ISO 9001:2026 — Prepare for the New Requirements

Introduction: Why is the 2026 Revision Coming?

The quality management standard ISO 9001 will be revised in 2026, bringing it up to date for the first time in more than ten years. The current ISO 9001:2015 was published in 2015 – since then, technologies, business models, and expectations have evolved significantly. An international survey in 2023 confirmed the consensus that an update would add value to keep the standard aligned with changing needs. ISO 9001 is considered a “cornerstone” of quality management, and regular revisions ensure that it remains relevant in today’s complex and dynamic environments.

For companies, the new revision primarily means moderate adjustments rather than radical changes. The current status: The Draft International Standard (DIS) was published at the end of August 2025 and is now open for voting. The final ISO 9001:2026 is planned for release in the second half of 2026 (expected in autumn 2026).

Timeline and Transition Periods

After the DIS (published in August 2025), the Final Draft (FDIS) will follow in 2026, and finally the official release of the international standard. Typically, certified organizations are given a transition period to adjust after a new ISO standard is released. Most likely, there will be a three-year transition period, as in previous revisions. If the standard is released as planned in autumn 2026, companies will have until around autumn 2029 to make the transition. The exact timeframe will be determined by the International Accreditation Forum (IAF). Some experts suggest that, given the limited changes, a shorter transition period might also be possible – but this will only be certain once the IAF publishes the official transition rules. In general, both versions (2015 and 2026) will be valid during the transition period, so certificates remain valid and organizations have sufficient time to adapt.

What Is New in Clause 5.1 Leadership and Commitment?

One of the most striking updates concerns top management: Clause 5.1 “Leadership and Commitment” now explicitly requires that top management promotes a quality culture and demonstrates ethical behavior within the organization. This means leadership must actively create an environment where quality awareness and integrity are the norm. In the informative annex, additional guidance is provided on how this culture and ethics can be demonstrated in practice. For a quality manager, this means preparing leaders early for these new expectations. It is advisable to review how the leadership team already communicates quality and ethics – and where gaps still exist. The quality policy may also need slight adjustments to clearly emphasize the role of quality and integrity, visibly aligned with corporate strategy and organizational context (an aspect now highlighted even more strongly in the new version).

Overall, this change emphasizes the role-model function of leadership. Managers are expected not only to provide resources but also to act as role models for quality. This cultural aspect was only implicit in ISO 9001:2015 – now it is explicitly stated. Companies would do well to start embedding the concept of “quality culture” at the management level, for example, through leadership training or workshops on organizational values.

How Do the Requirements on Risks and Opportunities (Clause 6.1) Change?

The revision also introduces an important structural change to the treatment of risks and opportunities. In the past, Clause 6.1 covered both together; in the new draft, the clause is clearly subdivided into three sub-clauses (6.1.1 to 6.1.3), focusing separately on risks and on opportunities. This restructuring is intended to avoid misunderstandings and ensure that organizations systematically address both risks and opportunities – while distinguishing the measures required for each.

In practice, this means: Organizations should review their risk management within the QMS. Are the processes for handling risks and opportunities clearly separated? The DIS wording makes it clearer that risks (potential negative deviations) and opportunities (potential positive developments) should be addressed separately. Annex A provides extended guidance on how to identify, evaluate, and handle risks, as well as how to recognize and leverage opportunities. Companies should examine their planning processes (management reviews, SWOT analyses, etc.) to ensure that risks and opportunities are handled separately and transparently. If necessary, risk management procedures should be updated, or training on opportunity management strengthened, so that opportunities are not overlooked.

In short: The concept of risk-based thinking remains unchanged – but the standard now makes it more explicit that goals and actions for risks must be distinguished from those for opportunities. This should already be the case in a well-functioning QMS; if not, now is a good time to sharpen this aspect.

How Are Climate Change Aspects Integrated (Clauses 4.1 and 4.2)?

