8.3、产品和服务的设计和开发

注：条款8.3的适应性应根据4.3章节及附件A（见A.5）来决定。

8.3.1、总则

组织应建立、实施和保持适当的设计和开发过程，以确保后续的产品和服务的提供。

8.3.2、设计和开发策划

在确定设计和开发的各个阶段和控制时，组织应考虑：

a）设计和开发活动的性质、持续时间和复杂程度；

b）所需的过程阶段，包括适用的设计和开发评审；

c）所需的设计和开发验证、确认活动；

d）设计和开发过程涉及的职责和权限；

e）产品和服务的设计和开发所需的内部、外部资源：

f）设计和开发过程参与人员之间接口的控制需求；

g）顾客及使用者参与设计和开发过程的需求；

h）对后续产品和服务提供的要求；

i）顾客和其他有关相关方期望的对设计和开发过程的控制水平；

j）证实已经满足设计和开发要求所需的成文信息。

当适用时，组织应将设计和开发工作分解为不同的活动，并对每项活动，确定任务、必需的资源、职责、设计内容、输入和输出。

设计和开发策划应考虑提供、验证、测试和维护产品和服务的能力（参见8.1a 的输出）。

8.3 Design and Development of Products and Services

NOTE: Clause 8.3 applicability should be determined in accordance with section 4.3 and Annex A (see A.5).

8.3.1、General

The organization shall establish, implement, and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services.

8.3.2、Design and Development Planning

In determining the stages and controls for design and development, the organization shall consider:

a. the nature, duration, and complexity of the design and development activities;

b. the required process stages, including applicable design and development reviews;

c. the required design and development verification and validation activities;

d. the responsibilities and authorities involved in the design and development process;

e. the internal and external resource needs for the design and development of products and services;

f. the need to control interfaces between persons involved in the design and development process;

g. the need for involvement of customers and users in the design and development process;

h. the requirements for subsequent provision of products and services;

i. the level of control expected for the design and development process by customers and other relevant interested parties;

j. the documented information needed to demonstrate that design and development requirements have been met.