TS16949中英文对照
Introduction引言
0.1 General总则
ISO 9001:2000, Quality management systems － Requirements
Introduction引言
0.1 General总则
The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.
采用质量管理体系应当是组织的一项战略性决策。一个组织质量管理体系的设计和实施受各种需求、具体目标、所提供的产品、所采用的过程以及该组织的规模和结构的影响。统一质量管理体系的结构或文件不是本标准的目的。
The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement.
本标准所规定的质量管理体系要求是对产品要求的补充。“注”是理解和说明有关要求的指南。
This International Standard can be used by internal and external parties, including certification bodies, to assess the organization's ability to meet customer, regulatory and the organization's own requirements.
本标准能用于内部和外部（包括认证机构）评定组织满足顾客、法律法规和组织自身要求的能力。
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.
本标准的制定已经考虑了GB/T 19000和GB/T 19004中所阐明的质量管理原则。
0.2 Process approach过程方法
ISO 9001:2000, Quality management systems － Requirements
0.2 Process approach过程方法
This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.
本标准鼓励在建立、实施质量管理体系以及改进其有效性时采用过程方法，通过满足顾客要求，增强顾客满意。
For an organization to function effectively, it has to identify and manage numerous linked activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next.
为使组织有效运作，必须识别和管理众多相互关联的活动。通过使用资源和管理，将输入转化为输出的活动可视为过程。通常，一个过程的输出直接形成下一个过程的输入。
The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the “process approach”.
组织内诸过程的系统的应用，连同这些过程的识别和相互作用及其管理，可称之为“过程方法”。
An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.
过程方法的优点是对诸过程的系统中单个过程之间的联系以及过程的组合和相互作用进行连续的控制。
When used within a quality management system, such an approach emphasizes the importance of
过程方法在质量管理体系中应用时，强调以下方面的重要性：
a) understanding and fulfilling requirements,
a）理解并满足要求；
b) the need to consider processes in terms of added value,
b）需要从增值的角度考虑过程；
c) obtaining results of process performance and effectiveness, and
c）获得过程业绩和有效性的结果；
d) continual improvement of processes based on objective measurement.
d）基于客观的测量，持续改进过程。
The model of a process based quality management system shown in Figure 1 illustrates the process linkages presented in clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of this International Standard, but does not show processes at a detailed level.
图1所反映的以过程为基础的质量管理体系模式展示了4～8章中所提出的过程联系。这种展示反映了在规定输入要求时，顾客起着重要作用。对顾客满意的监视要求对顾客有关组织是否已满足其要求的感受的信息进行评价。该模式虽覆盖了本标准的所有要求，但却未详细地反映各过程。
NOTE In addition, the methodology known as "Plan Do Check Act" (PDCA) can be applied to all processes. PDCA can be briefly described as follows.
注：此外，称之为“PDCA”的方法可适用于所有过程。PDCA模式可简述如下：
Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies.
P——策划：根据顾客的要求和组织的方针，为提供结果建立必要的目标和过程；
Do: implement the processes.
D——实施：实施过程；
Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results.
C——检查：根据方针、目标和产品要求，对过程和产品进行监视和测量，并报告结果；
Act: take actions to continually improve process performance.
A——处置：采取措施，以持续改进过程业绩。
Key图释
Value-adding activities增值活动
Information flow信息流
Figure 1 Model of a process based quality management system/图1 以过程为基础的质量管理模式
0.3 Relationship with ISO 9004 与GB/T 19004的关系
ISO 9001:2000, Quality management systems － Requirements
0.3 Relationship with ISO 9004 与GB/T 19004的关系
The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of quality management system standards which have been designed to complement each other, but can also be used independently.
GB/T 19001和GB/T 19004已制定为一对协调一致的质量管理体系标准，他们相互补充，但也可单独使用。
Although the two International Standards have different scopes, they have similar structures in order to assist their application as a consistent pair.
虽然这两项标准具有不同的范围，但却具有相似的结构，以有助于他们作为协调一致的一对标准的应用。
ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, or for certification, or for contractual purposes. It focuses on the effectiveness of the quality management system in meeting customer requirements.
GB/T 19001规定了质量管理体系要求，可供组织内部使用，也可用于认证或合同目的。在满足顾客要求方面，GB/T 19001所关注的是质量管理体系的有效性。
ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organization's overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes.
与GB/T 19001相比，GB/T 19004为质量管理体系更宽范围的目标提供了指南。除了有效性，该标准还特别关注持续改进组织的总体业绩与效率。对于最高管理者希望通过追求业绩持续改进而超越GB/T 19001要求的那些组织，GB/T 19004推荐了指南。然而，用于认证或合同不是GB/T 19004的目的。
NOTE The knowledge and use of the eight quality management principles referred to in the ISO 9000:2000 and ISO 9004:2000 can be demonstrated and cascaded through the organization by top management.
注：ISO 9000:2000和ISO 9004:2000涉及的八项质量管理原则的知识和应用，应该由最高管理者在组织内示范和传递。
0.3.1 IATF Guidance to ISO/TS 16949:2002
"IATF Guidance to ISO/TS 16949:2002" is a document containing recommended automotive industry practices, examples, illustrations and explanations, and provides assistance in the application to conform to the requirements of this Technical Specification.
“IATF关于ISO/TS 16949:2002的指南”是一份文件，该文件包括推荐的汽车行业的实践、范例、图解和解释，并为符合本技术规范的要求在实施上提供帮助。
This IATF Guidance document is not intended for certification or for contractual purposes
用于认证或合同不是本IATF指南的目的。
0.4 Compatibility with other management systems与其他管理体系的相容性
ISO 9001:2000, Quality management systems － Requirements
0.4 Compatibility with other management systems与其他管理体系的相容性
This International Standard has been aligned with ISO 14001:1996 in order to enhance the compatibility of the two standards for the benefit of the user community.
为了使用者的利益，本标准与GB/T 24001—1996相互趋近，以增强两类标准的相容性。
This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financial management or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible for an organization to adapt its existing management systems) in order to establish a quality management system that complies with the requirements of this International Standard.
本标准不包括针对其他管理体系的要求，如环境管理、职业卫生与安全管理、财务管理或风险管理的特定要求。然而本标准使组织能够将自身的质量管理体系与相关的管理体系要求结合或整合。组织为了建立符合本标准要求的质量管理体系，可能会改变现行的管理体系。
0.5 Goal of this Technical Specification本技术规范的目标
The goal of this Technical Specification is the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain.
本技术规范的目标是在供应链中开发提供持续改进、加强预防缺陷、减少变差和浪费的质量体系。
This Technical Specification, coupled with customer specific requirements, defines the fundamental quality management system requirements for those subscribing to this document.
本技术规范与顾客特殊要求相配合，规定了签署本文件的组织的基本质量管理体系要求。
This Technical Specification is intended to avoid multiple certification audits and provide a common automotive approach to a quality management system for automotive production, and relevant service part organizations.
本技术规范是为了避免多重认证审核，并为汽车行业生产件和相关服务件的组织提供了质量管理体系的共同的行业方法。
Quality management systems － Particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizations
质量管理体系－汽车行业生产件和相关服务件的组织实施ISO 9001:2000的特殊要求
1 Scope范围
1.1 General总则
ISO 9001:2000, Quality management systems － Requirements
1 Scope范围
1.1 General总则
This International Standard specifies requirements for a quality management system where an organization
本标准为有下列需求的组织规定了质量管理体系要求：
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and
a）需要证实其有能力稳定地提供满足顾客和适用的法律法规要求的产品；
b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.
b）通过体系的有效应用，包括体系持续改进的过程以及保证符合顾客与适用的法律法规要求，旨在增强顾客满意。
NOTE In this International Standard, the term “product” applies only to the product intended for, or required by, a customer.
注：在本标准中，术语“产品”仅适用于预期提供给顾客或顾客所要求的产品。
This Technical Specification, in conjunction with ISO 9001:2000, defines the quality management system requirements for the design and development, production and, when relevant, installation and servicing of automotive related products.
本技术规范与ISO 9001:2000相结合，规定了用于汽车相关产品的设计与开发、生产、以及安装和服务（相关时）的质量管理体系要求。
This Technical Specification is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured.
本技术规范适用于组织的顾客指定的生产件和/或服务件的制造现场。
Supporting functions, whether on-site or remote (such as design centres, corporate headquarters and distribution centres), form part of the site audit as they support the site, but cannot obtain stand alone certification to this Technical Specification.
现场或外部的支持性部门（如设计中心、公司总部和配送中心），当它们支持现场时，构成现场审核的一部分，但不能单独获得本技术规范的认证。
This Technical Specification can be applied throughout the automotive supply chain.
本技术规范适用于整个汽车供应链。
1.2 Application应用
ISO 9001:2000, Quality management systems － Requirements
1.2 Application应用
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
本标准规定的所有要求是通用的，旨在适用于各种类型、不同规模和提供不同产品的组织。
Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
当本标准的任何要求因组织及其产品的特点而不适用时，可以考虑对其进行删减。
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.
除非删减仅限于本标准第7章中那些不影响组织提供满足顾客和适用法律法规要求的产品的能力或责任的要求，否则不能声称符合本标准。
The only permitted exclusions for this Technical Specification relate to 7.3 where the organization is not responsible for product design and development.
当组织不具有产品设计和开发职责时，只有本技术规范与7.3有关的部分是允许的删减。
Permitted exclusions do not include manufacturing process design.
允许的删减不包括制造过程设计。
2 Normative reference引用标准
The following normative document contains provisions, which, through reference in this text, constitute provisions of this Technical Specification. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this Technical Specification are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards.
下列标准所包含的条文，通过在本标准中引用而构成为本标准的条文。本标准出版时，所示版本均为有效。所有标准都会被修订，使用本标准的各方应探讨使用下列标准最新版本的可能性。
ISO 9000:2000, Quality management systems Fundamentals and vocabulary.
GB/T 19000—2000 质量管理体系－基础和术语（idt ISO 9000：2000）
3 Terms and definitions术语和定义
ISO 9001:2000, Quality management systems － Requirements
3 Terms and definitions术语和定义
For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply.
本标准采用GB/T 19000中的术语和定义。
The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used:
本标准表述供应链所使用的以下术语经过了更改，以反映当前的使用情况：
Supplier organization customer
供方 组织 顾客
The term “organization” replaces the term “supplier” used in ISO 9001:1994, and refers to the unit to which this International Standard applies. Also, the term “supplier” now replaces the term “subcontractor”.