A completely new element is the integration of climate change aspects into the organizational context (Clause 4). In line with the ISO “London Declaration” on climate protection, an amendment was already published in 2024 to incorporate climate-related considerations into management systems. These changes have been included in the ISO 9001:2026 draft. Clause 4.1 now explicitly requires organizations to assess whether climate change is a relevant issue when analyzing their context. Additionally, Clause 4.2 includes a note that interested parties may have climate-related expectations.

This makes it clear: When organizations assess their environment (e.g., market, legislation, social trends), the issue of climate change can no longer be ignored. Of course, the relevance will depend on the business model. But the standard requires organizations to systematically address the question. In practice, this means that during the next context analysis or risk workshop, organizations should explicitly ask: “Does climate change affect us? If so, what risks or opportunities arise?” – and document the answers. The same applies to stakeholder analysis: Are there customers, authorities, neighbors, or others with climate-related expectations (e.g., CO₂ reduction, resilience to extreme weather)? If so, this must be reflected in the QMS.

Important: ISO 9001 remains a quality management standard, not an environmental standard. It is not about introducing a full climate management system, but about ensuring that climate change is not forgotten as a factor. For many organizations, this may not mean significant change – but for those that have completely ignored the issue so far, it requires action.

What Is the Purpose of the Expanded Annex A?

ISO 9001 contains an informative Annex A that clarifies terms and requirements. In the 2026 revision, this annex has been significantly expanded to make the interpretation of the standard easier. This means that nearly all main clauses (4–10) now come with more detailed notes, examples, or explanations in the annex. The aim is to eliminate application uncertainties without overloading the main text of the standard.

Examples: Annex A may explain what “quality culture” specifically means and how organizations can promote it – as support for the new Clause 5.1 requirement. Or it may describe steps for risk analysis (Clause 6.1) to give practitioners a roadmap. Additional notes are included for documentation requirements, audit programs, continuous improvement, and more. Organizations can use Annex A as an interpretation aid: It provides the background and intent behind the requirements, which is particularly helpful for staff training or aligning with auditors.

It is important to know: The annex is not binding – it is informative only. It is meant to reduce misunderstandings, but it does not create new obligations. Still, it is highly recommended to read the expanded Annex A carefully once the standard is published. It often answers practical questions that arise repeatedly. For busy quality managers, Annex A could be a valuable quick reference for interpreting the updates.

What Is Not Included in the DIS (Despite Speculation)?

Before the revision, there were many discussions about possible new content. Some of these did not make it into the DIS draft – it is important to clarify this to avoid false expectations. Here are a few topics that were widely speculated on but are not included in the current draft:

• Artificial Intelligence (AI) and Digital Transformation: While new technologies (automation, AI, big data) were cited as drivers for the revision, the DIS does not contain specific new requirements on validating or using AI in QMS. Those hoping for concrete rules on testing AI models or software quality will be disappointed – these topics remain outside the standard for now.
• Life Cycle Assessment (LCA): In light of the sustainability trend, some expected stronger ties between quality management and product life cycle – for example, mandatory inclusion of environmental LCAs. However, the DIS does not contain any such requirements. Beyond the climate amendments, there are no expanded sustainability obligations. ISO 9001 remains focused on process and product quality; environmental LCA continues to fall under ISO 14001 or product-specific standards.
• Remote Audits and Remote Work: With the pandemic, remote audits and distributed work became highly relevant. Some expected the new standard to address this – e.g., requirements for the suitability of remote audit methods or infrastructure for home office. In reality, ISO 9001:2026 includes no such provisions. No specific audit mode is mandated, and remote work is not explicitly covered. The standard remains technology-neutral – organizations remain free to decide how to conduct audits (on-site or via video) and how to use modern tools.

Other topics discussed included organizational resilience, supply chain quality, or stronger service orientation. None of these are major additions in the DIS. These aspects may be discussed in ISO circles but are only indirectly reflected in the draft (e.g., through context analysis or existing requirements on communication and knowledge management). In summary, the core of the standard remains largely unchanged from 2015. The 2026 revision focuses on targeted additions and clarifications – no sweeping new requirements. For organizations, this means: No need to fear a complete overhaul of the QMS, but rather fine-tuning of existing elements.

