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Decoding ISO 9001:2026 Revision: Key Amendments, Impacts, and Company Response Strategies

ISO 9001, one of the most universally recognized standards for quality management systems, is about to be revised. The draft international standard for ISO 9001:2026 (ISO/DIS 9001:2025) was published at the end of August 2025 and offers initial insights into the planned changes. However, due to extensive feedback from stakeholders, the final publication of ISO 9001:2026 is not expected until the second half of 2026.

 

Why is the revision necessary?

The current version of ISO 9001 dates back to 2015. ISO standards should be reviewed every five years to ensure that they are up-to-date and reflect current legal requirements and the changing needs of organizations and the global economy. Another goal is to enhance compatibility with other standards. Among other things, the upcoming revision will place greater emphasis on the subject of climate protection, as this is becoming increasingly important in day-to-day business practice.

Significant changes to ISO 9001:2026

· Integration of the Harmonized Structure (HS): The standard will be adapted to the new Harmonized Structure, which replaces the former High-Level Structure and entails minor changes in terms of content and terminology.

· Terms and definitions: Section 3 is supplemented by relevant terms from the Harmonized Structure.

· Context of the organization: Section 4 is extended to include aspects of climate change, as climate change is now an important external influencing factor. The contents of ISO 9001:2015/Amd 1:2024 in relation to climate change have been integrated into the revised version of the standard. Although ISO 9001:2026 will not become an ESG standard*, the draft places greater emphasis on the consideration of sustainability aspects. The integration of content related to climate change underlines the stronger links between quality and sustainability.

*ESG: Environmental, Social, Governance

· Leadership and commitment: The strategic direction is added as a new perspective. This relates to section 5.2.1 e) "Context of the organization and its strategic direction". Quality policy, goals and actions should be in line with the longer-term corporate strategy. The use of artificial intelligence (AI) can play a role in this context. The new addition underlines that the context and strategic direction of the organization must not only act as the background but must be an integral part of the QMS. 

· Actions to address risks and opportunities: A revision of the risk-based approach, which is reflected in standard section 6.1 “Actions to address risks and opportunities”, is being considered. In practice, it has been shown that quality managers are very much involved in identifying, analysing and managing risks, but tend to neglect the consideration of opportunities. However, at the present time, which is characterized by uncertainty and imponderables, it is essential that companies consistently look for opportunities in order to survive in the market over the long term.

In this context, there is also a discussion about whether it makes sense to decouple opportunity and risk management, i.e. to treat opportunities and risks separately from each other.

· Awareness: Section 7.3 is supplemented by requirements regarding the quality culture of the organization and ethical behaviour. It is becoming increasingly apparent that without a supportive corporate culture, management systems only have a formal effect. The revised standard aims to be more closely linked to reality without becoming too “soft”.

· Explanation of structure, terminology and concepts: Annex A has been fundamentally revised and now provides detailed explanations of Sections 4 to 10 in order to provide more guidance and clarity in the interpretation and application of the normative requirements.

· Removal of Annex B: The informative Annex B will be removed from the standard.