ISO9001-GBT19001-2015FDIS中英文对照版

GB/T19001-2015, ISO 9001:2015 idt, (Version:FDIS)

Introduction引言

0.1General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.

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。

The potential benefits to an organization of implementing a quality management system based on this International Standard are:

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) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;

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) facilitating opportunities to enhance customer satisfaction;

b) 获取增强顾客满意的机会；

c) addressing risks and opportunities associated with its context and objectives;

c) 应对与组织情境和目标相关的风险；

d) the ability to demonstrate conformity to specified quality management system requirements.

d) 证实符合质量管理体系特定要求的能力。

This International Standard can be used by internal and external parties.

本标准可用于内部和外部。

It is not the intent of this International Standard to imply the need for:

以下方面不是本标准的目的：

- uniformity in the structure of different quality management systems;

- 统一不同质量管理体系的结构；

- alignment of documentation to the clause structure of this International Standard;

- 统一本标准条款结构的文件；

- the use of the specific terminology of this International Standard within the organization.

- 在组织中使用本标准的特定术语。

The quality management system requirements specified in this International Standard are complementary to requirements for products and services.

本标准所规定的质量管理体系要求是对产品要求的补充。

This International Standard employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking.

本标准采用过程方法，包括策划-实施-检查-改进（PDCA）循环和基于风险的思维。

The process approach enables an organization to plan its processes and their interactions.

过程方法使组织能够策划组织的过程及其相互作用。

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.

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。

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).

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）。

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.

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。

In this International Standard, the following verbal forms are used:

本标准中采用了以下动词形式：

- “shall” indicates a requirement;

“应”表示要求；

- “should” indicates a recommendation;

“可”表示建议；

- “may” indicates a permission;

“可以”表示允许；

- “can” indicates a possibility or a capability.

“能够”表示可能性或能力

Information marked as “NOTE” is for guidance in understanding or clarifying the associated requirement.

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 organization’s performance when applying the principle.

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。

The quality management principles are:

质量管理原则是：

- customer focus;

-以顾客为关注焦点；

- leadership;

- 领导力；

- engagement of people;

- 员工契合；

- process approach;

- 过程方法；

- improvement;

- 改进；

- evidence-based decision making;

- 基于事实的决策方法；

- relationship management.

- 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.

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。

Understanding and managing interrelated processes as a system contributes to the organiza tion’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.

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。

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.

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。

The application of the process approach in a quality management system enables:

在质量管理体系中应用过程方法能够：

a) understanding and consistency in meeting requirements;

a) 对满足要求的理解和一致性；

b) the consideration of processes in terms of added value;

b) 从增值的角度考虑过程；

c) the achievement of effective process performance;

c) 实现有效的过程绩效；

d) improvement of processes based on evaluation of data and information.

d) 在评价数据和信息的基础上改进过程。

Figure 1 gives a schematic representation of any process and shows the interaction of its elements.The monitoring and measuring checkpoints, which are necessary for control, are specific to each process and will vary depending on the related risks.

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。

Figure 1 - Schematic representation of the elements of a single process 0.

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

PDCA cycle can be applied to all processes and to the quality management system as a whole.

PDCA循环能够应用于所有过程和整个质量管理体系。

Figure 2 illustrates how Clauses 4 to 10 can be grouped in relation to the PDCA cycle.

图2展示了第4章到第10章分别与PDCA的关联。

The Figure 2 - Representation of the structure of this International Standard in the PDCA cycle

图2：本标准中的 PDCA 循环

The PDCA cycle can be briefly described as follows:

PDCA模式可以简要描述如下：

- 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;

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；

- Do: implement what was planned;

Do –实施：实施所策划的（安排）；

- Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives and requirements and report the results;

Check –检查：根据方针、目标和要求，对过程、产品和服务进行监视和测量（适用时），并报告结果；

- Act: take actions to improve performance, as necessary.

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, analysing any nonconformities that do occur, and taking action to prevent recurrence that is appropriate for the effects of the nonconformity.

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。

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.

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。

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.

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。来自风险的负面偏离可以提供机会，但不是风险的所有负面影

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).

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）。

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.

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。

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.

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Annex B provides details of other International Standards on quality management and quality management systems that have been developed by ISO/TC 176.

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。

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.

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。

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 ISO/FDIS 9001:2015(E) 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 公开获取网站找到本标准和 ISO 9001:2008 标准条款的对照矩阵表。

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.wendangku.net/doc/ce743704.html,/tc176/sc02/public

Quality management systems - Requirements质量管理体系要求

1 Scope范围【1 1.1】【整理者注：这种括号内表示2008版标准对应的条款】

This International Standard specifies requirements for a quality management system when 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 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.

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。

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.

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。

NOTE 1 In this Internati onal 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.

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【2】

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.

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, Quality management systems - Fundamentals and vocabulary

ISO 9000:2015 质量管理体系基础和术语

3 Terms and definitions术语和定义【3】

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组织情景【4】

4.1 Understanding the organization and its context理解组织及其情景【4】

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.

组织应确定与其宗旨和战略方向有关且影响质量管理体实现其预期结果的能力的内部和外部情况

The organization shall monitor and review the information about these external and internal issues.

组织应监视和评审有关内部和外部情况的信息

NOTE 1 Issues can include positive and negative factors or conditions for consideration.

注1 情况可能是正面或负面的因素或要考虑的状况；

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.

注2：可以通过考虑源于国际、国家、地区或本地的法律、技术、竞争、市场、文化、社会和经济环境的情况，促进对外部情景的了解。

NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.

注3 可以通过考虑与价值、文化、知识和组织业绩表现相关的问题来来促进（帮助、方便）对这些内部和外部背景的理解。

4.2 Understanding the needs and expectations of interested parties理解相关方的需求和期望【4】

Due to their effect or potential effect on the organiz ation’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:

由于对对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的影响或潜在影响，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.

The organization shall monitor and review the information about these interested parties and their relevant requirements.

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有关要求有关的信息。

4.3 Determining the scope of the quality management system确定质量管理体系的范围【1.2 4.2.2】

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:

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) the external and internal issues referred to in 4.1;

在4.1涉及的外部和内部情况

b) the requirements of relevant interested parties referred to in 4.2;

在4.2中涉及的有关相关方要求

c) the products and services of the organization.

组织的产品和服务

The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system.

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。

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.

组织的质量管理体系范围应可获取并保持文件化信息。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。

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 e nsure the conformity of its products and services and the enhancement of customer satisfaction.

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】

4.4.1The 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.

