General 总则
最高管理者应按策划的时间间隔评审质量管理体系，以确保其持续的适宜性、充分性和有效性。评审应包括评价质量管理体系改进的机会和变更的需要，包括质量方针和质量目标。
应保持管理评审的记录（见4.2.4）
5.6.2 Review input 评审输入
管理评审的输入应包括以下方面的信息：
a) 审核结果；
b) 顾客反馈；
c) 过程的业绩和产品的符合性；
d) 预防和纠正措施的状况；
e) 以往管理评审的跟踪措施；
f) 可能影响质量管理体系的变更；
g) 改进的建议。
5.6.3 Review output 评审输出
管理评审的输出应包括以下方面有关的任何决定和措施：
a) 质量体系及其过程有效性的改进；
b) 与顾客要求有关的产品的改进；
c) 资源需求。
Section 6 Resource management 第六章 资源管理
6.1 Provision of resources 资源提供
组织应确定并提供以下方面所需的资源：
a) 实施、保持质量管理体系并持续改进其有效性；
b) 通过满足顾客要求，增进顾客满意。
6.2 Human resources 人力资源
6.2.1 General 总则
基于适当的教育、培训、技能和经验，从事影响产品质量工作的人员应是能够胜任的。
6.2.2 Competence, awareness and training 能力、意识和培训
组织应：
a) 确定从事影响产品质量工作的人员所必要的能力；
b) 提供培训或采取其他措施以满足这些需求；
c) 评价所采取措施的有效性；
d) 确保员工认识到所从事活动的相关性和重要性，以及如何为实现质量目标作出贡献；
e) 保持教育、培训、技能和经验的适当记录（见4.2.4）
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。高级质量培训内容可以包括统计技术、过程能力、统计抽样、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, 作业指导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
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 基础设施组织应确定、提供并维护为达到产品符合要求所需的基础设施。适用时，基础设施包括：a)
建筑物、工作场所和相关的设施；b) 过程设备，（硬件和软件）；c) 支持性服务，（运输或通讯）。6.4 Work
environment 工作环境组织应确定和管理为达到产品符合要求所需的工作环境。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。Section
7 Product realization 产品实现7.1 Planning of product
realization
产品实现的策划组织应策划和开发产品实现所需的过程。产品实现的策划应与质量管理体系其他过程的要求相一致（见4.1）。在对产品实现进行策划时，组织应确定以下方面的适当内容：a)
产品的质量目标和要求；b) 针对产品确定过程、文件和资源的需求；c)
产品所要求的验证、确认、监视、检验和试验活动，以及产品接收准则；d)
为实现过程及其产品满足要求提供证据所需的记录。策划的输出形式应适于组织的运作方式。注：1、对应用于特定产品、项目或合同的质量管理体系的过程（包括产品实现过程）和资源作出规定的文件可称之为质量计划。2、组织也可将7.3的要求应用于产品实现过程的开发。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 disasterrecovery to ensure the
organization’s ability to recreate and service the
product throughout its life cycle.
[10]灾难恢复－组织应建立并维护灾难恢复的方法以确保组织有能力在整个产品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 documentedprocedure(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和责任，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，员工安排，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组织应确定：a)
顾客规定的要求，包括对交付及交付后活动的要求；b)
顾客虽然没有明示，但规定的用途或已知的预期用途所必需的要求；c) 与产品有关的法律法规要求；d)
组织确定的任何附加要求。7.2.2 Review of requirements related to the
product 与产品有关的要求的评审组织应评审与产品有关的要求。评审应在组织向顾客作出提供产品的承诺之前进行（如：提交标书、接受合同或订单及接收合同或订单的更改），并应确保：a)
产品要求得到规定；b) 与以前表述不一致的合同或订单的要求已予解决；c)
组织有能力满足规定的要求。评审结果及评审所引起的措施的记录应予保持（见4.2.4）。若顾客提供的要求没有形成文件，组织在接收顾客要求前应对顾客要求
进行确认。若产品要求发生变更，组织应确保相关文件得到修改，并确保相关人员知道已变更的要求。注：在某些情况中，如网上销售，对每一个订单进行正式的评审可能是不实际的。而代之对有关的产品信息，，如产品目录、产品广告内容等进行评审。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删除的责任和/或不一致的修正。[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
顾客沟通组织应对以下有关方面确定并实施与顾客沟通的有效安排：a) 产品信息；b)
问询、合同或订单的处理，包括对其的修改；c) 顾客反馈，包括顾客投诉。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 reportedproblems 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，（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 documentedprocedure(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。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
设计和开发策划组织应对产品的设计和开发进行策划和控制。在进行设计和开发策划时，组织应确定：a)
设计和开发阶段；b) 适于每个设计和开发阶段的评审、验证和确认活动；c)
设计和开发的职责和权限。组织应对参与设计和开发的不同小组之间的接口实施管理，以确保有效的沟通，并明确职责分工。随设计和开发的进展，在适当时，策划的输出予以更新。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, userdocumentation, 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
&, nbsp; 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以是独立的文件，也可以是其它文件的一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责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]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),
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), 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, 必要的可追踪性d) test
environment (e.g., relevancy to customer environment,
operational use), 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 apercent of functions
tested), 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, 期望结果，g) data definition and database
requirements, 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), 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 外部检测方法，等j) method of reporting
and resolving defects. [11] 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), 方法和程序文件
b) responsibilities, 职责
c) schedule for integration, and 综合进度，等
d) test requirements. [10] 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：
a) requirements analysis and definition of
migration, 必要的分析及迁移定义
b) development of migration tools, 迁移工具的建立
c) conversion of product and data, 产品及数据的转换
d) migration execution, 迁移执行
e) migration verification, and 迁移验证，等
f) support for the old environment in the future. [10]
将来对旧环境的支持. [10]
7.3.2 Design and development inputs 设计和开发输入
应确定与产品要求有关的输入，并保持记录（见4.2.4）。这些输入应包括：
a) 功能和性能要求；
b) 适用的法律法规要求；
c) 适用时，以前类似设计提供的信息；
d) 设计和开发所必需的其他要求。
应对这些输入进行评审，以确保其充分性与适宜性，要求应完整、清楚，并且不能自相矛盾。
7.3.2.C.1 Customer and Supplier Input – The organization
shall establish and maintain methods for soliciting and
using customer and supplier input dur
用户登录 
