《《ISO_9001-2016%28中英文%29共33页》.doc

ISO 9001:2008 English – Chinese Bilingual Quality management system – Requirement 质量管理体系 – 要求 Copyright reserved, for reference to Intertek systems certification customers only ISO 9001:2008 Introduction 引言 0.1 General 总则 The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organizations quality management system is influenced by a) its organizational environment, changes in that environment, and the risks associated with that environment, b) its varying needs, c) its particular objectives, d) the products it provides, e) the processes it employs, f) its size and organizational structure. 采用质量管理体系应当是组织的一项战略性决策。一个组织质量管理体系的设计和实施受下列因素的影 响： a) 组织的业务环境、该环境的变化或与该环境有关的风险， b) 组织的不同需求， c) 组织的特定目标， d) 所提供的产品， e) 所采用的过程， f) 组织的规模和组织结构。 It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation. 统一质量管理体系的结构或文件不是本标准的目的。 The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement. 本标准所规定的质量管理体系要求是对产品要求的补充。“注”是帮助理解、澄清有关要求的参考性信息。 This International Standard can be used by internal and external parties, including certification bodies, to assess the organizations ability to meet customer, statutory and regulatory requirements applicable to the product, and the organizations own requirements. 本标准能用于内部和外部各方（包括认证机构）评定组织满足顾客要求、适用的产品的法律法规要求和组织自身要求的能力。 The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard. 本标准的制定已经考虑了ISO 9000和ISO 9004中所阐明的质量管理原则。 0.2 Process approach 过程方法 This International Standard promotes the adoption of a process approach when developing,implementing and improving the effectiveness of a quality management system, to enhance customer s