TA的首页ISO/DIS9001《质量管理体系 要求》（2014国际标准草案）
2015.3.12：局部修订
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ADRAFT INTERNATIONAL STANDARD
国际标准草案
ISO/DIS 9001
ISO/TC 176/SC 2Secretariat: BSI
Voting begins on: Voting terminates on:
投票起始时间投票终止时间
2014-07-10 2014-10-10
Quality management systems — Requirements
质量管理体系——要求
Systèmes de management de la qualité — Exigences
ICS: 03.120.10
Contents
Foreword .前言........................................................................................................................................ 5
Introduction 介绍................................................................................................................................... 6
0.1 General .总则...................................................................................................................................... 6
0.2 The ISO standards for quality management 质量管理ISO标准.................................................. 6
0.4 Plan-Do-Check-Act cycle ...PDCA循环........................................................................................... 8
0.5 “Risk-based thinking” 基于风险的思考......................................................................................... 9
0.6 Compatibility with other management system standards 与其他管理体系标准的兼容性........ 9
1 Scope 范围......................................................................................................................................... 11
2 Normative references规范性引用文件.............................................................................................. 12
3 Terms and definitions 术语与定义................................................................................................... 12
4 Context of the organization 组织的环境.......................................................................................... 25
4.1 Understanding the organization and its context .理解组织及其环境......................................... 25
4.2 Understanding the needs and expectations of interested parties理解相关方的需求和期望.... 25
4.3 Determining the scope of the quality management system质量管理体系范围的确定.............. 25
4.4 Quality management system and its processes 质量管理体系及其过程.................................... 26
5 Leadership .领导............................................................................................................................... 26
5.1 Leadership and commitment 领导和承诺.................................................................................. 26
5.2 Quality policy 质量方针................................................................................................................. 27
5.3 Organizational roles, responsibilities and authorities组织的作用、职责和权限....................... 28
6 Planning for the quality management system 质量管理体系策划................................................ 28
6.1 Actions to address risks and opportunities风险和机遇的应对措施............................................ 28
6.2 Quality objectives and planning to achieve them 质量目标及其实施的策划........................... 29
6.3 Planning of changes 变更的策划................................................................................................... 29
7 Support 支持....................................................................................................................................... 30
7.1 Resources 资源................................................................................................................................ 30
7.1.1 General总则................................................................................................................................... 30
7.1.2 People人员 .................................................................................................................................. 30
7.1.3 Infrastructure基础设施................................................................................................................ 30
7.1.4 Environment for the operation of processes过程运作环境..................................................... 30
7.1.5 Monitoring and measuring resources 监视和测量资源........................................................... 30
7.1.6 Organizational knowledge 组织的知识...................................................................................... 31
7.2 Competence能力 ........................................................................................................................... 31
7.3 Awareness 意识............................................................................................................................... 31
7.4 Communication沟通 ..................................................................................................................... 32
7.5 Documented information 形成文件的信息................................................................................... 32
7.5.1 General总则 ................................................................................................................................. 32
7.5.2 Creating and updating编制与更新.............................................................................................. 32
8 Operation运行..................................................................................................................................... 33
8.1 Operational planning and control 运行策划和控制.................................................................... 33
8.2 Determination of requirements for products and services产品和服务要求的确定.................. 33
8.2.1 Customer communication顾客沟通............................................................................................ 33
8.2.2 Determination of requirements related to products and services确定需求的相关产品和服务.....34
8.2.3 Review of requirements related to products and services 产品和服务要求的评审................ 34
8.3 Design and development of products and services 产品和服务的设计和开发.......................... 34
8.3.1 General总则 ................................................................................................................................. 34
8.3.2 Design and development planning设计和开发策划................................................................... 35
8.3.3 Design and development Inputs设计和开发输入........................................................................ 35
8.3.4 Design and development controls设计和开发控制..................................................................... 35
8.3.5 Design and development outputs 设计和开发输出.................................................................36
8.3.6 Design and development changes设计和开发变更..................................................................... 36
8.4 Control of externally provided products and services外部提供产品和服务的控制................. 36
8.4.1 General 总则................................................................................................................................ 36
8.4.2 Type and extent of control of external provision外部提供的控制类型和程度........................ 36
8.4.3 Information for external providers 外部供方的信息............................................................... 37
8.5 Production and service provision生产和服务提供........................................................................ 37
8.5.1 Control of production and service provision生产和服务提供的控制....................................... 37
8.5.2 Identification and traceability 标识和可追溯性........................................................................ 38
8.5.3 Property belonging to customers or external providers顾客或外部供方的财产.................... 38
8.5.4 Preservation防护 ......................................................................................................................... 38
8.5.5 Post-delivery activities交付后的活动........................................................................................... 38
8.5.6 Control of changes变更的控制..................................................................................................... 39
8.6 Release of products and services 产品和服务的放行................................................................... 39
8.7 Control of nonconforming process outputs, products and services不合格过程输出、产品和服务的控制 ..................................................................................................................................................... 39
9 Performance evaluation绩效评价 ..................................................................................................... 40
9.1 Monitoring, measurement, analysis and evaluation监视、测量、分析和评价............................. 40
9.1.1 General 总则................................................................................................................................. 40
9.1.2 Customer satisfaction顾客满意度................................................................................................ 40
9.1.3 Analysis and evaluation分析和评价............................................................................................. 40
9.2 Internal audit 内部审核................................................................................................................... 41
9.3 Management review管理评审 ........................................................................................................ 41
10 Improvement改进 ............................................................................................................................ 42
10.1 General 总则................................................................................................................................... 42
10.2 Nonconformity and corrective action不合格和纠正措施........................................................... 42
10.3 Continual improvement持续改进 ................................................................................................ 43
Annex A (informative) Clarification of new structure, terminology and concepts 附录A（信息）澄清的新结构、术语和概念...................................................................................................................... 44
Annex B (informative) Quality management principles附录B（信息）质量管理原则 ................. 47
Annex C (informative) The ISO 10000 portfolio of quality management standards附录B（信息）ISO质量管理标准的组合 ..................................................................................................................... 49
Bibliography参考书目 ......................................................................................................................... 52
Foreword前言
(略)
Introduction介绍
（略）
Quality management systems — Requirements
质量管理体系——要求
1 Scope
范围
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 or service that meets customer and applicable statutory and regulatory requirements, and
需要证实其具有稳定的提供满足顾客要求和适用的法律法规要求的产品和服务的能力；
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 statutory and regulatory requirements.
通过体系的有效应用，包括体系持续改进过程的有效应用，以及保证符合顾客要求和适用的法律法规要求，旨在增强顾客满意
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
本标准的所有要求是通用的，并且适用于不同类型、不同规模、和提供不同产品的所有组织。
NOTE 1 In this International Standard, the terms “product” or “service” only apply to products and services intended for, or required by, a customer.
