ISO 9001:2026. Preparing for the Next Generation of Quality Management

ISO 9001 is the world’s leading quality management standard, used by over one million organisations in 189 countries. It provides a framework for consistently delivering products and services that meet customer and regulatory requirements. By establishing a formal Quality Management System (QMS) based on principles like customer focus and continual improvement, ISO 9001 helps companies build robust processes, raise customer confidence, and continually optimise their operations. For example, ISO notes that certified organisations see benefits such as greater customer trust, efficient complaint resolution, process waste reduction, and ongoing system optimisation. In short, ISO 9001’s structured approach to quality is a cornerstone of many firms’ operational excellence and competitive strategy.

Evolution of ISO 9001: 2008, 2015 and the Road to 2026

ISO 9001 was first published in 1987 and has been periodically updated. In the 2008 revision (ISO 9001:2008), the changes were largely clarifications: wording was improved and alignment with ISO 14001 (environmental management) was enhanced, but no new requirements were introduced. In contrast, the 2015 edition (ISO 9001:2015) was a major overhaul. It adopted the Annex SL high-level structure (10 common clauses) to better align with other ISO management standards, and introduced several key requirements: leadership accountability, risk-based thinking, greater process focus, and flexible documentation (“documented information”). For example, top management involvement was elevated, and risk-based thinking was embedded to make the QMS more proactive. These changes were aimed at making ISO 9001 more strategic, integrating the QMS with business strategy.

ISO standards are reviewed every five to ten years. After a 2023 consultation, ISO TC 176 confirmed that another revision is needed to keep ISO 9001 relevant in today’s business environment. Factors driving the 2026 update include rapid technological change (AI, automation, data analytics), sustainability and climate imperatives, complex global supply chains, and new work models (remote/hybrid operations). In particular, ISO has passed a climate action declaration (the “London Declaration”), prompting inclusion of climate-related concerns in management standards. The draft ISO 9001:2026 (the DIS) is now in circulation, with final publication expected in late 2026.

Why Revise ISO 9001 Again?

ISO’s stated goal is to “ensure the standard remains relevant, addressing modern business needs and stakeholder expectations. In practice, this means weaving today’s priorities into the QMS. Certification bodies and experts note that quality systems today must be agile and resilient. For example, a TÜV SÜD analysis observes that increasing complexity, digitalisation and sustainability demands “necessitate adjustments” to keep ISO 9001 effective. Similarly, DNV highlights that in today’s dynamic environment, ISO 9001 must evolve or risk obsolescence. In short, the 2026 revision is driven by the need to integrate new concepts  like climate impact, digital tools, ethics and broader risk management  into the ISO 9001 framework.

The ISO project committee (WG 29) has explicitly set out to “ensure the revised standard addresses current and future needs”. Early drafts indicate planned adjustments for resilience, supply-chain management, change management, sustainability, and organisational knowledge. These align with the ISO working group’s agenda and with stakeholder input. Certified organisations will get a transition period (likely up to 3 years) to adapt to the new edition. In practice, experts agree the changes appear moderate  building on the solid 2015 foundation rather than reinventing it.

Major Changes in ISO 9001:2026

Based on the Committee Draft and industry previews, the 2026 revision keeps the familiar Annex SL structure but introduces targeted updates. Key expected changes include:

• Leadership & Quality Culture (Clause 5.1): A new requirement explicitly directs top management to foster a quality culture and demonstrate ethical behavior within the organisation. In other words, leaders must go beyond assigning resources to role-modeling quality-first values. For example, Sternberg Consulting notes that management will have to actively create an environment of quality awareness and integrity, and may need to adjust the quality policy to emphasise ethics and strategic direction. This marks a shift from ISO 9001:2015, where such cultural expectations were only implicit; in 2026 they are stated outright.

• Risk and Opportunity Management (Clause 6.1): The draft reworks how risks and opportunities are handled. Clause 6.1 is split into Risk and Opportunity sub-clauses (6.1.1–6.1.3) to ensure each is dealt with distinctly. This structural change is meant to avoid confusion and ensure organisations systematically identify and address negative risks and positive opportunities separately. Practically, companies should review their risk management processes: the DIS clarifies that risk mitigation and opportunity exploitation require different actions. Annex A will give extended guidance on both aspects. In essence, risk-based thinking is retained, but the standard now makes it more explicit that risks and opportunities must have separate goals and plans.

