ISO 9001 is evolving. What the 2026 revision really means for Leaders

Christian Musialek | Senior Quality & Assurance Leader | Nuclear, Civil & Infrastructure

This revision is evolutionary by design. Organisations do not need another wholesale reset, they need a standard that rewards everyday discipline and sharpens leadership accountability.

Christian Musialek
Senior Quality & Assurance Leader

In late August, ISO published the Draft International Standard (DIS) for the next edition of ISO 9001. Final publication is expected in the second half of 2026, with most registrars anticipating a multi-year transition window once it lands. This is not a rip-and-replace rewrite. It is a focused refresh that nudges quality management from compliance to culture, resilience and real-world risk.

What is actually changing

Early summaries from the Chartered Quality Institute (CQI) and several accredited registrars agree on the shape of the DIS:

◈ The 2024 climate change amendment is integrated into the core text in clauses 4.1 and 4.2.

◈ Leadership language is strengthened, with a clearer emphasis on quality culture and ethical behaviour.

◈ Planning for risks and opportunities is structured more explicitly, with expanded guidance in Annex A.

◈ There is a stronger linkage between policy, context and strategic direction, and broader recognition of interested parties and awareness requirements. None of this is radical, but it is directionally important.

It is also worth noting that ISO has already issued a formal amendment to the current ISO 9001:2015 that requires organisations to consider whether climate change is a relevant issue in their context and in the needs of interested parties. Many auditors are already checking how you address this in practice. If you have not closed that gap, do it now.

Why the revision now

The official working group notes cite a need to keep ISO 9001 “fit for purpose” as technology, markets and stakeholder expectations move on. CQI’s position is clear: the new text is useful but should stretch further on digitalisation, sustainability and competence. That tells you where influential voices want the standard to travel over the next decade, even if the current update remains measured.

The practical shift leaders should make

The headline is culture. Quality leaders have lived through two decades of process maturity models, corrective actions and audit calendars. The DIS steers the discussion toward leadership behaviours, ethics and the everyday choices that make quality visible without a clipboard in sight. That is a good thing. If you get the culture right, the clauses follow.

The second shift is risk clarity. By separating and clarifying the way we identify and treat risks and opportunities, the DIS encourages more disciplined planning drivers, not just well-worded risk registers. Used well, this will tighten the line of sight from context to objectives to controls across your value chain.

The third is relevance. The climate change requirement is not about turning ISO 9001 into an environmental standard. It simply asks a sensible management question: is climate change relevant to the achievement of your intended outcomes, your customers and your supply chain, and if so, what are you doing about it. For some organisations this will be minimal. For others—especially those with climate-sensitive logistics, materials or infrastructure—it deserves a structured response.

What it means across sectors

ISO 9001 sits at the centre of a family of sector standards. When the base moves, the ripples follow.

◈ Aerospace: IAQG is preparing the next aerospace QMS revision, now branded IA9100, with a publication target aligned to the ISO 9001 release in 2026. Expect a familiar three-year transition pattern.

◈ Automotive: IATF has already modernised scheme rules (Rules Sixth Edition, effective 2025) and has formally started its next revision process. Because IATF 16949 builds on ISO 9001, organisations should anticipate an update after ISO 9001:2026 is final and transition rules are issued.

◈ Medical devices: ISO 13485 will remain its own standard, but note that the US FDA’s Quality Management System Regulation aligns with 13485 from February 2026, raising the bar on regulatory coherence.

◈ Nuclear, rail, telecoms and food: Standards such as ISO 19443, ISO/TS 22163 (IRIS), TL 9000 and ISO 22000 typically adopt ISO 9001 updates in their next cycles. The 2024 climate change amendment already applies across many Type A ISO management system standards, which includes 9001, 19443, 22000 and others.

A readiness plan I recommend

1. Close the climate change gap in your current ISO 9001:2015 system. Evidence of how you determine relevance is in 4.1 and 4.2. If it is relevant, show the risks, opportunities and controls you have introduced. Keep it proportionate.

2. Refresh leadership behaviours. Build a practical quality culture plan: visible leadership routines, ethical decision making in operations and procurement, and measures that go beyond audit pass rates.

3. Tighten risk planning. Structure risks and opportunities more explicitly, and ensure links from context through objectives to change management and control plans are auditable.

4. Map interested parties again. Stakeholder expectations have shifted since 2015. Revisit customers, regulators, suppliers and communities. Make the linkage to policy and strategy explicit.

5. Strengthen supply chain resilience. Even if the clauses stay light, the direction of travel is resilience. Treat this as a strategic quality topic rather than a purchasing checklist.

6. Digitisation with judgement. CQI has pressed for stronger treatment of digitalisation and competence. Use this window to address data integrity, human competence and ethical use of automation in your core processes.

My take

This revision is evolutionary by design. That is the right call. Organisations do not need another wholesale reset. What they need is a standard that rewards everyday discipline, sharpens leadership accountability and acknowledges the realities of digital operations and systemic risk. Used well, ISO 9001:2026 can move quality from assurance to advantage: fewer surprises, faster learning and more consistent outcomes for customers.

I will be watching the transition rules and sector updates closely as the DIS moves to the final ballot. In the meantime, the prize is cultural. If you can describe how your quality culture shows up in decisions, in supplier choices and in the way you treat risk, you are already future-ready.

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