ISO 9001:2026 is the upcoming revision of the ISO 9001 quality management standard, expected to be published in late 2026, with an increased focus on leadership behavior, risk-based thinking, sustainability, and digitalized quality processes. In quality management, nothing stays the same for too long. What works today often needs to be reviewed tomorrow, and standards are no exception. ISO, as an international organization, is already working on the adjustments that will shape the 2026 version of its standards—particularly ISO 9001. The current context demands it: companies deeply engaged in digital transformation, increasing pressure to demonstrate sustainability, and an environment where global risks and customer expectations evolve rapidly. It is therefore no surprise that this upcoming update is generating both strong interest and uncertainty among those responsible for quality management systems. Anticipation is key. That is why we are sharing an early overview of the most recent and relevant aspects, supported by reliable sources regarding the revision of ISO 9001 (and its relationship with other ISO standards). ISO 9001:2026 At A Glance ISO 9001:2026 introduces targeted updates focused on leadership culture, risk-based thinking, sustainability, and digitalization. While core requirements remain stable, organizations will need to adapt governance, risk management, and data-driven processes to align with the revised standard. Early preparation through gap analysis and transition planning will be critical to ensure compliance and operational continuity. Area ISO 9001:2015 ISO 9001:2026 (Expected) Leadership Commitment required Active quality culture & ethical behavior Risk management Integrated approach Clear separation of risks & opportunities Sustainability Indirect consideration Explicit climate relevance Digitalization Limited references Software, data & AI validation Annex A Basic guidance Expanded interpretative guidance Structure Stable Clarified clauses & terminology Why a New Version of ISO 9001? Several years have passed since the last major revision of ISO 9001 in 2015. Since then, this standard has become a backbone for countless quality management systems worldwide. It was, and remains, a clear guide for structuring processes and ensuring consistency. However, it is evident to organizations that the environment has changed rapidly. Today, we speak of digital transformation, supply chains spanning continents, environmental pressures, and a much stronger awareness of organizational risk. All of this makes a revision necessary—not because the standard has lost value, but because the context demands new answers, new approaches, and a different perspective. The responsible technical committee (ISO/TC 176/SC 2) has set September 2026 as the target publication date for the revised version. However, the communicated dates are not yet definitive: some projections indicate October or November 2026 for the final release. During the revision process, a Draft International Standard (DIS) was issued and submitted to public consultation for approximately 12 weeks. The transition window for organizations to migrate from ISO 9001:2015 to the 2026 version could be up to three years, as has traditionally been the case. So why start thinking about it now? Two main reasons: Avoid last-minute pressure: Organizations that wait until the end may struggle to adapt their processes smoothly. Use the moment to innovate: This is not just about compliance, but about improvement—integrating new practices and raising internal standards before the external environment forces the change. Who Should Prepare for ISO 9001:2026? Preparation for ISO 9001:2026 is particularly relevant for: Organizations currently certified to ISO 9001:2015 Companies operating complex or global supply chains Manufacturers and service providers with digitalized processes Organizations integrating ESG, sustainability, or risk management initiatives Businesses planning integrated management systems (ISO 9001, ISO 14001, ISO 45001) Key Expected Areas of Change in ISO 9001:2026 Although the final text has not yet been published, the DIS already provides a clear indication of the direction of the update. No radical changes are expected; instead, the objective is to refine certain clauses, reinforce emerging themes, and ensure that ISO 9001 remains practical in the face of current challenges. For this reason, it is worth paying attention to topics that are increasingly mentioned, as they are likely to form the backbone of the upcoming version: 1. Leadership, Culture, and Ethical Behavior Clause 5.1 (“Leadership and Commitment”) is expected to require stronger evidence that top management actively promotes a culture of quality and ethical behavior within the organization. Commitment on paper will no longer be sufficient—organizations will need to demonstrate how this culture is practiced daily. 2. Clearer Treatment of Risk and Opportunity Clause 6.1 will be reorganized into sub-clauses (6.1.1 to 6.1.3), separating risk and opportunity more explicitly and providing additional guidance. This supports a more proactive, rather than purely reactive, approach. 3. Integrated Climate Change and Sustainability A recent innovation already introduced through a 2024 amendment requires organizations to assess whether climate change is a relevant issue in their context (clauses 4.1 and 4.2). The 2026 version will formally integrate these provisions. In other words, sustainability moves from a peripheral topic to a core element of the Quality Management System. 4. Emerging Technologies and Digitalization The DIS includes new references to technologies such as automation, artificial intelligence, and digital tools for measurement, monitoring, and data analysis. For example, organizations may be required to validate specialized software used for data analysis. Additionally, Annex A (interpretative guidance) will be expanded to provide more detailed explanations aligned with clauses 4 through 10. 5. Harmonization with Other ISO Standards To facilitate integrated management systems (for example, quality combined with environmental or occupational health and safety systems), ISO 9001:2026 will continue to align with other standards under the common structure (Annex SL). This creates opportunities for more coherent and less fragmented management approaches. 