ISO 9001:2015 specifies the requirements for a quality management system of an organization, when:

• it needs to demonstrate its ability to consistently provide products or services  that meets customer’s requirements and the applicable statutory and regulatory requirements, and
• aims to enhance customer satisfaction through the effective implementation of the system, including processes for continual improvement of the system and the assurance of conformity towards the customer and the applicable statutory and regulatory requirements.

All requirements of ISO 9001:2015 are generic and intend to apply to all organizations, regardless the type, size and products provided.

Although certification is not a requirement of the standard, the QMS of about one million organizations have been audited and certified by independent certification bodies (also known in some countries as registration bodies) according to the ISO 9001:2000 standard.

ISO 9001 certification is frequently used in both private and public sector, in order to increase reliance to the products and services provided by certified organizations, relations between business partners during the selection of suppliers in supply chains and in the right to tender for procurement contracts.