注1：在本标准中，“产品”或“服务”仅适用于顾客用于或要求的产品和服务
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.
注2：法律法规要求可称作法定要求。
2 Normative references
引用标准
There are no normative references. This clause is included to maintain clause numbering alignment with other ISO management system standards,
没有引用标准，这一条款旨在与其他ISO管理体系标准保持对应的条款号。
3 Terms and definitions术语和定义
For the purposes of this document, the following terms and definitions apply.
下列术语和定义适用于本标准
（略）3.01~3.69【合计69个术语】
4 Context of the organization
组织的环境
4.1 Understanding the organization and its context
理解组织及其环境
The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.
组织应确定内部和外部那些与组织的宗旨、和其战略方向有关、影响实现质量管理体系的预期结果的能力的问题。
The organization shall monitor and review the information about these external and internal issues.
组织应监视和评审这些外部和内部问题的信息。
NOTE 1 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional or local.
注1：理解外部环境可以通过考虑法律、技术、竞争、市场、文化、社会和经济环境所产生的问题，无论是国际，国家，地区或本地。
NOTE 2 Understanding the internal context can be facilitated by considering issues related to values, culture knowledge and performance of the organization.
注2：理解内部环境可以通过考虑组织的价值观、文化知识和组织的绩效所产生的问题
4.2 Understanding the needs and expectations of interested parties
理解相关方的需求和期望
Due to their impact or potential impact on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:
由于他们的影响和潜在影响组织持续提供满足顾客和适用法律法规要求的产品和服务的能力，组织应确定：
a) the interested parties that are relevant to the quality management system;
与质量管理体系有关的相关方
b) the requirements of these interested parties that are relevant to the quality management system.
与质量管理体系有关的这些相关方的要求
The organization shall monitor and review the information about these interested parties and their relevant requirements.
组织应监视和评审这些相关方的信息及其相关要求
4.3 Determining the scope of the quality management system
质量管理体系范围的确定
The organization shall determine the boundaries and applicability of the quality management system to establish its scope.
组织应界定质量管理体系的边界及应用，以确立其范围。
When determining this scope, the organization shall consider:
在确定这些范围时，组织应该考虑：
a) the external and internal issues referred to in 4.1;
标准4.1条款中提到的内部和外部问题
b) the requirements of relevant interested parties referred to in 4.2;
标准4.2提及的与相关方有关的要求
c) the products and services of the organization.
组织的产品和服务
Where a requirement of this International Standard within the determined scope can be applied, then it shall be applied by the organization.
若本标准中关于确定范围的要求适用于组织，组织应使用该要求。
If any requirement(s) of this International Standard cannot be applied, this shall not affect the organization’s ability or responsibility to ensure conformity of products and services.
如果本标准的任何要求不适用时，这将不影响组织确保产品和服务的符合性的能力或责任。
The scope shall be available and be maintained as documented information stating the:
范围应是可获得并形成文件的信息，表述为：
products and services covered by the quality management system;
质量管理体系所覆盖的产品和服务；
justification for any instance where a requirement of this International Standard cannot be applied.
本标准要求的任何不适用情况的正当理由
4.4 Quality management system and its processes
质量管理体系及其过程
The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.
组织应依据本标准要求建立、实施、保持和持续改进质量管理体系，包括所需的过程及其相互作用。
The organization shall determine the processes needed for the quality management system and their application throughout the organization and shall determine:
组织应确定质量管理体系所需的过程及其在整个组织中的应用，并应确定：
a) the inputs required and the outputs expected from these processes;
a）来自这些过程要求的输入和期望的输出
b) the sequence and interaction of these processes;
b）这些过程的顺序和相互作用
c) the criteria, methods, including measurements and related performance indicators needed to ensure the effective operation, and control of these processes;
c）所需的准则、方法，包括测量和相关的绩效指标，以确保这些过程的有效运行和控制；
d) the resources needed and ensure their availability;
d）所需的资源并确保其可用性
e) the assignment of the responsibilities and authorities for these processes;
e）这些过程的职责和权限的分配
f) the risks and opportunities in accordance with the requirements of 6.1, and plan and implement the appropriate actions to address them;
f）依据6.1条款要求的风险和机会，和处理这些风险和机会所策划和实施的适当措施。
g) the methods for monitoring, measuring, as appropriate, and evaluation of processes and, if needed, the changes to processes to ensure that they achieve intended results;
g）监视、测量方法，适用时，并评价过程；如果需要，变更过程以确保产生预期的结果；
h) opportunities for improvement of the processes and the quality management system.
h）过程和质量管理体系改进的机会。
The organization shall maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned.
组织应保持形成文件的信息一定程度上以支持过程的实施，并确保他们按策划的结果实施。
（待续）
2014.11.30（续）
5 Leadership
领导
5.1 Leadership and commitment
领导和承诺
5.1.1 Leadership and commitment for the quality management system
对质量管理体系的领导和承诺
Top management shall demonstrate leadership and commitment with respect to the quality management system by:
最高管理者应该通过以下方面，证明关于质量管理体系的领导和承诺
a) taking accountability of the effectiveness of the quality management system;
a）对质量管理体系的有效性负责；
b) ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the strategic direction and the context of the organization;
b）确保质量管理体系的质量方针和质量目标得到建立，并与组织的战略方向和组织的环境相适应；
c) ensuring that the quality policy is communicated, understood and applied within the organization;
c）确保质量方针在组织内得到沟通、理解和应用；
d) ensuring the integration of the quality management system requirements into the organization’s business processes;
d）确保质量管理体系要求纳入到组织的业务流程；
e) promoting awareness of the process approach;
e）提升过程方法的意识
f) ensuring that the resources needed for the quality management system are available;
f）确保质量管理体系所需的资源的获得；
g) communicating the importance of effective quality management and of conforming to the quality management system requirements;
g）传达有效的质量管理以及满足质量管理体系要求的重要性；
h) ensuring that the quality management system achieves its intended results;
h）确保质量管理体系实现预期的效果
i) engaging, directing and supporting persons to contribute to the effectiveness of the quality management system;
i）吸纳、指导和支持员工对质量管理体系的有效性做出贡献；
j) promoting continual improvement;
j）促进持续改进
k) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.
K）支持其他的相关管理者在其负责的领域证实其领导作用
NOTE Reference to “business” in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the organization’s existence; whether the organization is public, private, for profit or not for profit.
注：本标准的“业务”可以广泛地理解为组织存在的目的核心活动；无论组织是公有的，私有的，盈利或非盈利。
5.1.2 Customer focus
以顾客为关注焦点
Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that:
最高管理者应通过以下方面确保，证实其关于以顾客为关注焦点的领导与承诺。
a) customer requirements and applicable statutory and regulatory requirements are determined and met;
顾客要求和适用的法律法规要求得到确定和满足；
b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;
可能影响产品和服务的符合性、增强顾客满意度的能力的风险和机会得到识别和应对；
c) the focus on consistently providing products and services that meet customer and applicable statutory and regulatory requirements is maintained;
保持以稳定提供满足顾客和适用法律法规要求的产品和服务为焦点
d) the focus on enhancing customer satisfaction is maintained.
