IS09001:2026质量管理体系标准CD QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS 一要求 质量管理体系 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 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。 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； 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 ISO/cD 9000 including the following apply. ISO and IEC 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 1so 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 4CONTEXT OFTHE ORGANIZATION 4组织的背景环境 4.1 UNDERSTANDING 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。 4.2 UNDERSTANDING 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 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 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