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。

The organization shall determine the processes needed for the quality management system and their application throughout the organization and shall:

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) determine the inputs required and the outputs expected from these processes;

确定这些过程所需的输入和期望的输出；

b) determine the sequence and interaction of these processes;

确定这些过程的顺序和相互作用；

c) determine the criteria, methods, including measurements and related performance indicators needed to

ensure the effective operation, and control of these processes;

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) determine the resources needed and ensure their availability;

确定这些过程所需的资源并确保其可用性；

e) assign the assignment of the responsibilities and authorities for these processes;

规定这些过程的职责和权限；

f) address the risks and opportunities in accordance with the requirements of 6.1, and plan and implement the appropriate actions to address them;

应对按照6.1的要求确定的风险和机会；

g) evaluate 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;

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) improve the processes and the quality management system.

改进过程和质量管理体系。

4.4.2To the extent necessary, the organization shall:

组织应保持必要程度的文件化信息：

a) maintain documented information to support the operation of its processes;

a) 保持文件化信息，为过程运行提供支持；

b) retain documented information to have confidence that the processes are being carried out as planned.

b) 保留文件化信息，以证实过程是按策划执行的。

5 Leadership 领导力【5】

5.1 Leadership and commitment 领导力和承诺【5.1】

5.1.1 General总则【5.1】

Top management shall demonstrate leadership and commitment with respect to the quality management system by:

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) taking accountability for the effectiveness of the quality management system;

对质量管理体系的有效性承担责任；

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;

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情境保持一致；

c) ensuring of the organthe integration of the quality management system requirements into the organization’s business processes;

c)确保质量管理体系要求整合到组织的业务过程中；

d) promoting the use of the process approach and risk-based thinking;

d)促进过程方法和基于风险的思维的应用；

e) ensuring that the resources needed for the quality management system are available;

e) 确保获得质量管理体系所需的资源；

f) communicating the importance of effective quality management and of conforming to the quality management system requirements;

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) ensuring that the quality management system achieves its intended results;

g) 确保质量管理体系实现其预期的结果；

h) engaging, directing and supporting persons to contribute to the effectiveness of the quality management system;

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) promoting improvement;

i) 增强改进；

j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

j) 支持其他相关管理者在其负责的区域证实其领导力。

NOTE Reference to “business” in this International Standard c an 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顾客为关注焦点【5.2】

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，证实其对以顾客为关注焦点的领导力和承诺：

a) customer and applicable statutory and regulatory requirements are determined, understood and consistently met;

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) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;

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) the focus on enhancing customer satisfaction is maintained.

c)保持以增强顾客满意为关注焦点。

5.2 Quality policy质量方针【5.3】

5.2.1 制定质量方针Developing the quality policy【5.3】

Top management shall establish, implement and maintain a quality policy that:

最高管理者应建立、实施和保持质量方针，方针应：

a) is appropriate to the purpose and context of the organization and supports its strategic direction;

a) 与组织的宗旨和情境相适应，并支持其战略方向；

b) provides a framework for setting quality objectives;

b) 提供制定质量目标的框架；

c) includes a commitment to satisfy applicable requirements;

c) 包括对满足适用要求的承诺；

d) includes a commitment to continual improvement of the quality management system.

d) 包括对持续改进质量管理体系的承诺。

5.2.2沟通质量方针Communicating the quality policy【5.3】

The quality policy shall:

质量方针应

a) be available and be maintained as documented information;

a) 为可获得的文件化信息；

b) be communicated, understood and applied within the organization;

b) 在组织内得到沟通、理解和应用；

c) be available to relevant interested parties, as appropriate.

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【5.5.1 5.5.2 5.4.2】

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整个组织得到规定、沟通和理解。

Top management shall assign the responsibility and authority for:

最高管理者应规定职责和权限以：

a) ensuring that the quality management system conforms to the requirements of this International Standard;

a) 确保质量管理体系符合本标准的要求；

b) ensuring that the processes are delivering their intended outputs;

b) 确保过程实现其预期的输出；

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;

c) 向最高管理者报告质量管理体系绩效和改进机会；

d) ensuring the promotion of customer focus throughout the organization;

d) 确保在整个组织提高以顾客为关注焦点的意识；

e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

e) 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。

6 Planning for the quality management system 策划【5.4.2】

6.1 Actions to address risks and opportunities应对风险和机会的措施【5.4.2 8.5.3】

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:

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) give assurance that the quality management system can achieve its intended result(s);

a) 确保质量管理体系能够实现其预期的结果；

b) enhance desirable effects;

b) 增强期望的影响；

c) prevent, or reduce, undesired effects;防止或者减少不良效果

c) 预防或减少非预期的影响；

d) achieve improvement.

d) 实现持续改进。

6.1.2 The organization shall plan:

6.1.2组织应策划：

a) actions to address these risks and opportunities;

a) 应对风险和机会的措施；

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.

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。

Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.

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。

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.

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。

NOTE 2 Opportunities can lead to the adoption of new practices, launching new products, opening new markets, addressing new clients, building partnerships, using new technology and other desirable and viable possibilities to address the organization’s or its customers’ needs.

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 质量目标和实现计划【5.4.1】

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:.

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) be consistent with the quality policy,

a) 与质量方针保持一致；

b) be measurable;

b) 可测量；

c) take into account applicable requirements;

c) 考虑适用的要求；

d) be relevant to conformity of products and services and to enhancement of customer satisfaction;

d) 与产品和服务的符合性以及增强顾客满意有关；

e) be monitored;

e) 得到监视；

f) be communicated;

f) 得到沟通；

g) be updated as appropriate. 适用时得到更新

g) 适当时进行更新。

The organization shall maintain documented information on the quality objectives.

组织应保持质量目标的文件化信息。

6.2.2 When planning how to achieve its quality objectives, the organization shall determine:

6.2.2策划如何实现其质量目标时，组织应确定：

a) what will be done;

a) 要做什么；

b) what resources will be required;

b) 需要什么资源；

c) who will be responsible;

c) 由谁负责；

d) when it will be completed;

d) 什么时候完成；

e) how the results will be evaluated.

e) 如何评价结果。

6.3 Planning of changes变更的策划【5.4.2】

Planning of changes 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:

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、系统化的方式进行变更。

组织应考虑：

a) the purpose of the changes and their potential consequences;

a) 变更的目的及其潜在后果；

b) the integrity of the quality management system;

b) 质量管理体系的完整性；

c) the availability of resources;

c) 资源的获得；

d) the allocation or reallocation of responsibilities and authorities.

d) 职责和权限的分配与再分配。

7 Support支持【6】

7.1 Resources资源【6】

7.1.1 General 总则【6.1】

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:

组织应确定和提供建立、实施、保持和改进质量管理体系所需的资源。

组织应考虑：

a) the capabilities of, and constraints on, existing internal resources;

a) 现有内部资源的能力和局限；

b) what needs to be obtained from external providers.

b) 需要从外部供方获取的资源。

7.1.2 People 人员【6.1】

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【6.3】

The organization shall determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services.

