New ISO 9001 revision: Draft International Standard published

Last update: November 2025

ISO has published the document ISO/DIS 9001:2025, which represents the official draft of the next edition of the quality management system standard, expected to become ISO 9001:2026. It is an evolutionary update: the structure of the current ISO 9001:2015 is maintained, while additional clarifications and some new requirements are introduced to keep the standard aligned with the current context.

Main changes in the Draft ISO 9001

The most significant elements in the new text can be summarised as follows:

• Clause 3 – Terms and definitions: the standard now includes a list of key definitions (organization, interested party, process, risk, opportunity, documented information, etc.), making the text more self-contained.
• Clauses 4.1 and 4.2 – Context of the organization: the amendments on climate change introduced in 2024 are now fully integrated into the body of the standard. Organizations are required to determine whether climate change is a relevant issue in their context and to consider any related requirements in the needs and expectations of pertinent interested parties.
• Clause 5.1 – Leadership: top management is explicitly required to promote a culture of quality and ethical behaviour, supported by notes explaining how these aspects can be demonstrated in practice.
• Clause 6.1 – Actions to address risks and opportunities: the approach to risks and opportunities is set out more clearly, with distinct subclauses for risks and for opportunities and additional guidance on identification, evaluation and actions to be taken.
• Clause 6.3 – Planning of changes: the requirement to plan changes to the quality management system is reinforced, with a stronger focus on the effectiveness of changes, communication and the review of results.
• Clauses 7.2 and 7.3 – Competence and Awareness: the text clarifies the link between competence, quality management system performance and documented information (e.g. training records, qualifications, experience) and requires that people are also aware of aspects related to the culture of quality and ethical behaviour, in line with the role of top management.
• Clause 8 – Operation: for the requirements relating to customer requirements, design and development, and production and service provision, several explanatory notes are introduced or revised, with the aim of clarifying the intent of existing requirements without fundamentally changing them.

What this means for organizations already certified

At this stage, ISO 9001:2015 certificates remain fully valid and no immediate action on issued certificates is required. The formal rules for migration to the new edition (timelines, transition arrangements, audit management) will be defined by ISO, IAF and ACCREDIA through specific documents and official communications.

However, organizations already certified must ensure conformity to ISO 9001:2015 including the climate change amendment. This means that the quality management system must already:

• consider, in the analysis of the context (clause 4.1) and of interested parties (clause 4.2), whether climate change represents a relevant issue and whether there are specific needs or expectations related to it;
• reflect these aspects, where relevant, in the actions to address risks and opportunities (clause 6.1) and in the planning of processes.

The publication of the new edition does not require organizations to “start from scratch”; instead, it provides an opportunity to review the robustness of what has already been implemented and to align with the themes highlighted in the Draft:

• assessing to what extent the culture of quality and ethical behaviour are genuinely promoted and monitored (leadership, communication, staff engagement);
• revisiting the approach to actions for risks and opportunities, in light of the clearer separation in the new text and the enhanced emphasis on opportunities;
• checking how changes to the quality management system (clause 6.3) are currently planned, including the evaluation of effectiveness and internal communication;
• confirming the robustness of evidence of competence and awareness (clauses 7.2 and 7.3), in particular for key roles and with regard to the understanding of quality objectives.

Timelines and transition period

The publication of the final version of ISO 9001 is currently expected in 2026. Based on established practice for revisions of management system standards, it is reasonable to expect a transition period of approximately three years from the publication date of the new edition.

At the time of writing, ISO, IAF and ACCREDIA have not yet published official documents setting out the mandatory rules and deadlines for migration from ISO 9001:2015 to the new edition. Information on timelines and transition arrangements will therefore be confirmed through specific communications and reference documents (IAF resolutions, ACCREDIA circulars, and updates to our certification regulation RG01).

Support from our certification body

Our certification body is closely following the revision work on the standard and taking part in discussions with accreditation bodies and other interested parties.

As official information on the final content, timelines and transition rules becomes available, we will update this section of our website and provide our clients with detailed guidance, including dedicated communications and training initiatives.

We encourage all certified organizations to maintain regular contact with their certification representatives, so that activities and the transition to the new ISO 9001 can be planned in a gradual and effective way, in line with the guidance that will be issued by IAF and ACCREDIA.

---