ISO 9001:2026 – a comprehensive, point-by-point overview of the changes

The upcoming revision of ISO 9001 has been the subject of discussion for some time now – the direction of the changes, their impact on specific sectors and the role of quality culture in the new edition of the standard have already been analysed. This time, we’re taking a different approach – rather than yet another analysis of trends, we’ve prepared a structured, point-by-point overview of what is actually changing in the standard’s content compared to the 2015 edition. This is a useful resource to consult when planning a specific gap audit of your quality management system.

Before we get into the details – an important caveat. The standard has not yet been officially published. Voting on the final draft (FDIS – Final Draft International Standard) concluded on 9 July 2026, and the publication of the final version of ISO 9001:2026 is scheduled for September 2026. The text may therefore still be subject to minor editorial amendments, but the substantive scope of the changes is, in practice, already settled.

Clause 4 – Organisational context: climate change permanently incorporated into the standard

In February 2024, ISO introduced an amendment to all management system standards – including ISO 9001:2015 – requiring organisations to take climate change into account in their context analysis (clauses 4.1 and 4.2). In ISO 9001:2026, this requirement is permanently incorporated into the text of the standard and no longer functions as a separate amendment.

In practice, this means that when identifying the external and internal factors affecting the quality management system, an organisation must also take into account climate-related risks and opportunities – alongside the traditionally analysed legal, technological, competitive and market factors.

Clause 5 – Leadership: a culture of quality and ethical conduct as a requirement

This is one of the most frequently discussed new features. Clause 5.1.1 explicitly states that top management has a duty to promote a culture of quality and ethical conduct within the organisation – not merely through declarations, but through concrete, observable actions: leading by example, open communication, and supporting teams in making decisions consistent with the organisation’s values.

This is a philosophical shift – until now, the standard had focused mainly on management’s involvement in overseeing processes. The new version clearly extends this responsibility to include cultural and ethical dimensions, which has a direct impact on how audits are conducted – auditors will have to look for evidence not only in documentation, but in the actual behaviour and decisions of management, because it is the day-to-day habits of staff, rather than declarations, that ultimately determine the success of certification.

Clause 6 – Separation of risks and opportunities

In ISO 9001:2015, risks and opportunities were treated collectively as a single planning requirement. The new edition introduces a clear division into separate sub-clauses: 6.1.2 (Risks) and 6.1.3 (Opportunities).

The difference is not merely cosmetic. The standard now requires not only the identification, but also the separate analysis and evaluation of both categories – which is intended to encourage organisations to treat opportunities as a genuine tool for development, rather than merely a by-product of risk management. Example: a supplier delay is a risk, whereas the implementation of a new quality control method that speeds up the process is an opportunity that can be consciously planned and utilised.

Clause 7 – Knowledge management is gaining in importance

The requirement concerning organisational knowledge was already present in the 2015 edition, but it is explicitly strengthened in the new standard. Organisations will need to adopt a more systematic approach to the collection, protection and utilisation of knowledge as a resource – particularly important in the context of staff turnover, the transfer of skills and the building of long-term process stability.

Point 9 – Performance assessment: focus on sustainability indicators

The standard extends the requirements for monitoring and evaluating performance to include elements related to sustainability, in line with the direction set by the CSRD (Corporate Sustainability Reporting Directive) and other ESG regulations. This does not mean that ISO 9001:2026 is becoming an environmental standard – but the quality management system will need to provide, to a greater extent, data that can be used in an organisation’s non-financial reporting, forming part of the broader context of digitalisation, ESG and the growing resilience of supply chains, which are shaping quality management today.

A formal change: Annex A

For the first time in the history of the ISO 9001 standard, Annex A has been introduced – a supplement of over a dozen pages explaining the structure, terminology and interpretation of the standard’s individual provisions. This represents a genuine qualitative change for those implementing the system, particularly those without many years’ experience of previous editions – the annex is intended to serve as a practical guide, minimising the scope for misinterpretation.

Harmonised Structure (Harmonised Structure)

ISO 9001:2015 was the first standard published in accordance with the High Level Structure (HLS) in force at the time. The new edition aligns the standard with the current, updated Harmonised Structure (HS), which already applies to other, more recent management system standards. In practice, this will facilitate the integration of the quality management system with other systems – such as environmental management (ISO 14001) or information security (ISO 27001) – thanks to more consistent section numbering and standardised terminology.

Terminological changes

In addition to substantive changes, the standard also introduces a number of linguistic adjustments designed to clarify the existing wording. For example, the term ‘steered’ in the English version is replaced by the more precise term ‘controlled’ – a seemingly minor change, but one that eliminates long-standing interpretative uncertainties regarding the supervision of processes.

What ISO 9001:2026 does NOT change

Just as important as what is changing is what remains unchanged. The standard retains:

• the basic PDCA cycle (Plan – Do – Check – Act) as the foundation of the process-based approach,
• the general structure of the seven main clauses (4–10),
• the risk-based approach as a central element of system planning,
• the principle that certification is not mandatory, but serves as confirmation of the implementation and maintenance of the standard’s requirements.

In other words, organisations with a mature, well-functioning quality management system do not face the need to build anything from scratch. It will be far more important to translate the new emphases – quality culture, ethics, and the distinction between risks and opportunities – into practice, rather than merely into documentation; this becomes fully apparent only when both versions of the standard are compared side by side, clause by clause.

What next?

There are still a few weeks to go before the standard is formally published, but the scope of the changes is already largely known and finalised at the FDIS stage. This is a good time to start planning an initial review of your system – without the time pressure that will arise once the official transition timetable is announced.