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 a) 组织的业 、该环境的变 ， b) 组织的不同需求， c) 组织的特定目标， d) 所提供的产 ， e) 所采用的过程， f) 组织的规模 。 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 息。 。“注”是帮 、澄清有关要求的参考性信 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 组织自身要求的能 。 （ ）评定组织满足顾客要求、适用的产 The quality manageme