ISO 9001:2015 vs ISO 9001:2026: A Direct Comparison of the Requirements

ISO 9001

ISO 9001:2026 is the sixth edition of the world’s most widely used quality management system standard. It replaces ISO 9001:2015 and incorporates ISO 9001:2015/Amd 1:2024. The overall structure and core principles of ISO 9001 remain familiar, but a number of requirements have been revised, expanded or reorganized. ISO itself identifies quality culture and ethical behaviour, clearer separation of risks and opportunities, and strengthened management of change among the principal changes.

The comparison below focuses only on wording that has changed. It is intended to work almost like a redline comparison: the left column contains direct excerpts from ISO 9001:2015, while the right column contains the corresponding direct excerpts from ISO 9001:2026. Bold text highlights the changed or newly added wording. No interpretation has been added inside the table.

Note: Only the relevant changed passages are reproduced. Unchanged parts of the clauses are omitted for clarity.

ISO 9001:2015 vs ISO 9001:2026 — direct comparison

The new edition retains the familiar clauses on context, leadership, planning, support, operation, performance evaluation and improvement. The most visible structural changes include splitting the treatment of risks and opportunities into separate subclauses, restructuring internal audit requirements and consolidating continual improvement under Clause 10.1.

Climate change: part of ISO 9001:2026, but not entirely new

Clause 4.1 now explicitly requires an organization to determine whether climate change is a relevant issue. Clause 4.2 also notes that relevant interested parties can have requirements related to climate change.

For organizations that already updated their QMS following ISO 9001:2015/Amd 1:2024, this should not be a completely new requirement. ISO 9001:2026 expressly incorporates that amendment.

The wording also does not mean that every organization must conclude that climate change is significant to its QMS. The requirement is to determine whether it is relevant. The conclusion will depend on factors such as industry, location, supply chain, products and services, customer requirements and applicable legal or regulatory conditions.

Interested-party requirements become more explicit

Clause 4.2 contains a relatively short addition with potentially important consequences. Under ISO 9001:2026, the organization must determine not only its relevant interested parties and their relevant requirements, but also which of those requirements will be addressed through the QMS.

This makes the relationship between interested-party analysis and the actual management system clearer. A long stakeholder register alone may not demonstrate how the organization decided which requirements belong within the scope of its QMS.

For organizations in the US and UK, this can be particularly relevant where customer, contractual, regulatory, corporate-group and supply-chain expectations overlap but are not all managed through the quality system.

Quality culture and ethical behaviour enter the requirements

One of the most recognizable additions in ISO 9001:2026 is the explicit treatment of quality culture and ethical behaviour.

Clause 5.1.1 requires top management to promote them, while Clause 7.3 requires people working under the organization’s control to be aware of the organization’s quality culture and ethical behaviour.

This does not automatically create a requirement for a separate “quality culture procedure,” ethics policy or code of conduct. The focus is broader: whether leadership, behaviours, decisions and everyday practices support the quality objectives and the effectiveness of the QMS.

For auditors, this is likely to shift attention toward practical evidence: how management responds to quality problems, whether employees feel able to raise concerns, how conflicts between delivery targets and quality requirements are handled, and whether actual behaviours match stated values.

Risks and opportunities are treated separately

ISO 9001:2015 largely treated “risks and opportunities” as one combined concept. ISO 9001:2026 separates the two much more clearly.

Clause 6.1.2 now addresses risks, while Clause 6.1.3 addresses opportunities. In both cases, organizations are required to determine, analyse and evaluate them before planning and evaluating appropriate actions.

This distinction matters because risks and opportunities do not necessarily require the same logic. Risks concern potential undesired effects. Opportunities concern circumstances that can contribute to desired results.

At the same time, Annex A clarifies that risk-based thinking does not imply the mandatory use of a formal risk-management methodology or a documented risk-management process. Organizations can still choose an approach proportionate to their context and complexity.

Management of change is significantly strengthened

Clause 6.3 existed in ISO 9001:2015, so management of change itself is not new. What changes is the depth of the requirement.

The 2015 edition focused on the purpose and consequences of a change, QMS integrity, resources and responsibilities. ISO 9001:2026 adds information, communication, monitoring and evaluation of effectiveness, and review of the results of the change.

In practice, this creates a more complete management cycle:

plan the change → allocate resources and responsibilities → communicate it → implement it → monitor effectiveness → review the result.

This may be particularly relevant to organizations dealing with frequent changes in technology, software, production methods, suppliers, organizational structure, products or customer requirements.

Organizational knowledge moves beyond simply maintaining information

Clause 7.1.6 also changes in a meaningful way.

