The ISO 9001 standard has long been the cornerstone of quality management systems across industries. With over one million certified organizations worldwide, ISO 9001 continues to shape how businesses ensure customer satisfaction, manage risk, and improve operational performance.
Nearly a decade after the release of ISO 9001:2015, the next major revision—ISO 9001:2026—is in development. As of mid-2025, the second committee draft (CD2) has been completed, and a Draft International Standard (DIS) is expected in the second half of the year. The final publication is anticipated for late 2026.
This article explores the key elements of the draft version of ISO 9001:2026, what’s likely to change, and how organizations can start preparing now.
Why a New Revision?
The ISO 9001:2015 standard introduced risk-based thinking, process approaches, and a high-level structure (HLS) to harmonize with other ISO standards. While it brought clarity and consistency, rapid developments in digital transformation, climate responsibility, and organizational resilience have prompted the need for further updates.
The new revision aims to reflect:
The widespread use of digital technologies in QMS
Increased expectations for sustainability and ESG integration
Stronger emphasis on data integrity, automation, and remote management
Lessons learned from global events like the COVID-19 pandemic and supply chain disruptions
What Are the Key Draft Changes in ISO 9001:2026?
The ISO/TC 176/SC 2 working group is still finalizing many of the details, but several key themes have emerged in the draft documents:
1. Digital Integration and Data Systems
One of the most notable changes in ISO 9001:2026 is the recognition of digital and automated systems within quality management. While ISO 9001:2015 was relatively silent on digital tools, the 2026 draft makes it clear that software-driven processes, AI applications, and validated systems must be considered in the context of control, monitoring, and improvement.
For example, clause revisions are expected to:
Require controls for digitally captured data
Emphasize the validation and verification of digital QMS tools
Incorporate cybersecurity and data integrity aspects relevant to quality
This is particularly important for industries like pharmaceuticals and medical devices, where computerized systems are deeply embedded in compliance.
2. Sustainability and ESG Focus
ISO 9001:2026 aligns more closely with sustainability and Environmental, Social, and Governance (ESG) expectations. This doesn’t mean it becomes an ESG standard, but it requires organizations to:
Consider environmental impact as part of context and risk analysis
Align quality objectives with broader corporate responsibility frameworks
Show leadership engagement in ESG-relevant goals
Organizations will need to document how quality management supports sustainable business practices, especially in supply chain and product development.
3. Structural Realignment: From HLS to Harmonized Structure
The 2026 version moves from the High-Level Structure (HLS) to the Harmonized Structure (HS) introduced by ISO in recent years. This change will make ISO 9001 more consistent with other standards like ISO 14001 (environmental) and ISO 45001 (occupational health and safety).
While the main clause numbers (4 to 10) will remain largely unchanged, the language and guidance will be more aligned across disciplines, making multi-standard integrations easier.
4. Resilience, Risk, and Quality Culture
ISO 9001:2015 introduced risk-based thinking. ISO 9001:2026 builds on that with clearer guidance on:
Distinguishing between risk and opportunity
Building organizational resilience through robust planning and monitoring
Promoting a quality culture that goes beyond compliance
This reflects growing demand from regulators and customers for proactive risk management and cultural maturity in organizations.
5. Expanded Annex A: Guidance on Application
Annex A in the draft standard is being significantly expanded. Rather than only clarifying requirements, it now includes practical guidance for implementation, similar to an embedded best practice guide.
This makes the standard more accessible, especially for smaller organizations or those implementing ISO 9001 for the first time.
Timeline and Next Steps
Here is the expected timeline for ISO 9001:2026:
| Milestone | Expected Date |
|---|---|
| Committee Draft 2 (CD2) | Q1 2025 |
| Draft International Standard (DIS) | Q3 2025 |
| Final Draft International Standard (FDIS) | Mid 2026 |
| Publication of ISO 9001:2026 | Q4 2026 |
| Transition Period | Likely 2–3 years |
Organizations are advised to begin preparing now by:
Reviewing current QMS alignment with digital and ESG trends
Training internal auditors and QMRs on upcoming changes
Conducting gap assessments using available committee guidance
Following updates from ISO/TC 176 and national standards bodies
Conclusion
ISO 9001:2026 is not a reinvention but a timely modernization. It aims to ensure that quality management systems are relevant, robust, and resilient in the face of digital disruption, global complexity, and increased regulatory expectations.
For companies that want to remain competitive, compliant, and forward-thinking, the upcoming revision is an opportunity—not a burden. Now is the time to anticipate, evaluate, and act.
References
Alireza Zarei is the founder and CEO of Zamann Pharma Support GmbH in Germany. He pairs 20 years in GMP—beginning in a lab in 2005—with front-line global project delivery for companies such as Boehringer Ingelheim, Roche, BioNTech, Takeda, Fresenius Medical Care, Biotest, ratiopharm and others. He focuses on innovative validation and qualification procedures, master data management strategies, end-to-end LIMS implementation and care, with pragmatic advice on general Quality Management topics and management level OpEx consulting. Together with his team he also created Pharmuni.com as the leading GMP learning platform in the industry.
