ISO 9001:2026
Introduction
ISO 9001 is entering its first major revision since 2015. For organisations already certified to ISO 9001:2015 (International Organization for Standardization [ISO], 2015), the new edition is not expected to require a complete redesign of the quality management system (QMS). Instead, the revision strengthens and clarifies several areas that have become increasingly important over the past decade, including organisational context, climate change, quality culture, ethical behaviour, risk and opportunity management, leadership and organisational resilience.
ISO 9001:2026 will replace ISO 9001:2015 when the new edition is published. Certified organisations will then need to transition their quality management systems under the formal certification arrangements issued for the new edition.
The Final Draft International Standard (FDIS) has been approved with overwhelming international support, and the sixth edition is scheduled for publication as ISO 9001:2026 on 16 September 2026 (ISO, in press; ISO/TC 176/SC 2, 2026c). It will replace ISO 9001:2015, including the climate action amendment introduced in 2024.
For certified organisations, the key message is to prepare, but not to overreact. Many existing QMS processes will remain relevant. The priority should be identifying where current arrangements do not adequately address the revised expectations and then incorporating those changes into normal business processes.
Publication Status and Transition Period
ISO/FDIS 9001 was released for ballot in May 2026, with voting closing in July (ISO/TC 176/SC 2, 2026b). On 7 August 2026 the committee announced that the FDIS had been approved, and publication of the sixth edition is scheduled for 16 September 2026 (ISO/TC 176/SC 2, 2026c).
A certification transition period is expected, but the formal transition requirements and deadlines have not yet been issued. Organisations should confirm the final arrangements with their certification body once they are published.
The transition window can be estimated from precedent. ISO management system standards have historically allowed up to three years to transition, certification bodies describe a transition audit within three years of publication for this revision, and ISO 14001:2026, published in April 2026, opened a transition period running to early 2029 (AFNOR, 2026; LRQA, 2026). On that precedent, organisations certified to ISO 9001:2015 can plan against a window running to approximately September 2029, subject to formal confirmation by the International Accreditation Forum. ISO 45001, the occupational health and safety management standard, is undergoing the same revision cycle and is scheduled for publication in 2027 (AFNOR, 2026).
This distinction is important. Organisations can undertake sensible preparatory work now, but major changes to documented systems should be based on the final published standard and applicable certification transition requirements.
When to act. Before publication: monitor ISO updates, brief top management and identify the QMS processes likely to be affected. After publication: obtain the final standard, confirm the transition requirements with the certification body and complete the clause-by-clause gap assessment. Before the transition audit: implement the changes, complete the internal audit and management review, and close the resulting corrective actions.
Do not use the FDIS as the final basis for changing controlled QMS documents or determining conformity. Complete the formal gap assessment against the published standard.
What Is Changing?
The overall structure of ISO 9001 remains familiar. The revision is generally regarded as a moderate update rather than the type of substantial structural change experienced when organisations transitioned from ISO 9001:2008 to ISO 9001:2015 (BSI, n.d.; DNV, n.d.).
Key areas of increased emphasis include organisational context, including climate-related considerations; leadership responsibility for quality culture and ethical behaviour; clearer consideration of risks and opportunities; greater emphasis on organisational resilience and changing business conditions; awareness and communication; clearer expectations around planning and implementing changes; and expanded guidance intended to assist organisations in interpreting the requirements (ISO/TC 176/SC 2, 2026a).
The practical effect will depend on the organisation. A mature QMS that is already integrated with business planning, risk management and leadership processes may require relatively modest changes. A system operated primarily as a certification exercise may require considerably more work.
Organisational Context and Climate Change
Climate change is not entirely new to ISO 9001. In February 2024, ISO published ISO 9001:2015/Amd 1:2024 as part of broader climate action amendments to management system standards (ISO, 2024; ISO/IAF, 2024). The amendment requires organisations to determine whether climate change is a relevant issue when considering their organisational context. It also recognises that relevant interested parties may have requirements related to climate change. The 2026 revision carries this consideration forward within the revised standard (ISO/TC 176/SC 2, 2026b).
