ISO 9001:2026: what changes in the new version

ISO 9001 is the best-known quality management standard in the world (source: ISO). More than 1.2 million sites were certified in 2023. Its sixth edition, ISO 9001:2026, has now reached the final draft stage (FDIS) and is expected to be published in September 2026. This article details, clause by clause, the changes confirmed by the official text of the draft, and how to prepare the transition.

ISO 9001, a reference standard: where the revision stands

Every ISO standard is reviewed periodically to stay aligned with organizations' practices and expectations. First published in 1987, ISO 9001 is now in its fifth edition (2015) and preparing its sixth. The revision is led by technical committee ISO/TC 176, subcommittee SC 2 (Quality systems), in collaboration with the European Committee for Standardization (CEN) under the Vienna Agreement (source: ISO/FDIS 9001). ISO describes ISO 9001 as the best-known quality standard in the world and confirms a publication expected in September 2026 (source: ISO).

The timeline: from the FDIS to publication in September 2026

An ISO standard goes through successive draft stages before publication: committee draft (CD), draft international standard (DIS), then final draft (FDIS). The FDIS is the last stage: the text is stabilised and submitted to the final vote of ISO members. At this point, the content is no longer meant to change in substance, only editorial adjustments remain possible. The draft is referenced on the ISO website (source: ISO/FDIS 9001).

After publication, certified organizations usually benefit from a three-year transition period to migrate to the new edition, a duration that is not decided by ISO but on the accreditation side, and that is not set to date: the IAF, which used to set it by resolution, ceased to exist on 1 January 2026, and Global ACI, which took over its remit, has published no binding document on the transition. In practice, ISO 9001:2015 certificates will remain valid during this window, while certification bodies themselves become accredited on the new version and carry out transition audits. There is therefore no urgency, but a clear interest in anticipating.

The five major changes of the 2026 edition

The foreword of the FDIS explicitly lists the main changes compared with the 2015 edition (source: ISO/FDIS 9001:2026, foreword):

• Terms and definitions in the text: Clause 3 now includes a set of definitions (organization, interested party, top management, quality management system, quality policy, etc.) and draws on ISO/DIS 9000 and the ISO Online Browsing Platform. The 2015 edition referred entirely to ISO 9000.
• Quality culture and ethical behaviour: these notions enter the requirements, particularly under leadership (clause 5.1.1), awareness and the environment for the operation of processes.
• Separation of risks and opportunities: clause 6.1 addresses them in distinct subclauses, with actions specific to each.
• Strengthened management of change: requirements relating to changes to the quality management system are reinforced, notably maintaining the integrity of the system when changes are planned and implemented (clause 5.3).
• Enhanced Annex A: this informative annex clarifies the structure, terminology and intent of the requirements, without adding any new requirement.

Quality culture and ethical behaviour: the new leadership dimension

This is one of the most visible novelties. Clause 5.1.1 now requires top management to promote quality culture and ethical behaviour, on the same footing as the process approach or continual improvement. The text explicitly links top management to promoting both risk-based thinking and opportunity-based thinking, and to taking accountability for the effectiveness of the system (source: ISO/FDIS 9001:2026, 5.1.1).

A note in the draft states that an organization's quality culture and ethical behaviour are reflected in its shared values, attitudes, practices and actions. In other words, documentary conformity is no longer enough: management's exemplarity and behaviours become a point of attention for audit as well as improvement.

Risks and opportunities: a now explicit separation

Since 2015 the standard has relied on risk-based thinking. The 2026 edition goes further by clearly distinguishing risks and opportunities, right down to the structure of the requirements: clause 6.1 is broken down into determining risks and opportunities (6.1.1), actions to address risks (6.1.2) and actions to address opportunities (6.1.3) (source: ISO/FDIS 9001:2026, 6.1).

The definitions are clarified: risk is the effect of uncertainty that can negatively affect the achievement of results; opportunity refers to circumstances that make it possible to achieve beneficial effects on the performance of the quality management system. The PDCA cycle is presented with this dual perspective. Opportunities can arise from changes in market conditions, emerging technologies or new regulatory requirements. For organizations, the challenge is to move from a defensive stance to a balanced one, where opportunities to improve performance are also actively seized.

What does not change: the fundamentals

For organizations that are already certified, the essentials remain stable. The revision keeps the seven quality management principles: customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management. The process approach and the PDCA cycle remain the backbone of the standard (source: ISO/FDIS 9001:2026, Introduction). The scope (clause 1) remains generic and applicable to any organization, whatever its size and sector. A quality management system that is robust today will remain a solid basis for the transition: the 2026 edition evolves the framework, it does not rebuild it.

Preparing the transition: where to start

With publication expected in September 2026 and a three-year transition, there is time to act calmly. Three areas concentrate most of the changes and are worth starting now: consolidating process logic, structuring the management of change, and clarifying the distinction between risks and opportunities. In parallel, making managers aware of quality culture and ethical behaviour prepares the ground for the new leadership expectations.

Two HEMC resources help you take action:

Need a diagnosis or support for the transition to ISO 9001:2026? HEMC consultants help you secure your certification and integrate the new expectations.

Sources and references

• ISO/FDIS 9001, Quality management systems, Requirements (official ISO page, final draft, ISO/TC 176/SC 2).
• The ISO Survey of certifications (ISO).
• ISO, Quality management (overview and timeline).
• ISO 9001:2015 (edition in force).
• Related standards cited by the draft: ISO 9000 (fundamentals and vocabulary), ISO 9004 (sustained success), ISO 9002 (guidelines on application), ISO 10013 (documented information).

Informative article based on the final draft (FDIS) and subject to change until the official publication of the standard. It will be updated at that time.