ISO 9001:2026: the changes & tips

The new ISO 9001 is here! The international standard for quality management is moving from its 2015 version to a 2026 one. The new version builds on the 2015 version. The structure and core principles, such as customer focus, the process approach and risk-based thinking, remain. There are, however, a number of substantive changes, which we’re happy to explain here.

The introduction of an auditable quality culture

Quality culture has always been an implicit part of ISO 9001. The new version makes it explicit. This means an auditor will want to see evidence of behaviour. Ethical conduct is also included.

What does that mean in practice? A poster in the canteen, a code of conduct in the onboarding pack and an attendance list from a culture training session are not good enough on their own. They’re not entirely unimportant, but they’re not enough to demonstrate a genuine quality culture.

So what do you need? Reports from employees with a (timely) response from management. Cases where quality visibly took priority over the schedule. Or measures that actually remove the root cause of a problem.

If your organisation already has a genuine quality culture, this won’t be very difficult. You may need to put together a report or collect some data. Does quality in your organisation still mainly exist on paper? Then it’s time to get to work.

Tip: Start by mapping where things go wrong. Do you notice colleagues aren’t reporting incidents? Has it been said time and again that quality is a priority, while in practice the schedule still comes first? Don’t make assumptions about the causes. Once you have a clear picture of the underlying friction points, you can start working on solutions. Solutions that address the actual problem and can thereby lay the foundation for a genuine quality culture.

Quality policy as part of the strategy

This isn’t entirely new. The quality policy already had to fit the purpose and context of the organisation and support its strategic direction. That doesn’t change in 2026. What does change is the structure and the emphasis. The quality policy will be examined more critically, especially in combination with the auditable quality culture.

A quality policy can’t be a standard text. A good test question: could another company copy this policy word for word? If so, it’s too generic. The policy must show how quality supports your strategy, and you must demonstrate how it is applied and understood within the organisation (just like the quality culture).

Tip: Set a number of concrete priorities. This helps sharpen the quality policy, and these points will be the topics that feed directly into the strategy. That way you avoid an endless quality policy that’s impossible to work with, and you’re forced to take a critical look at the most important topics.

Risks and opportunities are assessed separately

Risks and opportunities may no longer be assessed in a single line. Previously, when onboarding a new supplier, for example, you could capture both what could go wrong and what the partnership could deliver in one overview.

Opportunities were too easily overlooked when placed alongside risks. That makes sense: potential losses tend to demand more attention than potential gains. ISO 9001:2026 calls for a more deliberate approach to seizing opportunities.

This doesn’t mean you have to build an entirely separate second register. As long as every risk and every opportunity is demonstrably assessed on its own, this can stay in the same tool. The tool you use must, of course, support this.

Tip: Identify the opportunities that are currently hidden in your risk assessment. They often appear as a side note to your risks. Record each opportunity on its own line and link the corresponding actions. Don’t forget to reconsider who is responsible here as well. An opportunity doesn’t necessarily have to be picked up by the same colleague as the risk.

Stricter requirements for change management

The 2015 version set out four points you had to consider when making a change to the quality management system: the purpose and potential consequences of the change, the integrity of the system, the availability of resources, and the allocation of responsibilities.

ISO 9001:2026 adds three more points of attention:

• How is the change communicated?
• How is the change monitored and evaluated?
• How are the results assessed?

This shows a shift from merely preparing a change to actively following up on it.

Tip: Schedule the review moment at the same time you implement the change. In practice, a review that isn’t scheduled almost never happens. Add this step to your procedure and put the discussion of the outcome straight onto the management review agenda.

Additional tips

• Start with a gap analysis between your quality management system under the 2015 version and what’s missing for the new version.
• Create a plan that allows for a phased approach. This works better than cramming everything into a few months.
• Appoint a project owner and involve senior management from the start.
• Make sure the project owner, and any project team, are given the space, time and resources to take this on.
• Treat the transition itself as a change under the new change management requirements.
• If needed, start with the quality culture. A document or system configuration can be adjusted quickly, but evidence of behaviour has to build up over time.