ISO程序文件英文版04设计和开发控制程序.doc

Version：B/1 Version：B/1 Revised Version： B/0 Revision Effective Date： File Name：设计和开发控制程序 File Name：设计和开发控制程序Design and Development Procedure Edited by：ISO Office PAGE PAGE 1/15 Author： Checked by： Approved by： 1. 目的：对产品设计开发全过程进行控制，确保设计和开发的新产品满足规定的要求。 Purpose：Control the whole process of product design and development to ensure that the design and development of new product meet the stated requirements. 2. 适用范围：适用于产品设计和开发的全过程。 Applicable Scope：Apply to the whole process of product design and development. 3. 职责Responsibility： 3.1董事总经理负责设计开发项目的立项、设计输入及试产交接会的组织和批准工作。 The Director General shall be responsible for approving the establishment of design and development project, design input and organizing the meeting for hand-over of pre-production . 3.2技术总监领导负责产品的设计开发全过程的组织协调及审批工作。 The C.T.O will organize and coordinate the overall process of design and development of product, take charge of audit and approval as well. 3.3项目工程师负责统筹产品的设计开发、型式试验及组织设计开发过程中产品的装配测试工作。 The project engineer shall be in charge of coordinating the design and development and type-test of product, organize the work related to assembly and test during the process of design and development. 3.4 生产技术部负责配合执行产品测试及试验工作，组织产品试产，组织生产装配工艺文件和检验文件的编制及审核工作。 The Production Technique Dept. shall provide cooperation for test and inspection, organize the pre-production, in addition, prepare and approve the production and assembly technology and inspection documents. 3.5品保部负责编制检验标准/规程，参与新产品样品的验证及试产过程中各阶段的检验测试工作。 The QC Dept. will draft the test criterion/ instruction, involve in verification for the sample of new product, also the test and inspection at every stage of pre-production. 3.6采购部负责协调设计开发过程中所需物资的采购工作。 The Purchasing Department will involve in ordering of material needed in the process of design and development . 3.7 生产技术部负责设计开发过程的样品试制和工艺协作。 The Production Technique Dept. shall be responsible for building prototypes in the design and development p