本标准中的术语“组织”用以取代GB/T 19001—1994所使用的术语“供方”，术语“供方”用以取代术语“分承包方”。
Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.
本标准中所出现的术语“产品”，也可指“服务”。
3.1 Terms and definitions for the automotive industry汽车行业的术语和定义
For the purposes of this Technical Specification, the terms and definitions given in ISO 9000 : 2000 and the following apply.
基于本技术规范的目的，适用ISO 9000 : 2000和以下给出的术语和定义。
3.1.1
control plan控制计划
documented descriptions of the systems and processes required for controlling products (see annex A)
控制产品所要求的体系和过程的文件化的描述（参见附录A）。
3.1.2
design responsible organization具有设计职责的组织
organization with authority to establish a new, or change an existing, product specification
组织有权制定新的，或更改现有的产品规范。
NOTE This responsibility includes testing and verification of design performance within the customer's specified application.
注：本职责包括在顾客制定的范围内的设计性能的试验和验证。
3.1.3
error proofing防错
product and manufacturing process design and development to prevent manufacture of nonconforming products
防止制造不合格品的产品和制造过程设计和开发。
3.1.4
laboratory实验室
facility for inspection, test or calibration that may include, but is not limited to, chemical, metallurgical, dimensional, physical, electrical, or reliability testing
进行检验、试验或校准的设施，包括但不限于化学、冶金、尺寸、物理、电学或可靠性试验。
3.1.5
laboratory scope实验室范围
controlled document containing
受控文件包括：
 specific tests, evaluations and calibrations that a laboratory is qualified to perform,
实验室有资格进行的特定试验、评价和校准，
 list of the equipment which it uses to perform the above, and
用于进行上述活动的设备清单，
 list of methods and standards to which it performs the above
进行上述活动的方法和标准的清单。
3.1.6
manufacturing制造
process of making or fabricating
下述制造或装配过程
 production materials,
生产原材料，
 production or service parts,
生产件或服务件，
 assemblies, or
装配，或
 heat treating, welding, painting, plating or other finishing services
热处理，焊接，喷漆、电镀或其他表面处理
3.1.7
predictive maintenance预测性维护
activities based on process data aimed at the avoidance of maintenance problems by prediction of likely failure modes
根据过程数据，通过预测可能的失效模式，来避免维护问题发生的活动。
3.1.8
preventive maintenance预防性维护
planned action to eliminate causes of equipment failure and unscheduled interruptions to production, as an output of the manufacturing process design
为消除设备失效原因和非计划的生产中断而策划的活动，是制造过程设计的一项输出。
3.1.9
premium freight超额运费
extra costs or charges incurred additional to contracted delivery
合同规定的交付以外发生的额外的成本或费用。
NOTE This can be caused by method, quantity, unscheduled or late deliveries, etc.
注：超额运费可能是由方法、数量、非计划或延迟的交付等引起的。
3.1.10
remote location外部场所
location that supports sites and at which non production processes occur
支持现场的非生产的场所。
3.1.11
site现场
location at which value added manufacturing processes occur
增值制造过程发生的场所。
3.1.12
special characteristics特殊特性
product characteristics or manufacturing process parameters which can affect safety or compliance with regulations, fit, function, performance or subsequent processing of product
可能影响产品的安全或法规的符合性、配合、功能、性能、或后续加工的产品特性或制造过程参数。
4 Quality management system质量管理体系
4.1 General requirements总要求
ISO 9001:2000, Quality management systems － Requirements
4 Quality management system质量管理体系
4.1 General requirements总要求
The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.
组织应按本标准的要求建立质量管理体系，形成文件，加以实施和保持，并持续改进其有效性。
The organization shall
组织应：
a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2),
a）识别质量管理体系所需的过程及其在组织中的应用（见1．2）；
b) determine the sequence and interaction of these processes,
b）确定这些过程的顺序和相互作用；
c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
c）确定为确保这些过程的有效运行和控制所需的准则和方法；
d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
d）确保可以获得必要的资源和信息，以支持这些过程的运行和对这些过程的监视；
e) monitor, measure and analyse these processes, and
e）监视、测量和分析这些过程；
f) implement actions necessary to achieve planned results and continual improvement of these processes.
f）实施必要的措施，以实现对这些过程策划的结果和对这些过程的持续改进。
These processes shall be managed by the organization in accordance with the requirements of this International Standard.
组织应按本标准的要求管理这些过程。
Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.
针对组织所选择的任何影响产品符合要求的外包过程，组织应确保对其实施控制。对此类外包过程的控制应在质量管理体系中加以识别。
NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.
注：上述质量管理体系所需的过程应当包括与管理活动、资源提供、产品实现和测量有关的过程。
4.1.1 General requirements － Supplemental总要求－补充
Ensuring control over outsourced processes shall not absolve the organization to the responsibility of conformity to all customer requirements.
确保控制外包过程不能免除组织对符合顾客所有要求的职责。
NOTE See also 7.4.1 and 7.4.1.3.
注：同时参见7.4.1和7.4.1.3。
4.2 Documentation requirements文件要求
4.2.1 General总则
ISO 9001:2000, Quality management systems － Requirements
4.2 Documentation requirements文件要求
4.2.1 General总则
The quality management system documentation shall include
质量管理体系文件应包括：
a) documented statements of a quality policy and quality objectives,
a）形成文件的质量方针和质量目标；
b) a quality manual,
b）质量手册；
c) documented procedures required by this International Standard,
c）本标准所要求的形成文件的程序；
d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and
d）组织为确保其过程的有效策划、运作和控制所需的文件；
e) records required by this International Standard (see 4.2.4).
e）本标准所要求的记录（见4．2．4）。
NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained.
注1：本标准出现“形成文件的程序”之处，即要求建立该程序，形成文件，并加以实施和保持。
NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to
注2：不同组织的质量管理体系文件的多少与详略程度取决于：
a) the size of organization and type of activities,
a）组织的规模和活动的类型；
b) the complexity of processes and their interactions, and
b）过程及其相互作用的复杂程度；
c) the competence of personnel.
c）人员的能力。
NOTE 3 The documentation can be in any form or type of medium.
注3：文件可采用任何形式或类型的媒体。
4.2.2 Quality manual质量手册
ISO 9001:2000, Quality management system － Requirements
4.2.2 Quality manual质量手册
The organization shall establish and maintain a quality manual that includes
组织应编制和保持质量手册，质量手册包括：
a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),
a）质量管理体系的范围，包括任何删减的细节与合理性（见1．2）；
b) the documented procedures established for the quality management system, or reference to them, and
b）为质量管理体系编制的形成文件的程序或对其引用；
c) a description of the interaction between the processes of the quality management system.
c）质量管理体系过程之间的相互作用的表述。
4.2.3 Control of documents文件控制
ISO 9001:2000, Quality management system － Requirements
4.2.3 Control of documents文件控制
Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
质量管理体系所要求的文件应予以控制。记录是一种特殊类型的文件，应依据4．2．4的要求进行控制。
A documented procedure shall be established to define the controls needed
应编制形成文件的程序，以规定以下方面所需的控制：
a) to approve documents for adequacy prior to issue,
a）文件发布前得到批准，以确保文件是充分与适宜的；
b) to review and update as necessary and re approve documents,
b）必要时对文件进行评审与更新，并再次批准；
c) to ensure that changes and the current revision status of documents are identified,
c）确保文件的更改和现行修订状态得到识别；
d) to ensure that relevant versions of applicable documents are available at points of use,
d）确保在使用处可获得适用文件的有关版本；
e) to ensure that documents remain legible and readily identifiable,
e）确保文件保持清晰、易于识别；
f) to ensure that documents of external origin are identified and their distribution controlled, and
f）确保外来文件得到识别，并控制其分发；
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
g）防止作废文件的非预期使用，若因任何原因而保留作废文件时，对这些文件进行适当的标识。
4.2.3.1 Engineering specifications工程规范
The organization shall have a process to assure the timely review, distribution and implementation of all customer engineering standards/specifications and changes based on customer-required schedule. Timely review should be as soon as possible, and not exceed two working weeks.
组织必须建立过程以确保按照顾客要求的进度及时评审、发放和实施所有的顾客工程标准/规范和更改。及时评审应该尽可能快地进行，并且不应该超过两个工作周。
The organization shall maintain a record of the date on which each change is implemented in production. Implementation shall include updated documents.
组织必须保存每项更改在生产中实施的日期的记录。实施必须包括更新的文件。
NOTE A change in these standards/specifications requires an updated record of customer production part approval when these specifications are referenced on the design record or if they affect documents of production part approval process, such as control plan, FMEAs, etc.
注：当这些标准/规范在设计记录中引用或影响生产件批准程序的文件（如控制计划、FMEA等）时，这些标准/规范的更改需要顾客生产件批准的更新记录。
4.2.4 Control of records记录控制
IS0 9001:2000, Quality management system － Requirements
4.2.4 Control of records记录控制
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.
应建立并保持记录，以提供符合要求和质量管理体系有效运行的证据。记录应保持清晰、易于识别和检索。应编制形成文件的程序，以规定记录的标识、贮存、保护、检索、保存期限和处置所需的控制。
NOTE 1 "Disposition" above includes disposal.
注1 上述“处置”包括最终处理。
NOTE 2 "Records" also include customer specified records.
注2 “记录”也包括顾客指定的记录。
4.2.4.1 Records retention记录保存
The control of records shall satisfy regulatory and customer requirements.
记录控制必须满足法规和顾客要求。
5 Management responsibility管理职责
5.1 Management commitment管理承诺
ISO 9001:2000, Quality management systems － Requirements
5 Management responsibility管理职责
5.1 Management commitment管理承诺
Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by
最高管理者应通过以下活动，对其建立、实施质量管理体系并持续改进其有效性的承诺提供证据：
a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,
a）向组织传达满足顾客和法律法规要求的重要性；
b) establishing the quality policy,
b）制定质量方针；
c) ensuring that quality objectives are established,
c）确保质量目标的制定；
d) conducting management reviews, and
d）进行管理评审；
e) ensuring the availability of resources.
e）确保资源的获得。
5.1.1 Process efficiency过程效率
Top management shall review the product realization processes and the support processes to assure their effectiveness and efficiency.
