摘要：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。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。

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Quality managementsystems — Requirements

质量管理体系要求

1Scope范围

This International Standard specifies requirements fora quality management system when an organization:

a) needs to demonstrate its ability to consistentlyprovide products and services that meet customer

and applicable statutory and regulatory requirements,and

b) aims to enhance customer satisfaction through theeffective application of the system, including processes for improvement of thesystem and the assurance of conformity to customer and applicable statutory andregulatory requirements.

All the requirements of this International Standardare generic and are intended to be applicable to any organization, regardlessof its type or size, or the products and services it provides.

NOTE 1 In this International Standard, theterms “product” or “service” only apply to products and services

intended for, or required by, a customer.

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

本标准为有下列需求的组织规定了质量管理体系要求：

a) 需要证实其有能力稳定地提供满足顾客要求和适用的法律法规要求的产品或服务；

b) 通过体系的有效应用，包括体系改进过程的有效应用，以及保证符合顾客要求和适用的法律法规要求，旨在增强顾客满意。

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

注1：本标准中，术语“产品”或“服务”仅适用于预期提供给顾客或顾客所要求的产品和服务。

注2：法律法规要求可称作法定要求。

2Normative references规范性引用文件

The following documents, in whole or in part, arenormatively referenced in this document and are indispensable for itsapplication. 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

3Terms and definitions术语和定义

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

本标准采用ISO 9000:2015中的术语和定义。

4Context of the organization组织的环境

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

The organization shall determine external and internalissues that are relevant to its purpose and its strategic direction and thataffect its ability to achieve the intended result(s) of its quality managementsystem.

The organization shall monitor and review informationabout these external and internal issues.

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

NOTE 2 Understanding the external context canbe facilitated by considering issues arising from legal, technological,competitive, market, cultural, social and economic environments, whetherinternational, national, regional or local.

NOTE 3 Understanding the internal context canbe facilitated by considering issues related to values, culture, knowledge andperformance of the organization.

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

组织应监视和评审有关内部和外部环境的信息。

注1：环境可能是正面或负面的因素或要考虑的状况；

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

注3：可以通过考虑与价值、文化、知识和组织绩效相关的情况，促进对内部环境的了解。

4.2Understanding 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 theorganization’s ability to consistently provide products and services that meetcustomer and applicable statutory and regulatory requirements, the organizationshall determine:

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

b) the requirements of these interested parties thatare relevant to the quality management system.

The organization shall monitor and review informationabout 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。

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

The organization shall determine theboundaries and applicability of the quality management system

to establish its scope.

When determining this scope, theorganization shall consider:

a) the external and internal issuesreferred to in 4.1;

b) the requirements of relevant interestedparties referred to in 4.2;

c) the products and services of theorganization.

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

The scope of the organization’s qualitymanagement system shall be available and be maintained as documentedinformation. The scope shall state the types of products and services covered,and provide justification for any requirement of this International Standardthat the organization determines is not applicable to the scope of its qualitymanagement system.

Conformity to this International Standardmay only be claimed if the requirements determined as not being applicable donot affect the organization’s ability or responsibility to ensure theconformity of its products and services and the enhancement of customersatisfaction.

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。

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

4.4.1 Theorganization shall establish, implement, maintain and continually improve aquality management system, including the processes needed and theirinteractions, in accordance with the requirements of this InternationalStandard.

The organization shall determine theprocesses needed for the quality management system and their applicationthroughout the organization, and shall:

a) determine the inputs required and theoutputs expected from these processes;

b) determine the sequence and interactionof these processes;

c) determine and apply the criteria andmethods (including monitoring, measurements and related performance indicators)needed to ensure the effective operation and control of these processes;

d) determine the resources needed forthese processes and ensure their availability;

e) assign the responsibilities andauthorities for these processes;

f) address the risks and opportunities asdetermined in accordance with the requirements of 6.1;

g) evaluate these processes and implementany changes needed to ensure that these processes achieve their intendedresults;

h) improve the processes and the quality managementsystem.

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 theextent necessary, the organization shall:

a) maintain documented information tosupport the operation of its processes;

b) retain documented information to have confidencethat 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。

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