保持以增强顾客满意为焦点
5.2 Quality policy
质量方针
5.2.1 Top management shall establish, review and maintain a quality policy that:
最高管理者应制定、评审和保持质量方针：
a) is appropriate to the purpose and context of the organization;
与组织的宗旨和环境相适应；
b) provides a framework for setting and reviewing quality objectives;
提供建立和评审质量目标的框架；
c) includes a commitment to satisfy applicable requirements;
包括满足适用要求的承诺；
d) includes a commitment to continual improvement of the quality management system.
包括持续改进质量管理体系的承诺
5.2.2 The quality policy shall:
质量方针应该：
a) be available as documented information;
作为形成文件的信息可获得
b) be communicated, understood and applied within the organization;
在组织内得到沟通、理解和应用；
c) be available to relevant interested parties, as appropriate.
适用时，可供相关方使用；
5.3 Organizational roles, responsibilities and authorities
组织的作用、职责和权限
Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization.
最高管理者应确保相关角色的职责和权限在组织内得到分配、沟通和理解；
Top management shall assign the responsibility and authority for:
最高管理者应该分配职责和权限以便：
a) ensuring that the quality management system conforms to the requirements of this International Standard;
确保质量管理体系符合本标准要求
b) ensuring that the processes are delivering their intended outputs;
确保过程产生预期的结果；
c) reporting on the performance of the quality management system, on opportunities for improvement and on the need for change or innovation, and especially for reporting to top management;
报告尤其是向最高管理者报告质量管理体系的绩效、改进的机会和变革或创新的需求；
d) ensuring the promotion of customer focus throughout the organization;
确保在整个组织内促进以顾客为关注焦点
e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
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。
2014.12.04（续）
6 Planning for the quality management system
质量管理体系策划
6.1 Actions to address risks and opportunities
风险和机遇的应对措施
6.1.1 When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:
当策划质量管理体系时，组织应考虑4.1涉及的事务和4.2涉及的要求，并确定需应对的风险和机遇，以便：
a) give assurance that the quality management system can achieve its intended result(s);
确保质量管理体系可以实现其预期的结果；
b) prevent, or reduce, undesired effects;
预防或减少非预期的影响；
c) achieve continual improvement.
实现持续改进
6.1.2 The organization shall plan:
组织应策划：
a) actions to address these risks and opportunities;
风险和机遇的应对措施
b) how to:
如何
1) integrate and implement the actions into its quality management system processes (see 4.4);
在其质量管理体系过程中整合和实施这些措施（见4.4）
2) evaluate the effectiveness of these actions.
评价这些措施的有效性
Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.
应对风险和机遇所采取的的措施应与其对产品和服务的符合性的潜在影响相适应。
NOTE Options to address risks and opportunities can include: avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.
注：应对风险和机遇的选择可以包括：规避风险、冒风险来追求一个机会、消除危险源、改变的可能性或后果、风险分担、或通过明智的决定保留风险。
6.2 Quality objectives and planning to achieve them
质量目标及其实施的策划
6.2.1 The organization shall establish quality objectives at relevant functions, levels and processes.
组织应在相关职能、层次、过程上建立质量目标。
The quality objectives shall:
质量目标应：
a) be consistent with the quality policy,
与质量方针保持一致；
b) be measurable;
可测量
c) take into account applicable requirements;
考虑适用的要求
d) be relevant to conformity of products and services and the enhancement of customer satisfaction;
与产品和服务的符合性、增强顾客满意度相关；
e) be monitored;
得到监视
f) be communicated;
得到沟通
g) be updated as appropriate.
适当时进行更新
The organization shall retain documented information on the quality objectives.
组织应将质量目标形成记录信息予以保留
6.2.2 When planning how to achieve its quality objectives, the organization shall determine:
在策划质量目标的实现时，组织应确定：
a) what will be done;
做什么
b) what resources will be required;
所需的资源
c) who will be responsible;
责任人
d) when it will be completed;
完成的时间表
e) how the results will be evaluated.
结果如何评价。
6.3 Planning of changes
变更的策划
Where the organization determines the need for change to the quality management system (see 4.4) the change shall be carried out in a planned and systematic manner.
当组织决定改变质量管理体系的需求（见4.4），这些改变应当有计划地和系统地进行。
The organization shall consider:
组织应当考虑：
a) the purpose of the change and any of its potential consequences;
变更的目的及其任何潜在的后果；
b) the integrity of the quality management system;
质量管理体系的完整性；
c) the availability of resources;
资源的可用性
d) the allocation or reallocation of responsibilities and authorities.
职责权限的确定或重新确定
2014.12.22，各位抱歉！最近有点忙，这项工作耽搁了，今天补上第7章内容。
7 Support
支持
7.1 Resources
资源
7.1.1 General
总则
The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system.
组织应确定和提供为建立、实施、保持和持续改进质量管理体系所需的资源。
The organization shall consider:
组织应考虑：
a) the capabilities of, and constraints on, existing internal resources;
关于现有内部资源的能力和约束
b) what needs to be obtained from external providers.
需要从外部获得的资源
7.1.2 People
人员
To ensure that the organization can consistently meet customer and applicable statutory and regulatory requirements, the organization shall provide the persons necessary for the effective operation of the quality management system, including the processes needed.
为了确保组织可以持续满足顾客和适用的法律法规要求，组织应当提供质量管理体系有效运行所需的人员，包括过程所需的人员。
7.1.3 Infrastructure
基础设施
The organization shall determine, provide and maintain the infrastructure for the operation of its processes to achieve conformity of products and services.
组织应当确定、提供和维护为其过程运行以实现产品和服务符合性所需的基础设施
NOTE Infrastructure can include:
注：基础设施可以包括：
a) buildings and associated utilities;
建筑物和相关设施
b) equipment including hardware and software;
设备，包括硬件和软件
c) transportation;
运输
d) information and communication technology.
信息和通讯技术
7.1.4 Environment for the operation of processes
过程运作环境
The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services.
组织应当确定、提供并维护为其过程运行和实现产品和服务符合性所需环境
NOTE Environment for the operation of processes can include physical, social, psychological, environmentaland other factors (such as temperature, humidity, ergonomics and cleanliness).
注：过程运行环境可包括：物理的、社会的、心理的、环境和其他环境的因素（如温度、湿度、人体工效学和清洁度）
7.1.5 Monitoring and measuring resources
监视和测量资源
Where monitoring or measuring is used for evidence of conformity of products and services to specified requirements the organization shall determine the resources needed to ensure valid and reliable monitoring and measuring results.
