ISO 9001:2026: publication of the draft standard

Article written by Valérie Le Couedic 

On 27 August 2025, the Draft International Standard (DIS) version of the ISO 9001:2026 revision was officially published, launching the approximately 12-week public consultation phase. The Final Draft (FDIS) is scheduled for early January 2026, with final publication expected in autumn 2026.

The structure of the standard’s chapters has not changed. The main changes proposed in the DIS are as follows:

– Chapters 4.1 & 4.2: Amendment 2024 on climate change has been explicitly incorporated to assess whether this is a relevant issue for the QMS. As a reminder, this amendment is already being audited, as there was no transition period.

– Chapter 4.2: Organisations must now identify which stakeholder requirements will be addressed by the QMS.

– Chapter 5.1 (Leadership): Addition of an explicit requirement for management to promote a culture of quality and ethical behaviour through its values, attitudes and practices.

– Chapter 6.1 (Action on risks and opportunities): The chapter is now split into two: (6.1.2 risks) and (6.1.3 opportunities). Both must therefore be identified, analysed and treated individually.

This chapter introduces enhanced requirements for managing risks and opportunities related to business continuity. It stipulates that the organisation must determine and analyse risks and opportunities that may have an undesirable (for risks) or desirable (for opportunities) effect on its ability to provide and ensure the continuous and consistent delivery of compliant products and services and to improve customer satisfaction.

This means that management, in exercising its leadership (5.1), must ensure that risk/opportunity management (6.1) is effectively integrated into the planning and implementation of strategies to maintain business continuity. This approach aims to strengthen the organisation’s resilience to environmental, social and economic challenges.

Actions to address risks and opportunities must be implemented within the QMS processes, and their effectiveness evaluated.

Chapter 6.3 (Planning for changes): chapter restructured to place greater emphasis on the availability of information, the evaluation of effectiveness, and how to review the results of changes.

– Chapter 7.1.3 (Infrastructure): Remote working and hybrid working have been taken into account.

– Chapter 7.3 (Awareness): Staff must be made aware of the culture of quality and ethical behaviour.

– Chapter 8.2.1 (Communication with customers): there is no longer any mention of establishing specific requirements for emergency actions, but rather of information to be communicated to customers, including disruptions to the products or services provided, which is clearer.

– Chapter 8.2.4 (Changes to requirements): Changes relating to products and services must now be communicated to all interested parties, not just staff.

Annex A: This is an informative annex that does not contain any additional requirements and provides clarifications to facilitate understanding and application of the requirements in chapters 4 to 10.

This annex addresses the concept of organisational sustainability in relation to Chapter 6, i.e. how the quality management system ensures the resilience of the organisation and its supply chain in the face of risks related to climate change, resource shortages, social impacts, loss of reputation, new regulations, etc.

However, the organisation is not required to implement sustainable practices simply because the Annex mentions them. This must be taken into account in the organisation’s strategic thinking and objectives.

Finally, digitalisation and emerging technologies such as AI, automation and data management in decision-making processes are addressed.

In conclusion, the 2026 version does not constitute a major transformation of the standard. It retains the structure and fundamental principles already in place, while making adjustments designed to enhance the relevance of the quality management system in the face of current challenges, where relevant in the context of each organisation.

However, it is with regret that this new version does not place greater emphasis on a more cross-functional structuring of processes as a key lever for improving an organisation’s overall performance. However, strengthening risk management, quality culture and supply chain resilience will indirectly contribute to more cross-functional management by encouraging collaboration between different departments and business lines on these cross-functional issues.

Organisations are encouraged to incorporate these changes now, particularly by strengthening their quality culture, as this takes time, and thus better prepare themselves to comply with the 2026 version.

As usual, a three-year transition period, lasting until approximately the end of 2029, will allow certified organisations to comply. It is still possible to obtain certification before the three-year deadline when renewing certification.

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