ISO程序文件中英文版04设计和开发控制程序

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1/15 Version :B/1 Revised Version : B/0 Revision Effective Date : File Name :设计和开发控制程序Design and Development Procedure Edited by :ISO Office

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 process also the collaboration of technology.

3.8其他各部门负责完成董事总经理交办的产品配套性开发项目的协作和完

善工作。

Version :B/1 Revised Version : B/0 Revision Effective Date : File Name :设计和开发控制程序Design and Development Procedure Edited by :ISO Office

Other Departments shall be responsible for completing job of coordinating and perfecting the Production Assembling Development

Project which is ordered by Director General.

4. 工作程序Procedures for work

4.1设计方案制定流程Procedures for formulating the “Design

Brief”

4.1.1市场部或其它部门人员通过整理市场调查,提出产品开发建议,编写

“产品开发建议书”,报董事总经理审批.

Marketing Dept. or other party may, through the collation of market intelligence, evolve a product concept .When this happens, a “Product Development Proposal” is submitted to the Director General for approval.

4.1.2董事总经理根据公司人力资源情况,以及通过对竞争对手的产品分析,

审批“产品开发建议”;必要时,召集技术总监、营运总监、市场总监、及其它各部