Context of the organization

Context of the organization

An organization’s context is its business environment. It includes all of the internal and external factors and conditions that affect its products and services, have an influence on its QMS, and are relevant to its purpose and strategic direction. An organization’s external context includes all of the needs and expectations of interested parties, as well as its social, cultural, legal, technological, regulatory, and competitive environment.

An organization’s internal context includes its values, culture, knowledge, and performance. ISO 9001 2015 expects you to consider your organization’s internal and external context when you define the scope of its QMS and when you plan it's design and development.