护－组织应建立和维持可传软件病毒防护，检查和排除的。〔9〕
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7.6 Control of monitoring and measuring devices 监控和测量设备的控制
7.6.H.1 Identified Equipment – Monitoring and measuring devices that are either inactive or unsuitable for use shall be visibly identified and not used. All monitoring and measuring devices that do not require calibration shall be identified. [5]
7.6.H.1 鉴别的设备－不动的或不好用的监控和测量设备显然是好鉴别的和不能用的。所有不要求标度的监控和测量设备将被鉴别。
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Section 8 Measurement, analysis and improvement 第8部分 衡量，分析和改善
8.1 General 8.1 概述
8.2 Monitoring and measurement 8.2 监控和衡量
8.2.1 Customer satisfaction 8.2.1 客户满意度
8.2.1.C.1 Customer Satisfaction Data – The organization shall establish and maintain a method to collect data directly from customers concerning their satisfaction with provided products. The organization shall also collect customer data on how well the organization meets commitments and its responsiveness to customer feedback and needs. This data shall be collected and analyzed. Trends of the data shall be kept. [4]
8.2.1.C.1 客户满意度数据－组织应建立和维持一种收集直接来自客户关于他们对所提供产品的满意程度的数据的方法。组织也应从客户处收集组织满足承诺和对客户反馈和要求的反应的情况。这些数据应被汇集和分析。数据的趋势图应画出。
8.2.2 Internal audit 内审
8.2.3 Monitoring and measurement of processes 过程的监控和测量
8.2.3.C.1 Process Measurement – Process measurements shall be developed, documented, and monitored at appropriate points to ensure continued suitability and promote increased effectiveness of processes. [9]
8.2.3.C.1 过程测量－过程测量应在适当点发展，文件化和监控以确保持续的合格性和促进过程增长的有效性。
8.2.4 Monitoring and measurement of product
产品的监控和测量
8.2.4.HV.1 Inspection and Test Documentation – Each inspection or testing activity shall have detailed documentation. Details should include the following: a) parameters to be checked with acceptable tolerances, b) the use of statistical techniques, control charts, etc.,
c) sampling plan, including frequency, sample size, and acceptance criteria, d) handling of nonconformances, e) data to be recorded,
f) defect classification scheme,
g) method for designating an inspection item or lot, and h) electrical, functional, and feature testing. [5]
8.2.4.HV.1 检验和试验文件－每次检验和试验活动将有详细的文件。具体如下： a) 用可接受的公差检测的参数 b) 统计技术，控制图等的运用
c) 抽样计划，包括频率，抽样尺寸和接受标准
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汽车基地 http://www.qcbase.com 主机厂与供应商的信息、服务、交流中心! d) 不合格品的处理 e) 要记录的数据 f) 缺陷分类方法
g) 指定一个或许多检验项的方法 h) 电气，功能性和特征试验
8.2.4.HV.2 Inspection and Test Records – Inspection and test records shall include: a) product identification,
b) quantity of product inspected,
c) documented inspection procedure(s) followed, d) person performing the test and inspection, e) date of inspection and/or test, and
f) number, type, and severity of defects found. [5]
8.2.4.HV.2 检验和试验记录－检验和试验记录包括： a) 产品鉴定
b) 检验产品的数量
c) 紧接的文件性的检验程序 d) 进行检验和试验的人 e) 检验和/或试验的日期
f) 发现缺陷的数量，类型和严重性
8.2.4.H.1 Periodic Retesting – The organization shall establish and maintain a documented procedure(s) that ensures products are periodically retested to assess the product's ability to continue to meet design requirements. [5]
8.2.4.H.1 定期再试验－组织应建立和维持一个文件性的程序确保产品定期再检去评估产品持续满足设计需求的能力。〔5〕
8.2.4.H.2 Content of Testing – The initial test and periodic retest shall be more extensive than the routine quality tests. The initial test shall include those that are contained in the customer’s and/or organization’s product specifications and/or contracts. The results of these tests shall be documented. [5]
8.2.4.H.2 试验内容－初始试验和定期再试验将比例行的质量试验更广泛。初始试验包括纳入客户和/或组织的产品规范书和/或合同。这些试验的结果将成文。
8.2.4.H.2-NOTE 1: Product specifications may include environmental, vibration, flammability, and operational stress type testing.
