ISO 9001：2015
Quality management systems —Requirements
质量管理体系-要求
Introduction引言
0.1 General 总则
The adoption of a quality management system is a strategic decision for an organization that can help
to improve its overall performance and provide a sound basis for sustainable development initiatives.
The potential benefits to an organization of implementing a quality management system based on this International Standard are:
a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;
b) facilitating opportunities to enhance customer satisfaction;
c) addressing risks and opportunities associated with its context and objectives;
d) the ability to demonstrate conformity to specified quality management system requirements.
This International Standard can be used by internal and external parties.
It is not the intent of this International Standard to imply the need for:
— uniformity in the structure of different quality management systems;
— alignment of documentation to the clause structure of this International Standard;
— the use of the specific terminology of this International Standard within the organization.
The quality management system requirements specified in this International Standard are complementary to requirements for products and services.
This International Standard employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking.
The process approach enables an organization to plan its processes and their interactions.
The PDCA cycle enables an organization to ensure that its processes are adequately resourced and managed, and that opportunities for improvement are determined and acted on.
Risk-based thinking enables an organization to determine the factors that could cause its processes and its quality management system to deviate from the planned results, to put in place preventive controls to minimize negative effects and to make maximum use of opportunities as they arise (see Clause A.4).
Consistently meeting requirements and addressing future needs and expectations poses a challenge for organizations in an increasingly dynamic and complex environment. To achieve this objective, the organization might find it necessary to adopt various forms of improvement in addition to correction and continual improvement, such as breakthrough change, innovation and re-organization.
In this International Standard, the following verbal forms are used:
—“shall” indicates a requirement;
—“should” indicates a recommendation;
—“may” indicates a permission;
—“can” indicates a possibility or a capability.
Information marked as “NOTE” is for guidance in understanding or clarifying the associated requirement.采用质量管理体系应该是组织的一项战略性决策，可以帮助组织改进其整体绩效，并为可持续发展计划提供良好的基础。对于根据本标准实施质量管理体系的组织来说，潜在的收益是：
a) 稳定提供满足顾客要求和法律法规要求的产品和服务的能力；
b) 获取增强顾客满意的机会；
c) 应对与组织环境和目标相关的风险；
d) 证实符合质量管理体系特定要求的能力。
本标准可用于内部和外部。
以下方面不是本标准的目的：
- 统一不同质量管理体系的结构；
- 统一本标准条款结构的文件；
- 在组织中使用本标准的特定术语。
本标准所规定的质量管理体系要求是对产品要求的补充。
本标准采用过程方法，该方法结合了策划-实施-检查-改进（PDCA）循环和基于风险的思维。
过程方法使组织能够策划组织的过程及其相互作用。
PDCA循环使组织能够确保其过程得到充分的资源和管理，并确定和实施改进机会。
基于风险的思维能够使组织确定可能导致其过程和质量管理体系偏离所策划的结果的因素，采取预防性控制，以最小化负面影响并在机会出现时将机会利用最大化（见A.4条款）。
在日益变化和复杂的环境中，持续满足要求和应对未来的需求和期望是组织面临的挑战。要实现这个目标，组织可能发现除了纠正和持续改进以外，变革、创新和重组也是必要的。
本标准中采用了以下动词形式：
“shall”表示要求；
“should”表示建议；
“may”表示允许；
“can”表示可能性或能力
标注为“注”的信息是理解或说明相关要求的指南。
0.2 Quality management principles质量管理原则
This International Standard is based on the quality management principles described in ISO 9000. The descriptions include a statement of each principle, a rationale of why the principle is important for the organization, some examples of benefits associated with the principle and examples of typical actions to improve the o rganization’s performance when applying the principle.
The quality management principles are:
— customer focus;
— leadership;
— engagement of people;
— process approach;
— improvement;
— evidence-based decision making;
— relationship management.
本标准基于ISO 9000中阐述的质量管理原则，该阐述包括每项原则的说明、对组织的重要性、与该原则相关的益处的示例，以及应用该原则时改进组织绩效所采取的典型措施的示例。
质量管理原则是：
- 以顾客为关注焦点；
- 领导力；
- 全员参与；
- 过程方法；
- 改进；
- 循证决策；
- 关系管理。
0.3 Process approach过程方法
0.3.1 General 总则
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. Specific requirements considered essential to the adoption of a process approach are included in 4.4.
Understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its intended results. This approach enables the organization to control the interrelationships and interdependencies among the processes of the system, so that the overall performance of the organization can be enhanced.
The process approach involves the systematic definition and management of processes, and their interactions, so
as to achieve the intended results in accordance with the quality policy and strategic direction of the organization. Management of the processes and the system as a whole can be achieved using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking advantage of opportunities and preventing
undesirable results.
The application of the process approach in a quality management system enables:
a) understanding and consistency in meeting requirements;
b) the consideration of processes in terms of added value;
c) the achievement of effective process performance;
d) improvement of processes based on evaluation of data and information.
Figure 1 gives a schematic representation of any process and shows the interaction of its elements. The monitoring and measuring check points, which are necessary for control, are specific to each process and will vary depending on the related risks
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。采用过程方法须考虑的特定要求包含在4.4中。
将相互关联的过程作为体系进行理解和管理，会有助于组织实现其预期结果的有效性和效率。该方法能够是组织控制体系的过程间的相互关系和相互依存，以使组织的整体绩效得到提高。
过程方法运用系统的定义和管理过程及其相互作用，以期实现与组织的质量方针和战略方向一致的预期结果。将PDCA循环全面用于旨在利用机会优势和预防不期望的结果的基于风险的思维（见0.3.3），能够实现对过程和整个体系进行管理。
在质量管理体系中应用过程方法能够：
a) 对满足要求的理解和一致性；
b) 从增值的角度考虑过程；
c) 实现有效的过程绩效；
d) 在评价数据和信息的基础上改进过程。
图1给出了过程示意图并展示了过程要素的相互作用。将必要控制的监视和测量检查具体到每个过程并将根据相关风险而改变。
图1：单一过程要素图
0.3.2 Plan-Do-Check-Act cycle策划-实施-检查-改进循环
The PDCA cycle can be applied to all processes and to the quality management system as a whole.
Figure 2 illustrates how Clauses 4 to 10 can be grouped in relation to the PDCA cycle.
PDCA循环能够应用于所有过程和整个质量管理体系。
图2展示了第4章到第10章分别与PDCA的关联。
组织及其情境（4.1）
产品和服务
结果
顾客满意
有关相关方的需求和期望（4.2）
顾客要求
NOTE Numbers in brackets refer to the clauses in this International Standard.图中数字表示本国际标准中的章节。
图2：本标准中的 PDCA 循环模式
The PDCA cycle can be briefly described as follows:
— Plan : establish the objectives of the system and its processes, and the resources needed to deliver results in
accordance with customers’ requirements and the organization’s policies; and identify and address risks and opportunitys;
— Do: implement what was planned;
— Check: monitor and (where applicable) measure processes and the resulting products and services against
policies, objectives and requirements and planned activities, and report the results;
— Act: take actions to improve performance, as necessary. PDCA 模式可以简要描述如下：
Plan – 策划：根据顾客要求和组织方针，为提供结果建立体系目标及其过程，以及所需的资源，识别并提出风险
及机会；
Do – 实施：实施所策划的（安排）；
Check – 检查：根据方针、目标和要求及策划的活动，对过程、产品和服务进行监视和测量（适用时），并报告
结果；
Act – 处置：必要时，采取措施，以改进过程绩效。 0.3.3 Risk-based thinking 基于风险的思维
Risk-based thinking (see Clause A.4) is essential for achieving an effective quality management system. The
concept of risk-based thinking has been implicit in previous editions of this International Standard including, for example, carrying out preventive action to eliminate potential nonconformities, analyzing any nonconformities that do occur, and taking action to prevent recurrence that is appropriate for the effects of the nonconformity. To conform to the requirements of this International Standard, an organization needs to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the quality management system, achieving improved results and preventing negative effects.
Opportunities can arise as a result of a situation favourable to achieving an intended result, for example, a set of circumstances that allow the organization to attract customers, develop new products and services, reduce waste or improve productivity. Actions to address opportunities can also include consideration of associated risks. Risk is the effect of uncertainty and any such uncertainty can have positive or negative effects. A positive deviation arising from a risk can provide an opportunity, but not all positive effects of risk result in opportunities.
