ISO published the new ISO 9001:2026 on September 16, 2026. It is the sixth edition of the world’s most widely used quality management system standard and replaces ISO 9001:2015 and its Amendment 1:2024. With this publication, the transition period begins: certified organizations have until September 30, 2029, to migrate.
This is not a radical overhaul. The 10-clause structure remains in place, and most of the requirements are the same. The changes focus on a culture of quality and ethical behavior, the separate treatment of risks and opportunities, and the integration of climate change. In this guide, we explain what has changed, what has not changed, and how to plan for the transition.
Highlights of the article:
Why was ISO 9001 revised?
ISO standards are reviewed periodically to ensure they remain useful. The 2026 review addresses three main needs:
- Align with the Harmonized Structure, which is shared by ISO 14001, ISO 45001, and all other management system standards. This makes it easier to integrate quality, the environment, and occupational health and safety into a single system.
- Clarify requirements that were interpreted in different ways in the 2015 version, particularly those related to risks and opportunities.
- Strengthen management’s role in fostering a culture of quality, beyond mere compliance with documentation requirements.
Changes to ISO 9001:2026, Clause by Clause
| Clause | What’s Changing |
|---|---|
| 3. Terms and Definitions | It explicitly includes the harmonized terms common to all management system standards, in addition to referring to ISO 9000 (the new edition of which was published in 2026). |
| 4.1 and 4.2 Context | The requirement from Amendment 1:2024 is incorporated: the organization must determine whether climate change is a relevant issue, and stakeholders may have requirements related to it. |
| 5.1.1 Leadership | New requirement: Senior management must promote a culture of quality and ethical behavior. |
| 5.2 Quality Policy | Policy should take the context into account and support the strategic direction more explicitly. |
| 6.1 Risks and Opportunities | It is divided into 6.1.1, 6.1.2 (actions to address risks), and 6.1.3 (actions to address opportunities). Opportunities are no longer “the flip side” of risk: they are managed separately. |
| 6.3 Change Planning | Change management within the QMS is being strengthened. |
| 7.1.4 and 7.3 Environment and Awareness | People should be familiar with the organization’s culture of quality and ethical principles. |
| 8. Operation | Minor changes, primarily to wording and numbering. It is advisable to review references to clauses in procedures and records. |
| 10.1 Improvement | The new 10.1 consolidates requirements that, in 2015, were split between 10.1 and 10.3 (continuous improvement). |
| Appendix A | The scope of the guidance has been greatly expanded, particularly regarding a culture of quality, ethics, and risk. It does not add any requirements. |
What Does NOT Change in ISO 9001:2026
Prior to its publication, there were many expectations that the final text did not address. ISO 9001:2026:
- It does not include specific requirements regarding artificial intelligence, digitization, or automation. It remains technology-neutral.
- It does not expand sustainability or ESG requirements beyond climate change.
- It does not change the logic of the PDCA cycle or the process-oriented approach.
Just because the standard doesn’t require digitization doesn’t mean it isn’t helpful: demonstrating a culture of quality, identifying risks and opportunities, and preparing for audits is much easier with centralized data.
Transition Deadlines for ISO 9001:2026
- September 16, 2026: Publication of ISO 9001:2026.
- September 30, 2029: End of the transition period. As of that date, ISO 9001:2015 certificates will no longer be valid.
Global Accreditation Cooperation (Global ACI), the international accreditation organization that succeeds IAF and ILAC, has established the transition requirements. Before issuing certificates under the new version, certification bodies must be accredited for it, so during the first few months, there will be limited availability of audits under the 2026 version. Check with your certification body soon to find out their schedule.
The transition can take place during a follow-up audit, a recertification audit, or a specific audit.
How to Migrate to ISO 9001:2026 in 6 Steps
- Set the standard and build the team. Obtain ISO 9001:2026 (or its UNE-EN version) and train QMS managers and internal auditors on the changes.
- Conduct a gap analysis. Compare your QMS with the new requirements, particularly those in clauses 4.1/4.2, 5.1.1, 6.1, 6.3, and 7.3.
- Update the documentation. Review the quality policy, the risk and opportunity register (now separate), the change management procedure, and the references to clauses.
- Define how you will demonstrate a culture of quality. It establishes management commitments, internal communication, ethics training, and certain metrics (participation, incident reporting, suggestions for improvement).
- Audited internally and reviewed by management. Conduct an internal audit covering the scope of the 2026 version and a management review that addresses the new elements.
- Plan your transition audit with your certification body—don’t wait until 2029.
A Culture of Quality: The Major Change in ISO 9001:2026
The most significant trend is a culture of quality. It is no longer enough to simply have procedures in place: management must demonstrate that it promotes values of quality and ethics that permeate the entire organization. In practice, the auditor will look for evidence such as the following:
- visible leadership: management’s involvement in reviews, goals, and communication;
- people who understand politics and know how they contribute to it;
- channels for reporting problems without fear of retaliation;
- Decisions based on data, not perceptions.
How Quality Management Software Helps You Through the Transition
Quality management software like Prodity allows you to:
- centralize risks and opportunities—separately—in a dynamic registry, as required by the new 6.1;
- manage nonconformities, corrective actions, and changes with full traceability;
- plan and conduct internal audits using checklists tailored to ISO 9001:2026;
- measure quality culture indicators and submit them for review by management;
- Integrate quality, environmental management (ISO 14001), and occupational health and safety (ISO 45001) into a single platform, leveraging the Harmonized Structure.
Do you want to prepare for your transition to ISO 9001:2026 without using spreadsheets? Request a demo of Prodity Calidad.
Frequently Asked Questions About ISO 9001:2026
When was ISO 9001:2026 published?
September 16, 2026. This is the sixth edition of the standard.
How long is my ISO 9001:2015 certificate valid?
Through September 30, 2029, which is when the three-year transition period ends.
What are the main changes compared to ISO 9001:2015?
A culture of quality and ethical conduct (5.1.1 and 7.3), the distinction between risks and opportunities (6.1), the strengthening of change management (6.3), the integration of climate change (4.1 and 4.2), and alignment with the Harmonized Framework.
Does ISO 9001:2026 require the use of AI or the digitization of processes?
No. The standard is technology-neutral, but digital tools make it easier to gather the evidence required by the new standards.
Do I have to start from scratch with my management system?
No. If your QMS complies with the 2015 version, the migration involves closing specific gaps, not rebuilding the system from scratch.ISO 31010 in Risk Prevention: The 9 Most Useful Tools forRisk Prevention SpecialistsLaw 16,744 and Presidential Decree No. 594: What Every Company in Chile Must Have Up to Date by2026How to Choose the Best EHS Software: 7 Key Criteria for Comparing Options