组织应确定所需监视和测量的资源，以便为产品和服务符合确定的要求提供证据，组织应确保这些资源监视和测量的结果是有效的可靠的。
The organization shall ensure that the resources provided:
组织应确保提供的资源：
a) are suitable for the specific type of monitoring and measurement activities being undertaken;
适宜于特定类型的正在开展的监视和测量活动；
b) are maintained to ensure their continued fitness for their purpose.
得到维护确保它们持续满足监视和测量的目的；
The organization shall retain appropriate documented information as evidence of fitness for purpose of monitoring and measurement resources.
组织应保留适当的记录信息作为监视和测量资源适用性的证据。
Where measurement traceability is: a statutory or regulatory requirement; a customer or relevant interested party expectation; or considered by the organization to be an essential part of providing confidence in the validity of measurement results; measuring instruments shall be:
测量的溯源性是：一个法律或法规要求、一个顾客和相关方期望、或被组织认为是一个在测量结果的有效性方面提供信心的重要组成部分；计量器具应是：
verified or calibrated at specified intervals or prior to use against measurement standards traceable to international or national measurement standards. Where no such standards exist, the basis used for calibration or verification shall be retained as documented information;
对照能溯源的国际或国家的测量标准，按照规定的时间间隔或在使用前对监视和测量设备进行校准和检定。当不存在上述标准时，用于校准或验证的依据应像记录信息一样予以保留；
identified in order to determine their calibration status;
具有标识，以确定其校准状态；
safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results.
防止引起校准状态及其测量结果无效的调节、损坏或坠落；
The organization shall determine if the validity of previous measurement results has been adversely affected when an instrument is found to be defective during its planned verification or calibration, or during its use, and take appropriate corrective action as necessary.
当发现设备在其计划的检定或校准过程中，或在使用过程中有缺陷时，组织应确定以往测量结果的有效性是否有不利的影响，必要时采取适当的纠正措施。
7.1.6 Organizational knowledge
组织知识
The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services.
组织应确定其过程运作和满足产品和服务符合性所必要的知识
This knowledge shall be maintained, and made available to the extent necessary.
这些知识应予以保留，并且必要程度上可获取。
When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access the necessary additional knowledge.
在应对不断变化的需求和趋势时，组织应考虑其现有的知识并确定如何获得或使用必需的补充知识。
NOTE 1 Organizational knowledge can include information such as intellectual property and lessons learned.
注1：组织的知识可以包括如下信息：知识产权和培训课程中获得的信息。
NOTE 2 To obtain the knowledge required, the organization can consider:
注2：为了获得所需要的知识，组织可以考虑：
a) internal sources (e.g. learning from failures and successful projects, capturing undocumented knowledge and experience of topical experts within the organization);
内部来源（例如：组织内的项目成功和失败的经验教训、从组织专家那里获取的未记录的知识和经验）
b) external sources (e.g. standards, academia, conferences, gathering knowledge with customers or providers).
外部来源（如：标准、文献、会议、从顾客或供方获取的知识）
7.2 Competence
能力
The organization shall:
组织应：
a) determine the necessary competence of person(s) doing work under its control that affects its quality performance;
确定在组织控制下从事影响质量绩效工作的人员所必需的能力
b) ensure that these persons are competent on the basis of appropriate education, training, or experience;
基于适当的教育、培训和经验，确保这些人员是胜任的。
c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken;
适当时，采取措施以获取必要的能力，并评价这些措施的有效性。
d) retain appropriate documented information as evidence of competence.
保留适当的记录信息作为能力的证据
NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the re-
assignment of currently employed persons; or the hiring or contracting of competent persons.
注：适当的措施可以包括：例如，提供的培训、指导、当前雇员的重新分配任务，胜任人员的招聘或外包。
7.3 Awareness
意识
在组织控制下工作的人员应意识到：
a) the quality policy;
质量方针
b) relevant quality objectives;
相关的质量目标
c) their contribution to the effectiveness of the quality management system, including the benefits of improved quality performance;
他们对质量管理体系有效性的贡献，包括提高质量绩效的好处；
d) the implications of not conforming with the quality management system requirements.
不符合质量管理体系要求的影响
7.4 Communication
沟通
The organization shall determine the internal and external communications relevant to the quality management system including:
组织应确定与质量管理体系相关的内部和外部沟通，包括：
a) on what it will communicate;
沟通的内容
b) when to communicate;
沟通的时机
c) with whom to communicate;
沟通的对象
d) how to communicate.
沟通的方法
7.5 Documented information
记录信息
7.5.1 General
总则
The organization’s quality management system shall include
组织的质量管理体系应包括：
a) documented information required by this International Standard;
本标准要求的记录信息
b) documented information determined by the organization as being necessary for the effectiveness of the quality management system.
必要时，为了质量管理体系的有效性由组织确定的记录信息；
NOTE The extent of documented information for a quality management system can differ from one organization to another due to:
注：对质量管理体系记录信息的程度，不同的组织可以不同，取决于：
a) the size of organization and its type of activities, processes, products and services;
组织的规模大小和活动类型、过程、产品和服务
b) the complexity of processes and their interactions;
过程及其相互作用的复杂程度
c) the competence of persons.
人员的能力
7.5.2 Creating and updating
编制与更新
When creating and updating documented information the organization shall ensure appropriate:
在编制和更新记录信息时，组织应确保适当的：
a) identification and description (e.g. a title, date, author, or reference number);
标识和描述（例如：标题、日期、作者、索引编号等）
b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic);
格式（例如：语言、软件版本、图示）和媒介（例如：纸质、电子格式）
c) review and approval for suitability and adequacy.
适宜性和充分性的评审与批准
7.5.3 Control of documented Information
文件信息的控制
7.5.3.1 Documented information required by the quality management system and by this International Standard shall be controlled to ensure:
由质量管理体系和本标准所要求的文件信息应进行控制，以确保：
a) it is available and suitable for use, where and when it is needed;
在所需要的场合，文件信息是有效的和适用的；
b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).
文件信息得到充分的保护（如：防止泄密、使用不当、缺损）
7.5.3.2 For the control of documented information, the organization shall address the following activities, as applicable:
适用时，为了记录信息的控制，组织应解决以下活动：
a) distribution, access, retrieval and use;
发布、访问、回收和使用
b) storage and preservation, including preservation of legibility;
保管与保护，包括保持清晰
c) control of changes (e.g. version control);
变更的控制（例如：版本的控制）
d) retention and disposition.
保留和处置
Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system shall be identified as appropriate, and controlled.
组织所确定的策划和运行质量管理体系所需的外来文件，适当时应得到识别和控制
NOTE Access can imply a decision regarding the permission to view the documented information only, or the permission and authority to view and change the documented information.