为实现有效的质量管理体系，基于风险的思维（见A.4条款）是必要的。基于风险的思维的概念在本标准的以往版本中一直是没有言明的，包括如实施预防措施以消除潜在不合格、分析发生的不合格并采取与不合格的影响相适应的措施防止其再发生。
为符合本标准的要求，组织需要策划和实施应对风险和机会的措施。应对风险和机会是为提高质量管理体系有效性、实现改进的结果并防止负面影响建立基础。
机会可以形成有益于实现预期结果的状况的结果，例如，让组织吸引顾客、开发新产品和服务、减少浪费或改进生产效率的一系列情况。应对机会的措施还可以包括对相关风险的考虑。风险是不确定的影响，这种不确定可能是正面或负面的影响。来自风险的正面偏离可以提供机会，但不是风险的所有正面影响都能产生机会。
0.4 Relationship with other management system standards与其他管理体系标准的关系
This International Standard applies the framework developed by ISO to improve alignment among its International Standards for management systems (see Clause A.1).
This International Standard enables an organization to use the process approach, coupled with the PDCA cycle and risk-based thinking, to align or integrate its quality management system with the requirements of other management system standards.
This International Standard relates to ISO 9000 and ISO 9004 as follows:
— ISO 9000 Quality management systems — Fundamentals and vocabulary provides essential background for the proper understanding and implementation of this International Standard;
— ISO 9004 Managing for the sustained success of an organization — A quality management approach provides guidance for organizations that choose to progress beyond the requirements of this International Standard. Annex B provides details of other International Standards on quality management and quality management systems that have been developed by ISO/TC 176.
This International Standard does not include requirements specific to other management systems, such as those for environmental management, occupational health and safety management, or financial management.
Sector-specific quality management system standards based on the requirements of this International Standard have been developed for a number of sectors. Some of these standards specify additional quality management system requirements, while others are limited to providing guidance to the application of
this International Standard within the particular sector.
A matrix showing the correlation between the clauses of this edition of this International Standard and the previous edition (ISO 9001:2008) can be found on the ISO/TC 176/SC 2 open access web site at:
https://www.doczj.com/doc/a811051735.html,/tc176/sc02/public.
本标准采用了ISO 为改进其管理体系国际标准间的一致性而开发的框架（见A.1条款）。
本标准能够是使组织应用过程方法，再加上PDCA循环和基于风险的思维，使其质量管理体系与与其他管理体系标准的要求保持一致或整合。
本标准与 ISO 9000 和 ISO 9004 相关联：
ISO 9000 质量管理体系基础和术语为本标准的正确理解和实施提供了必要的背景
ISO 9004 组织持续成功的管理一种质量管理方法为选择超越本标准要求的发展的组织提供了指南
附录B 提供了ISO TC/176 开发的与质量管理和质量管理体系有关的其他标准的信息。
本标准不包括针对其他管理体系的特定要求，如环境管理、职业健康安全管理或财务管理。
已开发了一部分基于本标准要求的特定行业的质量管理体系标准，这些标准中的某些标准规定了附加的质量管理体系要求，而其他标准限于为本标准在特定行业内的应用提供指南。
在 ISO/TC 176/SC 2 公开获取网站可以找到本标准和 ISO 9001:2008 标准条款的对照矩阵表。
https://www.doczj.com/doc/a811051735.html,/tc176/sc02/public
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 when an organization:
a) needs to demonstrate its ability to consistently provide products and services that meet customer
and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
NOTE 1 In this International Standard, the terms “product” or “service” only apply to products and services
intended for, or required by, a customer.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.
本标准为有下列需求的组织规定了质量管理体系要求：
a) 需要证实其有能力稳定地提供满足顾客要求和适用的法律法规要求的产品或服务；
b) 通过体系的有效应用，包括体系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。
本标准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和服务的组织。
注1：本标准中，术语“产品”或“服务”仅适用于预期提供给顾客或顾客所要求的产品和服务。
注2：法律法规要求可称作法定要求。
2 Normative references规范性引用文件
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
下列文件中的全部和部分内容在本标准中引用并在应用中不可或缺。凡是注日期的引用文件，仅该版本适用于本标准。凡未标注日期的引用文件，引用文件的最新版（包括修订）适用于本标准。
ISO 9000:2015 质量管理体系基础和术语
3 Terms and definitions术语和定义
For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply.
本标准采用ISO 9000:2015中的术语和定义。
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.
The organization shall monitor and review information about these external and internal issues.
NOTE 1 Issues can include positive and negative factors or conditions for consideration.
NOTE 2 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.
NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.
组织应确定与其宗旨和战略方向有关且影响质量管理体系实现其预期结果的能力的内部和外部环境。
组织应监视和评审有关内部和外部环境的信息。
注1：环境可能是正面或负面的因素或要考虑的状况；
注2：可以通过考虑源于国际、国家、地区或本地的法律法规、技术、竞争、市场、文化、社会和经济环境的情况，促进对外部环境的了解。
注3：可以通过考虑与价值、文化、知识和组织绩效相关的情况，促进对内部环境的了解。
4.2 Understanding the needs and expectations of interested parties理解相关方的需求和期望
Due to their effect or potential effect on the organization’s ability to consistently provide products a nd services
that meet customer and applicable statutory and regulatory requirements, the organization shall determine:
a) the interested parties that are relevant to the quality management system;
b) the requirements of these interested parties that are relevant to the quality management system.
The organization shall monitor and review information about these interested parties and their relevant requirements.
由于对组织持续提供满足顾客和适用的法律法规要求的产品和服务的能力的影响或潜在影响，组织应确定：
a) 与质量管理体系有关的相关方；
b) 与质量管理体系有关的相关方的要求。
组织应监视和评审有关相关方及其有关要求的信息。
4.3 Determining the scope of the quality management system确定质量管理体系的范围
The organization shall determine the boundaries and applicability of the quality management system
to establish its scope.
When determining this scope, the organization shall consider:
a) the external and internal issues referred to in 4.1;
b) the requirements of relevant interested parties referred to in 4.2;
c) the products and services of the organization.
The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system.
The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.
Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of it s products and services and the enhancement of customer satisfaction.
组织应确定质量管理体系的边界和适用性来建立其范围。
在确定质量管理体系范围时，组织应考虑：
a) 在4.1中涉及的外部和内部情况；
b) 在4.2中涉及的有关相关方要求；
c) 组织的产品与服务。
如本标准的要求在确定的范围内适用，组织应应用本标准的所有要求。组织的质量管理体系范围应可获取并保持形成文件的信息。范围应说明质量管理体系所覆盖的产品和服务，并对组织确定不适用于管理体系范围的本标准的要求说明正当理由。
当被确定为不适用的要求不影响组织确保产品和服务的符合性以及增强顾客满意的能力或责任时，才能声称符合本标准的要求。
4.4 Quality management system and its processes质量管理体系及其过程
4.4.1 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.
The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:
a) determine the inputs required and the outputs expected from these processes;
b) determine the sequence and interaction of these processes;
c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;
d) determine the resources needed for these processes and ensure their availability;
e) assign the responsibilities and authorities for these processes;
f) address the risks and opportunities as determined in accordance with the requirements of 6.1;
g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;
h) improve the processes and the quality management system.
4.4.1 组织应按本标准的要求建立、实施、保持和持续改进质量管理体系，包括质量管理体系所需的过程及其相互作用。
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，组织应：
a) 确定这些过程所需的输入和期望的输出；
b) 确定这些过程的顺序和相互作用；
c) 确定和应用所需的准则和方法（包括监视、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) 确定这些过程所需的资源并确保其可用性；
e) 规定这些过程的职责和权限；
f) 应对按照6.1的要求确定的风险和机会；
g) 评价这些过程并实施所需的变更，以确保这些过程实现预期的结果；
h) 改进过程和质量管理体系。
4.4.2 To the extent necessary, the organization shall:
a) maintain documented information to support the operation of its processes;
b) retain documented information to have confidence that the processes are being carried out as planned.
4.4.2 组织应保持必要程度的：
a) 保持形成文件的信息，为过程运行提供支持；
b) 保留形成文件的信息，以证实过程是按策划执行的。
5 Leadership 领导力
5.1 Leadership and commitment 领导力和承诺
5.1.1 General 总则
Top management shall demonstrate leadership and commitment with respect to the quality management system by:
a) taking accountability for the effectiveness of the quality management system;
b) ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization;
c) ensuring the integration of the quality management system requirements into the organization’s business processes;
d) promoting the use of the process approach and risk-based thinking;
e) ensuring that the resources needed for the quality management system are available;
f) communicating the importance of effective quality management and of conforming to the quality management system requirements;
g) ensuring that the quality management system achieves its intended results;
h) engaging, directing and supporting persons to contribute to the effectiveness of the quality
management system;
i) promoting improvement;
j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.