6. “Minor to Moderate” Changes to Requirements No major overhaul of core requirements is expected. Many changes will focus on clarifying definitions, notes, or guidance. This is not a complete revolution, but rather a structured and deliberate evolution. What Does ISO 9001:2026 Mean for Your Organization? These changes go beyond technical adjustments and will influence organizational mindset and daily practice. Key implications include: Stronger and more visible involvement of top management in promoting a quality culture. Quality teams needing skills not only in auditing, but also in risk management, technology, and sustainability. Early gap analysis against the DIS to anticipate action plans. Easier integration of quality, environmental, and safety management systems when approaches are aligned. Organizations already engaged in digital transformation or ESG initiatives will have a clear advantage. In parallel, certification bodies and accreditation organizations (such as IAF) will issue transition guidelines as the final version approaches. How Pro QC Supports the Transition to ISO 9001:2026 At Pro QC International, we understand that the upcoming changes are not simply about updating documents and procedures. Each revision of ISO 9001 sends a clear signal: the way organizations manage quality must evolve alongside their operational, regulatory, and risk environment. This requires more than passive observation—it requires structured preparation. With more than 40 years of on-the-ground experience supporting ISO-certified organizations across manufacturing, consumer goods, medical devices, and industrial sectors, Pro QC brings a practical, auditor-level understanding of ISO 9001 requirements and how they are applied in real operating conditions. Now is the time to act, not to wait. As a company specialized in quality assurance and audit solutions, Pro QC supports organizations through ISO 9001 audit services, including: ISO 9001 gap analysis ISO 9001 internal audits transition readiness assessments corrective action follow-up These services are designed to help organizations assess their current quality management system, identify areas requiring adjustment, and prepare for ISO 9001:2026 in a controlled and structured manner—without disruption to operations. How to begin? While each organization must adapt its approach to its own context, several practical steps consistently prove effective. First, organizations should maintain active awareness of the ISO revision process and forthcoming certification guidance. Monitoring official ISO communications, IAF publications, and certification body bulletins helps anticipate how the revised requirements will be assessed during audits. Second, internal alignment is essential. Facilitated internal audits and management reviews provide an opportunity to evaluate leadership practices, risk-based thinking, quality culture, sustainability considerations, and the governance of digital tools—topics expected to carry greater weight in ISO 9001:2026. Third, organizations should conduct a structured comparison between their existing quality management system and the published Draft International Standard (DIS). A focused gap analysis, supported by independent auditors, allows teams to identify compliance gaps, prioritize corrective actions, and strengthen the system before the formal transition period begins Conclusion: Anticipation Is Key for ISO 9001:2026 ISO 9001:2026 is not a radical rewrite, but it represents a meaningful shift in how organizations approach leadership, risk, sustainability, and digitalization within quality management systems. Organizations that begin preparing early will face fewer disruptions and gain more strategic value from the transition. ISO 9001:2026 FAQ Q1. When will ISO 9001:2026 be published? ISO 9001:2026 is expected to be published in 2026. Current working targets discussed publicly indicate late 2026, but the exact month depends on the ISO development process and final approvals. Q2. Will organizations need to recertify immediately when ISO 9001:2026 is released? No. ISO transitions typically include an official transition period (often up to three years). During that window, certified organizations usually keep their ISO 9001:2015 certification while preparing for audits against the revised version. Q3. What are the most likely changes in ISO 9001:2026 compared with ISO 9001:2015? The revision is expected to reinforce leadership accountability and quality culture, clarify risk and opportunity planning, incorporate climate-change relevance into context analysis, and better reflect the role of digital tools and data in quality management. Q4. Does ISO 9001:2026 require addressing climate change and sustainability? Organizations are expected to evaluate whether climate change is relevant to their context and interested parties. If relevant, it must be considered within the management system’s planning and decision-making. Sustainability is therefore treated more directly than in earlier versions. Q5. How should organizations start preparing for ISO 9001:2026 today? A practical starting point is to monitor ISO updates, run a gap analysis against the latest draft text when available, and plan targeted improvements in leadership practices, risk management, and governance of digital tools used for monitoring, measurement, and analysis. Q6. Will ISO 9001:2026 affect internal audits and management reviews? Yes—most organizations should expect updates to audit criteria, audit checklists, and management review inputs so they reflect the revised emphasis on leadership behavior, risk-based planning, climate-change relevance, and performance monitoring through digital systems. About Pro QC For more than four decades, organizations across multiple industries have trusted Pro QC International as a global partner for quality assurance and audit solutions. Founded in 1984, Pro QC supports companies worldwide with factory and supplier audits, inspections, and quality management system audits adapted to complex regulatory and operational environments. As ISO 9001:2026 introduces a stronger focus on leadership, risk management, sustainability, and digitalization, Pro QC provides practical ISO 9001 audit services to help organizations assess their current systems, identify gaps, and implement corrective actions. Through an auditor-level, on-the-ground approach, Pro QC works closely with quality teams to support structured preparation and strengthen long-term quality performance beyond certification alone.