This does not mean every ISO 9001-certified organisation must establish an environmental management programme or treat climate change as a significant quality risk. The requirement is contextual. Organisations need to determine whether climate change is relevant to the ability of their QMS to achieve its intended results.
For example, relevant considerations could include disruption to supply chains, extreme weather affecting facilities or transport, availability of materials, changing customer specifications, infrastructure reliability, insurance requirements, regulatory developments or stakeholder expectations. An organisation should therefore be able to demonstrate that climate change has been considered and explain the basis for determining whether it is relevant to its QMS. Existing context registers, SWOT or PESTLE analyses, interested-party registers, risk assessments and management review processes can generally be adapted rather than replaced.
Leadership, Quality Culture and Ethical Behaviour
One of the more notable developments in the revision is the stronger emphasis on leadership, quality culture and ethical behaviour. The FDIS introduces promoting quality culture and ethical behaviour within leadership and commitment, while awareness provisions also reinforce these concepts (ISO/TC 176/SC 2, 2026b). For certified organisations, this moves the discussion beyond having a quality policy displayed on a wall or employees being able to repeat basic quality objectives.
Leadership should be able to demonstrate that behaviours supporting quality are encouraged throughout the organisation. This could include transparent reporting of problems, appropriate escalation of quality concerns, learning from mistakes, responsible decision-making, accountability and avoiding pressures that encourage employees to bypass controls simply to meet production, delivery or financial targets.
Auditors may therefore increasingly look beyond procedures and ask how leadership influences behaviour in practice. Useful evidence could include leadership communications, meeting records, employee awareness activities, codes of conduct, escalation processes, training, employee feedback, actions arising from reported concerns and examples showing that quality considerations are incorporated into operational and strategic decisions.
Risks, Opportunities and Planning
Risk-based thinking was a major feature of ISO 9001:2015 and remains fundamental to the revised standard. The revision provides clearer distinction between addressing risks and pursuing opportunities (ISO/TC 176/SC 2, 2026b). This is significant because some organisations have historically treated “risks and opportunities” as a single risk-register exercise, with limited evidence that opportunities were actively identified and pursued. Organisations should review whether their current planning process adequately considers both.
Risks might include supplier failure, loss of organisational knowledge, equipment failure, skills shortages, changing regulatory requirements, technology disruption or inability to meet customer requirements. Opportunities could include automation, improved process capability, alternative suppliers, new technology, better use of data, improved competence, simplified processes or changes that improve customer experience.
The objective is not necessarily to create two large registers. The organisation should demonstrate a systematic process for determining what needs attention, deciding what action is appropriate, integrating those actions into its QMS processes and evaluating whether the actions have been effective.
Resources and the Work Environment
Certified organisations should also reconsider whether the resources and environment required for effective processes remain suitable as working arrangements and technology continue to change. The work environment should not be interpreted only as the physical workplace. Depending on the organisation, relevant factors can include remote and hybrid working arrangements, technology, communication methods, employee interaction, competence, accessibility, workplace conditions and other human factors that can influence process and product or service quality.
The key question remains practical: does the organisation provide and maintain the conditions necessary for its processes to operate effectively and consistently? Evidence may include resource planning, workforce and competence reviews, IT and infrastructure assessments, maintenance records, workplace inspections, employee feedback and management review decisions.
Communication and Operational Control
Communication requirements should be reviewed alongside operational controls. Organisations should determine what QMS information needs to be communicated, when communication is required, who needs to receive it, how it will be communicated and who is responsible.
This applies internally and, where relevant, externally. External communication can be particularly important where customers, contractors, suppliers and other external providers need accurate information concerning specifications, changes, acceptance criteria, delivery requirements, responsibilities or quality controls.
Organisations should therefore review whether communication controls are built into processes rather than relying heavily on informal knowledge. Examples of evidence include customer communications, supplier specifications, approved change notifications, meeting records, project communications, contract reviews, purchasing information and controlled electronic workflows.
