ISO 9001:2026 has been published, replacing ISO 9001:2015 following the release of the ISO 9001:2026 Final Draft International Standard (FDIS) earlier this year.
For organisations already working with ISO 9001:2015, the good news is that this is not a fundamental rebuild of the Standard.
The familiar Clause 4–10 structure remains, as do the process approach and Plan-Do-Check-Act cycle. Much of the existing framework carries forward.
Instead, the ISO 9001:2026 changes introduce a series of targeted updates that reflect how expectations of quality management have developed since 2015.
Some of the most significant changes relate to quality culture and ethical behaviour, risks and opportunities, awareness, and the planning of changes. The revision also introduces clearer wording, improved alignment with other ISO management system standards, and additional guidance to help organisations interpret and apply the requirements.
ISO 9001:2026 key changes at a glance
The key changes include:
🔹 Quality culture and leadership receive greater emphasis, recognising the role organisational culture plays in supporting an effective QMS.
🔸 Risks and opportunities are more clearly separated, with greater emphasis on organisations proactively identifying and pursuing opportunities as well as addressing risks.
🔹 Quality culture and ethical behaviour are reflected more explicitly in awareness requirements, extending these concepts more broadly across the organisation.
🔸 Planning of changes receives greater emphasis, including how changes are planned, implemented, and evaluated.
🔹 Annex A provides additional explanatory information to support understanding and interpretation of the requirements.
The revised Standard also introduces clearer wording and improved alignment with other ISO management system standards.
So, what do these changes mean in practice?
Quality culture and ethical behaviour become explicit
One of the more significant developments appears within Clause 5.1.1 Leadership and commitment.
ISO 9001 has always placed responsibility for the effectiveness of the QMS with top management. The 2026 edition builds on this by explicitly addressing quality culture and ethical behaviour.
This is an important distinction.
Quality is not determined by procedures alone. It is also influenced by how people behave when making decisions, responding to problems, raising concerns, and working under pressure.
For organisations, the question becomes less about whether quality culture is mentioned somewhere within the QMS and more about how leadership demonstrates and supports it in practice.
That might be reflected in leadership communications, management review, decision-making, the way concerns are handled, and the behaviours that are encouraged or tolerated within the organisation.
This may also be one of the more challenging changes to evidence. Culture develops and becomes visible through patterns of behaviour over time. It cannot simply be created as a document immediately before an audit.
We explored the growing importance of quality culture and the future of ISO 9001 earlier this year, including what the increased focus on culture could mean for organisations and their Quality Management Systems.
Risks and opportunities receive more balanced treatment
ISO 9001:2026 provides clearer separation between risks and opportunities, reinforcing the need for organisations to consider not only what could prevent intended results, but also where opportunities could deliver beneficial outcomes.
Risk-based thinking remains an important part of ISO 9001, but Clause 6.1 now provides a clearer distinction between risks and opportunities.
Under ISO 9001:2015, the two concepts were addressed together. In practice, many organisations developed detailed processes for identifying and managing risk, while opportunities received considerably less attention.
The clearer separation gives opportunities greater visibility alongside risks and reinforces the need for organisations to proactively consider beneficial outcomes.
That means organisations should consider not only what could prevent the QMS from achieving its intended results, but also where there are opportunities to improve performance, processes, customer outcomes, or the effectiveness of the QMS.
The important point is not simply to create an “opportunities” column in an existing risk register.
Organisations should consider how opportunities are identified, assessed, actioned, integrated into the QMS, and evaluated for effectiveness.
Awareness extends to quality culture and ethical behaviour
The increased emphasis on quality culture also carries through to Clause 7.3 Awareness.
Personnel were already expected to be aware of the quality policy, relevant quality objectives, their contribution to the effectiveness of the QMS, and the implications of not conforming with its requirements.
ISO 9001:2026 extends this to include awareness of quality culture and ethical behaviour.
For many organisations, this may not require a completely new training programme.
It may instead mean reviewing existing induction, refresher training, team briefings, and internal communications to make sure these concepts are understood beyond the leadership team.
The connection between Clauses 5 (Leadership) and 7 (Support) is important. Quality culture cannot remain solely a leadership commitment if the behaviours and expectations associated with it are not understood throughout the organisation.
Greater emphasis on managing change
ISO 9001:2015 already required organisations to plan changes to the QMS.
The revised Clause 6.3 strengthens this area, placing greater emphasis on actively managing change and considering its implementation and effectiveness.
Organisations may need to demonstrate more clearly how significant QMS changes are planned, how responsibilities are assigned, how potential impacts are considered, how implementation is controlled, and how the effectiveness of the change is subsequently evaluated.
For organisations already applying structured change management practices, this may require little adjustment.
For others, it is an opportunity to consider whether their current approach demonstrates the full lifecycle of a change, rather than simply documenting the decision to make it.
Other requirements remain largely familiar
There are changes and clarifications within Clause 8 Operation, but organisations should not expect a wholesale redesign of their operational processes.
The revisions are comparatively minor and are primarily intended to improve clarity and consistency.
These include refinements relating to operational planning and control, externally provided processes, products and services, production and service provision, and communication around contingency arrangements.
Other minor wording changes appear elsewhere in the Standard. In Clause 9.1.2 Customer satisfaction, the specific reference to understanding customer “perceptions” has been removed. Clause 10.2 Nonconformity and corrective action also no longer includes an explicit requirement to consider nonconformities arising from complaints. Instead, complaints are referenced in an informative note.
These changes are relatively minor, but they reinforce the importance of reviewing the revised wording carefully rather than focusing only on the more prominent changes.
