Loading...
ISO 9001 Revision 2026
Overview of New Requirements and Changes
The revision of ISO 9001 is complete. On September 16, 2026, the Technical Committee ISO/TC 176/SC 2 published the final version of the international standard for quality management in English. The German translation of ISO 9001:2026 is expected in November 2026. For certified organizations, now is the time to prepare for the transition to the new standard.
DQS supports organizations with a wealth of experience: Since 1985, the year the first drafts of the ISO 9000 family were developed, we have actively helped shape the future of the world's most important standard for quality management.
On this page, you will find up-to-date information, concise background information, and practical resources.
ISO 9001:2026 – The New Standard
An overview of the key points
ISO 9001:2026 is the revised version of the world's most widely used management system standard. It introduces targeted changes rather than fundamental innovations: Existing requirements have been clarified, supplemented, and placed more strongly in context.
An ISO 9001-compliant quality management system remains an effective lever for organizations: In practice, it strengthens customer loyalty through reliable and traceable processes, accelerates onboarding into supplier portals, and reduces complaints, rework, and quality costs through effective process management. At the same time, it facilitates access to international markets and improves risk identification through regular, structured external assessments.
Content Changes
Among the most important developments compared with the previous version are a clearer distinction between opportunities and risks and a more systematic approach to addressing them. Climate change, sustainability, quality culture, and ethical behaviour are also more firmly embedded in the context of the organization and in relation to relevant interested parties.
Structure and Layout
The standard has been fully aligned with the Harmonized Structure (HS), bringing it into closer alignment with other ISO management system standards. Informative Annex A has been revised and continues to provide explanatory guidance on applying the requirements without introducing any additional obligations. In addition, definitions of key terms have been clarified to facilitate the practical application of the standard.
ISO 9001:2026 Revision – The Changes in Detail
Not every “emerging trend” – meaning the pressing developments shaping our time and the global economy – has been incorporated into the new standard as a specific requirement. Artificial intelligence, for example, despite extensive discussion, has not made it into the standard as a separate, specific requirement. ISO 9001:2026 deliberately remains technology-neutral and leaves it up to organizations to determine how they address AI. However, the following areas are directly relevant to the QMS:
Managing Risks and Opportunities
More Differentiated and Clearer
- What has changed? The distinction between risks and opportunities has been clarified. Previously, the risk-based approach was formulated relatively openly – now, the standard makes a clearer distinction between negative risks (threats) and positive opportunities (potential). In the new standard, Clause 6.1, “Actions to address risks and opportunities,” has been supplemented by Subclauses 6.1.2, “Actions to address risks,” and 6.1.3, “Actions to address opportunities.”
- Why? Many organizations find it difficult to identify and act on opportunities systematically. The standard can now provide more guidance in this area without creating additional bureaucracy.
Quality Culture and Ethical Behaviour
From Optional to Required
- What has changed? Quality culture and ethical behaviour are now explicitly embedded in the requirements for the first time. Clause 5.1.1 will explicitly require top management to actively promote a quality culture and ethical behaviour, while Clause 7.3 ensures that all employees are aware of this culture and the underlying ethical principles. A note to the standard further clarifies this: An organization's quality culture and ethical behaviour are reflected in its shared values, attitudes, and established practices.
- Why? Even the best-documented quality management system remains ineffective if it is not put into practice in day-to-day operations. By embedding these aspects in leadership and awareness, the standard moves closer to this lived practice – not to turn organizations into moral institutions, but with a focus on fundamental values such as integrity, reliability, and accountable conduct.
Context of the Organization
A Stronger Strategic Focus
- What has changed? ISO 9001:2026 introduces strategic alignment as a new perspective: Clause 5.2.1 e), “Context of the organization and strategic direction.” The quality policy, objectives, and actions are now expected to be more explicitly aligned with the organization's long-term strategy. Incidentally, the use of artificial intelligence (AI) can also be considered in this context.
- Why? This addition emphasizes that the context and strategic direction must not merely serve as background but must be an integral part of the quality management system.
Loading...
Free White Paper
ISO 9001:2015 vs. ISO/DIS 9001:2025
Comparison of Existing and Revised Standard Requirements
Changes in ISO 9001: Explore the changes introduced in the Draft International Standard (DIS) through a direct comparison of corresponding standard requirements. Benefit from the expertise of our specialists and identify potential areas requiring action at an early stage.
Annex A
The informative Annex A, “Explanation of the structure, terminology and concepts,” has been fundamentally revised and is intended to support the understanding of the requirements. It provides explanations and illustrates the relationships between requirements, helping users understand how the standard's requirements are to be interpreted and applied. This represents a significant update compared with ISO 9001:2015.