最高管理者必须评审产品实现过程和支持过程，以确保它们的有效性和效率。
5.2 Customer focus以顾客为关注焦点
ISO 9001:2000, Quality management systems – Requirements
5.2 Customer focus以顾客为关注焦点
Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1).
最高管理者应以增强顾客满意为目的，确保顾客的要求得到确定并予以满足（见7．2．1和8．2．1）。
5.3 Quality policy质量方针
ISO 9001:2000, Quality management systems – Requirements
5.3 Quality policy质量方针
Top management shall ensure that the quality policy
最高管理者应确保质量方针：
a) is appropriate to the purpose of the organization,
a）与组织的宗旨相适应；
b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,
b）包括对满足要求和持续改进质量管理体系有效性的承诺；
c) provides a framework for establishing and reviewing quality objectives,
c）提供制定和评审质量目标的框架；
d) is communicated and understood within the organization, and
d）在组织内得到沟通和理解；
e) is reviewed for continuing suitability.
e）在持续适宜性方面得到评审。
5.4 Planning策划
5.4.1 Quality objectives质量目标
ISO 9001:2000, Quality management systems － Requirements
5.4 Planning策划
5.4.1 Quality objectives质量目标
Top management shall ensure that quality objectives, including those needed to meet requirements for product are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.
最高管理者应确保在组织的相关职能和层次上建立质量目标，质量目标包括满足产品要求所需的内容。质量目标应是可测量的，并与质量方针保持一致。
5.4.1.1 Quality objectives － Supplemental质量目标－补充
Top management shall define quality objectives and measurements that shall be included in the business plan and used to deploy the quality policy.
最高管理者必须规定质量目标和测量方法，质量目标和测量方法必须包括在业务计划中，并用于展开质量方针。
NOTE Quality objectives should address customer expectations and be achievable within a defined time period.
注：质量目标应该强调顾客期望并在规定时间内可以达到。
5.4.2 Quality management system planning质量管理体系策划
ISO 9001:2000, Quality management systems － Requirements
5.4.2 Quality management system planning质量管理体系策划
Top management shall ensure that
最高管理者应确保：
a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and
a）对质量管理体系进行策划，以满足质量目标以及4．1的要求；
b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
b）在对质量管理体系的变更进行策划和实施时，保持质量管理体系的完整性。
5.5 Responsibility, authority and communication职责、权限与沟通
5.5.1 Responsibility and authority职责和权限
ISO 9001:2000, Quality management systems － Requirements
5.5 Responsibility, authority and communication职责、权限与沟通
5.5.1 Responsibility and authority职责和权限
Top management shall ensure that the responsibilities and authorities are defined and communicated within the organization.
最高管理者应确保组织内的职责、权限得到规定和沟通。
5.5.1.1 Responsibility for quality质量职责
Managers with responsibility and authority for corrective action shall be promptly informed of products or processes which do not conform to requirements.
负有纠正措施职责和权限的的经理必须迅速被告知不符合要求的产品或过程。
Personnel responsible for quality shall have the authority to stop production to correct quality problems.
负责质量的人员必须有权停止生产，以纠正质量问题。
Production operations across all shifts shall be staffed with personnel in charge of, or delegated responsibility for, ensuring product quality.
所有班次的生产操作必须配备专职负责质量的人员，或指定负责质量的人员，以确保产品质量。
5.5.2 Management representative管理者代表
ISO 9001:2000, Quality management systems － Requirements
5.5.2 Management representative管理者代表
Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes
最高管理者应指定一名管理者，无论该成员在其他方面的职责如何，应具有以下方面的职责和权限：
a) ensuring that processes needed for the quality management system are established, implemented and maintained,
a）确保质量管理体系所需的过程得到建立、实施和保持；
b) reporting to top management on the performance of the quality management system and any need for improvement, and
b）向最高管理者报告质量管理体系的业绩和任何改进的需求；
c) ensuring the promotion of awareness of customer requirements throughout the organization.
c）确保在整个组织内提高满足顾客要求的意识。
NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.
注：管理者代表的职责可包括与质量管理体系有关事宜的外部联络。
5.5.2 1 Customer representative顾客代表
Top management shall designate personnel with responsibility and authority to ensure that customer requirements are addressed. This includes selection of special characteristics, setting quality objectives and related training, corrective and preventive actions, product design and development.
最高管理者必须任命人员负责确保顾客要求被强调。这包括选择特殊特性、提出质量目标和相关的培训、纠正和预防措施、产品设计与开发。
5.5.3 Internal communication内部沟通
ISO 9001:2000, Quality management systems － Requirements
5.5.3 Internal communication内部沟通
Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.
最高管理者应确保在组织内建立适当的沟通过程，并确保对质量管理体系的有效性进行沟通。
5.6 Management review管理评审
5.6.1 General总则
ISO 9001:2000, Quality management systems － Requirements
5.6 Management review管理评审
5.6.1 General总则
Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.
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。
Records from management reviews shall be maintained (see 4.2.4).
应保持管理评审的记录（见4．2．4）。
5.6.1.1 Quality management system performance质量管理体系绩效
These reviews shall include all elements of the quality management system and its performance trends as an essential part of the continual improvement process.
作为持续改进过程的基本内容，这些评审必须包括质量管理体系的所有要素及其绩效趋势。
Part of the management review shall be the monitoring of quality objectives, and the regular reporting and evaluation of the cost of poor quality (see 8.4.1 and 8.5.1).
监控质量目标，以及不良质量成本定期报告和评估（参见8.4.1 and 8.5.1）必须是管理评审的一部分内容。
These results shall be recorded to provide, as a minimum, evidence of the achievement of
管理评审的结果必须被记录，至少为以下业绩提供证据：
 the quality objectives specified in the business plan, and
业务计划中规定的质量目标，和
 customer satisfaction with product supplied.
顾客对提供产品的满意度。
5.6.2 Review input评审输入
ISO 9001:2000, Quality management systems － Requirements
5.6.2 Review input评审输入
The input to management review shall include information on
管理评审的输入应包括以下方面的信息：
a) results of audits,
a）审核结果；
b) customer feedback,
b）顾客反馈；
c) process performance and product conformity,
c）过程的业绩和产品的符合性；
d) status of preventive and corrective actions,
d）预防和纠正措施的状况；
e) follow up actions from previous management reviews,
e）以往管理评审的跟踪措施；
f) changes that could affect the quality management system, and
f）可能影响质量管理体系的变更；
g) recommendations for improvement.
g）改进的建议。
5.6.2.1 Review input － Supplemental评审输入－补充
Input to management review shall include an analysis of actual and potential field failures and their impact on quality, safety, or the environment.
管理评审的输入必须包括对实际的和潜在的现场失效及其对质量、安全或环境的影响的分析。
5.6.3 Review output评审输出
ISO 9001:2000, Quality management systems – Requirements
5.6.3 Review output评审输出
The output from the management review shall include any decisions and actions related to
管理评审的输出应包括与以下方面有关的任何决定和措施：
a) improvement of the effectiveness of the quality management system and its processes,
a）质量管理体系及其过程有效性的改进；
b) improvement of product related to customer requirements, and
b）与顾客要求有关的产品的改进；
c) resource needs.
c）资源需求。
6 Resource management资源管理
6.1 Provision of resources资源提供
ISO 9001:2000, Quality management systems － Requirements
6 Resource management资源管理
6.1 Provision of resources资源提供
The organization shall determine and provide the resources needed
组织应确定并提供以下方面所需的资源：
a) to implement and maintain the quality management system and continually improve its effectiveness, and
a）实施、保持质量管理体系并持续改进其有效性；
b) to enhance customer satisfaction by meeting customer requirements.
b）通过满足顾客要求，增强顾客满意。
6.2 Human resources人力资源
6.2.1 General总则
ISO 9001:2000, Quality management systems － Requirements
6.2 Human resources人力资源
6.2.1 General总则
Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.
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
ISO 9001:2000, Quality management systems – Requirements
6.2.2 Competence, awareness and training能力、意识和培训
The organization shall
组织应：
a) determine the necessary competence for personnel performing work affecting product quality,
a）确定从事影响产品质量工作的人员所必要的能力；
b) provide training or take other actions to satisfy these needs,
b）提供培训或采取其他措施以满足这些需求；
c) evaluate the effectiveness of the actions taken,
c）评价所采取措施的有效性；
d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and
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) maintain appropriate records of education, training, skills and experience.
e）保持教育、培训、技能和经验的适当记录（见4．2．4）。
6.2.2.1 Product design skills产品设计技能
The organization shall ensure that personnel with product design responsibility are competent to achieve design requirements and are skilled in applicable tools and techniques.
组织必须确保负有产品设计职责的人员具备完成设计要求的能力并熟练掌握适用的工具和技术。
Applicable tools and techniques shall be identified by the organization.
组织必须识别适用的工具和技术。
6.2.2.2 Training培训
The organization shall establish and maintain documented procedures for identifying training needs and achieving competence of all personnel performing activities affecting product quality. Personnel performing specific assigned tasks shall be qualified, as required, with particular attention to the satisfaction of customer requirements.
组织必须建立和保持形成文件的程序以识别培训需求，并使所有从事影响产品质量的工作的人员能够胜任工作。从事特定工作的人员必须按照要求进行资格考核，考核应对满足顾客要求给予特别关注。
NOTE 1 This applies to all employees having an effect on quality at all levels of the organization.
注1 本条款适用于组织内各个层次影响质量的所有员工。
NOTE 2 An example of the customer specific requirements is the application of digitized mathematically based data.
顾客特殊要求的一个例子是数学数据的应用。
6.2.2.3 Training on the job在职培训
The organization shall provide on-the-job training for personnel in any new or modified job affecting product quality, including contract or agency personnel. Personnel whose work can affect quality shall be informed about the consequences to the customer of nonconformity to quality requirements.
组织必须对任何影响产品质量的新上岗或转岗人员，包括合同人员和代理人员，提供在职培训。对于其工作影响质量的人员，必须告知不符合质量要求对顾客的后果。
6.2.2.4 Employee motivation and empowerment员工激励与授权
The organization shall have a process to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment to promote innovation. The process shall include the promotion of quality and technological awareness throughout the whole organization.
组织必须有一个过程，以激励员工实现质量目标、进行持续改进、创造一个促进创新的环境。该过程必须包括在整个组织促进质量和科技意识。
The organization shall have a process to measure the extent to which its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives .
组织必须有一个过程，以测量其员工对他们的活动的相关性和重要性，以及对他们如何为实现质量目标做出贡献的认知程度。
6.3 Infrastructure基础设施
ISO 9001:2000, Quality management systems － Requirements
6.3 Infrastructure基础设施
The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable
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) buildings, workspace and associated utilities,
a）建筑物、工作场所和相关的设施；
b) process equipment (both hardware and software), and
b）过程设备（硬件和软件）；
c) supporting services (such as transport or communication).
c）支持性服务（如运输或通讯）。
6.3.1 Plant, facility and equipment planning工厂、设施和设备策划
The organization shall use a multidisciplinary approach (see 7.3.1.1) for developing plant, facility and equipment plans. Plant layouts shall optimize material travel, handling and value added use of floor space, and shall facilitate synchronous material flow. Methods shall be developed and implemented to evaluate and monitor the effectiveness of existing operations.
组织必须采取多方论证的方法（参见7.3.1.1）制定工厂、设施和设备计划。工厂的平面布置必须尽可能优化材料的流转、搬运，以及场地空间的增值使用。必须制定和实施评价和监控现有操作有效性的方法。
NOTE These requirements should focus on lean manufacturing principles and the link to the effectiveness of the quality management system.
注：这些要求应该关注精益生产的原则，并与质量管理体系的有效性相联系。
6.3.2 Contingency plans应急计划
The organization shall prepare contingency plans to satisfy customer requirements in the event of an emergency such as utility interruptions, labour shortages, key equipment failure and field returns.
组织必须制定应急计划以在紧急情况下(如公用事业中断、劳动力短缺、关键设备故障和现场退货)满足顾客要求。
6.4 Work environment工作环境
ISO 9001:2000, Quality management systems – Requirements
6.4 Work environment工作环境
The organization shall determine and manage the work environment needed to achieve conformity to product requirements.
组织应确定并管理为达到产品符合要求所需的工作环境。
6.4.1 Personnel safety to achieve product quality实现产品质量所需要的员工安全
Product safety and means to minimize potential risks to employees shall be addressed by the organization, especially in the design and development process and in manufacturing process activities.
组织必须强调产品安全和最大限度地减少员工潜在危险的方法，特别是在设计和开发过程和制造过程活动中。
6.4.2 Cleanliness of premises生产现场的清洁
The organization shall maintain its premises in a state of order, cleanliness and repair consistent with the product and manufacturing process needs.
组织必须使其生产现场保持有序、清洁的状态，并按照产品和制造过程的需求进行维护。
7 Product realization产品实现
7.1 Planning of product realization产品实现的策划
ISO 9001:2000, Quality management systems － Requirements
7 Product realization产品实现
7.1 Planning of product realization产品实现的策划
The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1).
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）。
In planning product realization, the organization shall determine the following, as appropriate:
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) quality objectives and requirements for the product;
a）产品的质量目标和要求；
b) the need to establish processes, documents, and provide resources specific to the product;
b）针对产品确定过程、文件和资源的需求；
c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;
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) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).
d）为实现过程及其产品满足要求提供证据所需的记录（见4．2．4）。
The output of this planning shall be in a form suitable for the organization's method of operations.
策划的输出形式应适合于组织的运作方式。
NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan.
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。
NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes.
注2：组织也可将7．3的要求应用于产品实现过程的开发。
NOTE Some customers refer to project management or advanced product quality planning as a means to achieve product realization. Advanced product quality planning embodies the concepts of error prevention and continual improvement as contrasted with error detection and is based on a multidisciplinary approach.
注：有些顾客将项目管理或产品质量先期策划作为完成产品实现的方法。产品质量先期策划包含了缺陷预防和持续改进（与缺陷探测不同）的概念，并基于多方论证的方法。
7.1.1 Planning of product realization － Supplemental产品实现的策划－补充
Customer requirements and references to its technical specifications shall be included in the planning of product realization as a component of the quality plan.
作为质量计划的一部分，顾客要求和引用的顾客技术规范必须包括在产品实现的策划中。
7.1.2 Acceptance criteria接收准则
Acceptance criteria shall be defined by the organization and, where required, approved by the customer.
接收准则必须由组织制定，并且在要求时，由顾客批准。
For attribute data sampling, acceptance criteria shall be zero defects (see 8.2.3.1).
对于计数型数据的抽样，接收准则必须是零缺陷（参见8.2.3.1）。
7.1.3 Confidentiality保密
The organization shall ensure the confidentiality of customer contracted products and projects under development, and related product information.
组织必须确保顾客合同产品和正在开发的项目，以及有关的产品信息的保密。
7.1.4 Change control/更改控制
The organization shall have a process to control and react to changes that impact product realization. The effects of any change, including those changes caused by any supplier, shall be assessed, and verification and validation activities shall be defined, to ensure compliance with customer requirements. Changes shall be validated before implementation.
组织必须有对影响产品实现的更改进行控制和反应的过程。必须评定任何更改（包括那些由任何供方引起的更改）的影响，而且必须规定验证和确认活动，以确保符合顾客要求。更改在实施前必须进行确认。
For proprietary designs, impact on form, fit and function (including performance, and/or durability) shall be reviewed with the customer so that all effects can be properly evaluated.
对于专有权设计，必须与顾客评审外形、配合和功能（包括性能和/或耐久性）的影响，以确保适当地评价所有的影响。
When required by the customer, additional verification/identification requirements, such as those required for new product introduction, shall be met.
当顾客要求时，必须满足附加的验证/标识要求，如引入新产品的要求。
NOTE 1 Any product realization change affecting customer requirements requires notification to, and agreement from, the customer.
注1：任何影响顾客要求的产品实现更改要求通知顾客并与取得顾客同意。
NOTE 2 The above requirement applies to product and manufacturing process changes.
注2：以上要求适用于产品和制造过程更改。
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
ISO 9001:2000, Quality management systems － Requirements
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
The organization shall determine
组织应确定：
a) requirements specified by the customer, including the requirements for delivery and post delivery activities,
a）顾客规定的要求，包括对交付及交付后活动的要求；
b) requirements not stated by the customer but necessary for specified or intended use, where known,
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) statutory and regulatory requirements related to the product, and
c）与产品有关的法律法规要求；
d) any additional requirements determined by the organization.
d）组织确定的任何附加要求。
NOTE 1 Post delivery activities include any after sales product servicing provided as part of the customer contract or purchase order.
注1：交付后活动包括作为顾客合同或采购订单一部分而提供的任何售后产品服务。
NOTE 2 This requirement includes recycling, environmental impact and characteristics identified as a result of the organization's knowledge of the product and manufacturing processes (see 7.3.2.3).
注2：本要求包括再回收、环境影响，以及根据组织对产品和制造过程的知识识别的特性（参见7.3.2.3）。
NOTE 3 Compliance to item c) includes all applicable government, safety and environmental regulations, applied to acquisition, storage, handling, recycling, elimination or disposal of materials.
注3：符合条款c）包括所有适用的政府、安全和环境法规，适用于材料的获得、贮存、搬运、再回收、去除或最终处理。
7.2.1.1 Customer designated special characteristics顾客指定的特殊特性
The organization shall demonstrate conformity to customer requirements for designation, documentation and control of special characteristics.
组织必须证明在特殊特性的确定、文件化和控制方面符合顾客要求。
7.2.2 Review of requirements related to the product与产品有关的要求的评审
ISO 9001:2000, Quality management systems － Requirements
7.2.2 Review of requirements related to the product与产品有关的要求的评审
The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that
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（例如：提交标书、接受合同或订单及接受合同或订单的更改），并应确保：
a) product requirements are defined,
a）产品要求得到规定；
b) contract or order requirements differing from those previously expressed are resolved, and
b）与以前表述不一致的合同或订单的要求已予解决；
c) the organization has the ability to meet the defined requirements.
c）组织有能力满足规定的要求。
Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).
评审结果及评审所引起的措施的记录应予保持（见4．2．4）。
Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.
若顾客提供的要求没有形成文件，组织在接受顾客要求前应对顾客要求进行确认。
Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.
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。
NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material.
注：在某些情况下，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。
7.2.2.1 Review of requirements related to the product－Supplemental与产品有关的要求的评审－补充
Waiving the requirement stated in 7.2.2 for a formal review (see note) shall require customer authorization.
放弃7.2.2中要求的正式评审（参见注）必须获得顾客授权。
7.2.2.2 Organization manufacturing feasibility组织制造可行性
The organization shall investigate, confirm and document the manufacturing feasibility of the proposed products in the contract review process, including risk analysis.
组织在合同评审过程中必须对提出的产品的制造可行性（包括风险分析）进行调查、确认并形成文件。
7.2.3 Customer communication顾客沟通
ISO 9001:2000, Quality management systems － Requirements
7.2.3 Customer communication顾客沟通
The organization shall determine and implement effective arrangements for communicating with customers in relation to
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) product information,
a）产品信息；
b) enquiries, contracts or order handling, including amendments, and
b）问询、合同或订单的处理，包括对其修改；
c) customer feedback, including customer complaints.
c）顾客反馈，包括顾客抱怨。
7.2.3.1 Customer communication － Supplemental顾客沟通－补充
The organization shall have the ability to communicate necessary information, including data, in a customer-specified language and format (e.g. computer aided design data, electronic data exchange).
组织必须具有按照顾客规定的语言和格式传递必要的信息，包括数据的能力（例如：计算机辅助设计数据，电子数据交换）。
7.3 Design and development设计和开发
NOTE The requirements of 7.3 include product and manufacturing process design and development, and focus on error prevention rather than detection.
注：条款7.3的要求包括产品和制造过程设计和开发，强调错误预防，而不只是探测。
7.3.1 Design and development planning设计和开发策划
ISO 9001:2000, Quality management systems － Requirements
7.3 Design and development设计和开发
7.3.1 Design and development planning设计和开发策划
The organization shall plan and control the design and development of product.
组织应对产品的设计和开发进行策划和控制。
During the design and development planning, the organization shall determine
在进行设计和开发策划时，组织应确定：
a) the design and development stages,
a）设计和开发阶段；
b) the review, verification and validation that are appropriate to each design and development stage, and
b）适合于每个设计和开发阶段的评审、验证和确认活动；
c) the responsibilities and authorities for design and development.
c）设计和开发的职责和权限。
The organization shall manage the interfaces between different groups involv
0.1 General总则
ISO 9001:2000, Quality management systems － Requirements
Introduction引言
0.1 General总则
The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.