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。

NOTE Infrastructure can include:

注：基础设施可包括：

a) buildings and associated utilities;

a) 建筑物和相关的设施；

b) equipment including hardware and software;

b) 设备（包括硬件和软件）；

c) transportation;

c) 运输资源；

d) information and communication technology.

d) 信息和通讯技术。

7.1.4 Environment for the operation of processes 过程运行环境【6.4】

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。

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, humidity, light, airflow, light, airflow, hygiene, noise).

These factors can differ substantially depending on the products and services provided.

注：适宜的环境可以是人的因素和物的因素的组合，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，这些因素可能有很大的不同。

7.1.5 Monitoring and measuring resources 监视和测量资源【7.6】

7.1.5.1General总则【7.6】

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:

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) are suitable for the specific type of monitoring and measurement activities being undertaken;

a) 与所进行的监视和测量活动的具体类型相适应；

b) are maintained to ensure their continuing fitness for their purpose.

b) 得到维护以确保其持续满足使用要求。

The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources.

组织应保持适当的文件化信息，作为监视和测量资源满足使用要求的证据。

7.1.5.2 测量的追溯性【7.6】

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: 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) 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;

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文件化信息；

b) identified in order to determine their status;

b) 具有标识，以确定其校准状态；

c) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results.

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。

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.

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【NEW】

The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services.

组织应确定过程的运行和达到产品和服务的符合性所需的知识。

knowledge shall be maintained, and made available to the extent necessary.

这些知识应得到维护并在需要时易于获取。

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。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.

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。

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).

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【6.2.1 6.2.2】

The organization shall:

组织应：

a) determine the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system;

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) ensure that these persons are competent on the basis of appropriate education, training, or experience;

b) 基于适当的教育、培训或经验，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;

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) retain appropriate documented information as evidence of competence.

d) 保留适当的文件化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 reassignment of currently employed persons; or the hiring or contracting of competent persons.

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【6.2.2】

The organization shall ensure that persons doing wo rk under the organization’s control are aware of:组织应确保在组织控制下工作的有关人员意识到：

a) the quality policy;

a) 质量方针；

b) relevant quality objectives;

b) 相关的质量目标；

c) their contribution to the effectiveness of the quality management system, including the benefits of improved performance;

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) the implications of not conforming with the quality management system requirements.

d) 不符合质量管理体系要求可能引发的后果。

7.4 Communication 沟通【5.5.3】

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有关的内部和外部沟通，包括：

a) on what it will communicate;

a) 沟通的内容；

b) when to communicate;

b) 沟通的时机；

c) with whom to communicate;

c) 沟通的对象；

d) how to communicate.

d) 如何沟通；

e) who communicates.

e) 谁负责沟通。

7.5 Documented information 文件化信息【4.2】

7.5.1 General 总则【4.2.1】

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;

a) 本标准要求的文件化信息；

b) documented information determined by the organization as being necessary for the effectiveness of the quality management system.

b) 组织确定的为确保质量管理体系有效运行所需的文件化信息。

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.

注：不同组织的质量管理体系文件化信息的程度可以因以下方面而不同：

a) 组织的规模、活动、过程、产品和服务的类型；

b) 过程及其相互作用的复杂程度；

c) 人员的能力。

7.5.2 Creating and updating 编制和更新【4.2.3 4.2.4】

When creating and updating documented information the organization shall ensure appropriate: 在编制和更新文件时，组织应确保适当的：

a) identification and description (e.g. a title, date, author, or reference number);

a) 标识和说明（例如：标题、日期、作者、文件编号等）；

b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic);

b) 格式（例如：语言、软件版本、图示）和媒介（例如：纸质、电子）；

c) review and approval for suitability and adequacy.

c) 评审和批准以确保适宜性和充分性。

7.5.3 Control of documented Information 文件化信息的控制【4.2.3 4.2.4】

7.5.3.1 Documented information required by the quality management system and by this International Standard shall be controlled to ensure:

7.5.3.1 应对质量管理体系和本标准所要求的文件化信息进行控制，以确保：

a) it is available and suitable for use, where and when it is needed;

a) 在需要使用文件之处和之时能获得适用的文件；

b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

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:

7.5.3.2 适用时，组织应实施以下活动对文件化信息进行控制：

a) distribution, access, retrieval and use;

a) 分发、获取、检索和使用；

b) storage and preservation, including preservation of legibility;

b) 储存、保护，包括保持清晰；

c) control of changes (e.g. version control);

c) 更改的控制（如：版本控制）；

d) retention and disposition.

d) 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 be controlled.

Documented information retained as evidence of conformity shall be protected from unintended alterations.

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。

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：获取是指有关文件化信息浏览许可的决定，或浏览和更改文件化信息的许可和权力。

8 Operation 运行

8.1 Operational planning and control 运行的策划和控制【7】

8.1 运行的策划和控制

The organization shall plan, implement and control the processes, as outlined (see 4.4), needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6.1, by:

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) determining the requirements for the products and services;

a) 确定产品和服务的要求；

b) establishing criteria for:

1) the processes;

2) the acceptance of products and services;

b) 建立以下准则：

1) 过程；

2) 产品和服务接收。

c) determining the resources needed to achieve conformity to the product and service requirements;

c) 确定为达到产品和服务符合要求所需的资源；

d) implementing control of the processes in accordance with the criteria;

d) 按照准则实施过程控制；

e) determining and keeping 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.

e) 确定和保持必要的文件化信息：

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。

NOTE “Keeping” implies both the maintaining and the retaining of documented information.

注：“保持”是指文件化信息的维护和保留。

The output of this planning shall be suitable for the organization’s operations.

策划的输出应适合组织的运行。

The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.

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。

The organization shall ensure that outsourced processes are controlled (see 8.4).