Internal Audits and Management Review
Internal audit and management review will be important mechanisms for demonstrating that the transition has been effectively implemented. Internal audit programmes should be updated once the final standard has been assessed against the organisation’s QMS. Auditors should understand the revised requirements and be competent to evaluate new or strengthened areas such as quality culture, ethical behaviour, organisational context, climate relevance and the treatment of opportunities.
Audits should test implementation rather than merely confirming that documents have been updated. For example, an audit of quality culture should not stop at confirming that the term appears in a policy. Auditors can examine whether employees understand expected behaviours, whether quality concerns can be raised, how management responds to problems and whether operational pressures undermine established controls.
Management review should similarly consider changes to context, relevant interested-party expectations, risks and opportunities, resource requirements, improvement opportunities and the progress of transition activities. Management review records can provide particularly strong evidence that top management has understood and directed the transition rather than delegating it entirely to the quality manager.
Planning and Controlling Change
Change management remains an important component of an effective QMS. Changes to processes, technology, suppliers, organisational structures, responsibilities, products, services and resources can create unintended quality consequences if they are introduced without adequate planning. The transition itself should therefore be managed as a controlled change.
Before implementing significant QMS changes, organisations should consider the purpose of the change, possible consequences, QMS integrity, available resources and responsibilities and authorities. A transition plan can be useful for larger organisations. It may identify each required change, responsible persons, target dates, affected documents, training requirements, implementation evidence and verification activities.
Smaller organisations may achieve the same outcome through existing action registers or management meeting processes. ISO 9001 does not require unnecessary bureaucracy; the level of control should be proportionate to the organisation and the significance of the change.
Evidence for Certification Audits
Updating documents alone will not demonstrate conformity. Certification auditors will normally seek objective evidence that revised requirements have been incorporated into the QMS and are operating effectively. Depending on the organisation, evidence could include updated organisational context and interested-party assessments; evidence that climate change relevance has been considered; risk and opportunity assessments and resulting actions; leadership and employee communications; quality culture and ethical behaviour awareness activities; revised competence or training records; updated operational controls; change-management records; internal audit reports; management review records; corrective actions; performance data demonstrating effectiveness; and controlled revisions to relevant QMS documented information.
Organisations should avoid creating documents solely because they believe an auditor expects a particular form or register. ISO 9001 generally focuses on effective processes and appropriate documented information rather than prescribing a specific documentation system.
Gap Assessment and QMS Implementation
A structured gap assessment should be one of the first formal transition activities after the final standard is available. The organisation should compare each applicable requirement of ISO 9001:2026 against the existing QMS and classify the result. A simple approach is to identify requirements as conforming, partially conforming, not conforming or not applicable where appropriate.
For each identified gap, determine what needs to change; why the change is required; which process or document is affected; who is responsible; what resources or training are required; when implementation will occur; and what evidence will demonstrate effective implementation.
The organisation can then update the QMS systematically. This may involve changes to policies, process maps, procedures, risk and opportunity processes, context analysis, interested-party information, objectives, competence arrangements, communication processes, audit programmes or management review agendas. The emphasis should be on integration. New requirements should become part of normal business processes rather than existing as separate “ISO 9001:2026” documents.
Corrective Actions and Transition Readiness
Once changes have been implemented, organisations should verify their effectiveness. Internal audits are particularly useful at this stage. Any nonconformities or weaknesses identified should be addressed through the organisation’s existing corrective-action process. Where a nonconformity occurs, the organisation should respond to the issue, address consequences where necessary, determine causes, consider whether similar problems could occur elsewhere, implement appropriate action and review whether that action was effective.
Before the certification transition audit, management should have reasonable confidence that the revised QMS has been operating long enough to provide meaningful evidence. A last-minute document update immediately before the audit is unlikely to demonstrate effective implementation.
Records to Retain
The precise documented information required will depend on the organisation and its QMS, but transition evidence should be retained in a controlled and accessible manner. Useful records may include the gap assessment, transition plan, revised context assessment, interested-party review, climate change determination, risk and opportunity records, change assessments, training and awareness records, internal audit results, management review records, corrective actions and evidence of completed QMS updates.
