ISO9001-2015 标准中英文

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:

/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。

/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。

< br>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。

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

< br>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