ISO 9001 2015 FDIS版中英文版

FINAL

DRAFT ISO/TC 176/SC 2

Secretariat: BSI

Voting begins on:

2015-07-09

Voting terminates on:

2015-09-09

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INTERNATIONAL ISO/FDIS STANDARD 9001 Quality management systems — Requirements Systèmes de management de la qualité — Exigences Please see the administrative notes on page iii

质量管理体系要求

ISO/FDIS 9001:2015(E)

This final draft has been developed within the International Organization for Standardization (ISO), and

processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement. The final

draft was established on the basis of comments received during a parallel enquiry on the draft.

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parallel two-month approval vote in ISO and formal vote in CEN.

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? ISO 2015, Published in Switzerland

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ISO/FDIS 9001:2015(E)

Contents 目录

Foreword 前言

0 Introduction 引言

0.1 General 总则

0.2 Quality management principles 质量管理原则

0.3 Process approach 过程方法

0.4 Relationship with other management system standards 与其他管理体系标准的关系

1 Scope 范围

2 Normative references 规范性引用文件

3 Terms and definitions 术语和定义

4 Context of the organization 组织环境

4.1 Understanding the organization and its context 理解组织及其环境

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

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

4.4 Quality management system and its processes 质量管理体系及其过程

5 Leadership

5.1 Leadership and commitment 领导作用和承诺

5.1.1 General 总则

5.1.2 Customer focus 以顾客为关注焦点

5.2 Policy 方针

5.2.1 Developing the quality policy 制定质量方针

5.2.2 Communicating the quality policy 沟通质量方针

5.3 Organizational roles, responsibilities and authorities 、职责和权限

组织的岗位领导作用

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6 Planning for the quality management system 质量管理体系策划

6.1 Actions to address risks and opportunities 应对风险和机遇的措施

6.2 Quality objectives and planning to achieve them 质量目标及其实现的策划

6.3 Planning of changes 变更的策划

7 Support 支持

7.1 Resources 资源

7.1.1 General 总则

7.1.2 People 人员

7.1.3 Infrastructure 基础设施

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

7.1.5 Monitoring and measuring resources 监视和测量资源

7.1.6 Organizational knowledge 组织的知识

7.2 Competence 能力

7.3 Awareness 意识

7.4 Communication 沟通

7.5 Documented information 形成文件的信息

7.5.1 General 总则

7.5.2 Creating and updating 创建和更新

7.5.3 Control of documented information 形成文件的信息的控制

8 Operation 运行

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

8.2 Determination of requirements for products and services 产品和服务要求的确定

8.2.1 Customer communication 顾客沟通

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

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

8.2.4 Change to requirements for products and services 产品和服务要求的更改

ISO/FDIS 9001:2015(E)

8.3 Design and development of products and services 产品和服务的设计和开发

8.3.1 General 总则

8.3.2 Design and development planning 设计和开发策划

8.3.3 Design and development Inputs 设计和开发输入

8.3.4 Design and development controls 设计和开发控制

8.3.5 Design and development outputs 设计和开发输出

8.3.6 Design and development changes 设计和开发更改

8.4 Control of externally provided processes, products and services

外部提供过程、产品和服务的控制

8.4.1 General 总则

8.4.2 Type and extent of control 控制类型和程度

8.4.3 Information for external providers 外部供方的信息

8.5 Production and service provision 生产和服务提供

8.5.1 Control of production and service provision 生产和服务提供的控制

8.5.2 Identification and traceability 标识和可追溯性

8.5.3 Property belonging to customers or external providers 顾客或外部供方的财产

8.5.4 Preservation 防护

8.5.5 Post-delivery activities 交付后的活动

8.5.6 Control of changes 更改控制

8.6 Release of products and services 产品和服务的放行

8.7 Control of nonconforming process outputs 不合格输出的控制

9 Performance evaluation 绩效评价

9.1 Monitoring, measurement, analysis and evaluation 监视、测量、分析和评价

9.1.1 General 总则

9.1.2 Customer satisfaction 顾客满意

9.1.3 Analysis and evaluation 分析与评价

9.2 Internal audit 内部审核

ISO/FDIS 9001:2015(E)

9.3 Management review 管理评审

9.3.1 General 总则

9.3.2 Management review input 管理评审输入

9.3.3 Management review output 管理评审输出

10 Improvement 改进

10.1 General 总则

10.2 Nonconformity and corrective action 不合格和纠正措施

10.3 Continual improvement 持续改进

Annex A (informative) Clarification of new structure, terminology and concepts

附录A（资料性附录）新结构、术语和概念说明

Annex B (informative) Other International Standards on quality management and quality

management systems developed by ISO/TC176

附录B（资料性附录）ISO/TC176 开发的其他有关质量管理和质量管理体系的国际标准

Bibliography 参考文献

ISO/FDIS 9001:2015(E) Foreword 前言

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which

a technical committee has been established has the right to be represented on that committee.

International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see https://www.360docs.net/doc/be60663.html,/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent

rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see https://www.360docs.net/doc/be60663.html,/patents).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL:

https://www.360docs.net/doc/be60663.html,/iso/foreword.html.

