ISO 9001

Who has to comply

Voluntary. Certification is driven by customer requirements, tenders, and supply chain expectations across manufacturing, construction, services, healthcare, and government contracting. Sector standards such as AS9100, IATF 16949, ISO 13485, API Q1, and TL 9000 build on it, so ISO 9001 is often the first step.

What you have to write

Documents on this site that ISO 9001 requires or expects, each with who must have it, the review cycle and the obligations that cite it.

• ISO 9001 Quality Policy and Documented Information Quality

What the assessor asks to see

Scope and quality policy; context and interested parties analysis; process map or list with owners, inputs, outputs, and performance indicators; risks and opportunities register with actions; quality objectives and plans; organizational roles; competence and training records; documented information control; customer requirement review and communication records; design and development records where applicable; supplier evaluation and control records; production and service provision controls, identification and traceability, calibration; release and nonconforming output records; customer satisfaction data; monitoring and measurement results; internal audit program and reports; management review inputs, outputs, and minutes; corrective action records.

Where the requirement sits: ISO 9001:2015 numbering (confirm against the 2026 edition when you transition): 7.5.2, 7.5.3 (documented information control incl. distribution, access, change control, retention); 5.2.2 (policy communicated, understood); 7.2 (competence records); 7.3 (awareness)

ISO 9001:2026 status and transition

ISO published ISO 9001:2026, the sixth edition, on September 16, 2026. The draft went to ballot on September 10, 2025 and was approved at 97 percent; the final draft ballot closed on July 9, 2026, and its approval was announced on August 7, 2026.

Global ACI, the body formed by the merger of the International Accreditation Forum and ILAC, published the mandatory transition requirements the same day.

Accreditation bodies have to be ready by March 31, 2027, certification bodies file their transition declarations by June 30, 2027, new and initial certificates are issued only to the 2026 edition from March 31, 2028, and organizations certified to the 2015 edition have until September 30, 2029.

ISO describes the revision as a greater emphasis on leadership, quality culture and ethical behavior, more clarity on risks and opportunities, and alignment with the common clause structure it uses across its management system standards. A new Annex A explains the intent of the requirements. Climate change was already added by the 2024 amendment and carries forward.

The text of the standard is sold rather than published, so clause-level detail in circulation comes from certification bodies that bought it. Our article on the transition dates covers what this means for a certified company.