TÜV SÜD on the new ISO 9001:2026

“The revision does not change the fundamental principles of ISO 9001, but it introduces new priorities and clarifications in several areas,” says Tobias Lurk, Global Product Performance Manager for ISO 9001 at TÜV SÜD, explaining the changes. “With the publication of the standard, practical implementation in companies begins. It will now be crucial to systematically integrate the new requirements into existing management systems while keeping an eye on the further development of industry-specific standards.”

Among other things, the revised standard places greater emphasis on climate-related aspects, specifies requirements for managing risks and opportunities, and highlights the importance of a culture of quality and ethical conduct. The publication also marks the start of a 36-month transition period for the conversion of existing quality management systems. Certificates issued under ISO 9001:2015 remain valid during this period. TÜV SÜD has compiled a detailed analysis of the changes in ISO 9001:2026 on its ISO 9001 revision page.

What Companies Should Do Now

Companies should now systematically align their existing processes, documentation, and responsibilities with the requirements of ISO 9001:2026. In addition to a gap analysis, the concurrently revised ISO 9000 series and the significantly expanded Annex A of ISO 9001 can provide important guidance for practical implementation.

“Especially when it comes to the changes regarding quality culture and ethical conduct, audits focus less on additional documentation and more on credible and consistently practiced implementation,” says Tobias Lurk. “Companies should therefore start early to clarify responsibilities, involve management, and integrate the new priorities into existing processes.”

Impact on Industry-Specific Standards

However, the publication of ISO 9001:2026 has implications not only for companies certified to this standard. ISO 9001 forms the basis for numerous industry-specific quality management standards and thus also influences their further development.

This is particularly relevant for the automotive industry. IATF 16949 is based on ISO 9001 and is currently undergoing revision as well. As of now, the revised version is expected to be published in mid-2027. Among other things, the goal is to formulate requirements more clearly and reduce overlaps with ISO 9001. In addition, the transition provisions are to be aligned with the deadlines for ISO 9001:2026.

The situation is different in the medical device sector. ISO 13485:2016 was confirmed in early 2026 as part of its systematic review and remains valid without change until April 2030. For manufacturers of medical devices, the revision of ISO 9001 does not currently result in any immediate changes to the normative requirements, as ISO 13485 remains valid without change until April 2030.

“Companies should not view the revision of ISO 9001 in isolation,” says Tobias Lurk. “Especially in regulated or highly quality-focused industries, it is worthwhile to monitor the further development of industry-specific standards early on. This makes it easier to understand future requirements and prepare necessary adjustments in a timely manner.”