(Note: If there are still surprises in the final version – e.g., after the review of DIS comments – these will of course be updated here. As of now, this article is based on the official DIS ISO/DIS 9001:2026.)

Practical Impact for Organizations – What Needs to Be Done?

Even though the changes are moderate, organizations should proactively prepare for the revision. Here are some concrete to-dos and recommendations for getting a quality management system ready for ISO 9001:2026:

• Stay informed: Follow the development of the standard. Subscribe to newsletters from ISO or certification bodies to avoid missing updates. This ensures you know when the FDIS and final version are published, as well as what transition rules IAF sets.
• Conduct a gap analysis: Compare the current QMS (ISO 9001:2015) against the new requirements once they are confirmed. The already known changes (culture/ethics, risk-opportunity separation, climate, etc.) can be checked in advance. Identify gaps and create a list of adjustments. Many certification bodies offer checklists or seminars – take advantage of them.
• Raise management awareness: Put quality culture and ethical behavior on the leadership agenda. Explain the new Clause 5.1 expectations to top management and discuss how they can demonstrate them. Consider trainings or workshops to prepare leaders for their role-model responsibility.
• Engage employees: Make the concept of quality culture tangible for employees. Clause 7.3 requires that employees understand the significance of quality culture and ethics – therefore include these topics in trainings, team meetings, or communications. Clarify what ethical behavior means (e.g., openness, honesty, keeping promises, reporting problems) and why it is important for quality.
• Update risk and opportunity management: Document clearly how risks are identified and addressed, and how opportunities are identified and utilized. If not already in place, consider introducing separate procedures for opportunity management. Ensure that both risks and opportunities are visible in quality objectives and action tracking. Update procedures or forms as needed to reflect the new 6.1.1–6.1.3 structure.
• Include climate change in context: Incorporate climate-related factors into the annual strategy or management review. Assign responsibility for assessing them. If the conclusion is that climate change is not significant, document this decision transparently. This ensures readiness for auditors when they ask how Clauses 4.1 and 4.2 have been implemented.
• Update documentation: Plan for an update of QMS documents (manual, process descriptions, procedures). Besides content updates, cross-references to new clause numbers may need to be adjusted – e.g., internal documents referring to “6.1” should be revised to reflect the sub-clauses 6.1.1/6.1.2/6.1.3. Also incorporate any newly worded requirements (e.g., in the quality policy or training program).
• Plan audits and certification: Start early discussions with the certification body about the best timing for the transition audit. Three years sounds long, but goes by quickly. It may be wise to upgrade in the second year of the transition to leave buffer. Internal audits should be used from 2026 onward to verify implementation of the new requirements – avoiding surprises in the external audit. A pre-audit or transition workshop with the certification body may also be helpful to clarify open questions.

In summary: While the practical impact is limited, early preparation pays off. The revision is an opportunity to consciously review and align the QMS with today’s best practices. Organizations that act now can manage the transition smoothly and even benefit from the improvements – whether through stronger values, streamlined risk management, or a modern stakeholder perspective.

Checklist: Preparing for ISO 9001:2026

• Gather information: Stay updated on the revision process (ISO news, associations, certification bodies) and await the publication of the standard.
• Conduct an impact analysis: Compare the current QMS against the new requirements (gap analysis). Which documents, processes, or objectives need adjustment?
• Involve top management: Brief leadership on new obligations regarding culture & ethics; review quality policy and leadership processes for potential adjustments.
• Raise employee awareness: Update training material and communication plans so employees understand the importance of quality culture and ethics.
• Separate risk and opportunity processes: Ensure risks and opportunities are assessed and tracked separately in the management system; update documentation accordingly.
• Expand context analysis: Include climate change in environmental and stakeholder analysis; identify related risks/opportunities or document if “not relevant.”
• Consult Annex A: After publication, review the new Annex A guidance and use it to clarify any uncertainties in implementation.
• Plan the transition: Set a schedule for switching to the new version (including buffer time); discuss the transition audit process with the certification body; use internal audits as test runs.