采用质量管理体系应当是组织的一项战略性决策。一个组织质量管理体系的设计和实施受各种需求、具体目标、所提供的产品、所采用的过程以及该组织的规模和结构的影响。统一质量管理体系的结构或文件不是本标准的目的。
The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement.
本标准所规定的质量管理体系要求是对产品要求的补充。“注”是理解和说明有关要求的指南。
This International Standard can be used by internal and external parties, including certification bodies, to assess the organization's ability to meet customer, regulatory and the organization's own requirements.
本标准能用于内部和外部（包括认证机构）评定组织满足顾客、法律法规和组织自身要求的能力。
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.
本标准的制定已经考虑了GB/T 19000和GB/T 19004中所阐明的质量管理原则。
0.2 Process approach过程方法
ISO 9001:2000, Quality management systems － Requirements
0.2 Process approach过程方法
This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.
本标准鼓励在建立、实施质量管理体系以及改进其有效性时采用过程方法，通过满足顾客要求，增强顾客满意。
For an organization to function effectively, it has to identify and manage numerous linked activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next.
为使组织有效运作，必须识别和管理众多相互关联的活动。通过使用资源和管理，将输入转化为输出的活动可视为过程。通常，一个过程的输出直接形成下一个过程的输入。
The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the “process approach”.
组织内诸过程的系统的应用，连同这些过程的识别和相互作用及其管理，可称之为“过程方法”。
An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.
过程方法的优点是对诸过程的系统中单个过程之间的联系以及过程的组合和相互作用进行连续的控制。
When used within a quality management system, such an approach emphasizes the importance of
过程方法在质量管理体系中应用时，强调以下方面的重要性：
a) understanding and fulfilling requirements,
a）理解并满足要求；
b) the need to consider processes in terms of added value,
b）需要从增值的角度考虑过程；
c) obtaining results of process performance and effectiveness, and
c）获得过程业绩和有效性的结果；
d) continual improvement of processes based on objective measurement.
d）基于客观的测量，持续改进过程。
The model of a process based quality management system shown in Figure 1 illustrates the process linkages presented in clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of this International Standard, but does not show processes at a detailed level.
图1所反映的以过程为基础的质量管理体系模式展示了4～8章中所提出的过程联系。这种展示反映了在规定输入要求时，顾客起着重要作用。对顾客满意的监视要求对顾客有关组织是否已满足其要求的感受的信息进行评价。该模式虽覆盖了本标准的所有要求，但却未详细地反映各过程。
NOTE In addition, the methodology known as "Plan Do Check Act" (PDCA) can be applied to all processes. PDCA can be briefly described as follows.
注：此外，称之为“PDCA”的方法可适用于所有过程。PDCA模式可简述如下：
Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies.
P——策划：根据顾客的要求和组织的方针，为提供结果建立必要的目标和过程；
Do: implement the processes.
D——实施：实施过程；
Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results.
C——检查：根据方针、目标和产品要求，对过程和产品进行监视和测量，并报告结果；
Act: take actions to continually improve process performance.
A——处置：采取措施，以持续改进过程业绩。
Key图释
Value-adding activities增值活动
Information flow信息流
Figure 1 Model of a process based quality management system/图1 以过程为基础的质量管理模式
0.3 Relationship with ISO 9004 与GB/T 19004的关系
ISO 9001:2000, Quality management systems － Requirements
0.3 Relationship with ISO 9004 与GB/T 19004的关系
The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of quality management system standards which have been designed to complement each other, but can also be used independently.
GB/T 19001和GB/T 19004已制定为一对协调一致的质量管理体系标准，他们相互补充，但也可单独使用。
Although the two International Standards have different scopes, they have similar structures in order to assist their application as a consistent pair.
虽然这两项标准具有不同的范围，但却具有相似的结构，以有助于他们作为协调一致的一对标准的应用。
ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, or for certification, or for contractual purposes. It focuses on the effectiveness of the quality management system in meeting customer requirements.
GB/T 19001规定了质量管理体系要求，可供组织内部使用，也可用于认证或合同目的。在满足顾客要求方面，GB/T 19001所关注的是质量管理体系的有效性。
ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organization's overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes.
与GB/T 19001相比，GB/T 19004为质量管理体系更宽范围的目标提供了指南。除了有效性，该标准还特别关注持续改进组织的总体业绩与效率。对于最高管理者希望通过追求业绩持续改进而超越GB/T 19001要求的那些组织，GB/T 19004推荐了指南。然而，用于认证或合同不是GB/T 19004的目的。
NOTE The knowledge and use of the eight quality management principles referred to in the ISO 9000:2000 and ISO 9004:2000 can be demonstrated and cascaded through the organization by top management.
注：ISO 9000:2000和ISO 9004:2000涉及的八项质量管理原则的知识和应用，应该由最高管理者在组织内示范和传递。
0.3.1 IATF Guidance to ISO/TS 16949:2002
"IATF Guidance to ISO/TS 16949:2002" is a document containing recommended automotive industry practices, examples, illustrations and explanations, and provides assistance in the application to conform to the requirements of this Technical Specification.
“IATF关于ISO/TS 16949:2002的指南”是一份文件，该文件包括推荐的汽车行业的实践、范例、图解和解释，并为符合本技术规范的要求在实施上提供帮助。
This IATF Guidance document is not intended for certification or for contractual purposes
用于认证或合同不是本IATF指南的目的。
0.4 Compatibility with other management systems与其他管理体系的相容性
ISO 9001:2000, Quality management systems － Requirements
0.4 Compatibility with other management systems与其他管理体系的相容性
This International Standard has been aligned with ISO 14001:1996 in order to enhance the compatibility of the two standards for the benefit of the user community.
为了使用者的利益，本标准与GB/T 24001—1996相互趋近，以增强两类标准的相容性。
This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financial management or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible for an organization to adapt its existing management systems) in order to establish a quality management system that complies with the requirements of this International Standard.
本标准不包括针对其他管理体系的要求，如环境管理、职业卫生与安全管理、财务管理或风险管理的特定要求。然而本标准使组织能够将自身的质量管理体系与相关的管理体系要求结合或整合。组织为了建立符合本标准要求的质量管理体系，可能会改变现行的管理体系。
0.5 Goal of this Technical Specification本技术规范的目标
The goal of this Technical Specification is the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain.
本技术规范的目标是在供应链中开发提供持续改进、加强预防缺陷、减少变差和浪费的质量体系。
This Technical Specification, coupled with customer specific requirements, defines the fundamental quality management system requirements for those subscribing to this document.
本技术规范与顾客特殊要求相配合，规定了签署本文件的组织的基本质量管理体系要求。
This Technical Specification is intended to avoid multiple certification audits and provide a common automotive approach to a quality management system for automotive production, and relevant service part organizations.
本技术规范是为了避免多重认证审核，并为汽车行业生产件和相关服务件的组织提供了质量管理体系的共同的行业方法。
Quality management systems － Particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizations
质量管理体系－汽车行业生产件和相关服务件的组织实施ISO 9001:2000的特殊要求
1 Scope范围
1.1 General总则
ISO 9001:2000, Quality management systems － Requirements
1 Scope范围
1.1 General总则
This International Standard specifies requirements for a quality management system where an organization
本标准为有下列需求的组织规定了质量管理体系要求：
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and
a）需要证实其有能力稳定地提供满足顾客和适用的法律法规要求的产品；
b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.
b）通过体系的有效应用，包括体系持续改进的过程以及保证符合顾客与适用的法律法规要求，旨在增强顾客满意。
NOTE In this International Standard, the term “product” applies only to the product intended for, or required by, a customer.
注：在本标准中，术语“产品”仅适用于预期提供给顾客或顾客所要求的产品。
This Technical Specification, in conjunction with ISO 9001:2000, defines the quality management system requirements for the design and development, production and, when relevant, installation and servicing of automotive related products.
本技术规范与ISO 9001:2000相结合，规定了用于汽车相关产品的设计与开发、生产、以及安装和服务（相关时）的质量管理体系要求。
This Technical Specification is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured.
本技术规范适用于组织的顾客指定的生产件和/或服务件的制造现场。
Supporting functions, whether on-site or remote (such as design centres, corporate headquarters and distribution centres), form part of the site audit as they support the site, but cannot obtain stand alone certification to this Technical Specification.
现场或外部的支持性部门（如设计中心、公司总部和配送中心），当它们支持现场时，构成现场审核的一部分，但不能单独获得本技术规范的认证。
This Technical Specification can be applied throughout the automotive supply chain.
本技术规范适用于整个汽车供应链。
1.2 Application应用
ISO 9001:2000, Quality management systems － Requirements
1.2 Application应用
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
本标准规定的所有要求是通用的，旨在适用于各种类型、不同规模和提供不同产品的组织。
Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
当本标准的任何要求因组织及其产品的特点而不适用时，可以考虑对其进行删减。
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.
除非删减仅限于本标准第7章中那些不影响组织提供满足顾客和适用法律法规要求的产品的能力或责任的要求，否则不能声称符合本标准。
The only permitted exclusions for this Technical Specification relate to 7.3 where the organization is not responsible for product design and development.
当组织不具有产品设计和开发职责时，只有本技术规范与7.3有关的部分是允许的删减。
Permitted exclusions do not include manufacturing process design.
允许的删减不包括制造过程设计。
2 Normative reference引用标准
The following normative document contains provisions, which, through reference in this text, constitute provisions of this Technical Specification. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this Technical Specification are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards.
下列标准所包含的条文，通过在本标准中引用而构成为本标准的条文。本标准出版时，所示版本均为有效。所有标准都会被修订，使用本标准的各方应探讨使用下列标准最新版本的可能性。
ISO 9000:2000, Quality management systems Fundamentals and vocabulary.
GB/T 19000—2000 质量管理体系－基础和术语（idt ISO 9000：2000）
3 Terms and definitions术语和定义
ISO 9001:2000, Quality management systems － Requirements
3 Terms and definitions术语和定义
For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply.
本标准采用GB/T 19000中的术语和定义。
The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used:
本标准表述供应链所使用的以下术语经过了更改，以反映当前的使用情况：
Supplier organization customer
供方 组织 顾客
The term “organization” replaces the term “supplier” used in ISO 9001:1994, and refers to the unit to which this International Standard applies. Also, the term “supplier” now replaces the term “subcontractor”.
