ISO9001-GBT19001-2015FDIS中英文对照版(8)

c) include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria;

c) 适当时，包含或引用监视和测量要求以及接收准则；

d) specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision.

d) 规定了产品和服务的预期目的以及安全和正常提供所必须的产品和服务的特性。 8.3.6 Design and development changes 设计和开发的更改【7.3.7】

Design and development changes The organization shall identify, review and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements.

组织应识别、评审产品和服务的设计和开发期间或后续过程中对产品和服务的设计和开发的更改并进行必要的控制，以确保对符合要求没有负面影响。

The organization shall retain documented information on:

组织应保持以下方面的文件化信息：

8.4 Control of externally provided processes, products and services 外部提供的过程、产品和服务的控制【4.1 7.4】

8.4.1 General 总则【7.4.1】

The organization shall ensure that externally provided processes, products and services conform to requirements.

组织应确保外部提供的过程、产品和服务符合要求。

The organization shall determine the controls to be applied to externally provided processes, products and services when:

当以下情况时，组织应确定要应用的对外部提供的过程、产品和服务的控制：

a) products and services from external providers are intended for incorporation into the organization’s own products and services;

a) 外部供方提供的产品和服务用于并入组织自己的产品和服务；

b) products and services are provided directly to the customer(s) by external providers on behalf of the organization;

b) 由外部供方代表组织直接提供给顾客的产品和服务；

c) a process, or part of a process, is provided by an external provider as a result of a decision by the organization.

c) 由外部供方提供的作为组织决定结果的过程或过程的一部分。

The organization shall determine and apply criteria for the evaluation, selection, monitoring of

performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements.

The organization shall retain documented information of these activities and any necessary actions arising from the evaluations.