September 10, 2026
Several changes to the implemented quality management system will require organizations to review how their QMS addresses leadership, quality culture, ethical behavior, risks and opportunities, organizational change, and performance evaluation against ISO 9001:2026.
ISO 9001:2026 is scheduled for publication on September 16, 2026. Organizations certified to ISO 9001:2015 should therefore start considering how the revised requirements will affect their existing Quality Management System (QMS).
The revision is described as a "measured revision rather than a fundamental recasting of the standard". The familiar management system structure remains, but several changes have potentially significant practical implications.
Main changes in ISO 9001:2026
The overall structure of ISO 9001 remains familiar. Clauses 4 through 10 continue to address Context, Leadership, Planning, Support, Operation, Performance Evaluation, and Improvement.
The revision introduces several important changes. The most significant are quality culture and ethical behavior, a clearer separation between risks and opportunities, strengthened requirements for managing QMS changes, additional requirements affecting operational processes and performance evaluation, and a substantially expanded Annex A.
1. Quality culture and ethical behavior
One of the most notable changes appears under leadership.
Top management will be expected to demonstrate leadership and commitment by promoting both a quality culture and ethical behavior. These concepts also appear in the awareness requirements, meaning relevant personnel need to understand the organization's quality culture and expectations for ethical behavior. This is potentially more significant than simply updating a Quality Policy.
Organizations should consider whether their quality culture can be demonstrated through management behavior, decision-making, communication, escalation of quality issues, and day-to-day operations.
For third-party auditors, this also shifts the focus. A policy stating that an organization has a positive quality culture may not by itself demonstrate effective implementation. The emphasis will increasingly be on
observable, objective evidence of how leadership promotes quality and ethical behavior.
2. Risks and opportunities are more clearly separated
Risk-based thinking remains an important element of ISO 9001, but Clause 6.1's structure changes. The revised structure separates the subject into:
6.1.1 – Determining risks and opportunities
6.1.2 – Actions to address risks
6.1.3 – Actions to address opportunities
QNET considers this a deliberate attempt to create a clearer distinction between risks and opportunities, which is an important practical change.
In many existing quality systems, opportunities are included as an additional column in a risk register but receive relatively little further attention. Under ISO 9001:2026, organizations should consider whether they genuinely identify, evaluate, and act on opportunities.
An opportunity could, for example, relate to process improvement, new technology, automation, improved supplier performance, digitalization, or other developments capable of improving QMS performance.
3. Stronger requirements for managing change
Planning changes to the QMS was already required by ISO 9001:2015. ISO 9001:2026 strengthens this considerably. When making changes to the QMS, organizations will additionally need to consider:
communication of the change → monitoring and evaluation of effectiveness → review of the results.
QNET identifies these as additional elements of the revised change-management requirements. This makes change management more of a closed-loop process. It is no longer sufficient to focus only on approving and implementing a change. Organizations should be able to establish whether the change achieved its intended result and whether unexpected consequences occurred.
4. Climate change becomes part of the standard
Climate change considerations introduced into ISO management system standards in 2024 are incorporated directly into ISO 9001:2026.
Under Clauses 4.1 and 4.2, organizations need to consider climate change when determining relevant internal and external issues and the requirements of relevant interested parties. This does not mean that every organization must establish a separate climate-management program. It does mean that organizations should determine whether climate change is relevant to their QMS and consider relevant requirements or expectations of interested parties.
5. Organizational knowledge is broadened
The requirements concerning organizational knowledge are also expanded.
Previously, the emphasis was primarily on knowledge needed to achieve conformity of products and services. The revised standard broadens this to include the knowledge required to support the achievement of the QMS's intended results. This is particularly relevant where organizations depend heavily on specialist personnel, digital systems, external providers, or rapidly changing technology.
Knowledge management should therefore be considered not simply as training and competence management, but also in relation to business continuity and QMS effectiveness.
6. Changes affecting customers and operations
Clause 8 also contains several changes that organizations should not overlook. Where relevant, organizations must provide customers with information about contingency actions and disruptions affecting product and service provision.
The requirements for reviewing product and service requirements are also strengthened. Documented information needs to address changes to existing requirements as well as newly established requirements.
The standard also implies changes related to design and development. The revised requirements broaden consideration from customers and users toward customers and other interested parties. Design and development outputs should address information necessary for the intended purpose and safe and proper use of products and services.
For design changes, organizations must now determine the impact of the change rather than merely identify the potential impact. We interpret this as requiring a decision based on evidence or reasoning.
For organizations operating design-controlled systems, this distinction may require changes to existing design-change procedures and records.
7. Performance evaluation and internal auditing
ISO 9001:2026 also strengthens aspects of performance evaluation. Organizations need to clarify what quality-performance information they analyze and how they evaluate QMS effectiveness.
Internal audit programs will need to define audit objectives, in addition to audit scope and criteria. Management Review is also reorganized into clearer requirements covering general provisions, inputs and results.
The overall direction is towards demonstrating QMS effectiveness, rather than simply demonstrating that required processes and procedures exist.
8. A significantly expanded Annex A
Annex A has been extensively revised.
In ISO 9001:2015, Annex A addressed a relatively limited number of subjects. In ISO 9001:2026, explanatory information is provided for every clause. This should help organizations and auditors interpret the intent of requirements more consistently. However, an important distinction remains: Annex A is for information only. It does not introduce, modify, or remove ISO 9001 requirements.
Annex B of ISO 9001:2015 has been removed. Relevant references to other ISO/TC 176 standards are instead incorporated into Annex A and supporting ISO information.
Do organizations need to redesign their QMS?
For most organizations, NO.
ISO 9001:2026 should not be approached as a requirement to rebuild an existing ISO 9001:2015 management system.
Organizations should not automatically:
- rewrite their complete Quality Manual;
- renumber procedures according to the new standard;
- reorganize their QMS according to the clause sequence;
- replace established terminology to match ISO terminology.
Our guidance specifically emphasizes that organizations should first examine what already works and then identify where the revised requirements create genuine gaps.
The objective should therefore be:
Existing QMS → ISO 9001:2026 Gap Assessment → Required changes → Implementation → Effectiveness review
rather than:
ISO 9001:2026 → Rewrite the entire QMS.
Preparing for the transition
Organizations currently certified against ISO 9001:2015 should begin preparing, but there is no reason for unnecessary urgency. A three-year transition period is available: 2026–2029.
A sensible first step is therefore to perform a structured gap assessment focusing particularly on:
quality culture and ethical behavior;
risks and opportunities;
change management;
organizational knowledge;
customer contingency communication;
design and development changes;
performance evaluation;
internal auditing; and
management review.
Organizations should then integrate necessary changes into their existing QMS rather than creating parallel processes solely for ISO 9001:2026 certification.
How QNET can support your ISO 9001:2026 transition
QNET can support organizations in assessing and preparing their Quality Management System for ISO 9001:2026.
Support can include an ISO 9001:2015 to ISO 9001:2026 gap assessment, review of existing QMS documentation and processes, management and auditor briefings, support with implementing identified changes, and independent readiness assessments before certification-body transition audits.
The objective should not be to "update the paperwork" for the new edition. A well-managed transition provides an opportunity to determine whether the QMS still supports the way the organization actually operates and whether it remains effective in achieving its intended results.
ISO 9001:2026 is an evolution, not a reset—but several of its changes deserve careful management attention.