注：“访问”可能意味着仅得到查阅文件信息的许可，或授权查阅和变更记录信息。
前不久收到认证机构发来的ISO/DIS9001国际标准草案英文版资料，最近利用业余时间开始陆续翻译，并于此分段与有兴趣的各位同仁提前共享。由于水平有限，不到之处希望各位指正！
当你阅读之后别忘记给个鼓励的赞！
ADRAFT INTERNATIONAL STANDARD
国际标准草案
ISO/DIS 9001
ISO/TC 176/SC 2Secretariat: BSI
Voting begins on: Voting terminates on:
投票起始时间投票终止时间
2014-07-10 2014-10-10
Quality management systems — Requirements
质量管理体系——要求
Systèmes de management de la qualité — Exigences
ICS: 03.120.10
Contents
Foreword .前言........................................................................................................................................ 5
Introduction 介绍................................................................................................................................... 6
0.1 General .总则...................................................................................................................................... 6
0.2 The ISO standards for quality management 质量管理ISO标准.................................................. 6
0.4 Plan-Do-Check-Act cycle ...PDCA循环........................................................................................... 8
0.5 “Risk-based thinking” 基于风险的思考......................................................................................... 9
0.6 Compatibility with other management system standards 与其他管理体系标准的兼容性........ 9
1 Scope 范围......................................................................................................................................... 11
2 Normative references规范性引用文件.............................................................................................. 12
3 Terms and definitions 术语与定义................................................................................................... 12
4 Context of the organization 组织的环境.......................................................................................... 25
4.1 Understanding the organization and its context .理解组织及其环境......................................... 25
4.2 Understanding the needs and expectations of interested parties理解相关方的需求和期望.... 25
4.3 Determining the scope of the quality management system质量管理体系范围的确定.............. 25
4.4 Quality management system and its processes 质量管理体系及其过程.................................... 26
5 Leadership .领导............................................................................................................................... 26
5.1 Leadership and commitment 领导和承诺.................................................................................. 26
5.2 Quality policy 质量方针................................................................................................................. 27
5.3 Organizational roles, responsibilities and authorities组织的作用、职责和权限....................... 28
6 Planning for the quality management system 质量管理体系策划................................................ 28
6.1 Actions to address risks and opportunities风险和机遇的应对措施............................................ 28
6.2 Quality objectives and planning to achieve them 质量目标及其实施的策划........................... 29
6.3 Planning of changes 变更的策划................................................................................................... 29
7 Support 支持....................................................................................................................................... 30
7.1 Resources 资源................................................................................................................................ 30
7.1.1 General总则................................................................................................................................... 30
7.1.2 People人员 .................................................................................................................................. 30
7.1.3 Infrastructure基础设施................................................................................................................ 30
7.1.4 Environment for the operation of processes过程运作环境..................................................... 30
7.1.5 Monitoring and measuring resources 监视和测量资源........................................................... 30
7.1.6 Organizational knowledge 组织的知识...................................................................................... 31
7.2 Competence能力 ........................................................................................................................... 31
7.3 Awareness 意识............................................................................................................................... 31
7.4 Communication沟通 ..................................................................................................................... 32
7.5 Documented information 形成文件的信息................................................................................... 32
7.5.1 General总则 ................................................................................................................................. 32
7.5.2 Creating and updating编制与更新.............................................................................................. 32
8 Operation运行..................................................................................................................................... 33
8.1 Operational planning and control 运行策划和控制.................................................................... 33
8.2 Determination of requirements for products and services产品和服务要求的确定.................. 33
8.2.1 Customer communication顾客沟通............................................................................................ 33
8.2.2 Determination of requirements related to products and services确定需求的相关产品和服务.....34
8.2.3 Review of requirements related to products and services 产品和服务要求的评审................ 34
8.3 Design and development of products and services 产品和服务的设计和开发.......................... 34
8.3.1 General总则 ................................................................................................................................. 34
8.3.2 Design and development planning设计和开发策划................................................................... 35
8.3.3 Design and development Inputs设计和开发输入........................................................................ 35
8.3.4 Design and development controls设计和开发控制..................................................................... 35
8.3.5 Design and development outputs 设计和开发输出.................................................................36
8.3.6 Design and development changes设计和开发变更..................................................................... 36
8.4 Control of externally provided products and services外部提供产品和服务的控制................. 36
8.4.1 General 总则................................................................................................................................ 36
8.4.2 Type and extent of control of external provision外部提供的控制类型和程度........................ 36
8.4.3 Information for external providers 外部供方的信息............................................................... 37
8.5 Production and service provision生产和服务提供........................................................................ 37
8.5.1 Control of production and service provision生产和服务提供的控制....................................... 37
8.5.2 Identification and traceability 标识和可追溯性........................................................................ 38
8.5.3 Property belonging to customers or external providers顾客或外部供方的财产.................... 38
8.5.4 Preservation防护 ......................................................................................................................... 38
8.5.5 Post-delivery activities交付后的活动........................................................................................... 38
8.5.6 Control of changes变更的控制..................................................................................................... 39
8.6 Release of products and services 产品和服务的放行................................................................... 39
8.7 Control of nonconforming process outputs, products and services不合格过程输出、产品和服务的控制 ..................................................................................................................................................... 39
9 Performance evaluation绩效评价 ..................................................................................................... 40
9.1 Monitoring, measurement, analysis and evaluation监视、测量、分析和评价............................. 40
9.1.1 General 总则................................................................................................................................. 40
9.1.2 Customer satisfaction顾客满意度................................................................................................ 40
9.1.3 Analysis and evaluation分析和评价............................................................................................. 40
9.2 Internal audit 内部审核................................................................................................................... 41
9.3 Management review管理评审 ........................................................................................................ 41
10 Improvement改进 ............................................................................................................................ 42
10.1 General 总则................................................................................................................................... 42
10.2 Nonconformity and corrective action不合格和纠正措施........................................................... 42
10.3 Continual improvement持续改进 ................................................................................................ 43
Annex A (informative) Clarification of new structure, terminology and concepts 附录A（信息）澄清的新结构、术语和概念...................................................................................................................... 44
Annex B (informative) Quality management principles附录B（信息）质量管理原则 ................. 47
Annex C (informative) The ISO 10000 portfolio of quality management standards附录B（信息）ISO质量管理标准的组合 ..................................................................................................................... 49
Bibliography参考书目 ......................................................................................................................... 52
Foreword前言
(略)
Introduction介绍
（略）
Quality management systems — Requirements
质量管理体系——要求
1 Scope
范围
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 or service that meets customer and applicable statutory and regulatory requirements, and
需要证实其具有稳定的提供满足顾客要求和适用的法律法规要求的产品和服务的能力；
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 statutory and regulatory requirements.
通过体系的有效应用，包括体系持续改进过程的有效应用，以及保证符合顾客要求和适用的法律法规要求，旨在增强顾客满意
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
本标准的所有要求是通用的，并且适用于不同类型、不同规模、和提供不同产品的所有组织。
NOTE 1 In this International Standard, the terms “product” or “service” only apply to products and services intended for, or required by, a customer.