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【7.2】

8.2.1 Customer communication 顾客沟通【7.2.3】

Communication with customers shall include:

与顾客沟通应包括：

a) providing information relating to products and services;

a) 提供与产品和服务有关的信息；

b) handling enquiries, contracts or orders, including changes;

b) 问询，合同或订单的处理，包括更改；

c) obtaining customer feedback relating to products and services, including customer complaints;

c) 获取顾客关于产品和服务的反馈，包括顾客抱怨；

d) handling or controlling customer property;

d) 顾客财产的处理和控制；

e) establishing specific requirements for contingency actions, when relevant.

e) 相关时，确定应急措施的特定要求。

8.2.2 Determination of requirements related to products and services与产品和服务有关的要求的确定【7.2.1】

Determining the requirements related to products and services When determining the requirements for the products and services to be offered to customers, the organization shall ensure that: 在确定提供给顾客的产品和服务的要求时，组织应确保：

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;

a) 产品和服务要求得到确定，包括：

1) 适用的法律法规要求；

2) 组织认为必要的要求。

b) the organization can meet the claims for the products and services it offers.

b) 组织能够满足其所提供产品和服务的索赔要求。

8.2.3 Review of requirements related to products and services与产品和服务有关的要求的评审

【7.2.2】

8.2.3.1 The organization shall ensure that it has the ability to meet the requirements for products and services to be offered to customers.

The organization shall conduct a review before committing to supply products and services to a customer, to include:

The customer’s requirements shall be confirmed by the organization before acceptance, when the customer does not provide a documented statement of their requirements.

NOTE In some situations, such as internet sales, a formal review is impractical for each order.

Instead, the review can cover relevant product information, such as catalogues or advertising material.

8.2.3.1组织应确保其有能力满足提供给顾客的产品和服务的要求，组织应在向顾客承诺提供产品和服务之前实施评审，包括：

a) requirements specified by the customer, including the requirements for delivery and post-delivery activities;

a) 顾客规定的要求，包括交付和交付后活动的要求；

b) requirements not stated by the customer, but necessary for the specified or intended use, when known;

b) 顾客虽然没有明示，但规定用途或已知的预期用途所必需的要求；

c) requirements specified by the organization;

c) 组织规定的要求；

d) statutory and regulatory requirements applicable to the products and services;

d) 适用于产品和服务的法律法规要求；

e) contract or order requirements differing from those previously expressed.

e) 与以前表述不一致的合同或订单的要求。

and shall ensure contract or order requirements differing from those previously defined are resolved.

组织应确保与以前规定不一致的合同或订单要求已得到解决。

The organization shall ensure that contract or order requirements differing from those previously defined are resolved.

顾客没有提供其要求的文件化说明时，组织应在接受前对顾客要求进行确认。

8.2.3.2 The organization shall retain documented information, as applicable:

a) on the results of the review;

b) on any new requirements for the products and services.

8.2.3.2 适用时，组织应保留以下方面的文件化信息：

a) 评审结果；

b) 产品和服务的任何新要求。

8.2.4Change to requirements for products and services产品和服务要求的变更【7.2.2】

The organization shall ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed.

若产品和服务要求发生变更，组织应确保相关的文件化信息得到修改，并确保相关人员知道已变更的

要求。

8.3 Design and development of products and services 产品和服务的设计和开发【7.3】8.3.1 General 总则【7.3.1】

The organization shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services.

组织应建立、实施和保持设计和开发过程，以适用于确保后续的产品和服务的提供。

8.3.2 Design and development planning 设计和开发的策划【7.3.1】

Design and development planning In determining the stages and controls for design and development,

the organization shall consider:

在确定设计和开发的阶段和控制时，组织应考虑：

a) the nature, duration and complexity of the design and development activities;

a) 设计和开发活动的性质、持续时间和复杂性；

b) the required process stages, including applicable design and development reviews;

b) 所需的过程阶段，包括适用的设计和开发评审；

c) the required design and development verification and validation activities;

c) 所需的设计和开发的验证和确认；

d) the responsibilities and authorities involved in the design and development process;

d) 设计和开发过程涉及的职责和权限；

e) the internal and external resource needs for the design and development of products and services;

e) 产品和服务的设计和开发所需的内部和外部资源；

f) the need to control interfaces between persons involved in the design and development process;

f) 控制设计和开发过程涉及的个人之间的接口的需求；

g) the need for involvement of customers and users in the design and development process;

g) 顾客和用户参与设计和开发过程的需求；

h) the requirements for subsequent provision of products and services;

h) 后续的产品和服务提供的要求；

i) the level of control expected for the design and development process by customers and other relevant interested parties;

i) 顾客和其他有关相关方对设计和开发过程所期望的控制程度；

j) the documented information needed to demonstrate that design and development requirements have been met.

j) 证实设计和开发要求已得到满足所需的文件化信息。

8.3.3 Design and development Inputs 设计和开发的输入【7.3.2】

The organization shall determine the requirements essential for the specific types of products and services to be designed and developed.

The organization shall consider:

The organization shall determine:

a) requirements essential for the specific type of products and services being designed and developed, including, as applicable, functional and performance requirements;

组织应确定有关设计和开发的产品和服务的具体类型的基本要求，组织应考虑：

a) functional and performance requirements;

a) 功能和性能要求；

b) information derived from previous similar design and development activities;

b) 来自以前类似设计和开发活动的信息；

c) statutory and regulatory requirements;

c) 法律法规要求；

d) standards or codes of practice that the organization has committed to implement;

d) 组织承诺执行的标准或行业规则；

e) potential consequences of failure due to the nature of the products and services.

产品和服务的设计和开发的内部和外部需要

e) the potential consequences of failure due to the nature of the products and services;

e) 产品和服务的性质引起的潜在失效后果。

Inputs shall be adequate for design and development purposes, complete and unambiguous.

输入应满足设计和开发目的，完整并且清楚。

Conflicting design and development inputs shall be resolved.

设计和开发输入的矛盾应予以解决。

The organization shall retain documented information on design and development inputs.

组织应保持设计和开发输入的文件化信息。

8.3.4 Design and development controls 设计和开发的控制【7.3.4、7.3.5、7.3.6】

Design and development controls The organization shall apply controls to the design and development process to ensure that:

d) validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use;

组织对设计和开发过程进行控制以确保：

a) the results to be achieved are defined;

a) 要实现的结果得到确定；

b) reviews are conducted to evaluate the ability of the results of design and development to meet requirements;

b) 实施评审，以评价设计和开发结果满足要求的能力；

c) verification activities are conducted to ensure that the design and development outputs meet the input requirements;

c) 实施验证活动，以确保设计和开发的输出满足设计和开发输入的要求；

d) validation is conducted to ensure that the resulting products and services are capable of meeting the requirements for the specified application or intended use (when known).

d) 实施确认活动，以确保形成的产品和服务能够满足规定的应用或预期用途；

e) any necessary actions are taken on problems determined during the reviews, or verification and validation activities;

e) 对评审或验证和确认活动中确定的问题采取必要的措施；

f) documented information of these activities is retained.

f) 保留这些活动的文件化信息。

NOTE Design and development reviews, verification and validation have distinct purposes.

