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1、目录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 组织的背景4.1 Understanding the organization and its context 理解组织及其背景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 syste
2、m 质量管理体系范围的确定4.4 Quality management system 质量管理体系5 Leadership 领导作用5.1 Leadership and commitment 领导作用和承诺5.2 Quality policy 质量方针5.3 Organizational roles, responsibilities and authorities 组织的作用、职责和权限6 Planning 策划6.1 Actions to address risks and opportunities 风险和机遇的应对措施6.2 Quality objectives and plannin
3、g to achieve them 质量目标及其实施的策划6.3 Planning of changes 变更的策划7 Support 支持7.1 Resources 资源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8 Operation 运行8.1 Operational planning and control 运行的策划和控制8.2 Determination of market needs and interactions with customers 市场
4、需求的确定和顾客沟通8.3 Operational planning process 运行策划过程8.4 Control of external provision of goods and services 外部供应产品和服务的控制8.5 Development of goods and services 产品和服务开发8.6 Production of goods and provision of services 产品生产和服务提供8.7 Release of goods and services 产品和服务放行8.8 Nonconforming goods and services 不
5、合格产品和服务9 Performance evaluation 绩效评价9.1 Monitoring, measurement, analysis and evaluation 监视、测量、分析和评价9.2 Internal Audit 内部审核9.3 Management review 管理评审10 Continual improvement 持续改进10.1 Nonconformity and corrective action 不符合和纠正措施10.2 Improvement 改进附录A Annex A Quality management principles (Informative
6、)质量管理原则文献1. Scope 范围This International Standard specifies requirements for a quality management system where an organization 本标准为有下列需求的组织规定了质量管理体系要求：a）needs to demonstrate its ability to consistently provide goods and services that meet customer and applicable statutory and regulatory requirements,
7、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 continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements 通过体系的的有效应用，包括
8、体系持续改进的过程，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。注 1：In this International Standard, the term “product” only applies to 在本标准一中，术语“产品”仅适用于：a) goods and services intended for, or required by, a customer, and 预期提供给顾客或顾客所要求的商品和服务；b) any intended output resulting from the operational processes 运行过程所产生的任何预期输出。注 2：St
9、atutory and regulatory requirements can be expressed as legal requirements 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 referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest
10、edition of the referenced document (including any amendments) applies 下列文件中的条款通过本标准的引用而构成本标准的条款。凡是注日期的引用文件，只有引用的版本适用。凡是不注日期的引用文件，其最新版本（包括任何修订）适用于本标准。ISO 9000:2015, Quality management systems Fundamentals and vocabulary GB/T19000-2015 质量管理体系 基础和术语243 Term and definitions 术语和定义For the purposes of this
11、 document, the terms and definitions given in ISO 9000 apply 本标准采用 GB/T19000 中所确立的术语和定义。4 Context of the organization 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
12、direction and that affect its ability to achieve the intended outcome(s) of its quality management system 组织应确定外部和内部那些与组织的宗旨、战略方向有关、影响质量管理体系实现预期结果的能力的事务。The organization shall update such determinations when needed 需要时，组织应更新这些信息。When determining relevant external and internal issues, the organizatio
13、n shall consider those arising from:在确定这些相关的内部和外部事宜时，组织应考虑以下方面：a) changesand trends which can have an impact on the objectives of the organization 可能对组织的目标造成影响的变更和趋势；b) relationships with, and perceptions and values of relevant interested parties 与相关方的关系， 以及相关方的理念、价值观；c) governance issues, strategic
14、 priorities, internal policies and commitments; and 组织管理、战略优先、内部政策和承诺；d) resource availability and priorities and technological change 资源的获得和优先供给、技术变更。注 1：Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, cultural, social, eco
15、nomic and natural environment, whether international, national, regional or local.外部的环境，可以考虑法律、技术、竞争、文化、社会、经济和自然环境方面，不管是国际、国家、地区或本地。注 2：When understanding the internal context the organization could consider those related to perceptions, values and culture of the organization.内部环境，可以组织的理念、价值观和文化。4.2
16、 Understanding the needs and expectations of interested parties 理解相关方的需求和期望The organization shall determine 组织应确定：a) the interested parties that are relevant to the quality management system, and 与质量管理体系有关的相关方b) the requirements of these interested parties 相关方的要求The organization shall update such determinations in order to unde