Conclusion: Evolution Rather Than Revolution
The 2026 revision does not introduce an entirely new standard. Instead, it represents a targeted evolution that sharpens, supplements, and contextualizes existing requirements.
What Do You Need to Do Now?
Have you already implemented a quality management system in accordance with ISO 9001? Then the publication of the final version of the standard is the right time for a focused reality check – without taking hasty action, but with a view to identifying the first meaningful steps toward transitioning to ISO 9001:2026.
In particular, the following steps can be useful:
- Get an overview: Briefly introduce relevant FDIS topics internally, such as leadership and culture, structured risks and opportunities, the context of the organization, digitalization, and climate-related considerations.
- Start with a quick self-assessment: Use a concise readiness checklist to assess where you are well prepared and where action may be needed.
- Set priorities: Based on the self-assessment, select 2–3 topics to focus on with a view to your next certification audit, such as risk and opportunity registers, keeping risk and opportunity lists up to date, transparency in software-supported processes, and supplier criticality.
- Set milestones: Plan internal audits covering the new topics, schedule management reviews, and use them as useful milestones to regularly review progress and outstanding issues.
A Smooth Transition to ISO 9001:2026 – Resources and Tools Available to You
Concise Transition Plan: Our roadmap provides a clear overview of how you can prepare for the transition to ISO 9001:2026. Access the free ISO 9001 Transition Plan here.
Newsletter: Concise updates throughout the transition period, new articles on the standard, and information about upcoming events – delivered straight to your inbox. Sign up for the newsletter.
DQS – Your Partner for the Transition to ISO 9001:2026
Historically Connected to ISO 9001
DQS and ISO 9001 have been closely connected since the very beginning. Founded by DGQ and DIN in 1985, DQS issued the first ISO 9001 certificate in Germany as early as 1986 – one year after the first drafts of the ISO 9000 series were published. This close connection to standardization has grown into more than 40 years of auditing experience that continues to shape DQS's work today.
First-Hand Guidance
This experience pays off when transitioning to ISO 9001:2026: DQS experts continue to be actively involved in the relevant standardization committees, translating discussions and drafts into clear, accessible information from an auditor's perspective – independent, objective, and practical. This gives organizations reliable guidance at an early stage on what changes to expect and where to focus their preparations.
A Seamless Transition
With more than 80 offices in 60 countries and a global network of over 3,000 auditors, DQS supports organizations of all sizes throughout the certification process – with industry-specific expertise and auditors who understand the respective context from first-hand experience. As a member of IQNet, the international certification network, DQS also ensures the cross-border recognition of certificates issued.
In short: With its historic connection to the standard, active involvement in standardization committees, and decades of auditing experience, DQS combines in-depth knowledge with practical application – for a transition that is focused, clear, and reliable.
Loading...
Blog Post
CSR is the quality management of the future
Find out how ISO 9001:2026 strengthens social and environmental responsibility – and what this means for the future of quality management.
What do industry experts expect from the ISO 9001 revision?
Quality management is about more than simply meeting requirements – it provides an opportunity to build high-performing organizations and drive progress in areas such as sustainability, digitalization, and corporate culture. We asked experts for their expectations regarding the revision – practitioners and standards specialists who are closely connected to the industry, contribute their experience to professional networks and standardization activities, and offer insights into the future readiness of quality management.
Learn more here.
What Was the Timeline for the ISO 9001 Revision?
The revision of ISO 9001 followed a defined, multi-year process. With the publication of ISO 9001:2026 on September 16, 2026, this process has now been completed. The key milestones can be seen at a glance in our infographic.
The entire revision process was planned over a period of 36 months and coordinated by the international Technical Committee ISO/TC 176 SC2 WG29.
The Revision Phases at a Glance
- Working Draft (WD): Initial working draft within the committee, providing a general basis for discussion.
- Committee Draft (CD): First version to be reviewed and discussed internally within ISO.
- Draft International Standard (DIS): More mature draft that was made available for public comment for the first time.
- Final Draft International Standard (FDIS): Near-final version in which only editorial changes were possible.
- International Standard (IS): The official publication by ISO on September 16, 2026 – since then, the basis for certification to ISO 9001:2026.
Why Did the Revision Take So Long?
ISO 9001 is the world's most widely used standard for quality management – more than one million organizations work according to it. Revising such a widely used standard takes time: More than 160 member countries contributed their perspectives, multiple rounds of commenting and voting ensured that all voices were heard, and the standard had to be translated into numerous languages. At the same time, it had to work for start-ups as well as multinational corporations – across all industries. The result is a standard that is recognized worldwide and works reliably in a wide range of contexts.
Other Quality Management Standards Under Revision
There is also plenty happening in the wider ISO 9001 environment. The fundamentals and terminology for quality management systems are currently being revised – and updates have also been made to ISO 14001 and ISO 19011 in 2026.
Why the ISO 9001 Revision Matters to You
The revision of ISO 9001 affects more than just quality managers – it has an impact on virtually every industry, from highly regulated sectors to public institutions.
The requirements of the standard are identical for all organizations. In practice, however, industry-specific priorities and implementation strategies often differ considerably. This makes it all the more important for the revised standard to be practical in its wording and applicable across different industries.
A Look at Key Industries
A closer look at industry-specific expectations shows where organizations see a particular need for action – especially in sectors with high regulatory requirements, a strong customer focus, or complex supply chains.
In the automotive industry, ISO 9001 is closely linked to the industry-specific standard IATF 16949. Changes to ISO 9001 therefore have a direct impact on the requirements along the supply chain. The industry is challenged in terms of verification, process stability and supplier management. Topics such as risk and opportunity assessment, traceability and continuous improvement are also central to the automotive industry - the revision will certainly be followed closely.
Even though ISO 9001 is traditionally very widely used in these sectors, the focus is often still on a more pragmatic application. A revision could provide impetus here - for example by anchoring a strategic understanding of quality more firmly, through a clearer understanding of opportunities and risks or through a stronger emphasis on sustainable corporate management.
For manufacturers of medical devices, but also for service providers in the healthcare sector, an effective quality management system is required by law - for example by the EU MDR or requirements of the US FDA. ISO 13485, the industry-specific standard, is based on ISO 9001. The revision therefore also has an impact here. Clarity and structure in regulatory requirements, consistent documentation and practical guidelines on quality culture and management are particularly important.
The revision of ISO 9001 is particularly important here due to its close integration with other management system standards - such as ISO 14001 for environmental management or ISO 50001 for energy management. The harmonization of the standard structure is important in order to be able to implement integrated management systems efficiently. At the same time, topics such as sustainability, ESG requirements and resilient corporate governance are coming more into focus
Service companies, especially in the IT environment, often use ISO 9001 as the structural backbone for integrated management systems - for example in combination with ISO/IEC 27001 (information security). Customer satisfaction, continuous improvement, agility and trust are key keywords. The revision is seen as an opportunity to sharpen the standard, particularly with regard to digital transformation, leadership and ethical behavior
In the education sector, ISO 9001 is particularly relevant where it is a prerequisite for public funding or accreditation. Many educational institutions have implemented QM systems that are strongly oriented towards the standard. In the revision, impulses relating to quality culture, impact measurement and customer orientation (in the sense of participant and stakeholder orientation) are seen as helpful in further developing the understanding of quality in the education sector. The revision will therefore also have an impact on the ISO 21001 management system standard specifically for the education sector
The public sector is increasingly turning to quality management in accordance with ISO 9001 - for example in administrations, public utilities or municipal service companies. However, change is taking place more slowly than in the private sector. Nevertheless, impetus is needed for more effective process design, strategic control and transparent communication. The audit offers the opportunity to establish quality management more strongly as an instrument of good governance and citizen-oriented service provision
ISO 9001 is also of central importance in the aerospace, pharmaceutical, life sciences and food industries - whether as the basis for industry-specific standards such as EN 9100, ISO 13485 or FSSC 22000. In these highly regulated sectors, the focus is on topics such as product safety, traceability, risk management and compliance. The revision is being closely monitored here, as it can provide important impetus for greater clarity, future orientation and integrated requirements
White Papers, Articles and Training on ISO 9001:2026
Our guides and white papers, blog articles, and training courses help you stay ahead of developments, reflect on current practices, and continuously develop your quality management system with the future in mind. Here is a selection:
In Brief
3 Things to Keep in Mind About ISO 9001:2026
- Prepare for the changes: Opportunity management, organizational context, sustainability, strategy, and culture are becoming more important. Identify effective approaches for further developing your quality management system.
- No need for immediate action, but now is the time to take the first steps: Identify your priorities and begin your analysis for transitioning to the new standard.
- DQS as a reliable source of guidance: Founded by DGQ and DIN, responsible for the first ISO 9001 certification in Germany, and actively involved in standardization committees – we are ideally positioned to support you throughout the transition to ISO 9001:2026.
Loading...
Do you have questions about the ISO 9001 revision?
We are here to help.
Changes often raise questions.
We look forward to addressing them together with you. If you have questions about topics such as transfer audits or matrix certification, we will be happy to provide you with further information upon request.
Get in touch with us – with no obligation and free of charge.
Trust and expertise
Our texts and brochures are written exclusively by our standards experts or long-standing auditors. If you have any questions about the text content or our services to our author, we look forward to hearing from you.