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, priv ate, for profit or not for profit.
最高管理者应通过以下方面证实其领导力和对质量管理体系承诺：
a) 对质量管理体系的有效性承担责任；
b) 确保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环境保持一致；
c) 确保将质量管理体系要求融入组织的业务过程；
d) 促进过程方法和基于风险的思维的应用；
e) 确保获得质量管理体系所需的资源；
f) 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；
g) 确保质量管理体系实现其预期的结果；
h) 鼓励、指导和支持员工为质量管理体系的有效性做出贡献；
i) 增强改进；
j) 支持其他相关管理者在其负责的区域证实其领导力。
注：本标准中的“业务”从广义上解释为对于组织的存在而言具有核心价值的活动，组织可以是公有的、私有的、盈利或非盈利的。
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: a) customer and applicable statutory and regulatory requirements are determined, understood and consistently met;
b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;
c) the focus on enhancing customer satisfaction is maintained.
最高管理者应通过以下方面，证实其对以顾客为关注焦点的领导力和承诺：
a) 确定、理解和持续满足顾客要求和适用的法律法规要求；
b) 确定和应对影响产品和服务符合性以及增强顾客满意能力的风险与机会；
c) 维护以增强顾客满意为关注焦点。
5.2 Policy方针
5.2.1 Establishing the quality policy 建立质量方针
Top management shall establish, implement and maintain a quality policy that:
a) is appropriate to the purpose and context of the organization and supports its strategic direction;
b) provides a framework for setting quality objectives;
c) includes a commitment to satisfy applicable requirements;
d) includes a commitment to continual improvement of the quality management system.
最高管理者应建立、实施和保持质量方针，方针应：
a) 与组织的宗旨和环境相适应，并支持其战略方向；
b) 提供制定质量目标的框架
c) 包括对满足适用要求的承诺；
d) 包括对持续改进质量管理体系的承诺。
5.2.2 Communicating the quality policy沟通质量方针
The quality policy shall:
a) be available and be maintained as documented information;
b) be communicated, understood and applied within the organization;
c) be available to relevant interested parties, as appropriate.
质量方针应：
a) 为可获得的保持为形成文件的信息；
b) 在组织内得到沟通、理解和应用
c) 适当时，可为相关方所获取。
5.3 Organizational roles, responsibilities and authorities 组织的角色、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.
Top management shall assign the responsibility and authority for:
a) ensuring that the quality management system conforms to the requirements of this International Standard;
b) ensuring that the processes are delivering their intended outputs;
c) reporting on the performance of the quality management system and on opportunities for improvement (see
10.1), in particular to top management;
d) ensuring the promotion of customer focus throughout the organization;
e) ensuring that the integrity of the quality management system is maintained when changes to the quality
management system are planned and implemented.
最高管理者应确保相关角色的职责和权限在整个组织得到分派、沟通和理解。
最高管理者应规定职责和权限以：
a) 确保质量管理体系符合本标准的要求；
b) 确保过程实现其预期的输出；
c) 向最高管理者报告质量管理体系绩效和改进机会；
d) 确保在整个组织提高以顾客为关注焦点的意识；
e) 对质量管理体系的变更进行策划和实施时，维护质量管理体系的完整性。
6 Planning 策划
6.1 Actions to address risks and opportunities 应对风险和机会的措施
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:
a) give assurance that the quality management system can achieve its intended result(s);
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
d) achieve improvement..
6.1.1 策划质量管理体系时，组织应考虑 4.1和 4.2的要求，并确定需要应对的风险和机会以：
a) 确保质量管理体系能够实现其预期的结果；
b) 增强期望的影响；
c) 预防或减少非预期的影响；
d) 实现持续改进。
6.1.2 The organization shall plan:
a) actions to address these risks and opportunities;
b) how to:
1) integrate and implement the actions into its quality management system processes (see 4.4);
2) evaluate the effectiveness of these actions.
Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.
NOTE 1 Options to address risks 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.
NOTE 2 Opportunities can lead to the adoption of new practices, launching new products, opening new markets, addressing new customers, building partnerships, using new technology and other desirable and viable possibilities to address the organization’s or its customers’ needs.
