7.1.1、总则
组织应确定并提供所需的资源,以建立、实施、保持和持续改进质量管理体系。
组织应考虑:
a)现有内部资源的能力和局限;
b)需要从外部供方获得的资源。
7.1.2、人员
组织应确定并配备所需的人员,以有效实施质量管理体系,并运行和控制其过程。
7.1.3、基础设施
组织应确定、提供并维护所需的基础设施,以运行过程,并获得合格产品和服务。
注:基础设施可包括:
a)建筑物和相关设施;
b)设备,包括硬件和软件;
c)运输资源;
d)信息和通讯技术。
7.1.4、程运行环境
组织应确定、提供并维护所需的环境,以运行过程,并获得合格产品和服务。
注:适宜的过程运行环境可能是人为因素与物理因素的结合,例如:
a)社会因素(如非歧视、安定、非对抗);
b)心理因素(如减压、预防过度疲劳、稳定情绪);
c)物理因素(如温度、热量、湿度、照明、空气流通、卫生、噪声)。
由于所提供的产品和服务不同,这些因素可能存在显著差异、
7.1.1、General
The organization shall determine and provide the resources needed for the establishment, implementation, maintenance, and continual improvement of the quality management system.
The organization shall consider:
a. the capabilities of, and constraints on, existing internal resources;
b. what needs to be obtained from external providers.
7.1.2、People
The organization shall determine and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes.
7.1.3、Infrastructure
The organization shall determine, provide, and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services.
NOTE: Infrastructure can include:
a. buildings and associated utilities;
b. equipment, including hardware and software;
c. transportation resources;
d. information and communication technology.
7.1.4、Environment for the Operation of Processes
The organization shall determine, provide, and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services.
NOTE: A suitable environment can be a combination of human and physical factors, such as:
a. social (e.g., non-discriminatory, calm, non-confrontational);
b. psychological (e.g., stress-reducing, burnout prevention, emotionally protective);
c. physical (e.g., temperature, heat, humidity, light, airflow, hygiene, noise).
These factors can differ substantially depending on the products and services provided.