ISO publishes the new ISO 9001:2026

📅 Published: 16 September 2026

📢 On 16 September 2026 ISO published the sixth edition of ISO 9001, Quality management systems — Requirements, which replaces ISO 9001:2015 after more than a decade in force. 🌍 The standard, used by more than one million organisations worldwide, will also be available in an enhanced digital format from 1 October 2026.

The revision keeps the harmonised structure (Annex SL), which makes it easy to integrate with ISO 14001 or ISO 13485, and is not a change of model but an update aimed at clarity.

✨ Main changes

Quality culture and ethical behaviour added to clause 5.1 (Leadership and commitment).
Clearer distinction between risks and opportunities (clause 6.1, now 6.1.1 to 6.1.3).
Stronger management of changes to the system (clause 6.3) and consolidation of continual improvement in the new clause 10.1.
Integration of the 2024 amendment on climate change (clauses 4.1 and 4.2).
Expanded Annex A with clarifications on the intent of the requirements.

🗓️ Transition

Global ACI (the merger of IAF and ILAC) published on the same day the mandatory document Global ACI-TECH-3-TR 2029-09-30 (M), which sets a three-year transition period:

16 September 2026 — Publication of the standard and start of the transition period.
31 March 2028 — Initial certifications may only be issued against ISO 9001:2026.
30 September 2029 — End of the transition: deadline for organisations certified to ISO 9001:2015 to complete the change.

The transition can take place during a surveillance audit, a recertification audit or a dedicated transition audit. 🇪🇸 ENAC has yet to publish the plan applicable in Spain.

🏥 What does it mean for medical device manufacturers?

Many manufacturers maintain ISO 9001 alongside ISO 13485 in an integrated system. The common structure makes it easy to incorporate the 2026 changes (quality culture, risks and opportunities, change management) without duplicating processes, but the transition should be planned early so that it lines up with audits already scheduled.

At MeDev Consulting we advise medical device manufacturers on MDR/IVDR compliance, EUDAMED registration, and the implementation and auditing of quality management systems under ISO 9001 and ISO 13485. Contact us at: info@medev.es