6.1.2 组织应策划：
a) 应对风险和机会的措施；
b) 如何：
1) 在质量管理体系过程中融入和实施这些措施（见 4.4）；
2) 评价这些措施的有效性。
所采取的应对风险和机会的措施应与对产品和服务符合性的潜在影响相适应。
注1：应对风险的选择可以包括：避免风险、为获取机会而接受风险、消除风险源、改变可能性或结果、分担风险或经过决策而保留风险。
注2：机会可以带来新实践的采用、发布新产品、打开新市场、获得新客户、建立合作关系、使用新技术以及其他期望的或可行的可能性以满足组织或其顾客的需求。
6.2 Quality objectives and planning to achieve them 质量目标及实现策划
6.2.1 The organization shall establish quality objectives at relevant functions, levels and processes needed for the quality management system.
The quality objectives shall:
a) be consistent with the quality policy;
b) be measurable;
c) take into account applicable requirements;
d) be relevant to conformity of products and services and to enhancement of customer satisfaction;
e) be monitored;
f) be communicated;
g) be updated as appropriate.
The organization shall maintain documented information on the quality objectives..
6.2.1 组织应在质量管理体系所需的相关职能、层次和过程上建立质量目标。
质量目标应：
a) 与质量方针保持一致；
b) 可测量；
c) 考虑适用的要求；
d) 与产品和服务的符合性以及增强顾客满意有关；
e) 得到监视；
f) 得到沟通；
g) 适当时进行更新。
组织应保持质量目标的形成文件的信息。
6.2.2 When planning how to achieve its quality objectives, the organization shall determine:
a) what will be done;
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated.
6.2.2 策划如何实现其质量目标时，组织应确定：
a) 要做什么；
b) 需要什么资源；
c) 由谁负责；
d) 什么时候完成；
e) 如何评价结果。
6.3 Planning of changes 变更的策划
When the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner (see 4.4).
The organization shall consider:
a) the purpose of the changes and their potential consequences;
b) the integrity of the quality management system;
c) the availability of resources;
d) the allocation or reallocation of responsibilities and authorities.
当组织确定了质量管理体系变更的需求时（见4.4），应按策划的方式进行变更。
组织应考虑：
a) 变更的目的及其潜在后果；
b) 质量管理体系的完整性；
c) 资源的获得；
d) 职责和权限的分配与再分配。
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.
The organization shall consider:
a) the capabilities of, and constraints on, existing internal resources;
b) what needs to be obtained from external providers.
组织应确定和提供建立、实施、保持和持续改进质量管理体系所需的资源。
组织应考虑：
a) 现有内部资源的能力和局限；
b) 需要从外部供方获取的资源。
7.1.2 People 人
The organization shall determine and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes.
组织应确定和提供质量管理体系有效实施及过程的运行和控制所需的人员。
7.1.3 Infrastructure基础设施
The organization shall determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services.
NOTE Infrastructure can include:
a) buildings and associated utilities;
b) equipment, including hardware and software;
c) transportation resources;
d) information and communication technology.
组织应确定、提供并维护为达到产品和服务符合要求的过程的运行所需的基础设施。
注：基础设施可包括：
a) 建筑物和相关的设施；
b) 设备，包括硬件和软件；
c) 运输资源；
d) 信息和通讯技术。
7.1.4 Environment for the operation of processes 过程运行环境
The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services.
NOTE A suitable environment can be a combination of human and physical factors, such as:
a) social (e.g. non-discriminatory, calm, non-confrontational);
b) psychological (e.g. stress-reducing, burnout prevention, emotionally protective);
c) physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise).
These factors can differ substantially depending on the products and services provided.
组织应确定、提供并维护过程的运行和达到产品和服务的符合性所需的环境。
注：适宜的环境可以是人文的因素和物理的因素的组合，例如：
a) 社会的（如不歧视、平和、不对抗）；
b) 心理的（如降低压力、倦怠预防、情感保护）
c) 物理的（温度、热度、湿度、照明、空气流通、卫生、噪音）
根据所提供的产品和服务，这些因素可能有显著的差异。
7.1.5 Monitoring and measuring resources 监视和测量资源
7.1.5.1 General
The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements.
The organization shall ensure that the resources provided:
a) are suitable for the specific type of monitoring and measurement activities being undertaken;
b) are maintained to ensure their continuing fitness for their purpose.
The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources.
