DIS 9001-2026-eng
The DIS of ISO 9001:2025 — what companies really ought to know at present
For the first time, the Draft International Standard (DIS) of ISO 9001:2025 provides a largely completed version of the next revision of this quality management standard, which is the world’s most widely used. The (final version of this) International Standard is expected to be published during the late summer half-year of 2026. However, it is becoming increasingly clear that ISO 9001:2026 will represent a cautious evolution of what already exists, rather than a new beginning.
Companies that are presently certified according to ISO 9001:2015 don’t need to prepare themselves for fundamental structural changes or for completely new mandatory requirements, based on what we know at present. The revision focuses instead on editorial changes, additional explanatory notes, and significantly expanded guidance.
A key finding of the draft is the largely stable nature of the normative requirements. Clauses 4 to 10, which constitute the mandatory core of the Standard, underwent merely the most minimum changes. New topics, such as sustainability, artificial intelligence, cybersecurity, or “Quality 4.0”, which were subject to frequent conjecture beforehand, are not among the mandatory requirements.
These respects can solely be found in the margins of explanatory texts or in the new Annex A, if at all, and they are not audit- or certification-relevant.
Annex A was newly introduced, and it occupies a considerable scope. It expands the Standard by numerous notes, comments, and examples. These are explicitly non-mandatory guidelines. For organizations, this means that these contents may be used as aids for interpretation, however, they may neither be understood as additional requirements nor demanded by auditors.
The process approach, which has been a core element of ISO 9001 for many years, was graphically represented again in the DIS. Admittedly, the visualization of the process logic was slightly revised. However, a really clear, consistent explanation was still not provided. Especially the linkage between process management as well as performance evaluation and improvement in terms of the PDCA cycle remains incomplete in the new version as well. There is still no definition of chances/opportunities, whereas risks are listed in Clause 3 of the Standard.
Within the Clauses on performance evaluation and improvement, there is still a lack of consistent linkage back to the processes defined in Clause 4.
The treatment of risk-based thinking is surprising. The respective paragraph was removed from the introduction and relocated completely to the new Annex A. In our view, this doesn’t result in greater clarity or better applicability, in terms of content. The additionally used term “chance-based thinking“ doesn’t replace a systematic methodology and might instead lead to further interpretative questions during practice.
Formulations on quality culture and ethical leadership were newly added. Admittedly, these additions underline the significance of the attitude and of the role model function of top management. However, they remain deliberately in general terms. That will cause challenges during actual auditing practice, since objective criteria for evaluating these respects have hardly been defined.
In our view, the devaluation of the top management accountability obligation, which was moved from Paragraph a) in the version of 2015 to the final Paragraph k) in the present draft, is problematic.
One change within the Clause on internal audits is also to be considered problematic. The previously explicitly formulated purpose of evaluating the conformity of the quality management system with the Standard and with the respective internal requirements has been worded differently and might be interpreted adversely. If this formulation remains in the (final version of the) International Standard, an increased need for interpretation is to be expected during auditing practice.
Altogether, the DIS of ISO 9001:2025 provides a familiar picture. The Standard remains true to its fundamental approach and deliberately omits buzzwords or technological promises. Primarily, this provides companies with planning certainty. A functioning, process-oriented quality management system, clear objectives, suitable metrics, and an effective improvement process will also continue to be the decisive success factors going forward.
Therefore, the upcoming revision should be used less as a cause for hectic system adjustments and more as an opportunity for unemotional reflection: How effective is the internal QM system really, independently of the next Standard Edition?
We are providing a detailed overview of the most important changes, including practice examples, through the following presentation: Die DIS ISO 9001:2026 – PeRoBa® Unternehmensberatung GmbH.
About PeRoBa:
PeRoBa Unternehmensberatung GmbH (PeRoBa Management Consultancy, LLC) is one of the leading impulse generators in the quality management department on a global scale. Its origins already date back to 1991. The company headquarters have been in Baldham since 2011, and there is also branch in Prinzregentenstraße, Munich. PeRoBa Unternehmensberatung (PeRoBa Management Consultancy) provides high-quality consultations, audits, and evaluations in order to support clients in introducing and implementing their management systems. On top of that, they also offer audits, QM training, seminars, and workshops.
Their innovative in-house software, the iVision® – Smart Remote Audit Solution had been on the market since January 2016 and complements our consulting portfolio.
The company’s founder and owner, Dr. Roland Scherb, PhD is an auditor, consultant, coach, and author. He is chairman of the German Federal Auditors’ Association and an active member of the DIN e.V. working group as well as a lecturer with the TÜV-Academy.
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