They can be conducted separately or in any combination, as is suitable for the products and services of the organization.

注：设计和开发的评审、验证和确认具有不同的目的，他们可以按适合组织的方式单独或任意组合进行。

8.3.5 Design and development outputs 设计和开发的输出【7.3.3】

The organization shall ensure that design and development outputs:

组织应确保设计和开发的输出：

a) meet the input requirements;

a) 满足输入的要求；

b) are adequate for the subsequent processes for the provision of products and services;

b) 对于产品和服务提供的后续过程是充分的；

c) include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria;

c) 适当时，包含或引用监视和测量要求以及接收准则；

d) specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision.

d) 规定了产品和服务的预期目的以及安全和正常提供所必须的产品和服务的特性。

The organization shall retain documented information on design and development outputs.

8.3.6 Design and development changes 设计和开发的更改【7.3.7】

Design and development changes The organization shall identify, review and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements.

组织应识别、评审产品和服务的设计和开发期间或后续过程中对产品和服务的设计和开发的更改并进行必要的控制，以确保对符合要求没有负面影响。

The organization shall retain documented information on:

组织应保持以下方面的文件化信息：

a) design and development changes;

b) the results of reviews;

b) 评审结果；

c) the authorization of the changes;

c) 变更的授权；

d) the actions taken to prevent adverse impacts.a) 设计和开发的变更

d) 所采取的预防负面影响的措施。

8.4 Control of externally provided processes, products and services 外部提供的过程、产品和服务的控制【4.1 7.4】

8.4.1 General 总则【7.4.1】

The organization shall ensure that externally provided processes, products and services conform to requirements.

组织应确保外部提供的过程、产品和服务符合要求。

The organization shall determine the controls to be applied to externally provided processes, products and services when:

当以下情况时，组织应确定要应用的对外部提供的过程、产品和服务的控制：

a) products and services from external p roviders are intended for incorporation into the organization’s own products and services;

a) 外部供方提供的产品和服务用于并入组织自己的产品和服务；

b) products and services are provided directly to the customer(s) by external providers on behalf of the organization;

b) 由外部供方代表组织直接提供给顾客的产品和服务；

c) a process, or part of a process, is provided by an external provider as a result of a decision by the organization.

c) 由外部供方提供的作为组织决定结果的过程或过程的一部分。

The organization shall determine and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements.

The organization shall retain documented information of these activities and any necessary actions arising from the evaluations.

组织应根据外部供方按照规定的要求提供过程或产品和服务的能力，确定和应用外部供方的评价、选择、绩效监视和重新评价的准则。组织应保持这些活动和由评价引起的必要措施的文件化信息。

8.4.2 Type and extent of control 控制类型和程度【7.4.1 7.4.3】

The organization shall ensure that externally provided processes, products and services do not adversely affect the organization’s ability to consistently deliver conforming products and services to its customers.

组织应确保外部提供的过程、产品和服务对组织稳定地向顾客交付符合要求的产品和服务的能力没有负面影响。

The organization shall:

组织应：

a) ensure that externally provided processes remain within the control of its quality management system;

a) 确保将外部提供的过程保持在其质量管理体系控制范围内；

b) define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output;

b) 确定拟对外部供方及其形成的输出实施的控制；

c) take into consideration:

1) the potential impact of the externally provided processes, products and services on the organization’s ability to consistently meet customer and applicable statutory and regulatory requirements;

2) the effectiveness of the controls applied by the external provider;

c) 考虑：

1) 外部提供的过程、产品和服务对组织持续满足顾客和适用的法律法规要求的能力的潜在影响；

2) 外部供方实施的控制的有效性。

d) determine the verification, or other activities, necessary to ensure that the externally provided processes, products and services meet requirements.

d) 确定验证或其他必要活动，以确定外部提供的过程、产品和服务满足要求。

8.4.3 Information for external providers 外部供方信息【7.4.2 7.4.3】

The organization shall ensure the adequacy of specified requirements prior to their communication to the external provider.

The organization shall communicate to external providers applicable requirements for the following: 在与外部供方沟通前，组织应确保要求的充分性。

组织应与外部供方沟通其以下方面的要求：

a) the products and services to be provided or the processes to be performed on behalf of the organization;

a) 将要提供的过程、产品和服务；

b) approval or release of products and services, methods, processes or equipment;

b) 以下批准：

1) 产品和服务；

2) 方法、过程和设备；

3) 产品和服务的放行；

c) competence of personnel, including necessary qualification;

c) 能力，包含所要求的人员资格；

d) their interactions with the organization's quality management system;

d) 外部供方和组织之间的相互作用；

e) the control and monitoring of the external provider’s performance to be applied by the organization;

e) 组织实施的对外部供方绩效的控制和监视；

f) verification activities that the organization, or its customer, intends to perform at the external provider’s premises.

f) 组织或其顾客拟在外部供方现场实施的验证或确认活动。

8.5 Production and service provision生产和服务的提供

8.5.1 Control of production and service provision 产品和服务提供的控制【7.5.1 7.5.2】

The organization shall implement controlled conditions for production and service provision, including delivery and post-delivery activities.

组织应在受控条件下实施产品和服务的提供。

UCP600中英文对照版

《跟单信用证统一惯例》（UCP600）中英文对照版 Article 1 Application of UCP 第一条统一惯例的适用范围 The Uniform Customs and Practice for Documentary Credits, 2007 Revis ion, ICC Publication no. 600 (“UCP”) are rules that apply to any do cumentary credit (“credit”) (including, to the extent to which they may be applicable, any standby letter of credit) when the text of t he credit expressly indicates that it is subject to these rules. The y are binding on all parties thereto unless expressly modified or ex cluded by the credit. 跟单信用证统一惯例，2007年修订本，国际商会第600号出版物，适用于所有在正文中标明按本惯例办理的跟单信用证（包括本惯例适用范围内的备用信用证）。除非信用证中另有规定，本惯例对一切有关当事人均具有约束力。 Article 2 Definitions 第二条定义 For the purpose of these rules: 就本惯例而言： Advising bank means the bank that advises the credit at the request of the issuing bank. 通知行意指应开证行要求通知信用证的银行。 Applicant means the party on whose request the credit is issued. 申请人意指发出开立信用证申请的一方。

《跟单信用证统一惯例UCP600》中英对照共75页word资料

《跟单信用证统一惯例（UCP600）》(中英对照版) 作者：国际商会易水寒译阅读2912次更新时间：2007-3-29 《跟单信用证统一惯例（UCP600）》 Article 1 Application of UCP 第一条统一惯例的适用范围 The Uniform Customs and Practice for Documentary Credits, 2007 Revision, ICC Publication no. 600 (“UCP”) are rules that apply to any documentary credit (“credit”) (including, to the extent to which they may be applicable, any standby letter of credit) when the text of the credit expressly indicates that it is subject to these rules. They are binding on all parties thereto unless expressly modified or excluded by the credit. 跟单信用证统一惯例，2007年修订本，国际商会第600号出版物，适用于所有在正文中标明按本惯例办理的跟单信用证（包括本惯例适用范围内的备用信用证）。除非信用证中另有规定，本惯例对一切有关当事人均具有约束力。 Article 2 Definitions 第二条定义 For the purpose of these rules: 就本惯例而言： Advising bank means the bank that advises the credit at the request of the issuing bank.