ISO 9001:2015 connected organizational knowledge primarily with operating processes and achieving conformity of products and services. ISO 9001:2026 links knowledge more broadly to achieving the intended results of the QMS and states that knowledge should be retained, applied and shared as necessary.

This is particularly relevant where essential knowledge is concentrated in a small number of experienced employees. A QMS can become vulnerable if critical process knowledge disappears when a specialist leaves, a technology changes or responsibilities move between locations.

Organizations may therefore want to examine not only procedures and knowledge databases, but also training, mentoring, handovers, succession arrangements and mechanisms for sharing lessons learned.

Operational requirements remain largely familiar

Clause 8 has not been fundamentally rebuilt. Requirements covering customer requirements, design and development, external providers, production and service provision, release and nonconforming outputs remain recognizable.

Most changes are targeted refinements. For example, contingency communication has been made more explicit, “new requirements” become “new or changed requirements,” and references to customers and users are in some places broadened to include other relevant interested parties.

The practical implication is that many mature organizations may not need major redesign of operational processes. Existing procedures should instead be checked against the revised wording to identify specific gaps.

Customer satisfaction: a shorter but broader formulation

ISO 9001:2015 required monitoring of “customers’ perceptions of the degree to which their needs and expectations have been fulfilled.”

ISO 9001:2026 instead states simply that the organization shall “monitor customer satisfaction” and determine methods for obtaining, monitoring and reviewing customer satisfaction information.

The change removes the former definition-like wording from the requirement itself and places the focus directly on customer satisfaction information and how it is obtained, monitored and reviewed.

Internal audits now require an audit objective

The change in Clause 9.2.2 is small in wording but important in practice.

ISO 9001:2015 required organizations to define the audit criteria and scope for each audit. ISO 9001:2026 requires the organization to define the audit objectives, criteria and scope.

This supports a more purpose-driven approach to internal auditing. Rather than performing an audit simply because a particular process is due to be audited, the organization should be able to state what the audit is intended to determine.

An audit objective might relate to evaluating the effectiveness of a changed process, investigating repeated nonconformities, verifying implementation of new controls, or determining whether a particular process achieves its intended results.

Management review gains additional inputs

Clause 9.3.2 now explicitly includes changes in the needs and expectations of interested parties relevant to the QMS.

The treatment of risks and opportunities is also separated: management review now considers the effectiveness of actions taken to address risks and the effectiveness of actions taken to address opportunities as distinct inputs.

For many organizations, this may require only a modest adjustment to the management-review agenda or template. However, it reinforces the expectation that management review should be a real management process rather than an annual compliance exercise conducted primarily for certification purposes.

Continual improvement is reorganized

The 2015 edition contained both Clause 10.1, General, and Clause 10.3, Continual improvement. ISO 9001:2026 consolidates the continual-improvement requirements into Clause 10.1.

The new text explicitly includes improvement of processes, products and services, addressing future needs and expectations, and correcting, preventing or reducing undesired effects.

The underlying principle of continual improvement has therefore not disappeared. Instead, the requirements have been reorganized and made more concise.

Do organizations need to rewrite their QMS documentation?

For most organizations, the publication of ISO 9001:2026 should not mean rebuilding the QMS from scratch.

The new edition retains the basic architecture of ISO 9001 and does not require an organization to structure its own documentation according to the clause structure of the standard. The practical starting point should therefore be a gap analysis, not wholesale document rewriting.

Particular attention should be given to:

Clause 4.2 — determining which interested-party requirements will be addressed through the QMS;
Clauses 5.1.1 and 7.3 — quality culture and ethical behaviour;
Clause 6.1 — separate determination, analysis and evaluation of risks and opportunities;
Clause 6.3 — strengthened management of change;
Clause 7.1.6 — retention, application and sharing of organizational knowledge;
Clause 9.2.2 — defining internal-audit objectives;
Clause 9.3.2 — revised management-review inputs.

For companies certified in the United States or the United Kingdom, the same principle applies: focus first on the actual gap between the existing QMS and the revised requirements. Transition timing and certification arrangements should then be confirmed with the organization’s certification body.

Conclusion

ISO 9001:2026 is an evolution of ISO 9001:2015 rather than a complete redesign.

The process approach, PDCA cycle, customer focus, leadership, operational control, performance evaluation and continual improvement remain at the heart of the standard. The new edition places greater emphasis on quality culture and ethical behaviour, the distinction between risks and opportunities, effective management of change, organizational knowledge, interested-party requirements and more purposeful auditing and management review.

For organizations with a mature ISO 9001 system, the transition is therefore likely to be less about creating new procedures and more about checking whether existing processes actually satisfy the revised requirements.

A structured clause-by-clause gap analysis is the most practical place to begin.

Alexander Chumachenko

2026-09-25 20:20