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Don’t Get Left Behind - Get Ahead of the ISO 9001:2026 Changes

I made a promise to myself back in 2015 when the last revision of ISO 9001 was released: I’d be retired before the next one. Well, here we are in 2025 (wait—10 years already?!), and I’m still here, saying, “Alright, just this one last update… and then I’ll retire!”

But this isn’t a reflection on how time seems to speed up when you’re busy—it’s an opportunity to dive into what’s next for ISO 9001. The first revision I worked with was way back in 1994, which means I’ve had the privilege (no sarcasm, I promise!) of witnessing over 30 years of changes and implementation.

As of January 2025, the revision process for ISO 9001:2026 is advancing steadily. The working group responsible for the update has finalized the second Committee Draft (CD), and the consultation ballot opened on January 17, 2025, with a closing date of March 29, 2025. Notably, the standard development timeline has been extended to 36 months to accommodate this additional CD stage. As a result, the publication of the revised ISO 9001 standard is now anticipated in September 2026. You can find the latest updates directly from the ISO committee here.

The ISO 9001 Change Framework

The upcoming revision of ISO 9001:2026 is bringing key changes that reflect the evolving landscape of quality management. From the integration of risk-based thinking to the increasing focus on sustainability and technology, these updates aim to align quality systems with modern business challenges. Understanding these changes now will help organizations stay ahead and prepare for a smooth transition.

The ISO 9001 Change Framework below highlights the four key areas of focus in the upcoming revision.

1. Risk-Based Thinking (Clause 6.1 – Actions to Address Risks and Opportunities & Clause 0.0 – Introduction)

• The concept of risk-based thinking (RBT) has been reinforced, with a clarification of the relationship between risk, opportunity, and preventive action, but still links RBT to preventive action.
• The introduction section (Clause 0.0) has been rewritten to provide a more detailed explanation of risk-based thinking and its role in the quality management system (QMS).
• Clause 6.1 retains its core structure but does not separate risks and opportunities into distinct sub-clauses, reverting to less clear language compared to earlier drafts.

2. Quality Culture (Clause 5.1.1 – Leadership & Commitment)

• New requirement for top management to foster a quality culture and ethical behavior within the organization.
• This change reinforces the role of leadership in embedding quality values and making them part of daily operations.
• Annex A now references ISO 10010 (Quality Culture), which could influence how organizations implement and demonstrate quality culture initiatives.

3. Climate Change (Clause 4.1 – Understanding the Organization & Its Context & Clause 4.2 – Interested Parties)

• Climate change considerations were first introduced in the ISO 9001:2015 Amendment 2024, signalling the standard’s shift toward sustainability and environmental responsibility.
• The 2026 revision retains and reinforces these amendments, ensuring that organizations formally consider climate-related risks and opportunities in their strategic context (Clause 4.1).
• Clause 4.2 (Interested Parties) continues to include climate change considerations, emphasizing that stakeholders may have expectations around environmental impact and sustainability commitments.

4. Emerging Technologies (Clause 7.1.5 – Monitoring & Measuring Resources & Annex A – Emerging Technologies)

• ISO 9001:2026 acknowledges the role of emerging technologies such as machine learning, and digital tools in shaping modern quality management.
• Clause 7.1.5 now introduces a requirement to validate software used for monitoring and measurement, ensuring accurate and reliable quality data.
• Annex A has been expanded to discuss the impact of emerging technologies, signalling a shift toward a more digital-driven approach to quality management.

These changes reflect ISO 9001’s ongoing evolution to align with modern business challenges, emphasizing risk management, leadership, sustainability, and technological advancements. Organizations that proactively adapt to these updates will be better positioned to maintain conformance, enhance efficiency, and drive long-term quality excellence.

Next Steps to Prepare for ISO 9001:2026

1. Evaluate Your Current QMS – Use our free IMS Gap Analysis Tool to assess where your system stands today and identify areas for improvement.
2. Stay Informed on ISO 9001:2026 Changes – Keep up with the latest updates and expert insights to ensure you're ready for the 2026 transition. Subscribe to industry newsletters or follow trusted ISO professionals.
3. Develop an Action Plan – Start planning now by reviewing key changes, engaging leadership, and considering necessary updates to your quality management system before the new standard takes effect..

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*Disclaimer: The information in this article is based on my independent research, industry insights, and publicly available information regarding the upcoming ISO 9001:2026 revision. As the official draft has not yet been publicly released, details may evolve as the revision process continues. Organizations should stay updated with official ISO communications and consult their National Standards Body for the most current and authoritative information.

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