7.1.5.1 总则
当监视或测量用于产品和服务符合特定要求的证据时，组织应确定和提供所需的资源以确保有效和可靠的结果。组织应确保所提供的资源：
a) 与所进行的监视和测量活动的具体类型相适应；
b) 得到保持以确保其持续满足使用要求。
组织应保留适当的形成文件的信息，作为监视和测量资源满足使用要求的证据。
7.1.5.2 Measurement traceability
When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be:
a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information;
b) identified in order to determine their status;
c) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status
and subsequent measurement results.
The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.
7.1.5.2 测量的追溯性
对测量有追溯性要求或组织认为是提供测量结果的有效性信心的必要部分时，测量设备应：
a) 对照能溯源到国际或国家标准的测量标准，按照规定的时间间隔或在使用前进行检定或校准，或两者都进行。当不存在上述标准时，应保留作为校准或检定依据的形成文件的信息；
b) 具有标识，以确定其校准状态；
c) 防止可能使校准状态和后续测量结果失效的调整、损坏或退化。
当发现测量设备不能满足其预期使用要求时，组织应确定以往测量结果的有效性是否受到不利影响，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.
This knowledge shall be maintained and be made available to the extent necessary.
When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates.
NOTE 1 Organizational knowledge is knowledge specific to the organization; it is gained by experience. It is information that is
used and shared to achieve the organization’s objectives.
NOTE 2 Organizational knowledge can be based on:
a) internal sources (e.g. intellectual property; knowledge gained from experience; lessons learned from failures and successful projects; capturing and sharing undocumented knowledge and experience; the results of improvements in processes, products and services);
b) external sources (e.g. standards; academia; conferences; gathering knowledge from customers or external providers).
组织应确定过程的运行和达到产品和服务的符合性所需的知识。
这些知识应得到维护并在需要时易于获取。
在应对变化的需求和趋势时，组织应考虑现有的知识，确定如何获取必要的附加知识和所需的更新。
注1：组织知识是组织的特定知识，是获得的经验，是实现组织目标所使用和分享的信息。
注2：组织知识可以基于：
a) 内部资源（如：知识产权、从经验获得的知识、从失败和成功项目中获得的教训、获取和分享非文件化知识和经验、过程、产品和服务的改进结果）；
b) 外部资源（如：标准、学术交流、会议以及从顾客和供方收集的知识）。
7.2 Competence 能力
The organization shall:
a) determine the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system;.
b) ensure that these persons are competent on the basis of appropriate education, training, or experience;
c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken;
d) retain appropriate documented information as evidence of competence.
NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the reassignment
of currently employed persons; or the hiring or contracting of competent persons.
组织应：
a) 确定在组织控制下从事影响质量管理体系绩效和有效性工作的人员的必要能力；
b) 基于适当的教育、培训或经验，确保这些人员是胜任的；
c) 适用时，采取措施以获取所需的能力，并评价这些措施的有效性；
d) 保留适当的形成文件的信息作为能力的证据。
注：适用的措施可以包括，如为现有员工提供培训、辅导或重新分配工作，雇佣或外包胜任的人员。
7.3 Awareness 意识
The organization shall ensure that persons doing work under the organization’s control are aware of:
a) the quality policy;
b) relevant quality objectives;
c) their contribution to the effectiveness of the quality management system, including the benefits of improved performance;
d) the implications of not conforming with the quality management system requirements.
组织应确保在组织控制下工作的有关人员意识到：
a) 质量方针；
b) 相关的质量目标；
c) 他们对质量管理体系有效性的贡献，包括改进绩效的益处；
d) 不符合质量管理体系要求可能引发的后果。
7.4 Communication 沟通
The organization shall determine the internal and external communications relevant to the quality management system, including:
a) on what it will communicate;
b) when to communicate;
c) with whom to communicate;
d) how to communicate;
e) who communicates.
组织应确定与质量管理体系有关的内部和外部沟通，包括：
a) 沟通的内容；
b) 沟通的时机；
c) 沟通的对象；
d) 如何沟通；
e) 谁负责沟通。
7.5 Documented information 形成文件的信息
7.5.1 General 总则
The organization’s quality management system shall include:
a) documented information required by this International Standard;
b) documented information determined by the organization as being necessary for the effectiveness of the quality management system.
NOTE The extent of documented information for a quality management system can differ from one organization to another due to:
— the size of organization and its type of activities, processes, products and services;
— the complexity of processes and their interactions;
— the competence of persons.