尽职调查访谈提纲-HR、资料要求清单(中英文)

尽职调查访谈提纲 （工薪和人事管理） 1、请简单介绍您个人的基本情况。 2、人力资源管理部门的职责主要是什么？岗位是如何设置的？目前有多少人？ 3、公司的人员构成（招聘、劳务派遣；学历构成；年龄结构；技术等级等）？ 4、员工的聘用要经过哪些环节？ 5、外聘劳务公司人员如何管理的？ 6、劳动合同的签订过程是如何控制的？（涉及哪些部门？谁签字？谁审批？） 7、薪酬标准如何制定的？ 8、福利包括哪些？按什么标准支付？ 9、是否发生劳务纠纷及处理措施？ 10、公司员工的社保费、公积金是按什么标准支付的？ 11、员工的业绩是如何考核的？与薪酬、职务是如何挂钩的？ 12、近两年业绩计划或任务的完成情况？ 13、员工薪酬的发放是如何控制的？ 14、公司经营管理有哪些地方可以进一步完善？

INFORMATION AND DOCUMENTATION REQUIRED 资料要求清单 Comments 注明 The list below is the information necessary for the due diligence work. The objective of the list is to make sure that our team can smoothly start its due diligence work according to the date noted on engagement. It is possible that the list doesn’t cover all the information we needed in our work. So, we would ask for other information not included in the list. 以下清单列明在对贵公司进行财务评阅之所需资料，此清单之目的是为了确保有足够的资料使得评阅小组能够在业务约定书约定之开始工作日期顺利开展工作。 The following list maybe not includes all documents and information we needed, so additional information will be required to provide during our financial due diligence. 清单所列之资料可能未有全面概括所需资料，因此在评阅过程中可能会提出获取附件中未列出的资料。 1Related legal materials 有关法定资料 Organization chart (including investors, investors’ holding company, subsidiaries and etc.) and list the legal name of these companies; 公司组织结构图(包括该公司之投资者、投资者之母公司、公司的子 公司等)并列出该些公司之法定名称； Organization chart of the management and organization structure; 公司管理层组织结构图和组织机构情况； Business license issued by SAIC; 国家工商管理局发出的营业执照；

尽职调查清单中英文

1 Due Diligence Issues Daniel Chan Bonded Processing Arrangements Issues relating to Bonded Processing Arrangements z factory transfer ?transfer of partially finished goods to another factory for further processing before export ? non-refund of VAT on inputs

3 Bonded Processing Arrangements (cont’d) z import processing (“buy-sell”) ?title to imported materials ?under customs supervision (no customs duties & import VAT) z processing & assembly (“consignment”)?no title to imported materials ?no VAT on processing fees Bonded Processing Arrangements (cont’d) z equipment import ? VAT and duty free ?preferential treatment may be changed

5 Licenses & Permits All licenses & permits (issued by national, provincial or other levels of government authorities)z e.g. chemical manufacturing WFOE ?permits for production of dangerous chemical products ? permits for emission of waste Taxes Smuggling z imported machinery z import VAT and Custom duties receipts Individual Income Tax z withholding tax z dual employment contract Potential issue of retroactive payment of taxes exempted under tax holiday, in asset acquisition scenario

UCP600的中英文版下载

ICC UNIFORM CUSTOMS AND PRACTICE FOR DOCUMENTARY CREDITS UCP 600 英文中文 FOREWORD (2) INTRODUCTION (4) ARTICLE 1 APPLICATION OF UCP (10) ARTICLE 2 DEFINITIONS (11) ARTICLE 3 INTERPRETATIONS (13) ARTICLE 4 CREDITS V. CONTRACTS (14) ARTICLE 5 DOCUMENTS V. GOODS, SERVICES OR PERFORMANCE (15) ARTICLE 6 AVAILABILITY, EXPIRY DATE AND PLACE FOR PRESENTATION (15) ARTICLE 7 ISSUING BANK UNDERTAKING (16) ARTICLE 8 CONFIRMING BANK UNDERTAKING (17) ARTICLE 9 ADVISING OF CREDITS AND AMENDMENTS (19) ARTICLE 10 AMENDMENTS (20) ARTICLE 11 TELETRANSMITTED AND PRE-ADVISED CREDITS AND AMENDMENTS (22) ARTICLE 12 NOMINATION (22) ARTICLE 13 BANK-TO-BANK REIMBURSEMENT ARRANGEMENTS (23) ARTICLE 14 STANDARD FOR EXAMINATION OF DOCUMENTS (24) ARTICLE 15 COMPLYING PRESENTATION (27) ARTICLE 16 DISCREPANT DOCUMENTS, WAIVER AND NOTICE (27) ARTICLE 17 ORIGINAL DOCUMENTS AND COPIES (29) ARTICLE 18 COMMERCIAL INVOICE (30) ARTICLE 19 TRANSPORT DOCUMENT COVERING AT LEAST TWO DIFFERENT MODES OF TRANSPORT (31) ARTICLE 20 BILL OF LADING (33) ARTICLE 21 NON-NEGOTIABLE SEA WAYBILL (36)