For most organisations, the appropriate starting point will be to compare existing processes with the revised wording and determine where clarification or adjustment is actually required, rather than assuming new processes need to be created.
Annex A provides additional guidance
Annex A provides additional explanatory information to support understanding and interpretation of the requirements.
Annex A is informative rather than normative, meaning it does not create additional requirements. Instead, it provides further clarification around the intent and application of particular requirements.
This is particularly useful in areas that rely heavily on judgement, including quality culture, ethical behaviour, and the treatment of risks and opportunities.
For quality professionals, implementers, and auditors, Annex A is worth reading alongside the requirements themselves.
It can help organisations move beyond simply asking what does the clause say? to considering what is the requirement trying to achieve, and what might that look like within our organisation?
What hasn’t changed in ISO 9001:2026?
With attention naturally focused on the new requirements, it is equally important to understand what remains familiar.
ISO 9001:2026 retains the established management system structure and the fundamental principles that organisations have been working with under ISO 9001:2015.
The process approach remains. The Plan-Do-Check-Act cycle remains. The fundamental purpose of a QMS remains.
For organisations with an effective ISO 9001:2015 system, transition should therefore begin with review and gap analysis, not redesign.
The question is not “How do we build a new QMS?”
It is “Where do the revised expectations require us to think differently, strengthen what we already do, or provide clearer evidence?”
What does ISO 9001:2026 mean for Australia?
UPDATE: 18 September 2026
On 18 September 2026, just two days after the international publication of ISO 9001:2026, the revised Standard was directly adopted in Australia and New Zealand as AS/NZS ISO 9001:2026. This is a much faster adoption than occurred with the previous edition, where ISO 9001:2015 was adopted locally as AS/NZS ISO 9001:2016 the following year.
As a direct adoption, AS/NZS ISO 9001:2026 maintains the same technical requirements as the international ISO 9001:2026 Standard, rather than introducing separate Australian or New Zealand requirements. This means organisations across Australia and New Zealand can begin working from the new edition immediately, with the local Standard aligned to the international requirements from the outset. Organisations currently certified to the previous edition will still need to follow the applicable certification transition arrangements as these are confirmed by accreditation and certification bodies.
How to prepare for the ISO 9001:2026 transition
Publication of ISO 9001:2026 is an important point to begin understanding and preparing for the changes. As mentioned above, the 2026 revision of the standard provides targeted upated to a set number of clauses, rather than a holistic rewrite of the standard. This means organisations can evolve their current QMS without the need for significant restructures; it does of course though serve as a great opportunity for organisations to review their QMS and ensure it aligns with their scope, context, strategic priorities, and organisational objectives.
A practical starting point is to:
- Obtain and become familiar with ISO 9001:2026
- Understand which changes are relevant to your organisation
- Compare the revised requirements with your existing QMS
- Identify gaps and determine what action is actually required
- Consider how quality culture and ethical behaviour are currently demonstrated
- Review how risks and opportunities are identified, assessed, and addressed
- Review existing approaches to managing and evaluating change
- Update awareness and training where required
- Speak with your certification body about transition arrangements and timing
There is particular value in starting early on areas where evidence develops over time.
Quality culture is a good example. Updating a procedure can happen relatively quickly. Demonstrating a consistent culture through leadership decisions, communication, behaviour, and organisational practice cannot.
Update your knowledge with our ISO 9001:2026 eLearn
For quality professionals and auditors who already have a strong working knowledge of ISO 9001:2015, Risk Training Professionals has developed a new ISO 9001:2026 Update eLearn.
The focused 90-minute eLearn takes you through the significant changes, what remains unchanged, and what the revised requirements mean in practice.
It covers quality culture and ethical behaviour, risks and opportunities, awareness, planning of changes, Annex A, and other key updates, with practical activities to help you consider the implications for an existing QMS.
For those who hold the Exemplar Global QM Auditing Quality Management Systems competency aligned to ISO 9001:2015, successful completion of the eLearn can also update your competency to ISO 9001:2026, subject to providing evidence of your existing qualification.
If you’re new to the Standard or looking to build your foundational knowledge, our Quality Management Systems training provides a broader introduction to ISO 9001 and its application.
If you’re looking to build broader auditing capability, you can also explore our Quality Management Systems Lead Auditor training.
Learn more and enrol in the ISO 9001:2026 Update eLearn
Frequently asked questions about ISO 9001:2026
What are the main changes in ISO 9001:2026?
The main changes include increased emphasis on quality culture and ethical behaviour, clearer separation of risks and opportunities, expanded awareness requirements, greater emphasis on managing change, selected operational clarifications, and additional explanatory guidance in Annex A.
Do organisations need to rebuild their QMS for ISO 9001:2026?
No. The fundamental structure, process approach, and Plan-Do-Check-Act cycle remain. Organisations should review their existing QMS against the revised requirements, identify gaps, and make targeted changes where necessary.
Is quality culture a new requirement in ISO 9001:2026?
ISO 9001 has long relied on leadership and organisational behaviours to support an effective QMS. The 2026 revision makes quality culture and ethical behaviour more explicit within leadership requirements and extends awareness of these concepts more broadly within the organisation.
What should organisations do first to prepare for ISO 9001:2026?
Start by understanding the revised requirements and conducting a gap analysis against your existing QMS. Pay particular attention to areas such as quality culture and ethical behaviour, risks and opportunities, awareness, and planning of changes.
Organisations should also speak with their certification body about the transition arrangements that apply to their certification.
Enrol in the ISO 9001:2026 Update eLearn
Further reading
Find out how ISO 9001 drives quality, sustainability and customer trust
Read about quality standards beyond ISO 9001
Understand how ISO 9001 sets the global standard for quality management