8.2.4.H.2－注1：产品说明书可包括环境性，振动，可燃性和操作压力型式试验。
8.2.4.H.3 Frequency of Testing – The organization shall establish and document the frequency for test and periodic retest. When determining the test frequency, the organization shall include the following:
a) product complexity and service criticality,
b) number of design, engineering and/or manufacturing changes made to the product and whether the change(s) affect form, fit, and/or function, c) changes to the manufacturing process,
d) manufacturing variations, (e.g., tooling wear),
e) material and/or component substitutions and failure rates, and f) the field performance record of the product. [5]
8.2.4.H.3 试验频率－组织应该建立和编制试验及定期再试验的频率文件。确定试验频率时，组织可考虑如下：
a) 产品复杂性和服务的危险程度
b) 产品设计，生产和/或制造变更的数量，且无论变更是否影响结构，合格性和/或功能。 c) 制造过程的改变
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汽车基地 http://www.qcbase.com 主机厂与供应商的信息、服务、交流中心! d) 制造误差（如：加工磨损）
e) 材料和/或成分替代及不合格率，和 f) 产品的域性能记录〔5〕
8.2.4.H.4 Testing of Repair and Return Products – Repair and return products shall be subjected to the appropriate evaluation(s) and/or test(s) to ensure functionality to product specification. [5]
8.2.4.H.4 返修和返工产品的试验－返修和返工应接受适当的评估和/或试验以确保产品规格的功能。
8.2.4.S.1 Test Documentation – Software tests shall be conducted according to a documented procedure(s) and the test plan. Documentation of testing shall include: a) test results,
b) analysis of test results,
c) conformance to expected results, and
d) problem reporting for nonconforming items. [11]
8.2.4.S.1 试验文件－软件试验将按照文件性的程序和试验计划进行。试验文件包括： a) 试验结果
b) 试验结果的分析
c) 与期望结果的一致性，和 d) 不合格项报告的问题
8.3 Control of nonconforming product 不合格产品的控制
8.4 Analysis of data 数据分析
8.4.C.1 Trend Analysis of Nonconforming Product – Trend analysis of discrepancies found in nonconforming product shall be performed on a defined, regular basis and results utilized as input for corrective and preventive action.
8.4.C.1 不合格产品的趋势分析－在不合格产品中发现的差异的趋势分析应根据定义的、规则的根据及用于纠正和预防措施输入的结果执行。
8.4.H.1 Field Performance Data – The quality management system shall include the collection and analysis of field performance data which can be used to help identify the cause and
frequency of equipment failure. In addition, no trouble found (NTF) data shall also be maintained. This information shall be provided to the appropriate organizations to foster continual improvement. [5]
8.4.H.1 域性能数据－质量管理体系包括能用于帮助鉴别设备故障的起因和频率的域性能数据的收集和分析。另外，发现无错（NTF）的数据也要保留。这些信息用于适当的组织进行持续改善。
8.4.V.1 Service Performance Data – The quality management system shall include the
collection and analysis of service performance data, which can be used to identify the cause and frequency of service failure. This information shall be provided to the appropriate organizations to foster continual improvement of the service. [5]
8.4.V.1 服务性能数据－质量管理体系包括能用于帮助鉴别服务漏洞的起因和频率的服务性能数据的收集和分析。这些信息用于适当的组织进行服务的持续改善。〔5〕
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汽车基地 http://www.qcbase.com 主机厂与供应商的信息、服务、交流中心! 8.5 Improvement 改善
8.5.1 Continual improvement 持续改善
8.5.1.C.1 Quality Improvement Program – The organization shall establish and maintain a documented Quality Improvement Program to improve:
8.5.1.C.1 质量改善计划－组织应该建立和维持一个资料性的质量改善计划去改善： a) customer satisfaction, 客户满意度
b) quality and reliability of the product, and 产品质量和可靠度
c) other processes/products/services used within the organization. [5] 用于组织内部的其它的制程/产品/服务〔5〕
8.5.1.C-NOTE 2: Inputs to the continual improvement process may include lessons learned from past experience, lessons learned from previous projects, analysis of measurements and post-project reviews, and comparisons with industry best practices.
8.5.1.C－注2： 持续改善过程的输入可包括从过去经验及以前的工程中所学得的教训，衡量和工程后检讨的分析，以及与最好的工业实践的对照。
8.5.1.C.2 Employee Participation – The organization shall implement methods for encouraging employee participation in the continual improvement process. [4]
〔4〕
8.5.1.C.2 员工参与－组织将采取措施鼓励员工参与持续改善过程。
8.5.2 Corrective action 纠正措施
8.5.2.C-NOTE 1: Undesirable deviations from plans and objectives are considered nonconformances.
8.5.2.C－注1：不合需要的偏离计划和目标被认为是不合格的。
8.5.2.C-NOTE 2: Review of corrective action is intended to ensure that the action taken was effective.
8.5.2.C－注2：纠正措施的讨论倾向于确保所采取措施的有效性。
Review activities may include ensuring that root cause was properly identified and addressed, appropriate containment action was taken, and corrective actions have not introduced additional problems.
讨论活动可包括确保根本原因被正确地确定，适当的对策被采取，并且纠正措施也没有引入附加的问题。
8.5.2.C-NOTE 3: Consideration should be given to include training as part of implementing corrective and preventive actions.
8.5.2.C－注3：应考虑将培训作为实施纠正和预防措施的部分。
8.5.2.S.1 Problem Resolution – The organization shall establish and maintain a documented procedure(s) to initiate corrective action once a reported trouble is diagnosed as a problem. The documented procedure(s) should provide guidelines for distinguishing among potential solutions such as:
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汽车基地 http://www.qcbase.com 主机厂与供应商的信息、服务、交流中心! 8.5.2.S.1 问题决议－一旦一个被报告的故障被诊断为一个问题时，组织应建立和维持一个资料性的程序去促进纠正措施。资料性的程序文件应该提供区别如下潜在解决方案的准则。 a) patching, 修补程序
b) immediate source code corrections, 即时的源代码的纠正
c) deferring solutions to a planned release, and 延迟计划版本的解决方法
d) providing documented “work-around” operational procedure(s) and resolution within a designated timeframe based on the severity of the issue. [11]
依发行的严重性提供资料性的工作程序及在指定期限内的解决方案。〔11〕
8.5.3 Preventive action 8.5.3 预防措施
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