组织的质量管理体系应包括：
a) 本标准要求的形成文件的信息；
b) 组织确定的为确保质量管理体系有效运行所需的形成文件的信息。
注：不同组织的质量管理体系形成文件的信息的程度可以因以下方面而不同：
--组织的规模、活动、过程、产品和服务的类型；
--过程及其相互作用的复杂程度；
-- 人员的能力。
7.5.2 Creating and updating 编制和更新
When creating and updating documented information, the organization shall ensure appropriate:
a) identification and description (e.g. a title, date, author, or reference number);
b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic);
c) review and approval for suitability and adequacy.
在编制和更新形成文件的信息时，组织应确保适当的：
a) 标识和说明（例如：标题、日期、作者、文件编号等）；
b) 格式（例如：语言、软件版本、图示）和媒介（例如：纸质、电子）；
c) 评审和批准以确保适宜性和充分性。
7.5.3 Control of documented Information 形成文件的信息的控制
7.5.3.1 Documented information required by the quality management system and by this International Standard shall be controlled to ensure:
a) it is available and suitable for use, where and when it is needed;
b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).
7.5.3.1 应对质量管理体系和本标准所要求的形成文件的信息进行控制，以确保：
a) 在需要使用文件之处和之时能获得适用的文件；
b) 文件得到充分地保护（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:
a) distribution, access, retrieval and use;
b) storage and preservation, including preservation of legibility;
c) control of changes (e.g. version control);
d) retention and disposition.
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 be controlled. Documented information retained as evidence of conformity shall be protected from unintended alterations. 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.
7.5.3.2 适用时，组织应实施以下活动对形成文件的信息进行控制：
a) 分发、获取、检索和使用；
b) 储存、保护，包括保存易读性；
c) 更改的控制（如：版本控制）；
d) 保留和处置。
组织所确定的策划和运行质量管理体系所需的外来文件应得到适当的识别和控制。
作为符合性证据保留的形成文件的信息应妥善保存以防止其非预期的失效。
注：获取是指有关形成文件的信息访问许可的决定，或访问和更改形成文件的信息的许可和权力。
8 Operation 运行
8.1 Operational planning and control 运行的策划和控制
The organization shall plan, implement and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6, by:
a) determining the requirements for the products and services;
b) establishing criteria for:
1) the processes;
2) the acceptance of products and services;
c) determining the resources needed to achieve conformity to the product and service requirements;
d) implementing control of the processes in accordance with the criteria;
e) determining, maintaining and retaining documented information to the extent necessary:
1) to have confidence that the processes have been carried out as planned;
2) to demonstrate the conformity of products and services to their requirements.
The output of this planning shall be suitable for the organization’s operations.
The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.
The organization shall ensure that outsourced processes are controlled (see 8.4).
组织应策划、实施和控制满足产品和服务提供要求所需的过程（见4.4），并实施第6章确定的措施：
a) 确定产品和服务的要求；
b) 建立以下准则：
1) 过程；
2) 产品和服务接收。
c) 确定为达到产品和服务符合要求所需的资源；
d) 按照准则实施过程控制；
e) 确定，保持和保留必要的形成文件的信息：
1) 确信过程已按照策划予以实施；
2) 证实产品和服务与其要求的符合性。
策划的输出应适合组织的运行。
组织应控制有计划的变更，评审非预期的变更的后果，必要时采取措施减轻任何不良影响。
组织应确保外包过程得到控制（见8.4）。
8.2 Requirements for products and services产品和服务要求
8.2.1 Customer communication 顾客沟通
Communication with customers shall include:
a) providing information relating to products and services;
b) handling enquiries, contracts or orders, including changes;
c) obtaining customer feedback relating to products and services, including customer complaints;
d) handling or controlling customer property;
e) establishing specific requirements for contingency actions, when relevant.
与顾客沟通应包括：
a) 提供与产品和服务有关的信息；
b) 处理问询，合同或订单的处理，包括更改；
c) 获取顾客关于产品和服务的反馈，包括顾客抱怨；
d) 顾客财产的处理和控制；
e) 相关时，确定应急措施的特定要求。
8.2.2 Determination the requirements for products and services产品和服务要求的确定
When determining the requirements for the products and services to be offered to customers, the organization shall ensure that:
a) the requirements for the products and services are defined, including:
1) any applicable statutory and regulatory requirements;
2) those considered necessary by the organization;
b) the organization can meet the claims for the products and services it offers.