注1：在本标准中，“产品”或“服务”仅适用于顾客用于或要求的产品和服务
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.
注2：法律法规要求可称作法定要求。
2 Normative references
引用标准
There are no normative references. This clause is included to maintain clause numbering alignment with other ISO management system standards,
没有引用标准，这一条款旨在与其他ISO管理体系标准保持对应的条款号。
3 Terms and definitions术语和定义
For the purposes of this document, the following terms and definitions apply.
下列术语和定义适用于本标准
（略）3.01~3.69【合计69个术语】
4 Context of the organization
组织的环境
4.1 Understanding the organization and its context
理解组织及其环境
The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.
组织应确定内部和外部那些与组织的宗旨、和其战略方向有关、影响实现质量管理体系的预期结果的能力的问题。
The organization shall monitor and review the information about these external and internal issues.
组织应监视和评审这些外部和内部问题的信息。
NOTE 1 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional or local.
注1：理解外部环境可以通过考虑法律、技术、竞争、市场、文化、社会和经济环境所产生的问题，无论是国际，国家，地区或本地。
NOTE 2 Understanding the internal context can be facilitated by considering issues related to values, culture knowledge and performance of the organization.
注2：理解内部环境可以通过考虑组织的价值观、文化知识和组织的绩效所产生的问题
4.2 Understanding the needs and expectations of interested parties
理解相关方的需求和期望
Due to their impact or potential impact on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:
由于他们的影响和潜在影响组织持续提供满足顾客和适用法律法规要求的产品和服务的能力，组织应确定：
a) the interested parties that are relevant to the quality management system;
与质量管理体系有关的相关方
b) the requirements of these interested parties that are relevant to the quality management system.
与质量管理体系有关的这些相关方的要求
The organization shall monitor and review the information about these interested parties and their relevant requirements.
组织应监视和评审这些相关方的信息及其相关要求
4.3 Determining the scope of the quality management system
质量管理体系范围的确定
The organization shall determine the boundaries and applicability of the quality management system to establish its scope.
组织应界定质量管理体系的边界及应用，以确立其范围。
When determining this scope, the organization shall consider:
在确定这些范围时，组织应该考虑：
a) the external and internal issues referred to in 4.1;
标准4.1条款中提到的内部和外部问题
b) the requirements of relevant interested parties referred to in 4.2;
标准4.2提及的与相关方有关的要求
c) the products and services of the organization.
组织的产品和服务
Where a requirement of this International Standard within the determined scope can be applied, then it shall be applied by the organization.
若本标准中关于确定范围的要求适用于组织，组织应使用该要求。
If any requirement(s) of this International Standard cannot be applied, this shall not affect the organization’s ability or responsibility to ensure conformity of products and services.
如果本标准的任何要求不适用时，这将不影响组织确保产品和服务的符合性的能力或责任。
The scope shall be available and be maintained as documented information stating the:
范围应是可获得并形成文件的信息，表述为：
products and services covered by the quality management system;
质量管理体系所覆盖的产品和服务；
justification for any instance where a requirement of this International Standard cannot be applied.
本标准要求的任何不适用情况的正当理由
4.4 Quality management system and its processes
质量管理体系及其过程
The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.
组织应依据本标准要求建立、实施、保持和持续改进质量管理体系，包括所需的过程及其相互作用。
The organization shall determine the processes needed for the quality management system and their application throughout the organization and shall determine:
组织应确定质量管理体系所需的过程及其在整个组织中的应用，并应确定：
a) the inputs required and the outputs expected from these processes;
a）来自这些过程要求的输入和期望的输出
b) the sequence and interaction of these processes;
b）这些过程的顺序和相互作用
c) the criteria, methods, including measurements and related performance indicators needed to ensure the effective operation, and control of these processes;
c）所需的准则、方法，包括测量和相关的绩效指标，以确保这些过程的有效运行和控制；
d) the resources needed and ensure their availability;
d）所需的资源并确保其可用性
e) the assignment of the responsibilities and authorities for these processes;
e）这些过程的职责和权限的分配
f) the risks and opportunities in accordance with the requirements of 6.1, and plan and implement the appropriate actions to address them;
f）依据6.1条款要求的风险和机会，和处理这些风险和机会所策划和实施的适当措施。
g) the methods for monitoring, measuring, as appropriate, and evaluation of processes and, if needed, the changes to processes to ensure that they achieve intended results;
g）监视、测量方法，适用时，并评价过程；如果需要，变更过程以确保产生预期的结果；
h) opportunities for improvement of the processes and the quality management system.
h）过程和质量管理体系改进的机会。
The organization shall maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned.
组织应保持形成文件的信息一定程度上以支持过程的实施，并确保他们按策划的结果实施。
（待续）
2014.11.30（续）
5 Leadership
领导
5.1 Leadership and commitment
领导和承诺
5.1.1 Leadership and commitment for the quality management system
对质量管理体系的领导和承诺
Top management shall demonstrate leadership and commitment with respect to the quality management system by:
最高管理者应该通过以下方面，证明关于质量管理体系的领导和承诺
a) taking accountability of the effectiveness of the quality management system;
a）对质量管理体系的有效性负责；
b) ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the strategic direction and the context of the organization;
b）确保质量管理体系的质量方针和质量目标得到建立，并与组织的战略方向和组织的环境相适应；
c) ensuring that the quality policy is communicated, understood and applied within the organization;
c）确保质量方针在组织内得到沟通、理解和应用；
d) ensuring the integration of the quality management system requirements into the organization’s business processes;
d）确保质量管理体系要求纳入到组织的业务流程；
e) promoting awareness of the process approach;
e）提升过程方法的意识
f) ensuring that the resources needed for the quality management system are available;
f）确保质量管理体系所需的资源的获得；
g) communicating the importance of effective quality management and of conforming to the quality management system requirements;
g）传达有效的质量管理以及满足质量管理体系要求的重要性；
h) ensuring that the quality management system achieves its intended results;
h）确保质量管理体系实现预期的效果
i) engaging, directing and supporting persons to contribute to the effectiveness of the quality management system;
i）吸纳、指导和支持员工对质量管理体系的有效性做出贡献；
j) promoting continual improvement;
j）促进持续改进
k) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.
K）支持其他的相关管理者在其负责的领域证实其领导作用
NOTE Reference to “business” in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the organization’s existence; whether the organization is public, private, for profit or not for profit.
注：本标准的“业务”可以广泛地理解为组织存在的目的核心活动；无论组织是公有的，私有的，盈利或非盈利。
5.1.2 Customer focus
以顾客为关注焦点
Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that:
最高管理者应通过以下方面确保，证实其关于以顾客为关注焦点的领导与承诺。
a) customer requirements and applicable statutory and regulatory requirements are determined and met;
顾客要求和适用的法律法规要求得到确定和满足；
b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;
可能影响产品和服务的符合性、增强顾客满意度的能力的风险和机会得到识别和应对；
c) the focus on consistently providing products and services that meet customer and applicable statutory and regulatory requirements is maintained;
保持以稳定提供满足顾客和适用法律法规要求的产品和服务为焦点
d) the focus on enhancing customer satisfaction is maintained.
