8.3产品和服务的设计和开发

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和确认活动；

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和外部资源：

f. 设计和开发过程参与人员之间接口的控制需求；

g. 顾客和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形成文件的信息。

适当时，组织应将设计和开发工作划分为不同的活动，对每项活动，确定任务、必要的资源、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、试验和维护产品和服务的能力（参考8.1a输出）。

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.

When appropriate, the organization shall divide the design and development effort into distinct activities and, for each activity, define the tasks, necessary resources, responsibilities, design content, and inputs and outputs.

Design and development planning shall consider the ability to provide, verify, test and maintain products and services (reference output of 8.1 a).