The committee responsible for this document is Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 2, Quality systems.

This fifth edition cancels and replaces the fourth edition (ISO 9001:2008), which has been technically revised, through the adoption of a revised clause sequence and the adaptation of the revised quality management principles and of new concepts.

ISO/FDIS 9001:2015(E)

viii

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.

采用质量管理体系是组织的一项战略决策，能够帮助其提高整体绩效，

基础。

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.

组织根据本标准实施质量管理体系具有如下潜在益处：

a) 稳定提供满足顾客要求以及适用的法律法规要求的产品和服务的能力；；

b) 促成增强顾客满意的机会；

c) 应对与其环境和目标相关的风险和机遇；

d) 证实符合规定的质量管理体系要求的能力。

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.

- 统一不同质量管理体系的架构；

- 形成与本标准条款结构相一致的文件；

- 在组织内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.

本标准规定的质量管理体系要求是对产品和服务要求的补充。

This International Standard employs the process approach, which incorporates the Plan-Do-

Check-Act (PDCA) cycle and risk-based thinking.

为推动可持续发展奠定良好内部和外部各方均可使用本标准。

实施本标准并不意味着需要：

ISO/FDIS 9001:2015(E)

本标准采用过程方法，

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

过程方法能使组织策划其过程及其相互作用。

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

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).

基于风险的思维使得组织能确定可能导致其过程和质量管理体系偏离策划结果的各种因素，采取

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.

在日益复杂的动态环境中的一项挑战。为了实现这一目标，组织可能会发现，除了纠正和持续改进，还有必要采取各种形式

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.

在本标准中使用如下助动词：

表示要求；

表示建议；

表示允许；

表示可能或能够。

“注”是理解和说明有关要求的指南。

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

该方法结合了PDCA(策划、实施、检查、处置）循环与基于风险的思维。循环使得组织确保对其过程进行恰当管理，提供充足资源，确定改进机会并采取行动。预防控制，最大限度地降低不利影响，并最大限度地利用出现的机遇（见附录A.4）。

持续满足要求，并针对未来需求和期望采取适当行动，这无疑是组织面临的改进，比如变革突变、创新和重组。

“应”“宜”“可以”“能”

ISO/FDIS 9001:2015(E)

principle.

本标准是在ISO 9000所描述的质量管理原则基础上制定的。

The quality management principles are: 质量管理原则包括：

— customer focus 以顾客为关注焦点;

— leadership; 领导作用；

— engagement of people 全员参与；

— process approach 过程方法;

— improvement 改进;

— evidence-based decision making 循证决策；

— 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.

、

实施质量管理体系以及提高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。

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.

在实现其预期结果的过程中，系统地理解和管理相互关联的过程有助于提高组织的有效性和效率。

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.

过程方法包括按照组织的质量方针和战略方向，对各过程及其相互作用，系统地进行规定和管理，体系进行整体管理，从而有效利用机遇并防止发生非预期结果。

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：

每项原则的介绍均包含其释义、该原

则对组织重要性的理论依据，应用该原则的主要收益示例，以及应用该原则时组织绩效的典型改

进措施示例。本标准倡导在建立采用过程方法所需满足的具体要求见4.4。此的过程进行有效控制，以增强组织整体绩效。

种方法使组织能够对体系中相互关联和相互依赖从而实现预期结果。可通过采用PDCA 循环（见0.3.2）以及基于风险的思维（见0.3.3）对过程和

ISO/FDIS 9001:2015(E)

a) understanding and consistency in meeting requirements;

理解并持续满足要求；

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

从增值的角度考虑过程；

c) the achievement of effective process performance;

获得有效的过程绩效；

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

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.

这些检查点根据不同的风险有所不同。

Figure 1 — Schematic representation of the elements of a single process

单一过程各要素的相互作用如图1所示。每一过程均有特定的监视和测量检查点，以用于控制，

ISO/FDIS 9001:2015(E)

图1：单一过程要素示意图 0.3.2 Plan-Do-Check-Act cycle 策划-实施-检查-处置循环

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以及作为整体的质量管理体系。本标准第4章至第10章内容在PDCA

循环的应用如图２所示。

ISO/FDIS 9001:2015(E)

Figure 2 — Representation of the structure of this International Standard in the PDCA

cycle

图2：本

The PDCA cycle can be briefly described as follows:

PDCA 循环可以简要描述如下：

— 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; 策划：建立体系及其过程的目标、配备所需的资源，以实现与顾客要求和组织方针相一致的结果；

— Do : implement what was planned;

实施：实施所做的策划；

— Check : monitor and (where applicable) measure processes and the resulting products and

services against policies, objectives and requirements and report the results;

检查：根据方针、目标和要求对过程以及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.

处置：必要时，采取措施提高绩效。

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.

注：括号中的数字表示本标准的相应章节。

标准的基本结构适用PDCA 循环示

意图

ISO/FDIS 9001:2015(E)

行分析，并采取适当措施防止其再次发生。

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.

为了满足本标准的要求，组织需策划和实施应对风险和利用机遇的措施。应对风险和利用机遇

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.

