The new ISO 9001:2026 standard has been published: what changes for companies?

The International Organization for Standardization ( ISO ) today officially published the sixth edition of ISO 9001 , the international reference standard for quality management systems (QMS).

The new text replaces the previous 2015 version, which had been in force for over eleven years, and represents the first complete revision of the world's most widely used quality standard, with over one million certificates issued in 189 countries.

Why the rule was revised

The revision stems from a global consultation conducted in 2023 among users of the standard, which confirmed the need to update it to make it clearer, easier to apply and more aligned with the needs of modern organizations , including digitalization, sustainability and new challenges in supply chains.

What does NOT change

A reassuring point for companies already certified: the general structure of the standard remains the same .

The ten-clause structure and the high-level approach (Annex SL/Harmonised Structure) shared with other ISO management system standards (such as 14001 and 45001) are confirmed.

It is therefore not a remake, but a targeted update: those who already have a mature QMS do not have to "start from scratch", but rather adapt content, terminology and some practices.

The main novelties

Clause 4 – Context of the organization
Climate change and sustainability are explicitly included among the factors organizations must consider when determining their context (sections 4.1 and 4.2). No new environmental obligations are introduced in the strict sense, but companies will need to recognize these issues as factors that can impact quality, business continuity, and customer and stakeholder expectations.

Clause 5 – Strengthened Leadership
The role of management: The standard introduces ethical behavior and a culture of quality as explicit responsibilities of leadership. Top management is required to concretely demonstrate their commitment—for example, through training, openness to internal dialogue, and direct example—so that quality values spread throughout the organization.

Clause 6 – Planning
Risks and opportunities are treated separately (no longer as a single pair), to encourage organizations to address them with specific and more targeted actions rather than with a generic approach.

Clause 7 – Support
Organizational knowledge management is becoming more stringent: it is no longer enough to simply "determine" the necessary knowledge, but it must be preserved, made applicable, and actively shared within the organization.

Clause 8 – Operational Activities
The changes in this area are mostly editorial and terminological, with specific clarifications that do not overturn the operational requirements already known from the 2015 edition.

Effectiveness of QMS changes
A significant change concerns changes to the quality management system: they must now achieve the expected results, be formally communicated, and verified for effectiveness. The requirement has gone from a simple recommendation to an obligation ("shall").

Brand new: Annex A
For the first time in the standard's history, ISO 9001 is accompanied by an informative annex of approximately 15 pages that provides additional guidance on the structure, terminology, and requirements of clauses 4 to 10. This is a direct response to the criticisms of interpretative ambiguity that accompanied the 2015 edition, and a useful tool for both first-time implementers and more experienced users.
Annex B of the previous edition has been eliminated.

What companies should do

For organizations already certified to ISO 9001, the publication of the new edition does not mean they must immediately modify their management system. However, it is a good idea to start preparing for the transition.

Five activities can be a starting point:

• Understand the new standard, examining the modified requirements and related clarifications;
• carry out a gap analysis between the currently applied Management System and the requirements of ISO 9001:2026;
• review the management of risks and opportunities , verifying that the two aspects are addressed adequately and consistently with the new formulation;
• evaluate the culture of quality, ethical behavior and the role of leadership , verifying how these elements are concretely promoted within the organization;
• plan the necessary interventions, which may concern processes, documented information, staff training and awareness, internal audits and management reviews.

The goal should not be simply to “update the documentation,” but to use the transition to verify whether the Management System continues to be truly effective and functional to the organization’s needs.

The transition to ISO 9001:2026

With the publication of the new edition, the process that will lead organizations certified according to ISO 9001:2015 to progressively adapt their Management Systems begins.

CSQA will support certified organizations in the transition to ISO 9001:2026, providing necessary updates on the procedures and timelines for adapting to the new edition of the standard.