UCP600中英文对照版

跟单信用证统一惯例（ICC UCP600中英文对照版）

《跟单信用证统一惯例（UCP600）》 Article 1 Application of UCP 第一条统一惯例的适用范围 The Uniform Customs and Practice for Documentary Credits, 2007 Revision, ICC Publication no. 600 (“UCP”) are rules that apply to any documentary c redit (“credit”) (including, to the extent to which they may be applicable, any standby letter of credit) when the text of the credit expressly indicates that it is subject to these rules. They are binding on all parties thereto unless expressly modified or excluded by the credit. 跟单信用证统一惯例，2007年修订本，国际商会第600号出版物，适用于所有在正文中标明按本惯例办理的跟单信用证（包括本惯例适用范围内的备用信用证）。除非信用证中另有规定，本惯例对一切有关当事人均具有约束力。 Article 2 Definitions 第二条定义 For the purpose of these rules: 就本惯例而言： Advising bank means the bank that advises the credit at the request of the issuing bank. 通知行意指应开证行要求通知信用证的银行。 Applicant means the party on whose request the credit is issued. 申请人意指发出开立信用证申请的一方。 Banking day means a day on which a bank is regularly open at the place at which an act subject to these rules is to be performed. 银行日意指银行在其营业地正常营业，按照本惯例行事的行为得以在银行履行的日子。 Beneficiary means the party in whose favour a credit is issued. 受益人意指信用证中受益的一方。 Complying presentation means a presentation that is in accordance with the terms and conditions of the credit, the applicable provisions of these

四大会计师事务所之一尽职调查所需资料清单-中英文对照_最新修正版

Target – Project [ ] Information Request List (“IRL”) – Accounting and Tax As of [ , ] 审阅对象—项目 会计及税务资料清单 截止年月日 The following is IRL for conducting a review of financial, certain operational and tax information of ________(the “Group”; references to “Company” or “Target” refer to any of the subsidiaries or legal entities of the Group). The “historical period” referred to herein is defined as the years ended___________, ______, and ______ (“Fiscal______, _______and ______”) and the ____ months ended _________, ______and ______ (“Interim _____ and ______”). Thus, the historical period has ____ separate periods within it. Please note that this IRL has three sections: I. Financial and Accounting; II. Tax; and III. Discussion Items. 以下为对__________（以下简称“贵集团”；倘提及“贵公司”或“审阅对象”乃指贵集团之任何子公司或法定实体）进行的财务、经营及税务各方面的审阅,所需由贵公司准备的资料清单。以下提及之“历史期间”是指截至年、年及年月日止之年度（以下简称“、及财政年度”）以及截至年及年月日止 个月期间（“____ __及___ __中期”）。因此，历史期间包括_ __个独立期间。请注意资料清单包括三个部分：1）财务及会计；2）税务；3）讨论事项。 I. Financial and Accounting财务及会计 General综合 1.Annual audited financial statements of the Group and Companies for Fiscal____, _____and _____. 贵集团及各集团公司_ ___、__ ___ 及______财政年度的已审计财务报表。 2.Confidential information memorandum about the Group. 贵集团之商业计划书。 3.Monthly unaudited financial statements of the Group and Companies for the historical period. 贵集团及各集团公司历史期间每月未经审计的财务报表。 4.Assistance in gaining access to [name of accountants]’s [Year] and [Year] audit working papers of the Group and Companies. 协助获取__________ （审计师名称）为贵集团及各集团公司进行__ ___年度及_ ____年度审计的工作底稿。 5.Determine whether the Group is using accounting methods where other acceptable or even preferable methods should be used. Compare the accounting policies of the Company to the accounting policies of certain competitors as described in publicly available reports. 了解贵集团是否应采用其它认可或更可取的会计方法。将贵公司的会计政策与公开报告中所提到之竞争对手的会计政策作比较。 6.Summary of audit adjustments recorded during the historical period. 历史期间内审计调整记录概要。 7.Copies of any independent accountant’s management letters or outside consultants’ reports issued during the historical period. 历史期间内由独立会计师签发的经营管理建议书或外间顾问报告之副本。

eUCP(V1.1)中英文对照版

EUCP(V1.1) 中英文对照版 Introduction The official name for this publication is “Supplement to the Uniform Customs and Practice for Documentary Credits for Electronic Presentation (Version 1.1)”. It uses the acronym “eUCP”. During the course of drafting UCP 600, ICC national committees indicated that, due to the limited usage of eUCP Version 1.0, the eUCP should remain as a supplement to the UCP. Version 1.1 has, therefore, been updated solely to reflect the changes made in UCP with regard to terminology and style of presentation. The eUCP continues to provide definitions permitting UCP 600 terminology to accommodate the electronic presentation of the equivalent of paper documents and providing necessary rules to allow both sets of rules to work together. The eUCP allows for presentation electronically or for a mixture of paper documents and electronic presentation. It is important for the eUCP reader to understand that many articles of the UCP are not impacted by the presentation of the electronic equivalent of paper documents and do not require any changes to accommodate electronic presentation. When read together, the UCP and the eUCP provide the necessary rules for electronic presentation and are broad enough to anticipate developing practice in this area. Where specific words or phrases used in the UCP are defined in the eUCP, these definitions, unless otherwise stated, apply wherever the terms appear in the UCP. eUCP Version 1.1 is specific to UCP 600 and, if necessary, may have to be revised as technologies develop, perhaps prior to the next revision of the UCP. For that purpose, the eUCP is issued in version numbers that will allow for a revision and subsequent version if the need arises. The eUCP has been specifically drafted to be independent of specific technologies and developing electronic commerce systems, i.e., it does not address specific technologies or systems necessary to facilitate electronic presentation. These technologies are evolving, and it is left to the parties to the credit to agree on the technology or systems to be used for presentation of electronic records in compliance with the requirements of the eUCP. The eUCP has been created to meet the demands of the market for the presentation of electronic documents. The market has created a higher standard in anticipation of increased processing efficiencies when the electronic equivalents of paper documents are presented. In anticipation of this demand and to meet market expectations, several changes to the standards established by the UCP have been deemed necessary for an electronic presentation. These changes are consistent with current practice and the expectations of the marketplace. All of the articles of eUCP Version 1.1 are consistent with UCP 600 except as they relate specifically to electronic presentations. Where necessary, changes have been made to address the unique issues related to presentation of the electronic equivalent of paper documents. In order to avoid confusion between the articles of the UCP and those of the eUCP, the eUCP articles are numbered with an “e” preceding each article number.