本标准中的术语“组织”用以取代GB/T 19001—1994所使用的术语“供方”，术语“供方”用以取代术语“分承包方”。
Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.
本标准中所出现的术语“产品”，也可指“服务”。
3.1 Terms and definitions for the automotive industry汽车行业的术语和定义
For the purposes of this Technical Specification, the terms and definitions given in ISO 9000 : 2000 and the following apply.
基于本技术规范的目的，适用ISO 9000 : 2000和以下给出的术语和定义。
3.1.1
control plan控制计划
documented descriptions of the systems and processes required for controlling products (see annex A)
控制产品所要求的体系和过程的文件化的描述（参见附录A）。
3.1.2
design responsible organization具有设计职责的组织
organization with authority to establish a new, or change an existing, product specification
组织有权制定新的，或更改现有的产品规范。
NOTE This responsibility includes testing and verification of design performance within the customer's specified application.
注：本职责包括在顾客制定的范围内的设计性能的试验和验证。
3.1.3
error proofing防错
product and manufacturing process design and development to prevent manufacture of nonconforming products
防止制造不合格品的产品和制造过程设计和开发。
3.1.4
laboratory实验室
facility for inspection, test or calibration that may include, but is not limited to, chemical, metallurgical, dimensional, physical, electrical, or reliability testing
进行检验、试验或校准的设施，包括但不限于化学、冶金、尺寸、物理、电学或可靠性试验。
3.1.5
laboratory scope实验室范围
controlled document containing
受控文件包括：
 specific tests, evaluations and calibrations that a laboratory is qualified to perform,
实验室有资格进行的特定试验、评价和校准，
 list of the equipment which it uses to perform the above, and
用于进行上述活动的设备清单，
 list of methods and standards to which it performs the above
进行上述活动的方法和标准的清单。
3.1.6
manufacturing制造
process of making or fabricating
下述制造或装配过程
 production materials,
生产原材料，
 production or service parts,
生产件或服务件，
 assemblies, or
装配，或
 heat treating, welding, painting, plating or other finishing services
热处理，焊接，喷漆、电镀或其他表面处理
3.1.7
predictive maintenance预测性维护
activities based on process data aimed at the avoidance of maintenance problems by prediction of likely failure modes
根据过程数据，通过预测可能的失效模式，来避免维护问题发生的活动。
3.1.8
preventive maintenance预防性维护
planned action to eliminate causes of equipment failure and unscheduled interruptions to production, as an output of the manufacturing process design
为消除设备失效原因和非计划的生产中断而策划的活动，是制造过程设计的一项输出。
3.1.9
premium freight超额运费
extra costs or charges incurred additional to contracted delivery
合同规定的交付以外发生的额外的成本或费用。
NOTE This can be caused by method, quantity, unscheduled or late deliveries, etc.
注：超额运费可能是由方法、数量、非计划或延迟的交付等引起的。
3.1.10
remote location外部场所
location that supports sites and at which non production processes occur
支持现场的非生产的场所。
3.1.11
site现场
location at which value added manufacturing processes occur
增值制造过程发生的场所。
3.1.12
special characteristics特殊特性
product characteristics or manufacturing process parameters which can affect safety or compliance with regulations, fit, function, performance or subsequent processing of product
可能影响产品的安全或法规的符合性、配合、功能、性能、或后续加工的产品特性或制造过程参数。
4 Quality management system质量管理体系
4.1 General requirements总要求
ISO 9001:2000, Quality management systems － Requirements
4 Quality management system质量管理体系
4.1 General requirements总要求
The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.
组织应按本标准的要求建立质量管理体系，形成文件，加以实施和保持，并持续改进其有效性。
The organization shall
组织应：
a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2),
a）识别质量管理体系所需的过程及其在组织中的应用（见1．2）；
b) determine the sequence and interaction of these processes,
b）确定这些过程的顺序和相互作用；
c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
c）确定为确保这些过程的有效运行和控制所需的准则和方法；
d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
d）确保可以获得必要的资源和信息，以支持这些过程的运行和对这些过程的监视；
e) monitor, measure and analyse these processes, and
e）监视、测量和分析这些过程；
f) implement actions necessary to achieve planned results and continual improvement of these processes.
f）实施必要的措施，以实现对这些过程策划的结果和对这些过程的持续改进。
These processes shall be managed by the organization in accordance with the requirements of this International Standard.
组织应按本标准的要求管理这些过程。
Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.
针对组织所选择的任何影响产品符合要求的外包过程，组织应确保对其实施控制。对此类外包过程的控制应在质量管理体系中加以识别。
NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.
注：上述质量管理体系所需的过程应当包括与管理活动、资源提供、产品实现和测量有关的过程。
4.1.1 General requirements － Supplemental总要求－补充
Ensuring control over outsourced processes shall not absolve the organization to the responsibility of conformity to all customer requirements.
确保控制外包过程不能免除组织对符合顾客所有要求的职责。
NOTE See also 7.4.1 and 7.4.1.3.
注：同时参见7.4.1和7.4.1.3。
4.2 Documentation requirements文件要求
4.2.1 General总则
ISO 9001:2000, Quality management systems － Requirements
4.2 Documentation requirements文件要求
4.2.1 General总则
The quality management system documentation shall include
质量管理体系文件应包括：
a) documented statements of a quality policy and quality objectives,
a）形成文件的质量方针和质量目标；
b) a quality manual,
b）质量手册；
c) documented procedures required by this International Standard,
c）本标准所要求的形成文件的程序；
d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and
d）组织为确保其过程的有效策划、运作和控制所需的文件；
e) records required by this International Standard (see 4.2.4).
e）本标准所要求的记录（见4．2．4）。
NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained.
注1：本标准出现“形成文件的程序”之处，即要求建立该程序，形成文件，并加以实施和保持。
NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to
注2：不同组织的质量管理体系文件的多少与详略程度取决于：
a) the size of organization and type of activities,
a）组织的规模和活动的类型；
b) the complexity of processes and their interactions, and
b）过程及其相互作用的复杂程度；
c) the competence of personnel.
c）人员的能力。
NOTE 3 The documentation can be in any form or type of medium.
注3：文件可采用任何形式或类型的媒体。
4.2.2 Quality manual质量手册
ISO 9001:2000, Quality management system － Requirements
4.2.2 Quality manual质量手册
The organization shall establish and maintain a quality manual that includes
组织应编制和保持质量手册，质量手册包括：
a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),
a）质量管理体系的范围，包括任何删减的细节与合理性（见1．2）；
b) the documented procedures established for the quality management system, or reference to them, and
b）为质量管理体系编制的形成文件的程序或对其引用；
c) a description of the interaction between the processes of the quality management system.
c）质量管理体系过程之间的相互作用的表述。
4.2.3 Control of documents文件控制
ISO 9001:2000, Quality management system － Requirements
4.2.3 Control of documents文件控制
Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
质量管理体系所要求的文件应予以控制。记录是一种特殊类型的文件，应依据4．2．4的要求进行控制。
A documented procedure shall be established to define the controls needed
应编制形成文件的程序，以规定以下方面所需的控制：
a) to approve documents for adequacy prior to issue,
a）文件发布前得到批准，以确保文件是充分与适宜的；
b) to review and update as necessary and re approve documents,
b）必要时对文件进行评审与更新，并再次批准；
c) to ensure that changes and the current revision status of documents are identified,
c）确保文件的更改和现行修订状态得到识别；
d) to ensure that relevant versions of applicable documents are available at points of use,
d）确保在使用处可获得适用文件的有关版本；
e) to ensure that documents remain legible and readily identifiable,
e）确保文件保持清晰、易于识别；
f) to ensure that documents of external origin are identified and their distribution controlled, and
f）确保外来文件得到识别，并控制其分发；
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
g）防止作废文件的非预期使用，若因任何原因而保留作废文件时，对这些文件进行适当的标识。
4.2.3.1 Engineering specifications工程规范
The organization shall have a process to assure the timely review, distribution and implementation of all customer engineering standards/specifications and changes based on customer-required schedule. Timely review should be as soon as possible, and not exceed two working weeks.
组织必须建立过程以确保按照顾客要求的进度及时评审、发放和实施所有的顾客工程标准/规范和更改。及时评审应该尽可能快地进行，并且不应该超过两个工作周。
The organization shall maintain a record of the date on which each change is implemented in production. Implementation shall include updated documents.
组织必须保存每项更改在生产中实施的日期的记录。实施必须包括更新的文件。
NOTE A change in these standards/specifications requires an updated record of customer production part approval when these specifications are referenced on the design record or if they affect documents of production part approval process, such as control plan, FMEAs, etc.
注：当这些标准/规范在设计记录中引用或影响生产件批准程序的文件（如控制计划、FMEA等）时，这些标准/规范的更改需要顾客生产件批准的更新记录。
4.2.4 Control of records记录控制
IS0 9001:2000, Quality management system － Requirements
4.2.4 Control of records记录控制
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.
应建立并保持记录，以提供符合要求和质量管理体系有效运行的证据。记录应保持清晰、易于识别和检索。应编制形成文件的程序，以规定记录的标识、贮存、保护、检索、保存期限和处置所需的控制。
NOTE 1 "Disposition" above includes disposal.
注1 上述“处置”包括最终处理。
NOTE 2 "Records" also include customer specified records.
注2 “记录”也包括顾客指定的记录。
4.2.4.1 Records retention记录保存
The control of records shall satisfy regulatory and customer requirements.
记录控制必须满足法规和顾客要求。
5 Management responsibility管理职责
5.1 Management commitment管理承诺
ISO 9001:2000, Quality management systems － Requirements
5 Management responsibility管理职责
5.1 Management commitment管理承诺
Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by
最高管理者应通过以下活动，对其建立、实施质量管理体系并持续改进其有效性的承诺提供证据：
a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,
a）向组织传达满足顾客和法律法规要求的重要性；
b) establishing the quality policy,
b）制定质量方针；
c) ensuring that quality objectives are established,
c）确保质量目标的制定；
d) conducting management reviews, and
d）进行管理评审；
e) ensuring the availability of resources.
e）确保资源的获得。
5.1.1 Process efficiency过程效率
Top management shall review the product realization processes and the support processes to assure their effectiveness and efficiency.
最高管理者必须评审产品实现过程和支持过程，以确保它们的有效性和效率。
5.2 Customer focus以顾客为关注焦点
ISO 9001:2000, Quality management systems – Requirements
5.2 Customer focus以顾客为关注焦点
Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1).
