3、术语与定义

本国际标准采用 ISO9000:2015 中的以及下列的 术语与定义。.

在本标准中，特意使用术语“生产商”是为了清晰地描述产品的创造者与组织之间的关系。术语“外部供应商”和原始生产商某些情况下是同一个含义。

外部供应商（生产商/供应商） → 组织 → 顾客

3.1、件

由设计单位列出的、使用安装到产品里/上或包含在监管机关批准的设计数据中的材料、零件、组件、总成或装置。

3、TERMS AND DEFINITIONS

For the purposes of this document, the terms and definitions given in ISO 9000:2015 and the following apply.

Within this standard, the term manufacturer is intentionally used to clearly delineate the relationship between the product creator and the organization. The terms external provider and original manufacturer can be synonymous.

external provider (manufacturer / provider) organization customer

3.1、Article

Material, part, component, assembly, or appliance which is listed by the design organization as eligible for installation in/on the product or included in the design data approved by the authority.