保持以增强顾客满意为焦点
5.2 Quality policy
质量方针
5.2.1 Top management shall establish, review and maintain a quality policy that:
最高管理者应制定、评审和保持质量方针：
a) is appropriate to the purpose and context of the organization;
与组织的宗旨和环境相适应；
b) provides a framework for setting and reviewing quality objectives;
提供建立和评审质量目标的框架；
c) includes a commitment to satisfy applicable requirements;
包括满足适用要求的承诺；
d) includes a commitment to continual improvement of the quality management system.
包括持续改进质量管理体系的承诺
5.2.2 The quality policy shall:
质量方针应该：
a) be available as documented information;
作为形成文件的信息可获得
b) be communicated, understood and applied within the organization;
在组织内得到沟通、理解和应用；
c) be available to relevant interested parties, as appropriate.
适用时，可供相关方使用；
5.3 Organizational roles, responsibilities and authorities
组织的作用、职责和权限
Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization.
最高管理者应确保相关角色的职责和权限在组织内得到分配、沟通和理解；
Top management shall assign the responsibility and authority for:
最高管理者应该分配职责和权限以便：
a) ensuring that the quality management system conforms to the requirements of this International Standard;
确保质量管理体系符合本标准要求
b) ensuring that the processes are delivering their intended outputs;
确保过程产生预期的结果；
c) reporting on the performance of the quality management system, on opportunities for improvement and on the need for change or innovation, and especially for reporting to top management;
报告尤其是向最高管理者报告质量管理体系的绩效、改进的机会和变革或创新的需求；
d) ensuring the promotion of customer focus throughout the organization;
确保在整个组织内促进以顾客为关注焦点
e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
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。
2014.12.04（续）
6 Planning for the quality management system
质量管理体系策划
6.1 Actions to address risks and opportunities
风险和机遇的应对措施
6.1.1 When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:
当策划质量管理体系时，组织应考虑4.1涉及的事务和4.2涉及的要求，并确定需应对的风险和机遇，以便：
a) give assurance that the quality management system can achieve its intended result(s);
确保质量管理体系可以实现其预期的结果；
b) prevent, or reduce, undesired effects;
预防或减少非预期的影响；
c) achieve continual improvement.
实现持续改进
6.1.2 The organization shall plan:
组织应策划：
a) actions to address these risks and opportunities;
风险和机遇的应对措施
b) how to:
如何
1) integrate and implement the actions into its quality management system processes (see 4.4);
在其质量管理体系过程中整合和实施这些措施（见4.4）
2) evaluate the effectiveness of these actions.
评价这些措施的有效性
Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.
应对风险和机遇所采取的的措施应与其对产品和服务的符合性的潜在影响相适应。
NOTE Options to address risks and opportunities can include: avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.
注：应对风险和机遇的选择可以包括：规避风险、冒风险来追求一个机会、消除危险源、改变的可能性或后果、风险分担、或通过明智的决定保留风险。
6.2 Quality objectives and planning to achieve them
质量目标及其实施的策划
6.2.1 The organization shall establish quality objectives at relevant functions, levels and processes.
组织应在相关职能、层次、过程上建立质量目标。
The quality objectives shall:
质量目标应：
a) be consistent with the quality policy,
与质量方针保持一致；
b) be measurable;
可测量
c) take into account applicable requirements;
考虑适用的要求
d) be relevant to conformity of products and services and the enhancement of customer satisfaction;
与产品和服务的符合性、增强顾客满意度相关；
e) be monitored;
得到监视
f) be communicated;
得到沟通
g) be updated as appropriate.
适当时进行更新
The organization shall retain documented information on the quality objectives.
组织应将质量目标形成记录信息予以保留
6.2.2 When planning how to achieve its quality objectives, the organization shall determine:
在策划质量目标的实现时，组织应确定：
a) what will be done;
做什么
b) what resources will be required;
所需的资源
c) who will be responsible;
责任人
d) when it will be completed;
完成的时间表
e) how the results will be evaluated.
结果如何评价。
6.3 Planning of changes
变更的策划
Where the organization determines the need for change to the quality management system (see 4.4) the change shall be carried out in a planned and systematic manner.
当组织决定改变质量管理体系的需求（见4.4），这些改变应当有计划地和系统地进行。
The organization shall consider:
组织应当考虑：
a) the purpose of the change and any of its potential consequences;
变更的目的及其任何潜在的后果；
b) the integrity of the quality management system;
质量管理体系的完整性；
c) the availability of resources;
资源的可用性
d) the allocation or reallocation of responsibilities and authorities.
职责权限的确定或重新确定
2014.12.22，各位抱歉！最近有点忙，这项工作耽搁了，今天补上第7章内容。
7 Support
支持
7.1 Resources
资源
7.1.1 General
总则
The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system.
组织应确定和提供为建立、实施、保持和持续改进质量管理体系所需的资源。
The organization shall consider:
组织应考虑：
a) the capabilities of, and constraints on, existing internal resources;
关于现有内部资源的能力和约束
b) what needs to be obtained from external providers.
需要从外部获得的资源
7.1.2 People
人员
To ensure that the organization can consistently meet customer and applicable statutory and regulatory requirements, the organization shall provide the persons necessary for the effective operation of the quality management system, including the processes needed.
为了确保组织可以持续满足顾客和适用的法律法规要求，组织应当提供质量管理体系有效运行所需的人员，包括过程所需的人员。
7.1.3 Infrastructure
基础设施
The organization shall determine, provide and maintain the infrastructure for the operation of its processes to achieve conformity of products and services.
组织应当确定、提供和维护为其过程运行以实现产品和服务符合性所需的基础设施
NOTE Infrastructure can include:
注：基础设施可以包括：
a) buildings and associated utilities;
建筑物和相关设施
b) equipment including hardware and software;
设备，包括硬件和软件
c) transportation;
运输
d) information and communication technology.
信息和通讯技术
7.1.4 Environment for the operation of processes
过程运作环境
The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services.
组织应当确定、提供并维护为其过程运行和实现产品和服务符合性所需环境
NOTE Environment for the operation of processes can include physical, social, psychological, environmentaland other factors (such as temperature, humidity, ergonomics and cleanliness).
注：过程运行环境可包括：物理的、社会的、心理的、环境和其他环境的因素（如温度、湿度、人体工效学和清洁度）
7.1.5 Monitoring and measuring resources
监视和测量资源
Where monitoring or measuring is used for evidence of conformity of products and services to specified requirements the organization shall determine the resources needed to ensure valid and reliable monitoring and measuring results.
