The revision of ISO 9001 – Everything you need to know now!

The current version of ISO 9001 dates from 2015. A revision has been in the works for several years. On August 27, 2025, the ISO working group published the Draft International Standard (DIS). The final publication of ISO 9001:2026 is expected in September 2026. Organizations will have a three-year transition period after publication, until September 2029, to implement the changes.

What this means for you: You have ample time to adapt your quality management system to the new requirements or to achieve certification for the first time.

The 2026 revision brings some exciting developments. The key changes include:

1. Integration of sustainability aspects:
Already in spring 2024, ISO required companies to assess the relevance of climate change for their management system and, if necessary, incorporate it into their processes. For this purpose, the immediately effective amendment (ISO 9001:2015/Amd. 1:2024) was published. This amendment has now been incorporated into the Harmonized Structure (HS) and thus into the DIS of ISO 9001, keeping the topic in focus. Companies need to evaluate, among other things:

► Is your organization affected – for example, due to CO₂ requirements?

► Are there impacts on your product or service portfolio?

Companies must then draw conclusions, identify risks, and take measures, such as improving recycling options, systematically reducing energy or media usage, or adjusting their fleet. Climate change is already part of ISO 9001 and will continue to be emphasized in the revised standard.

2. Expanded leadership responsibilities:
Top management will be required to demonstrate leadership and commitment regarding the quality management system by explicitly promoting a quality culture, integrity, and ethical behavior. A new note in the revision states: “The culture and ethics of the organization can be demonstrated through shared values, beliefs, history, attitudes, and observed behaviors.”

3. Strategic alignment of organizational culture:
Top management must develop a quality culture that considers the organizational context and supports its strategic direction.

4. Handling of risk and opportunity management:
The 2026 version of ISO 9001 breaks down section 6.1 into sub-sections to allow a clearer distinction between measures to address risks and pursue opportunities.
Quality objectives and planning to achieve them: Quality objectives must be measurable, but only where practical.}

Planning of changes: The organization must consider how:
- the effectiveness of changes will be verified and evaluated, and
- the results of the changes will be reviewed.

5. Enhanced organizational awareness to promote quality culture and ethical behavior:
Clause 7.3 adds a new requirement for employee awareness regarding understanding “quality culture and ethical behavior.”

Implication: The core requirements largely remain the same. The standard has mainly been supplemented, editorially revised, and the language has been clarified and standardized (“Harmonized Structure”). Organizations already compliant with ISO 9001:2015 will therefore not need to make major adjustments.

ISO 9001 is a global standard – over 1 million certified organizations worldwide use it as a framework for their quality management. Accordingly, there is a high expectation that the revision is carried out thoroughly, based on consensus, and coordinated internationally. The reasons for the long timeframe include:

• Global participation: Over 160 member countries are represented in ISO committees, each with diverse expectations and areas of application.
• Complex process: Multiple rounds of involvement with corrections and opportunities for commenting by national standards bodies.
• Translation and coordination: The standard must be translated and published internationally in numerous languages.
• Wide applicability: ISO 9001 must work equally well for small businesses and multinational corporations – in industry, administration, and healthcare.

A standards revision is always also an opportunity to assess the effectiveness of your own QMS or to conduct a gap analysis. Ask yourself: What can we optimize? And: Are we already adequately addressing all the changes that are now the focus within our existing QMS?

If you are already certified, now is the time to review and optimize your existing quality management system. Your current system is not outdated; it is the best possible foundation for the 2026 version. This ensures a smooth transition to the new standard without unnecessary effort.

For companies that are not yet certified, my clear advice is: Don’t wait until 2026! Implementing ISO 9001:2015 is still worthwhile, as the upcoming revision is evolutionary and allows for a quick and easy transition based on the “old standard.”

Remember: The transition period until 2029 gives you ample time for a strategically sound plan – it is worth taking action early and being well-prepared. TÜV Rheinland is your reliable partner in implementing your quality management system.

The Need for Revisions in ISO 9001: Reasons and Background

The revision of ISO 9001, like any international standard, is necessary to ensure that it remains relevant, practical, and effective for organizations worldwide. The world is constantly evolving, and this affects business environments, technologies, market requirements, and regulatory frameworks. Here are the main reasons why ISO 9001 revisions are carried out:

1. Adapting to changing business environments:
   The standard must respond to changes in the global economy, such as new technologies, digital transformation, globalization, and climate change. Companies today face very different challenges than they did 10 or 20 years ago.
2. Integration of new management approaches:
   Leadership and quality management practices continue to evolve. New editions of the standard can incorporate current best practices, such as risk-based thinking, promoting agility, or enhancing customer focus.
3. Ensuring relevance and usability:
   Revisions ensure that organizations can apply the standard regardless of size, industry, or complexity. Older versions may include aspects that are less practical or relevant for modern businesses.
4. Better alignment with other standards:
   ISO 9001 is often combined with other standards, such as ISO 14001 (environmental management) or ISO 45001 (occupational health and safety management). Revisions take the “High-Level Structure” (HLS) into account to facilitate the integration of multiple management systems.
5. Supporting new stakeholder requirements:
   Customers, suppliers, governments, and other stakeholders have new expectations, for example regarding sustainability, social responsibility, or cybersecurity. An updated standard reflects these requirements.
6. Maintaining the credibility of certifications:
   If a standard becomes outdated, the credibility of certifications may be affected. A revised standard ensures that certifications remain relevant and recognized worldwide.
7. Regular review by ISO:
   The International Organization for Standardization (ISO) reviews its standards at least every five years to determine whether an update is necessary. This is part of the regular ISO process to ensure that standards remain up to date.

The current version, ISO 9001:2015, was a significant milestone, as it emphasized risk-based thinking and a process-oriented approach. A new revision typically builds on the needs of users and feedback from practical application. This is why revisions occur at regular intervals.

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