对ISO9001标准中设计和开发的理解

In ISO9001 standard understanding of design and exploitation

在质量管理体系推行中，对设计和开发条款的控制要点的理 解如下：

In the quality management system is carried out in, for the design and development of control points and solution conditions are as follows:

7.3.1设计和开发策划

7.3.1 design and development planning

        组织应对产品的设计 和开发进行策划和控制。

The organization shall plan and control the design and development.

        在进行设计和开发策划时，组织应确定：

During the design and development planning, the organization shall determine:

        a)   设计和开发阶段；

A ) the design and development stage;

        b)   适合每个设计和开发阶段的评审、验证和确认活动 ；

B ) are appropriate to each design and development stage of the review, verification and validation activities;

        c)   设计和开发的职责和权限。

C ) responsibilities and authorities for design and development.

        组织应对参与设计和开发不同小组之间的接口实施管理，以确保有 效的沟通，并明确职责分工。

Participate in the design and development organization shall manage the interfaces between different groups, to ensure effective communication and clear division of responsibilities.

        适当时，随设计和开发的进展，策划 的输出应予以更新。

When appropriate, as the design and development progresses, planning output shall be updated.

        A：定义：

A: definition:

         设计和开发策划：在对任何型号的产品进行设计和开发之前 的前期准备工作。如明确各阶段的职责、权限以及相关资源等等。

Design and development planning: in any type of product design and development of the preparatory work before. As the stage of the duties, rights and related resources.

        B ：理解要点：

B: understand the main points:

        1、设计和开发：是将要求转换成规定的特性或产品的 一组规范性过程。

1, design and development: the requirements into specified characteristics or product a group of normative process.

        2、工艺设计可按也可不按本条款进行控制。

2, process design can be or not according to the terms of control.

        3、对产品的设计和开发的策划包括：

In 3, the product design and development planning:

        a.   针对产品确定设计和开发过程的各个阶段， 包括完成期限。例如：对硬件产品，策划了方案确认、初步设计、详细设计、设计定型、生产定型阶段，有可能还有试产阶段、试销 阶段。

A. For product design and development stages of the process, including the time of completion. For example: for hardware products, planning scheme confirmation, preliminary design, detailed design, design, production of stereotypes, and possibly trial production phase, trial stage.

        b.   针对a条中各个阶段确定相适应的评审、验 证、确认的活动。

B. According to a in various stages define suitable evaluation, inspection certificate, validation activities.

        c.   确定每项活动的完成期限 时间及相互责任部门/人员。

C. Determine each activity deadline time and mutual responsibility departments / personnel.

        d.   对参加设计和开发的 不同小组之间的接口职责应明确，并规定沟通方式。

D. To participate in the design and development of the interfaces between different groups responsibilities shall be clearly specified, and communication method.

        e.   策划的输出应随设计和开发工作进展而及时修改。

E. The output of the planning should follow design and development work in progress and timely modification.

7.3.2设计和开发输 入

Design and development of transmission in 7.3.2

        应确定与产品要求有关的输入，并保持记录（见4.2.4）。这些输 入应包括：

Shall determine inputs relating to product requirements, and maintain records ( see 4.2.4 ). These should be included into the:

        a)   功能和性能要求；

A ) functional and performance requirements;

        b)   适用时，以前类似设计提供的信息；

B ) when applicable, information derived from previous similar designs;

        c)   设计和开发所必需的其他要求。