组织应确定所需监视和测量的资源，以便为产品和服务符合确定的要求提供证据，组织应确保这些资源监视和测量的结果是有效的可靠的。
The organization shall ensure that the resources provided:
组织应确保提供的资源：
a) are suitable for the specific type of monitoring and measurement activities being undertaken;
适宜于特定类型的正在开展的监视和测量活动；
b) are maintained to ensure their continued fitness for their purpose.
得到维护确保它们持续满足监视和测量的目的；
The organization shall retain appropriate documented information as evidence of fitness for purpose of monitoring and measurement resources.
组织应保留适当的记录信息作为监视和测量资源适用性的证据。
Where measurement traceability is: a statutory or regulatory requirement; a customer or relevant interested party expectation; or considered by the organization to be an essential part of providing confidence in the validity of measurement results; measuring instruments shall be:
测量的溯源性是：一个法律或法规要求、一个顾客和相关方期望、或被组织认为是一个在测量结果的有效性方面提供信心的重要组成部分；计量器具应是：
verified or calibrated at specified intervals or prior to use against measurement standards traceable to international or national measurement standards. Where no such standards exist, the basis used for calibration or verification shall be retained as documented information;
对照能溯源的国际或国家的测量标准，按照规定的时间间隔或在使用前对监视和测量设备进行校准和检定。当不存在上述标准时，用于校准或验证的依据应像记录信息一样予以保留；
identified in order to determine their calibration status;
具有标识，以确定其校准状态；
safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results.
防止引起校准状态及其测量结果无效的调节、损坏或坠落；
The organization shall determine if the validity of previous measurement results has been adversely affected when an instrument is found to be defective during its planned verification or calibration, or during its use, and take appropriate corrective action as necessary.
当发现设备在其计划的检定或校准过程中，或在使用过程中有缺陷时，组织应确定以往测量结果的有效性是否有不利的影响，必要时采取适当的纠正措施。
7.1.6 Organizational knowledge
组织知识
The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services.
组织应确定其过程运作和满足产品和服务符合性所必要的知识
This knowledge shall be maintained, and made available to the extent necessary.
这些知识应予以保留，并且必要程度上可获取。
When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access the necessary additional knowledge.
在应对不断变化的需求和趋势时，组织应考虑其现有的知识并确定如何获得或使用必需的补充知识。
NOTE 1 Organizational knowledge can include information such as intellectual property and lessons learned.
注1：组织的知识可以包括如下信息：知识产权和培训课程中获得的信息。
NOTE 2 To obtain the knowledge required, the organization can consider:
注2：为了获得所需要的知识，组织可以考虑：
a) internal sources (e.g. learning from failures and successful projects, capturing undocumented knowledge and experience of topical experts within the organization);
内部来源（例如：组织内的项目成功和失败的经验教训、从组织专家那里获取的未记录的知识和经验）
b) external sources (e.g. standards, academia, conferences, gathering knowledge with customers or providers).
外部来源（如：标准、文献、会议、从顾客或供方获取的知识）
7.2 Competence
能力
The organization shall:
组织应：
a) determine the necessary competence of person(s) doing work under its control that affects its quality performance;
确定在组织控制下从事影响质量绩效工作的人员所必需的能力
b) ensure that these persons are competent on the basis of appropriate education, training, or experience;
基于适当的教育、培训和经验，确保这些人员是胜任的。
c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken;
适当时，采取措施以获取必要的能力，并评价这些措施的有效性。
d) retain appropriate documented information as evidence of competence.
保留适当的记录信息作为能力的证据
NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the re-
assignment of currently employed persons; or the hiring or contracting of competent persons.
注：适当的措施可以包括：例如，提供的培训、指导、当前雇员的重新分配任务，胜任人员的招聘或外包。
7.3 Awareness
意识
在组织控制下工作的人员应意识到：
a) the quality policy;
质量方针
b) relevant quality objectives;
相关的质量目标
c) their contribution to the effectiveness of the quality management system, including the benefits of improved quality performance;
他们对质量管理体系有效性的贡献，包括提高质量绩效的好处；
d) the implications of not conforming with the quality management system requirements.
不符合质量管理体系要求的影响
7.4 Communication
沟通
The organization shall determine the internal and external communications relevant to the quality management system including:
组织应确定与质量管理体系相关的内部和外部沟通，包括：
a) on what it will communicate;
沟通的内容
b) when to communicate;
沟通的时机
c) with whom to communicate;
沟通的对象
d) how to communicate.
沟通的方法
7.5 Documented information
记录信息
7.5.1 General
总则
The organization’s quality management system shall include
组织的质量管理体系应包括：
a) documented information required by this International Standard;
本标准要求的记录信息
b) documented information determined by the organization as being necessary for the effectiveness of the quality management system.
必要时，为了质量管理体系的有效性由组织确定的记录信息；
NOTE The extent of documented information for a quality management system can differ from one organization to another due to:
注：对质量管理体系记录信息的程度，不同的组织可以不同，取决于：
a) the size of organization and its type of activities, processes, products and services;
组织的规模大小和活动类型、过程、产品和服务
b) the complexity of processes and their interactions;
过程及其相互作用的复杂程度
c) the competence of persons.
人员的能力
7.5.2 Creating and updating
编制与更新
When creating and updating documented information the organization shall ensure appropriate:
在编制和更新记录信息时，组织应确保适当的：
a) identification and description (e.g. a title, date, author, or reference number);
标识和描述（例如：标题、日期、作者、索引编号等）
b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic);
格式（例如：语言、软件版本、图示）和媒介（例如：纸质、电子格式）
c) review and approval for suitability and adequacy.
适宜性和充分性的评审与批准
7.5.3 Control of documented Information
文件信息的控制
7.5.3.1 Documented information required by the quality management system and by this International Standard shall be controlled to ensure:
由质量管理体系和本标准所要求的文件信息应进行控制，以确保：
a) it is available and suitable for use, where and when it is needed;
在所需要的场合，文件信息是有效的和适用的；
b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).
文件信息得到充分的保护（如：防止泄密、使用不当、缺损）
7.5.3.2 For the control of documented information, the organization shall address the following activities, as applicable:
适用时，为了记录信息的控制，组织应解决以下活动：
a) distribution, access, retrieval and use;
发布、访问、回收和使用
b) storage and preservation, including preservation of legibility;
保管与保护，包括保持清晰
c) control of changes (e.g. version control);
变更的控制（例如：版本的控制）
d) retention and disposition.
保留和处置
Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system shall be identified as appropriate, and controlled.
组织所确定的策划和运行质量管理体系所需的外来文件，适当时应得到识别和控制
NOTE Access can imply a decision regarding the permission to view the documented information only, or the permission and authority to view and change the documented information.
注：“访问”可能意味着仅得到查阅文件信息的许可，或授权查阅和变更记录信息。
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