ICCUCP600跟单信用证统一惯例中英文对照

ICC UCP600跟单信用证统一惯例(中英文对照) 第一条UCP的适用范围 第二条定义 第三条解释 第四条信用证与合同 第五条单据与货物、服务或履约行为 第六条兑用方式、截止日和交单地点 第七条开证行责任 第八条保兑行责任 第九条信用证及其修改的通知 第十条修改 第十一条电讯传输的和预先通知的信用证和修改 第十二条指定 第十三条银行之间的偿付安排 第十四条单据审核标准 第十五条相符交单 第十六条不符单据、放弃及通知 第十七条正本单据及副本 第十八条商业发票 第十九条涵盖至少两种不同运输方式的运输单据 第二十条提单 第二十一条不可转让的海运单 第二十二条租船合同提单 第二十三条空运单据 第二十四条公路、铁路或内陆水运单据 第二十五条快递收据、邮政收据或投邮证明 第二十六条“货装舱面”、“托运人装载和计数”、“内容据托运人报称”及运费之外的费用 第二十七条清洁运输单据 第二十八条保险单据及保险范围 第二十九条截止日或最迟交单日的顺延 第三十条信用证金额、数量与单价的伸缩度 第三十一条部分支款或部分发运 第三十二条分期支款或分期发运 第三十三条交单时间 第三十四条关于单据有效性的免责 第三十五条关于信息传递和翻译的免责 第三十六条不可抗力 第三十七条关于被指示方行为的免责 第三十八条可转让信用证 第三十九条款项让渡 The Uniform Customs and Practice for Documentary Credits, 2007 Revision, ICC Publication no. 600 (“UCP”) are rules that apply to any documentary credit (“credit”) (including, to the extent to which they may be applicable, any standby letter of credit) when the text of the credit expressly indicates that it is subject to these rules. They are binding on all

尽职调查资料-中英文对照版

. Due Diligence lists 尽职调查资料清单 1.Basic information company and History 一、公司基本资料及历史沿革 1.1The latest business license ,organization code certificate ; 最新的营业执照、组织机构代码证 1.2 Articles of Association currently; 现行有效的公司章程 1.3Detailed written description of the following main profiles: 下列主要概况的详细书面说明: 1.3.1History 历史沿革 1.3.2 Company on the industry and profile information of the company industry status .Business scope and the mode of operation ,the market share of the company are included. 公司所处行业及公司行业地位的简介资料；包括经营范围、经营方式、市场占有情况等； 1.4 The latest shareholding structure,organization chart (all departments and affiliated companies are contained). 最新的股权架构、组织结构图(含所有职能部门、下属企业) 1.5 Companies engaged in business activities Certificates (or franchise certificate).

海外并购初步尽职调查清单 国际并购初步尽职调查清单 中英文版

海外并购初步尽职调查问卷及文件清单

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UCP600中英对照

UCP600中英对照 UCP600中英对照 跟单信用证统一惯例中英文对照对照版（ICC UCP600 中英文对照 版） Article 1 Application of UCP 第一条统一惯例的适用范围 The Uniform Customs and Practice for Documentary Credits, 2007 Revision, ICC Publication no. 600 (“UCP”) are rules that apply to any documentary credit (“credit”) (including, to the extent to which they may be applicable, any standby letter of credit) when the text of the credit expressly indicates that it is subject to these rules. They are binding on all parties thereto unless expressly modified or excluded by the credit. 跟单信用证统一惯例，2007 年修订本，国际商会第 600 号出版物，适用于所有在正文中标明按本惯例办理的跟单信用证（包括本惯例适用范围内的备用信用证）。除非信用证中另有规定，本惯例对一 切有关当事人均具有约束力。 Article 2 Definitions 第二条定义 For the purpose of these rules: 就本惯例而言： Advising bank means the bank that advises

信用证样本中英文对照

跟单信用证： 目前采用SWIFT格式，依据《UCP600》规定，例样如下：FROM：CITIBANK INTERNATIONAL，LOS ANGELES, U.S.A. 开证行：花旗银行美国洛杉矶 TO：BANK OF CHINA QINGDAO BRANCH，QINGDAO，CHINA 通知行：中国银行青岛分行中国青岛 27: SEQUENCE OF TOTAL 1/1 27: 电文序列1/1 40A: FORM OF DOCUMENTARY CREDIT IRREVOCABLE 40A: 跟单信用证格式 不可撤销 20: DOCUMENTARY CREDIT NUMBER CRED1523349 20: 跟单信用证号CRED1523349 3lC: DATE OF ISSUE 070906 31C: 开证日期 070906 40E：APPLICABLE RULES UCP LATEST VERSION 40E: 适用规则 《UCP》最新版本

31D: DATE AND PLACE OF EXPIRY 071102 U.S.A. 31D: 有效期和有效地点 071102 美国 50: APPLICANT UNITED OVERSEAS TEXTILE CORP. 220E 8TH STREET A682 LOS ANGELES U.S.A. 50: 开证申请人 美国大华纺织公司 220栋，8号街，682室洛杉矶美国 59: BENEFICIARY QINGDAO QINGHAI CO.,LTD. 186 CHONGQIN ROA QINGDAO 266002 CHINA 59: 受益人 青岛青海有限公司 重庆路186号中国青岛266002（邮编） 32B: CURRENCY CODE, AMOUNT: USD58575，00 32B: 货币代码和金额 58575.00美元 39A：PRECENTAGE CREDIT AMOUNT TOLERANCE 10/10 39A: 信用证金额上下浮动百分比10/10（10%） 41A: A V AILABLE WITH.. BY.. CITIUS33LAX BY DEFERRED PAYMENT

法律尽职调查提纲问卷-中英文版

Reply Date 回复日期: 201 年_____月_____日 有关某某公司 的 初步法律尽职调查问卷 1

Reply Date 回复日期: 201 年_____月_____日 Preliminary Due Diligence Checklist 初步法律尽职调查问卷 致某某公司： It is important that we receive the relevant information about China Hualian Group Investment Holdings Limited (the “Company”) as set out in the list below. During the due diligence exercise, we may send the Company supplemental due diligence checklist and request further documents and/or information from the Company. 请贵公司就下列表格所述提供相关文件及信息，这对于本次法律尽职调查至关重要。随着法律尽职调查工作的不断深入和具体情况的变化，我所将向贵公司发出补充尽职调查清单并向贵公司索取进一步的文件及/或信息。 In respect of each listed item below, please provide a copy of the document (unless otherwise stated). Also, please return this checklist by indicating ‘Yes’ if the documents have been provided to us together with this checklist, ‘No’ if the documents have not been provided yet, or ‘N.A.’ if the items are not applicable to the Company and confirm that the Company does not have such document(s) and/or arra ngement(s). If the document has not been provided yet or is not applicable, please provide a brief explanation as to the reason that it has not been provided or is not applicable. In case an answer to the question is necessary, please give your answer below the question or in separate sheet(s) attached hereto. 就如下列出的每一个事项，请提供相关文件的复印本（除非另有定明）。在作出回复时, 若相关文件已经连同本清单提供给我们，请在清单中注明“已提供”；如文件尚未被提供，请在清单中注明“未能提供”；如相关事项不适用，则请在清单中注明“不适用”并确认公司无该等文件及/或安排。若未能提供相关文件或相关文件不适用时，请简单说明未能提供的理由或不适用的原因。若需要作出详细回馈，请在问题的下方书写或另附上附页。 2