Document-control records should also make it possible to identify relevant revisions and prevent obsolete information from being used unintentionally. Organisations should not retain records merely to increase the volume of audit evidence. Records should support control, traceability, decision-making and demonstration that the QMS is functioning as intended.
Practical Transition Checklist
Certified organisations can use the following sequence as a practical starting point. Work through each phase in order.
Phase 1: Prepare
Monitor the formal publication of ISO 9001:2026 and its transition requirements. Obtain and review the final published standard. Confirm the transition timetable with your certification body. Brief top management and the relevant process owners.
Phase 2: Assess the gap
Conduct a clause-by-clause gap assessment. Review organisational context and interested parties. Record the determination of whether climate change is relevant to the QMS. Review how leadership promotes quality culture and ethical behaviour. Review the organisation's approach to risks and opportunities.
Phase 3: Implement
Assess resource, competence, awareness and communication requirements. Review operational controls and change-management arrangements. Update the relevant QMS documented information. Train or brief affected personnel. Implement the revised arrangements and retain appropriate evidence.
Phase 4: Verify and close out
Conduct internal audits against the new requirements. Complete corrective actions arising from those audits. Conduct a management review covering transition readiness and QMS effectiveness. Confirm that all actions are complete before the certification transition audit.
Conclusion
ISO 9001:2026 should be approached as an evolution of the existing quality management framework rather than a requirement to rebuild the QMS. For well-established certified organisations, many of the underlying principles will already be familiar. The main task will be demonstrating that the QMS reflects current organisational realities and that strengthened expectations around context, climate change, leadership, quality culture, ethical behaviour, risks, opportunities and organisational change are meaningfully incorporated into business processes. Most certified organisations will complete the transition with the quality resources they already hold; OHSE Consultants provides independent support with gap assessments, internal audits and transition planning where it is wanted.
References
AFNOR. (2026, 16 April). ISO 9001 and ISO 14001: An overview of the latest version. https://www.afnor.org/en/decryptions/environmental-protection/iso-9001-and-iso-14001-an-overview-of-the-latest-version/
BSI. (n.d.). ISO 9001:2026 – Key changes and guidance. https://www.bsigroup.com/en-AU/products-and-services/standards-services/iso-9001-2026-key-changes-and-guidance/
DNV. (n.d.). ISO 9001 and ISO 14001 standards revisions. https://www.dnv.com.au/assurance/Management-System-Certification/new-iso/transition/revisions-of-iso-9001-and-14001/
International Organization for Standardization. (2015). Quality management systems – Requirements (ISO Standard No. 9001:2015).
International Organization for Standardization. (2024). Quality management systems – Requirements – Amendment 1: Climate action changes (ISO Standard No. 9001:2015/Amd 1:2024).
International Organization for Standardization. (in press). Quality management systems – Requirements (ISO Standard No. 9001, 6th ed.). Publication scheduled for 16 September 2026.
International Organization for Standardization and International Accreditation Forum (ISO/IAF). (2024). Joint communiqué on the addition of climate change considerations to management systems standards. https://iaf.nu/iaf_system/uploads/documents/Joint_ISO-IAF_Communique_re_Climate_Change_Amds_to_ISO_MSS_Feb_2024_Final.pdf
ISO/TC 176/SC 2. (2026a, 12 February). ISO 9001 revision update. https://committee.iso.org/sites/tc176sc2/home/news/content-left-area/news-and-updates/iso-9001-revision-update-3.html
ISO/TC 176/SC 2. (2026b, 27 May). ISO 9001 revision update – ISO/FDIS 9001 released for ballot as revision progresses to final stage. https://committee.iso.org/sites/tc176sc2/home/news/content-left-area/news-and-updates/iso-9001-revision-update-4.html
ISO/TC 176/SC 2. (2026c, 7 August). ISO 9001 revision update – ISO/FDIS 9001 approved. https://committee.iso.org/sites/tc176sc2/home/news/content-left-area/news-and-updates/news-1.html
LRQA. (2026). ISO 14001:2026 is live: The transition period has begun. https://www.lrqa.com/en/latest-news/iso-140012026-live/



