ISO9001:2026CD版介绍 01 QUALITY MANAGEMENT SYSTEMS – REQUIR
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ISO9001:2026CD版介绍 01
QUALITY MANAGEMENT SYSTEMS – REQUIREMENTS 质量管理体系——要求1SCOPE 1 范围
This Document specifies requirements for a quality management system when an organization:
本文件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
a）需要证实其具有持续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.
b）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 Document are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
本文件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 Document , the terms “product” or “service” only apply to products and services intended for, or required by, a customer.
注 1：在本文件中，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；
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.
注 2：法律法规要求可称作法定要求。
变化点： 本国际标准这词改成本文件，这应是普遍标准使用词语的改进
2NAORMATIVE REFERENCES2引用标准
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 9000CD, Quality management systems — Fundamentals and vocabulary
ISO 9000CD 质量管理体系 基础和术语
3TERMS AND DEFINITIONS3 术语和定义
For the purposes of this document, the terms and definitions given in lSO/cD 9000 including the following apply.
为便于本文件的理解，ISO/CD 9000中给出的术语和定义(包括以下内容)适用
lS0 and lEC maintain terminology databases for use in standardization at the following addresses.ISO 和IEC 在以下地址维护用于标准化的术语数据库:
1S0 Online browsing platform: available at https /^www iso.org/obp
1S0 在线浏览平台:可从https://www.iso.orgiobp
获取EC Electropedia:available at https./www.electropedia .com。
IEC电工术语:可从https://www.electropedia.or获取
变化点：增加了引用的术语网站，是为了便于查询，很多其它标准早已这样写。此外新版在此条款下面列出了主要的术语，这些术语还是来自于ISO9000，应是为了使用者查找。我记得ISO14001/ISO27001等也是这样写法，术语的就不一一列出。
4CONTEXT OF THE ORGANIZATION 4 组织的背景环境
4.1UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT 理解组织及其背景环境
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.
组织应确定与其宗旨和战略方向相关并影响其实现质量管理体系预期结果的能力的各种外部和内部因素。
The organization shall monitor and review information about these external and internal issues.
组织应确定气候变化是否是相关因素。
The organization shall monitor and review information, about these extremal and intimal 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：这些因素可能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 leg technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local.
注 2：考虑来自于国际、国内、地区和当地的各种法律法规、技术、竞争、市场、文化、社会和经济环境因素，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：考虑与组织的价值观、文化、知识和绩效等有关的因素，有助于理解内部环境。
变化点： 气候变化因素前二年ISO组织已发布过修订单，ISO组织参与了气候变化应对行动，所以几乎所有的标准都加了这个要求。
4.2UNDERSTANDING THE NEEDS AND EXPECTIATIONS 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具有影响或潜在影响，因此，组织应确定：
a) the interested parties that are relevant to the quality management system; a）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.
b）与质量管理体系有关的相关方的要求。
c) which of these requirements will be addressed through the quality management system
c)通过质量管理体系将解决哪些要求。
The organization shall monitor and review infomation about these interested parties and their relevant requirements.
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。
变化点：增加了质量体系可以解决的相关方要求，当然相关方要求很多，可能只有小部分才可以通过体系解决，如产品价格要求，所以在识别时明确是必要的。
4．3DETERMINING THE SCOPE OF THE QUALITY MANAGEMENTS 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.
应确定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;
a）内部和外部因素，见 4.1；
b)the requirements of relevant interested parties referred to in 4.2; b）有关相关方的要求，见 4.2；
c)the products and services of the organization. c）组织的产品和服务。
The organization shall apply all the requirements of this Document if they are applicable within the determined scope of its quality management system.
如果本文件的全部要求适用于组织确定的质量管理体系范围,组织应遵循本文件的全部要求。
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 Document 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作为形成文件的信息,可获得并得到保持。该范围应描述所覆盖的产品和服务类型，如果组织确定本文件的某些要求不适用于其质量管理体系范围，应说明理由。
conformity to this document 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 its products and services and the enhancement of customer satisfaction.
只有当所确定的不适用的要求不影响组织确保其产品和服务合格的能力或责任，对增强顾客满意也不会产生影响时。方可声称符合本文件的要求。
变化点：就本标准改成本文件，其它无变化。
4.4QUALITY 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 Document .
组织应按照本文件的要求，建立、实施、保持和持续改进质量管理体系，包括所需过程及其相互作用。
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，且应：
a) determine the inputs required and the outputs expected from these processes; a）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; b）确定这些过程的顺序和相互作用；
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;
c）确定和应用所需的准则和方法（包括监视、测量和相关绩效指标），以确保这些过程有效的运行和控制；
d) determine the resources needed for these processes and ensure their availability; d）确定这些过程所需的资源并确保其可用性；
e) assign the responsibilities and authorities for these processes; e）分派这些过程的职责和权限；
f) address the risks and opportunities as determined in accordance with the requirements of 6.1; f）应对按照 6.1 的要求所确定的风险和机遇；
g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;
g） 评价这些过程，实施所需的变更，以确保实现这些过程的预期结果；
h) improve the processes and the quality management system. h）改进过程和质量管理体系。
4.4.2 Documented information shall be available to the extent necessary.
4.4.2 形成文件的信息应在必要的范围和程度上可获取:
a)to support the operation of its processes,
a)支持其过程的运行:
b) as evidence that the processes are being carried out as planned
b)作为过程按策划执行的证据
变化点：直接改成成文件信息可获得，按成文信息存在的目的来写，B这条原来是这个：保留确认其过程按策划进行的形成文件的信息。改成证据可获得更符合实际。
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