产品和服务、减少浪费或提高生产率的一系列情形。利用机遇也可能需要考虑相关风险。风险

是不确定性的影响，不确定性可能是正面或负面的影响。风险的正面影响可能提供改进机遇，

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ISO 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.

本标准使组织能够使用过程方法，并结合PDCA 循环和基于风险的思维，将其质量管理体系要求与

This International Standard relates to ISO 9000 and ISO 9004 as follows:

本标准与 ISO 9000 和 ISO 9004 存在如下关系：

— ISO 9000 Quality management systems — Fundamentals and vocabulary provides essential

background for the proper understanding and implementation of this International Standard;

ISO 9000 为正确理解和实施本标准提供必要基础；

— 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.

ISO 9004 为组织选择超出本标准要求的质量管理方法提供指南。. Annex B provides details of other International Standards on quality management and quality

management systems that have been developed by ISO/TC 176.

基于风险的思维（见附录A.4）对质量管理体系有效运行是至关重要的。本标准以前的版本已经

隐含基于风险思维的概念，例如：采取预防措施消除潜在的不合格原因，对发生的不合格问题进

可为提高质量管理体系有效性、实现改进结果以及防止不利影响奠定基础。

机遇的出现可能意味着某种有利于实现预期结果的局面，例如：有利于组织吸引顾客、开发新

但并非所有的正面影响均可提供改进机遇。

制定的管理体系标准框架，以提高与其他管理体系标准的兼容性（见附录A.1

）。其他管理体系标准要求进行协调或整合。

《质量管理体系基础和术语》《追求组织的持续成功质量管理方法》

ISO/FDIS 9001:2015(E)

附录B 给出了的

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.

本标准不包括针对环境管理、职业健康和安全管理或财务管理等其他管理体系的特定要求。

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.

其中的某些标准规定了质量

管理体系的附加要求，

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.360docs.net/doc/be60663.html,/tc176/sc02/public .

质量管理和质量保证技术委员会（ISO TC/176）制定的其他质量管理和质量管理体系标准的详细信息。

在本标准的基础上，已经制定了若干行业特定要求的质量管理体系标准。而另一些标准则仅限于提供在特定行业应用本标准的指南。本标准的章节内容与之前版本（ISO 9001:2008）章节内容之间的对应关系见ISO/TC 176/SC 2

（国际标准化组织/质量管理和质量保证/质量体系分委员会）的公开网站：https://www.360docs.net/doc/be60663.html,/tc176/sc02/

public 。

FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 9001:2015(E)

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:

本标准为下列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

需要证实其具有稳定地提供满足顾客要求和适用法律法规要求的产品和服务的能力；

b) aims to enhance customer satisfaction through the effective application of the system, including

processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

通过体系的有效应用，包括体系改进的过程，以及保证符合顾客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.

本标准规定的所有要求是通用的，旨在适用于各种类型、不同规模和提供不同产品和服务的组织。

NOTE 1 In this International Standard, the terms “product” or “service” only apply to products and services intended for, or required by, a customer.

注1：在本标准中，仅适用于预期提供给顾客或顾客所要求的产品和服务；

术语“产品”或“服务”

NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.

注2：法律法规要求可称作为法定要求。

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.

下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件，仅注日期的版本适用于本文件。凡是不注日期的引用文件，其最新版本（包括所有的修改单）适用于本文件。

ISO 9000:2015, Quality management systems — Fundamentals and vocabulary

ISO 9000:2015 质量管理体系基础和术语

ISO/FDIS 9001:2015(E)

For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply.

ISO 9000:2015界定的术语和定义适用于本文件。

4 Context of the organization 组织环境

4.1 Understanding the organization and its context 理解组织及其环境

The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.

组织应确定与其目标和战略方向相关并影响其实现质量管理体系预期结果的各种外部和内部因素。 The organization shall monitor and review information about these external and internal issues.

组织应对这些内部和外部因素的相关信息进行监视和评审。

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

注1：这些因素可以包括需要考虑的正面和负面要素或条件。

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：考虑国际、国内、地区和当地的各种法律法规、技术、竞争、市场、文化、社会和经济因素，有助于理解外部环境。

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

注3：考虑组织的价值观、文化、知识和绩效等相关因素，有助于理解内部环境。

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 and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:

由于相关方对组织持续提供符合顾客要求和适用法律法规要求的产品和服务的能力产生影响或潜在影响，

a) the interested parties that are relevant to the quality management system;

与质量管理体系有关的相关方；

b) the requirements of these interested parties that are relevant to the quality management system. 与质量管理体系有关的相关方的要求。

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

组织应对这些相关方及其要求的相关信息进行监视和评审。

因此，组织应确定：

ISO/FDIS 9001:2015(E)

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.

组织应明确质量管理体系的边界和适用性，以确定其范围。

When determining this scope, the organization shall consider:

在确定范围时，组织应考虑：

a)the external and internal issues referred to in 4.1;

各种内部和外部因素，见4.1；

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

ISO 9001 2015 FDIS版 中英文版

ISO 9001 2015 FDIS版中英文版