• Climate Change and Context (Clause 4.1–4.2): A major addition is the formal integration of climate change considerations into the QMS. In line with ISO’s London Declaration, the DIS requires organizations to consider climate-related issues when analysing their context. Specifically, Clause 4.1 will explicitly ask: “Is climate change a relevant external issue?” and 4.2 will note that stakeholders may have climate-related expectations (e.g. CO₂ reduction commitments). This does not turn ISO 9001 into an environmental management standard, but it ensures that climate risks or opportunities are not ignored. Organisations will need to document how climate factors impact their business (or confirm they are not material) in context and stakeholder analyses. (Note: these climate clauses were already introduced by a 2024 amendment, and now are folded into the new edition.)

• Annex A Guidance Expanded: Annex A (informative guidance) is significantly expanded in ISO 9001:2026. Nearly all clauses 4–10 will have more detailed notes, examples and explanations. For instance, Annex A may define what “quality culture” means in practice, or outline steps for risk analysis tied to Clause 6.1. The goal is to reduce ambiguity without bloating the main text. Quality managers should plan to study Annex A closely once published, as it will clarify many of the new expectations (and aid training).

• Terms and Structure: The high-level structure of 10 clauses remains. Some QMS terms may be incorporated directly into the standard (reducing reliance on ISO 9000). Editorially, many clauses are refined for readability. For example, SGS notes that Clause 3 (Terms and Definitions) may include more QMS-specific terms, and Clause 7 (Support) may add awareness requirements related to quality culture and ethics. Clause 8 (Operation) and Clause 9 (Performance Evaluation) see minimal substantive changes, though layout and terminology are updated. Overall, the core of clauses 4–10 is intact, but with restructured sub-clauses and clarifying notes.

• Digitalization and Ethical Governance: While the draft does not impose new technical obligations (e.g. it does not mandate AI controls), it signals a sharper focus on digital and ethical dimensions. Intertek highlights that ISO 9001:2026 “introduces updated terminology, refined clauses, and a sharper focus on quality-enhancing technologies, digitalisation, and ethical governance”. In practice, this may mean encouraging use of AI, data analytics or automation within the QMS, and aligning quality practices with broader ESG (environmental, social, governance) expectations. For example, stronger language around “data-driven decision-making” or “continuous improvement through intelligent systems” is anticipated. At the very least, consultants advise that organisations plan for integrating digital quality tools and a commitment to integrity into their updated QMS.

• Supply Chain, Resilience and Stakeholders: Another theme is expanded oversight of supply chains and risk resilience. Industry previews note more emphasis on anticipating supply-chain disruptions and managing relationships with suppliers. The draft is reported to address “resilience, supply chain management… and stakeholder engagement”. In line with this, Intertek anticipates “strengthened focus on resilience, anticipation of risks, and supply chain performance, and more explicit calls to engage stakeholders (customers, employees, partners, communities). Quality management systems will likely need to map critical suppliers and ensure their performance is explicitly monitored, and to broaden the scope of stakeholder analysis to all those relevant to quality and climate.

• Other Notable Points: ISO 9001:2026 clarifies that the QMS remains performance-based. Documentation requirements are expected to remain flexible organisations “can now decide” what to document beyond mandatory records. There is no new prescriptive content on remote audits or AI validation (rumors of such were excluded in the current draft). In summary, most 2015 requirements carry forward. The changes largely refine and add emphasis rather than invent entirely new domains.

Transition Planning and Implementation Guidance

Organizations already certified to ISO 9001:2015 will have a transition period (historically up to three years) to adopt the new edition. In practice, this means ISO 9001:2015 certificates remain valid while ISO 9001:2026 is prepared. Certification bodies expect to begin issuing ISO 9001:2026 certificates by mid-2027, with transition likely complete by late 2029. (SGS forecasts a Q3/Q4 2026 publication and a 3-year deadline into 2029.) To make the switch smoothly, companies should start early. Key implementation steps include:

• Stay Informed and Analyse Gaps: Begin by monitoring the draft as it becomes available. Once the DIS is released, conduct a formal gap analysis comparing your current QMS to the new draft requirements. Focus on the changes above  e.g. does your quality policy address ethical behavior? Are climate risks considered in your context? Such an analysis will reveal what documentation and processes need updating.

• Revise Documentation and Processes: Use the gap analysis findings to update your QMS documentation. Revise policies, procedures and objectives to incorporate the new emphases. For example, update the Quality Policy to highlight integrity and strategic quality objectives (Clause 5.1), refine the context-analysis procedure to explicitly ask about climate change and stakeholder requirements, and split your risk management procedure into risk vs. opportunity sections. Many core clauses (e.g. planning, support, improvement) should be reviewed for clarity but likely need only editorial tweaks. In drafting, leverage the expanded Annex A as an interpretive aid once available.