最高管理者应以增强顾客满意为目的，确保顾客的要求得到确定并予以满足（见7．2．1和8．2．1）。
5.3 Quality policy质量方针
ISO 9001:2000, Quality management systems – Requirements
5.3 Quality policy质量方针
Top management shall ensure that the quality policy
最高管理者应确保质量方针：
a) is appropriate to the purpose of the organization,
a）与组织的宗旨相适应；
b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,
b）包括对满足要求和持续改进质量管理体系有效性的承诺；
c) provides a framework for establishing and reviewing quality objectives,
c）提供制定和评审质量目标的框架；
d) is communicated and understood within the organization, and
d）在组织内得到沟通和理解；
e) is reviewed for continuing suitability.
e）在持续适宜性方面得到评审。
5.4 Planning策划
5.4.1 Quality objectives质量目标
ISO 9001:2000, Quality management systems － Requirements
5.4 Planning策划
5.4.1 Quality objectives质量目标
Top management shall ensure that quality objectives, including those needed to meet requirements for product are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.
最高管理者应确保在组织的相关职能和层次上建立质量目标，质量目标包括满足产品要求所需的内容。质量目标应是可测量的，并与质量方针保持一致。
5.4.1.1 Quality objectives － Supplemental质量目标－补充
Top management shall define quality objectives and measurements that shall be included in the business plan and used to deploy the quality policy.
最高管理者必须规定质量目标和测量方法，质量目标和测量方法必须包括在业务计划中，并用于展开质量方针。
NOTE Quality objectives should address customer expectations and be achievable within a defined time period.
注：质量目标应该强调顾客期望并在规定时间内可以达到。
5.4.2 Quality management system planning质量管理体系策划
ISO 9001:2000, Quality management systems － Requirements
5.4.2 Quality management system planning质量管理体系策划
Top management shall ensure that
最高管理者应确保：
a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and
a）对质量管理体系进行策划，以满足质量目标以及4．1的要求；
b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
b）在对质量管理体系的变更进行策划和实施时，保持质量管理体系的完整性。
5.5 Responsibility, authority and communication职责、权限与沟通
5.5.1 Responsibility and authority职责和权限
ISO 9001:2000, Quality management systems － Requirements
5.5 Responsibility, authority and communication职责、权限与沟通
5.5.1 Responsibility and authority职责和权限
Top management shall ensure that the responsibilities and authorities are defined and communicated within the organization.
最高管理者应确保组织内的职责、权限得到规定和沟通。
5.5.1.1 Responsibility for quality质量职责
Managers with responsibility and authority for corrective action shall be promptly informed of products or processes which do not conform to requirements.
负有纠正措施职责和权限的的经理必须迅速被告知不符合要求的产品或过程。
Personnel responsible for quality shall have the authority to stop production to correct quality problems.
负责质量的人员必须有权停止生产，以纠正质量问题。
Production operations across all shifts shall be staffed with personnel in charge of, or delegated responsibility for, ensuring product quality.
所有班次的生产操作必须配备专职负责质量的人员，或指定负责质量的人员，以确保产品质量。
5.5.2 Management representative管理者代表
ISO 9001:2000, Quality management systems － Requirements
5.5.2 Management representative管理者代表
Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes
最高管理者应指定一名管理者，无论该成员在其他方面的职责如何，应具有以下方面的职责和权限：
a) ensuring that processes needed for the quality management system are established, implemented and maintained,
a）确保质量管理体系所需的过程得到建立、实施和保持；
b) reporting to top management on the performance of the quality management system and any need for improvement, and
b）向最高管理者报告质量管理体系的业绩和任何改进的需求；
c) ensuring the promotion of awareness of customer requirements throughout the organization.
c）确保在整个组织内提高满足顾客要求的意识。
NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.
注：管理者代表的职责可包括与质量管理体系有关事宜的外部联络。
5.5.2 1 Customer representative顾客代表
Top management shall designate personnel with responsibility and authority to ensure that customer requirements are addressed. This includes selection of special characteristics, setting quality objectives and related training, corrective and preventive actions, product design and development.
最高管理者必须任命人员负责确保顾客要求被强调。这包括选择特殊特性、提出质量目标和相关的培训、纠正和预防措施、产品设计与开发。
5.5.3 Internal communication内部沟通
ISO 9001:2000, Quality management systems － Requirements
5.5.3 Internal communication内部沟通
Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.
最高管理者应确保在组织内建立适当的沟通过程，并确保对质量管理体系的有效性进行沟通。
5.6 Management review管理评审
5.6.1 General总则
ISO 9001:2000, Quality management systems － Requirements
5.6 Management review管理评审
5.6.1 General总则
Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.
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。
Records from management reviews shall be maintained (see 4.2.4).
应保持管理评审的记录（见4．2．4）。
5.6.1.1 Quality management system performance质量管理体系绩效
These reviews shall include all elements of the quality management system and its performance trends as an essential part of the continual improvement process.
作为持续改进过程的基本内容，这些评审必须包括质量管理体系的所有要素及其绩效趋势。
Part of the management review shall be the monitoring of quality objectives, and the regular reporting and evaluation of the cost of poor quality (see 8.4.1 and 8.5.1).
监控质量目标，以及不良质量成本定期报告和评估（参见8.4.1 and 8.5.1）必须是管理评审的一部分内容。
These results shall be recorded to provide, as a minimum, evidence of the achievement of
管理评审的结果必须被记录，至少为以下业绩提供证据：
 the quality objectives specified in the business plan, and
业务计划中规定的质量目标，和
 customer satisfaction with product supplied.
顾客对提供产品的满意度。
5.6.2 Review input评审输入
ISO 9001:2000, Quality management systems － Requirements
5.6.2 Review input评审输入
The input to management review shall include information on
管理评审的输入应包括以下方面的信息：
a) results of audits,
a）审核结果；
b) customer feedback,
b）顾客反馈；
c) process performance and product conformity,
c）过程的业绩和产品的符合性；
d) status of preventive and corrective actions,
d）预防和纠正措施的状况；
e) follow up actions from previous management reviews,
e）以往管理评审的跟踪措施；
f) changes that could affect the quality management system, and
f）可能影响质量管理体系的变更；
g) recommendations for improvement.
g）改进的建议。
5.6.2.1 Review input － Supplemental评审输入－补充
Input to management review shall include an analysis of actual and potential field failures and their impact on quality, safety, or the environment.
管理评审的输入必须包括对实际的和潜在的现场失效及其对质量、安全或环境的影响的分析。
5.6.3 Review output评审输出
ISO 9001:2000, Quality management systems – Requirements
5.6.3 Review output评审输出
The output from the management review shall include any decisions and actions related to
管理评审的输出应包括与以下方面有关的任何决定和措施：
a) improvement of the effectiveness of the quality management system and its processes,
a）质量管理体系及其过程有效性的改进；
b) improvement of product related to customer requirements, and
b）与顾客要求有关的产品的改进；
c) resource needs.
c）资源需求。
6 Resource management资源管理
6.1 Provision of resources资源提供
ISO 9001:2000, Quality management systems － Requirements
6 Resource management资源管理
6.1 Provision of resources资源提供
The organization shall determine and provide the resources needed
组织应确定并提供以下方面所需的资源：
a) to implement and maintain the quality management system and continually improve its effectiveness, and
a）实施、保持质量管理体系并持续改进其有效性；
b) to enhance customer satisfaction by meeting customer requirements.
b）通过满足顾客要求，增强顾客满意。
6.2 Human resources人力资源
6.2.1 General总则
ISO 9001:2000, Quality management systems － Requirements
6.2 Human resources人力资源
6.2.1 General总则
Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.
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
ISO 9001:2000, Quality management systems – Requirements
6.2.2 Competence, awareness and training能力、意识和培训
The organization shall
组织应：
a) determine the necessary competence for personnel performing work affecting product quality,
a）确定从事影响产品质量工作的人员所必要的能力；
b) provide training or take other actions to satisfy these needs,
b）提供培训或采取其他措施以满足这些需求；
c) evaluate the effectiveness of the actions taken,
c）评价所采取措施的有效性；
d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and
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) maintain appropriate records of education, training, skills and experience.
e）保持教育、培训、技能和经验的适当记录（见4．2．4）。
6.2.2.1 Product design skills产品设计技能
The organization shall ensure that personnel with product design responsibility are competent to achieve design requirements and are skilled in applicable tools and techniques.
组织必须确保负有产品设计职责的人员具备完成设计要求的能力并熟练掌握适用的工具和技术。
Applicable tools and techniques shall be identified by the organization.
组织必须识别适用的工具和技术。
6.2.2.2 Training培训
The organization shall establish and maintain documented procedures for identifying training needs and achieving competence of all personnel performing activities affecting product quality. Personnel performing specific assigned tasks shall be qualified, as required, with particular attention to the satisfaction of customer requirements.
组织必须建立和保持形成文件的程序以识别培训需求，并使所有从事影响产品质量的工作的人员能够胜任工作。从事特定工作的人员必须按照要求进行资格考核，考核应对满足顾客要求给予特别关注。
NOTE 1 This applies to all employees having an effect on quality at all levels of the organization.
注1 本条款适用于组织内各个层次影响质量的所有员工。
NOTE 2 An example of the customer specific requirements is the application of digitized mathematically based data.
顾客特殊要求的一个例子是数学数据的应用。
6.2.2.3 Training on the job在职培训
The organization shall provide on-the-job training for personnel in any new or modified job affecting product quality, including contract or agency personnel. Personnel whose work can affect quality shall be informed about the consequences to the customer of nonconformity to quality requirements.
组织必须对任何影响产品质量的新上岗或转岗人员，包括合同人员和代理人员，提供在职培训。对于其工作影响质量的人员，必须告知不符合质量要求对顾客的后果。
6.2.2.4 Employee motivation and empowerment员工激励与授权
The organization shall have a process to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment to promote innovation. The process shall include the promotion of quality and technological awareness throughout the whole organization.
组织必须有一个过程，以激励员工实现质量目标、进行持续改进、创造一个促进创新的环境。该过程必须包括在整个组织促进质量和科技意识。
The organization shall have a process to measure the extent to which its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives .
组织必须有一个过程，以测量其员工对他们的活动的相关性和重要性，以及对他们如何为实现质量目标做出贡献的认知程度。
6.3 Infrastructure基础设施
ISO 9001:2000, Quality management systems － Requirements
6.3 Infrastructure基础设施
The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable
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) buildings, workspace and associated utilities,
a）建筑物、工作场所和相关的设施；
b) process equipment (both hardware and software), and
b）过程设备（硬件和软件）；
c) supporting services (such as transport or communication).
c）支持性服务（如运输或通讯）。
6.3.1 Plant, facility and equipment planning工厂、设施和设备策划
The organization shall use a multidisciplinary approach (see 7.3.1.1) for developing plant, facility and equipment plans. Plant layouts shall optimize material travel, handling and value added use of floor space, and shall facilitate synchronous material flow. Methods shall be developed and implemented to evaluate and monitor the effectiveness of existing operations.
组织必须采取多方论证的方法（参见7.3.1.1）制定工厂、设施和设备计划。工厂的平面布置必须尽可能优化材料的流转、搬运，以及场地空间的增值使用。必须制定和实施评价和监控现有操作有效性的方法。
NOTE These requirements should focus on lean manufacturing principles and the link to the effectiveness of the quality management system.
注：这些要求应该关注精益生产的原则，并与质量管理体系的有效性相联系。
6.3.2 Contingency plans应急计划
The organization shall prepare contingency plans to satisfy customer requirements in the event of an emergency such as utility interruptions, labour shortages, key equipment failure and field returns.
组织必须制定应急计划以在紧急情况下(如公用事业中断、劳动力短缺、关键设备故障和现场退货)满足顾客要求。
6.4 Work environment工作环境
ISO 9001:2000, Quality management systems – Requirements
6.4 Work environment工作环境
The organization shall determine and manage the work environment needed to achieve conformity to product requirements.
组织应确定并管理为达到产品符合要求所需的工作环境。
6.4.1 Personnel safety to achieve product quality实现产品质量所需要的员工安全
Product safety and means to minimize potential risks to employees shall be addressed by the organization, especially in the design and development process and in manufacturing process activities.
组织必须强调产品安全和最大限度地减少员工潜在危险的方法，特别是在设计和开发过程和制造过程活动中。
6.4.2 Cleanliness of premises生产现场的清洁
The organization shall maintain its premises in a state of order, cleanliness and repair consistent with the product and manufacturing process needs.
组织必须使其生产现场保持有序、清洁的状态，并按照产品和制造过程的需求进行维护。
7 Product realization产品实现
7.1 Planning of product realization产品实现的策划
ISO 9001:2000, Quality management systems － Requirements
7 Product realization产品实现
7.1 Planning of product realization产品实现的策划
The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1).
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）。
In planning product realization, the organization shall determine the following, as appropriate:
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) quality objectives and requirements for the product;
a）产品的质量目标和要求；
b) the need to establish processes, documents, and provide resources specific to the product;
b）针对产品确定过程、文件和资源的需求；
c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;
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) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).
d）为实现过程及其产品满足要求提供证据所需的记录（见4．2．4）。
The output of this planning shall be in a form suitable for the organization's method of operations.
策划的输出形式应适合于组织的运作方式。
NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan.
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。
NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes.
注2：组织也可将7．3的要求应用于产品实现过程的开发。
NOTE Some customers refer to project management or advanced product quality planning as a means to achieve product realization. Advanced product quality planning embodies the concepts of error prevention and continual improvement as contrasted with error detection and is based on a multidisciplinary approach.
注：有些顾客将项目管理或产品质量先期策划作为完成产品实现的方法。产品质量先期策划包含了缺陷预防和持续改进（与缺陷探测不同）的概念，并基于多方论证的方法。
7.1.1 Planning of product realization － Supplemental产品实现的策划－补充
Customer requirements and references to its technical specifications shall be included in the planning of product realization as a component of the quality plan.
作为质量计划的一部分，顾客要求和引用的顾客技术规范必须包括在产品实现的策划中。
7.1.2 Acceptance criteria接收准则
Acceptance criteria shall be defined by the organization and, where required, approved by the customer.
接收准则必须由组织制定，并且在要求时，由顾客批准。
For attribute data sampling, acceptance criteria shall be zero defects (see 8.2.3.1).
对于计数型数据的抽样，接收准则必须是零缺陷（参见8.2.3.1）。
7.1.3 Confidentiality保密
The organization shall ensure the confidentiality of customer contracted products and projects under development, and related product information.
组织必须确保顾客合同产品和正在开发的项目，以及有关的产品信息的保密。
7.1.4 Change control/更改控制
The organization shall have a process to control and react to changes that impact product realization. The effects of any change, including those changes caused by any supplier, shall be assessed, and verification and validation activities shall be defined, to ensure compliance with customer requirements. Changes shall be validated before implementation.
组织必须有对影响产品实现的更改进行控制和反应的过程。必须评定任何更改（包括那些由任何供方引起的更改）的影响，而且必须规定验证和确认活动，以确保符合顾客要求。更改在实施前必须进行确认。
For proprietary designs, impact on form, fit and function (including performance, and/or durability) shall be reviewed with the customer so that all effects can be properly evaluated.
对于专有权设计，必须与顾客评审外形、配合和功能（包括性能和/或耐久性）的影响，以确保适当地评价所有的影响。
When required by the customer, additional verification/identification requirements, such as those required for new product introduction, shall be met.
当顾客要求时，必须满足附加的验证/标识要求，如引入新产品的要求。
NOTE 1 Any product realization change affecting customer requirements requires notification to, and agreement from, the customer.
注1：任何影响顾客要求的产品实现更改要求通知顾客并与取得顾客同意。
NOTE 2 The above requirement applies to product and manufacturing process changes.
注2：以上要求适用于产品和制造过程更改。
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
ISO 9001:2000, Quality management systems － Requirements
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
The organization shall determine
组织应确定：
a) requirements specified by the customer, including the requirements for delivery and post delivery activities,
a）顾客规定的要求，包括对交付及交付后活动的要求；
b) requirements not stated by the customer but necessary for specified or intended use, where known,
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) statutory and regulatory requirements related to the product, and
c）与产品有关的法律法规要求；
d) any additional requirements determined by the organization.
d）组织确定的任何附加要求。
NOTE 1 Post delivery activities include any after sales product servicing provided as part of the customer contract or purchase order.
注1：交付后活动包括作为顾客合同或采购订单一部分而提供的任何售后产品服务。
NOTE 2 This requirement includes recycling, environmental impact and characteristics identified as a result of the organization's knowledge of the product and manufacturing processes (see 7.3.2.3).
注2：本要求包括再回收、环境影响，以及根据组织对产品和制造过程的知识识别的特性（参见7.3.2.3）。
NOTE 3 Compliance to item c) includes all applicable government, safety and environmental regulations, applied to acquisition, storage, handling, recycling, elimination or disposal of materials.
注3：符合条款c）包括所有适用的政府、安全和环境法规，适用于材料的获得、贮存、搬运、再回收、去除或最终处理。
7.2.1.1 Customer designated special characteristics顾客指定的特殊特性
The organization shall demonstrate conformity to customer requirements for designation, documentation and control of special characteristics.
组织必须证明在特殊特性的确定、文件化和控制方面符合顾客要求。
7.2.2 Review of requirements related to the product与产品有关的要求的评审
ISO 9001:2000, Quality management systems － Requirements
7.2.2 Review of requirements related to the product与产品有关的要求的评审
The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that
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（例如：提交标书、接受合同或订单及接受合同或订单的更改），并应确保：
a) product requirements are defined,
a）产品要求得到规定；
b) contract or order requirements differing from those previously expressed are resolved, and
b）与以前表述不一致的合同或订单的要求已予解决；
c) the organization has the ability to meet the defined requirements.
c）组织有能力满足规定的要求。
Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).
评审结果及评审所引起的措施的记录应予保持（见4．2．4）。
Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.
若顾客提供的要求没有形成文件，组织在接受顾客要求前应对顾客要求进行确认。
Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.
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。
NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material.
注：在某些情况下，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。
7.2.2.1 Review of requirements related to the product－Supplemental与产品有关的要求的评审－补充
Waiving the requirement stated in 7.2.2 for a formal review (see note) shall require customer authorization.
放弃7.2.2中要求的正式评审（参见注）必须获得顾客授权。
7.2.2.2 Organization manufacturing feasibility组织制造可行性
The organization shall investigate, confirm and document the manufacturing feasibility of the proposed products in the contract review process, including risk analysis.
组织在合同评审过程中必须对提出的产品的制造可行性（包括风险分析）进行调查、确认并形成文件。
7.2.3 Customer communication顾客沟通
ISO 9001:2000, Quality management systems － Requirements
7.2.3 Customer communication顾客沟通
The organization shall determine and implement effective arrangements for communicating with customers in relation to
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) product information,
a）产品信息；
b) enquiries, contracts or order handling, including amendments, and
b）问询、合同或订单的处理，包括对其修改；
c) customer feedback, including customer complaints.
c）顾客反馈，包括顾客抱怨。
7.2.3.1 Customer communication － Supplemental顾客沟通－补充
The organization shall have the ability to communicate necessary information, including data, in a customer-specified language and format (e.g. computer aided design data, electronic data exchange).
组织必须具有按照顾客规定的语言和格式传递必要的信息，包括数据的能力（例如：计算机辅助设计数据，电子数据交换）。
7.3 Design and development设计和开发
NOTE The requirements of 7.3 include product and manufacturing process design and development, and focus on error prevention rather than detection.
注：条款7.3的要求包括产品和制造过程设计和开发，强调错误预防，而不只是探测。
7.3.1 Design and development planning设计和开发策划
ISO 9001:2000, Quality management systems － Requirements
7.3 Design and development设计和开发
7.3.1 Design and development planning设计和开发策划
The organization shall plan and control the design and development of product.
组织应对产品的设计和开发进行策划和控制。
During the design and development planning, the organization shall determine
在进行设计和开发策划时，组织应确定：
a) the design and development stages,
a）设计和开发阶段；
b) the review, verification and validation that are appropriate to each design and development stage, and
b）适合于每个设计和开发阶段的评审、验证和确认活动；
c) the responsibilities and authorities for design and development.
c）设计和开发的职责和权限。
The organization shall manage the interfaces between different groups involv
没有找到相关结果
已邀请:
RSS Feed
15 个回复
wdg2539 (威望:0) (江苏 苏州) - where is a will there is...
赞同来自: