Quality leaders in every industry recognize the ISO 9001 standard as the global benchmark for a good Quality Management System. The current version, ISO 9001:2015, introduced important concepts like the high level structure and a formal emphasis on risk based thinking. The next evolution of this standard is now on the horizon with the planned revision, ISO 9001:2026. The announcement of a new revision creates a sense of uncertainty and concern about the work required to transition. This response is understandable, but the upcoming changes should be viewed as an opportunity to re-evaluate and strengthen your quality processes. This guide provides a clear look at what quality leaders can expect from ISO 9001:2026 and outlines how you can begin to prepare your organization today for a smooth transition.
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What is ISO 9001:2026?
The designation ISO 9001:2026 refers to the next planned revision of the ISO 9001 standard for Quality Management Systems. The International Organization for Standardization (ISO) periodically reviews its standards to make sure they remain relevant to the current business environment. The technical committee ISO/TC 176/SC 2 manages this process, which involves gathering global feedback, drafting changes, and building consensus among member countries. The exact text of the new standard is not yet final, but the revision process is officially underway.
The objective is not to completely rewrite the standard but to refine and enhance the existing framework established by ISO 9001:2015. The committee is evaluating global changes that have occurred since the last update. These include the rapid acceleration of digital transformation, increased supply chain disruptions, and a growing international focus on sustainability and Environmental, Social, and Governance (ESG) principles. A modern Quality Management System must be able to address these new realities. The upcoming ISO 9001:2026 will likely integrate these themes, helping organizations build a quality system that is also resilient, responsible, and forward looking. It aims to be an evolution that helps organizations build stronger and more adaptable quality operations for the future.
ISO 9001:2026 Timeline – From Draft to Publication
The journey to publishing a revised standard like ISO 9001:2026 is a structured process that takes several years and involves multiple stages of drafting and review. Understanding this timeline helps you understand the process and allows quality leaders to know when key information will become available. This knowledge enables them to plan their transition activities well.
- Working Draft (WD) Stage. A dedicated task group of experts within the ISO committee develops the initial drafts of the standard. This is where new ideas and proposed changes are first debated and written down. This stage involves extensive discussion to form the initial direction of the revision.
- Committee Draft (CD) Stage. The working group shares the draft with the full parent committee for comments once it is stable. This is the first point where the proposed changes are seen by a wider group of national standards bodies from around the world. The committee may produce several versions of the Committee Draft to resolve all comments and build a strong consensus.
- Draft International Standard (DIS) Stage. This stage is a huge milestone in the revision process. The draft is now considered mature enough to be shared with all ISO member bodies for a formal vote and public comment. This is typically the first time the general public can purchase and review the draft, offering a clear preview of the final standard.
- Final Draft International Standard (FDIS) Stage. The committee addresses all comments on the DIS and circulates a Final Draft for a last yes or no vote among ISO members. Only minor editorial changes are permitted at this stage. A successful vote means the standard has been approved for publication.
- Official Publication. The final, approved version of ISO 9001:2026 is officially published. Following publication, there is typically a transition period, often three years, for companies already certified to the previous version. This gives organizations like yours time to update their systems from ISO 9001:2015 and undergo a transition audit.
ISO 9001:2015 vs. ISO 9001:2026
The ISO 9001:2015 revision was a large overhaul that introduced the Annex SL high level structure and a strong focus on risk. The changes in ISO 9001:2026 are expected to be more evolutionary, building upon that base rather than replacing it. The goal is to refine the standard and integrate new concepts that have become central to modern business. We can expect to see shifts in emphasis across several key areas.
A Deeper Integration of Risk and Resilience
The 2015 version of ISO 9001 successfully introduced risk based thinking. The upcoming revision will likely deepen this concept to include broader ideas of organizational resilience. This could mean more explicit requirements for managing supply chain disruptions, planning for business continuity, and building a quality system that can adapt to unexpected global events. The focus is moving from just identifying risks to actively building a more resilient and durable operation.
Acknowledging Digital Transformation and Data
The business world is far more digital today than it was in 2015. The ISO 9001:2026 revision will likely address the impact of digitalization on the QMS. This may include a greater emphasis on data integrity, cybersecurity risks related to quality data, and the use of digital tools and automation in quality processes. The standard will need to recognize that a modern QMS is often an electronic system.
Incorporating Sustainability and ESG
There is a growing global expectation for companies to manage their environmental and social impact. Recent revisions of other major ISO standards have already begun to incorporate these concepts. It is highly likely that ISO 9001:2026 will follow this trend. This could involve requiring organizations to consider the environmental and social impact of their processes as part of their quality objectives, aligning quality management more closely with overall corporate responsibility.
These expected changes show that the next version of the standard will build upon ISO 9001:2015, making it more relevant to the interconnected, digital, and socially conscious business world of today and tomorrow.
Preparing Your QMS for ISO 9001:2026
Even though the final version of ISO 9001:2026 is still some time away, the time to start preparing is now. A proactive approach will put your organization in a strong position to adapt quickly once the new standard is published. Waiting until the last minute will create unnecessary stress and risk.
Here are some practical steps you can take today to get ready:
- Master Your Current System. The best way to prepare for the next version is to be fully and effectively compliant with the current one. Confirm that your QMS is truly aligned with all clauses of ISO 9001:2015. Conduct a thorough internal audit or a gap assessment to identify any weaknesses in your current processes, especially around risk based thinking.
- Go Deeper on Risk Management. Move beyond a simple risk register. Start integrating risk based thinking more deeply into all your quality processes. How do you manage risk in your supply chain? In your change control process? In new product development? Building a stronger risk management muscle now will almost certainly align with the direction of the new standard.
- Begin Integrating ESG and Sustainability. Start the conversation about how your QMS can support your organization’s broader ESG goals. Can your quality objectives include targets for waste reduction? Can your supplier qualification process include criteria for social responsibility? Thinking about these connections now makes it much easier to adapt to new requirements in this area.
- Review Your Digital Infrastructure. Take a hard look at the technology you use to manage your quality system. Are your records secure and easily accessible? Can you ensure data integrity? Is your system flexible enough to adapt to new requirements? The 7 principles of ISO 9001 are much easier to manage with digital tools.
- Stay Informed. Keep track of the revision process by following official sources. The ISO committee responsible for the update provides periodic news on their progress. You can find official updates on the ISO Revisions page for the technical committee, which will help you anticipate changes and avoid surprises.
Why a Cloud-Native eQMS Simplifies the Transition
When a new revision of a standard like ISO 9001 is released, every certified organization must review and potentially update its procedures, forms, and workflows. This is where the technology you use to manage your QMS can be either a great help or a major obstacle. A modern, cloud native eQMS is designed for this kind of change, making the transition simpler.
An on premise, legacy QMS is often rigid and difficult to change. If the ISO 9001:2026 revision requires you to add a new field to your CAPA form or a new step in your supplier qualification workflow, making that change in an old system could require expensive custom coding and a complex revalidation project. The system’s inflexibility becomes a barrier to compliance. In contrast, a modern, configurable cloud native eQMS is built for agility. Making a similar change in a no code system can often be done by a trained administrator in a matter of hours, with no custom coding required. The new workflow can then be deployed to all users globally at the same time. This flexibility is especially important when considering the specific needs of ISO 9001 in life sciences, where validation is key. A modern eQMS streamlines the validation of these changes, making the entire transition process faster and less expensive. A cloud native eQMS gives you the tools to adapt your quality system as standards evolve.
How To Pick The Right eQMS for ISO 9001:2026
Choosing an eQMS is a long term decision. The platform you select today will need to carry your organization through the upcoming ISO 9001:2026 transition and beyond. You need to evaluate potential systems not just for how they solve today’s problems, but for how well they can adapt to tomorrow’s challenges.
When selecting an eQMS with the future in mind, prioritize a platform that is highly configurable. The ability to change workflows, forms, and reports without custom coding is the single most important feature for ensuring long term agility. During your vendor evaluation, ask potential partners to show you exactly how a process can be modified in their system. You should also ask about their own roadmap. How is the vendor preparing for the new standard? A forward thinking partner will already be tracking the revision process and planning to update their workflows to align with the new standard. Consider the platform’s broader capabilities. A system that can integrate with other business tools and use new technologies will provide more value. The capabilities of an AI-powered QMS, for example, can help you meet the likely increased focus on risk and predictive quality. A system built on a modern platform will give you the tools you need to stay compliant with all QMS standards as they evolve.
Conclusion
The upcoming ISO 9001:2026 revision is an opportunity to improve, not a threat to fear. It is a prompt for all quality leaders to look at their systems and processes and ask if they are truly ready for the future. The expected focus on resilience, digitalization, and sustainability aligns with the direction that modern, competitive businesses are already heading. Preparation should start now, not by guessing at the final text, but by strengthening your current QMS and choosing flexible, modern tools.
At Quality Forward, we provide a modern, cloud native eQMS built on the ServiceNow platform, designed for the agility required by evolving QMS standards like ISO 9001:2026. Our no code, configurable platform allows you to adapt your processes quickly and without the high costs of customization, making sure your quality system is always current. If you are looking to build a future proof quality operation, contact us to see how we can help.