• Engage Leadership and Teams: Ensure top management understands and leads the transition. Train leaders on their new responsibilities (quality culture, ethics, stakeholder engagement). At the same time, educate employees on the changes  for instance, explain what “opportunity management” means, or why climate matters to quality. A phased roll-out is advised: form a cross-functional transition team, set objectives and timelines (Preparation phase), then plan and pilot the revised processes (Implementation phase), and finally validate them through audits and management reviews. Ideagen outlines a four-phase approach (prepare, plan, implement, validate) to manage the change systematically.

• Training and Awareness: Update internal and external training (auditor training, staff QMS training, etc.) to cover any new content. This might include workshops on quality culture and ethics, risk/opportunity workshops, or seminars on digital quality tools. Make sure auditors (internal or external) are prepared to assess the new clauses. Use the revised Annex A examples to illustrate concepts. Engage your organisation’s culture  communicate why these changes matter so that staff buy in, rather than just seeing it as paperwork.

• Use Transition Tools: Utilise resources from certification bodies and consultants. SGS and Intertek (among others) plan to offer gap assessments, readiness audits, and courses. Prepare internal audit checklists against the DIS clauses. You may also schedule pre-audit assessments or mock audits using draft requirements. As the final standard nears publication, consult your registrar about the official transition audit dates and whether you should “upgrade” during a surveillance audit or the next recertification.

• Stay Aligned with Strategy: Take this opportunity to align your QMS with your organisation’s strategic goals. For example, if sustainability is a corporate focus, use the new climate context requirement to integrate environmental metrics into quality objectives. If digital transformation is underway, incorporate how data analytics will feed into quality monitoring (as Intertek suggests) This alignment will turn the audit exercise into a business enabler.

In summary, early preparation is key: “Your ISO 9001:2015 certification is fully valid until 2029,” notes 9001Simplified, “so use that time to integrate improvements now”. Performing a thorough readiness review now will make the later transition fast and low-risk.

Potential Business Impact of ISO 9001:2026

Adopting the updated standard will have both positive and challenging implications for organizations:

• Positive Impacts: By refreshing the QMS requirements, ISO 9001:2026 can drive improvements in resilience, innovation and stakeholder trust. Intertek observes that the revision “moves ISO 9001 beyond a compliance-driven framework, positioning it as a strategic tool to enhance resilience, efficiency, and reputation”. In practice, firms that embrace the new clauses may find they have stronger corporate governance (through ethics requirements), better risk anticipation, and a higher profile in markets that value sustainability and transparency. For example, Ideagen notes that early adopters often “strengthen customer trust, meet tender requirements faster and enhance their market reputation” by signaling readiness. In other words, proactive organisations can turn compliance into a competitive advantage. Organisations may also reap operational benefits: the expanded focus on quality culture and continuous improvement can boost employee engagement and productivity over time Integrated consideration of climate and stakeholders may open new opportunities, such as entering sustainability-minded supply chains or avoiding climate-related disruptions. Overall, if implemented thoughtfully, ISO 9001:2026 should help firms align quality management with modern business challenges, yielding long-term gains.

• Challenges and Costs: On the flip side, every revision incurs some cost. Companies will need to invest in updating documents, training staff and possibly adjusting processes or IT systems. There may be short-term disruption as auditors and employees learn the new expectations. One consulting firm warns that even modest changes “increase cost and disruption for organisations worldwide”. Smaller firms or those with limited resources may feel the pinch more acutely, particularly if they must hire consultants or pay for new training.

  In addition, some proposed changes (e.g. climate or stakeholder clauses) may seem tangential to a strict “quality” focus, requiring broadening of the traditional QMS scope. Organisations must guard against compliance becoming a mere checkbox exercise; instead, they should integrate the changes into meaningful business processes.

In practice, however, most analysts expect only moderate transition burden for well-run QMSs. DNV notes that the revealed DIS changes “mean quite moderate changes for companies”. Because ISO 9001:2026 builds on existing structures and offers interpretive guidance, the risks of misalignment are lower. With good planning, the costs of transition can be managed (and often offset by efficiency gains). Ultimately, the decision to adopt the new standard is usually driven by customers or regulators: since ISO 9001:2015 certificates must eventually be upgraded, organisations will likely choose how and when to transition within the allowed timeframe.

Early Adopters and Case Insights

At this stage, few formal case studies of ISO 9001:2026 adoption exist, since the standard is not yet finalised. However, industry commentators highlight examples of organisations gearing up. For instance, some companies are participating in pilot studies or using the draft clauses in internal audits. Anecdotally, sectors like tech and automotive  where digital quality and supply-chain issues are critical  are closely monitoring the revisions.

Even without named case studies, thought-leaders offer insight. As noted above, Ideagen emphasises the market advantage of early readiness. Similarly, certification bodies suggest that firms can “realign your QMS with strategic goals” and “refresh stakeholder engagement” during the revision process. In other domains, companies that faced rapid digitalisation or climate regulations have informally reported using ISO 9001 reviews to drive change. For example, a manufacturing firm might pilot adding climate risk questions to its risk register. These experiences, while not yet published, illustrate how organisations can integrate anticipated 2026 changes on a trial basis.

As the FDIS and final standard are released, we can expect formal pilot reports or webinars from ISO, auditors, and industry groups. Until then, the general lesson is clear: firms that engage early, studying the draft and adjusting their systems, will be best positioned to make the switch smoothly and gain first-mover benefits.

Recommendations for Quality Managers and Consultants

To capitalize on ISO 9001:2026, quality leaders and consultants should take a proactive, strategic approach:

• Plan Ahead and Stay Informed: Register for ISO and accreditation updates, and follow publications from IAF and certification bodies. Keep track of WG 29 meeting reports and subscribe to newsletters (ISO offers email alerts for new drafts). Being aware of timelines (e.g. DIS ballot dates, expected publication) lets you allocate resources. Form a dedicated transition team now and set clear objectives.

• Leverage the Existing QMS: Recognise that most of ISO 9001:2015 will carry over. Use your current QMS as a foundation. Map out which new clauses (5.1, 6.1 sub-clauses, climate) differ from your 2015 system. Performing a gap analysis against the draft will show exactly where updates are needed. Anything already compliant (e.g. if you already manage risks and opportunities separately) will serve you well. Align the updates with your quality policy and strategic goals  for example, tighten supplier controls if you foresee stricter requirements.

• Focus on Leadership and Culture: Prepare top management for their new role. Review how leadership currently communicates quality and ethics, and identify gaps. You may want to conduct a workshop on “quality leadership” or update the management review agenda to include culture and ethics topics. Quality consultants should include training on these new leadership requirements when advising clients.

• Train and Engage Your Team: Develop training materials that cover the new focus areas (clause 5.1 quality culture, clause 6.1 risk/opportunities, climate context, etc.). Use the expanded Annex A (once available) as training material  it provides examples that clarify implementation. Communicate early with staff about the coming changes so they understand why these matters are being added. Engaged, well-informed employees make the transition smoother.

• Align with Other Initiatives: Many of the ISO 9001:2026 updates overlap with other trends (sustainability, digitalization). If your organisation has ISO 14001 (environment), ISO 45001 (safety) or ESG programs, look for integration opportunities. Consultants should advise clients on how the new clauses can dovetail with existing risk, supplier, and sustainability processes. Using an integrated approach will save duplication of effort.

• Monitor Competitors and Industry Practices: Keep an eye on peers and competitors. If major customers or industry groups start to reference ISO 9001:2026 readiness (for example in RFQs or policy documents), respond accordingly. Early implementation in one part of the organisation can be showcased as a success story and then rolled out company-wide.

• Treat It as an Opportunity: Emphasise to executives that ISO 9001:2026 is not just extra work, but a chance to modernize and improve the QMS. Recommendations from SGS and Intertek underscore that even with moderate changes, the revision is an opportunity to “realign your QMS with strategic goals, refresh stakeholder engagement and integrate modern values like ethical practice and quality culture”. Position the transition as a quality improvement project, not a mere compliance checkbox.

In summary, quality managers and consultants should start planning now: review the draft when available, update their processes on paper, and build awareness across the organisation. By doing so methodically, they can ensure ISO 9001:2026 becomes a source of renewed value rather than a source of hassle.

The upcoming ISO 9001:2026 revision reflects the evolution of business challenges since 2015. It embeds important themes  leadership accountability, ethical culture, clear risk management, and environmental awareness  into the quality framework. While the core of ISO 9001 remains familiar, these refinements are aimed at making QMSs more strategic and resilient. Early insight from ISO and industry experts suggests the transition will be very manageable for most organisation.

For professionals in quality and compliance, the message is clear: use the lead time wisely. Update your QMS now with the mindset of continuous improvement. Engage stakeholders, train your people, and integrate the new concepts into daily operations. By treating ISO 9001:2026 as an opportunity to strengthen your QMS, you can not only maintain certification status but also drive lasting business benefits  from higher customer trust to greater operational excellence.