质量管理（中-英）

质量管理体系总要求

General Requirements of the Quality Management System

1. 管理者代表负责质量管理体系的建立、实施、保持和质量管理体系有效的持续改进。

1. The management representative is responsible for the establishment, implementation, maintenance and continuous improvement of the quality management system.

2. 质量保证部是质量管理体系建立、实施、保持，并持续改进的归口管理单位，协助管理者代表开展日常质量管理体系的运行管理工作。

2. The Quality Assurance Department is in charge of the centralized management of the establishment, implementation, maintenance and continuous improvement of the quality management system, and it shall assist the management representative in routine quality management operations. 

3. 公司质量管理体系满足：

3. The quality management system shall meet the following requirements:

a) 采用以过程为基础的质量管理体系模式，GB/T19001-2000idtISO9001：2000《质量管理体系要求》标准中的过程都适用；

a) Adoption of a process-based quality management mode as described in the Quality Management Systems – Requirements (GB/T19001-2000idtISO9001:2000);

b) 识别质量管理体系所需的过程和这些过程的顺序和相互作用；明确各类人员质量职责；

b) Identification of the processes required by the quality management system and their sequence & interactions, as well as definition of the quality-related responsibilities of all personnel concerned;

c) 对已识别的过程的输入、输出、所需资源和应开展的活动作出明确的规定，给出对过程进行监视、测量和分析的方法。按照国家的法律法规和标准要求，编制公司质量管理体系文件及技术要求、工艺规范，为过程有效运行和控制提供所需要的准则和方法确保这些过程的有效运行；

c) Definition of input, output and required resources of the identified processes, necessary activities to be carried out, and methods to be adopted to monitor, measure and analyze the processes; compilation of related documents, technical requirements and procedure regulations applicable to the corporate quality management system in accordance with national laws, regulations and standards so as to provide necessary criteria and methods for effective operation and control of these processes; 

d) 通过对顾客要求的理解和企业的内部沟通，规定必要的资源保证途径和来源，确保已识别过程的有效运行和控制可以获得必要的资源和信息，以支持这些过程的运行和监视。

d) Formulation of regulations on the assurance methods and sources of necessary resources through understanding of customer demands and internal corporate communication to ensure effective performance of identified processes and control over necessary available resources and data, thus to support the operation and monitoring of these processes;

e) 通过对顾客满意程序的调查、产品的监视和测量、不合格品的控制、纠正和预防措施的控制、管理评审、内审等活动的开展，对已识别过程实施测量、监视和分析。

e) Measurement, monitoring and analysis of identified processes through customer satisfaction surveys, product monitoring and measurement, non-conformance control, corrective and preventative measures, administration appraisal and internal examination;

f) 必要时，通过对已识别过程运行的有效信息的分析结果制订措施，以实现对这些过程策划的结果和这些过程的持续改进；

f) Proposal of measures for the analytical results of effective data about the identified processes operation when necessary, to make continuous improvements to the planning efficiency and the process performance;

g) 识别产品实现的直接过程中，所有影响产品符合性的外包过程并对其实施控制，确保对外包过程的控制按GB／T19001－2000idtISO9001：2000标准中7.4条款的要求予以规定。

g) Identification and control of all outsourcing processes that may influence the product conformity in the direct processes of product realization, to ensure that the outsourcing processes are controlled in line with Clause 7.4 in GB/T19001－2000idtISO9001:2000.