ABSTRACT

The requirement means that any processes, products and services acquired from external providers must meet the requirements specified by the organization and any requirements of its customers or statutes and regulations that apply to these products or services. Organizations ensure that externally provided processes, products and services conform to requirements by applying controls to external providers and the products and services they provide. Externally sourced processes, products and services can have varying degrees of impact on the processes of the organization and the products and services it provides to its customers. The standard requires the organization to ensure that externally provided processes remain within the control of its quality management system (QMS). When an organization outsources a function or a process to an external provider, that function or process becomes a service provided by an external body.