ISO 9001 (QMS Requirements)

ISO 9001 is the international standard specifying requirements for a quality management system. The current edition, ISO 9001:2015, applies to any organization regardless of size or sector and is the world’s most widely adopted QMS standard, often the prerequisite for tendering in B2B and public contracts.

Scope

ISO 9001 sets requirements for context, leadership, planning, support, operation, performance evaluation, and improvement. It is the foundation on which sector-specific QMS standards layer additional requirements: ISO 13485 for medical devices, IATF 16949 for automotive, AS9100 for aerospace, and TL 9000 for telecom.

Relationships (see sidebar)

• Normative for the Quality Management System (QMS) capability and the CAPA data object.
• Foundation underneath ISO 13485 (medical), AS9100 (aerospace), and ISO 10007 (configuration management).

Steward

ISO/TC 176 (Quality management and quality assurance).