Quality management standards are never static. They evolve, just as industries evolve. For more than a decade, ISO 9001:2015 has set the benchmark for organizations worldwide seeking to demonstrate efficiency, consistency, and customer trust. In February 2024, a modest amendment added a focus on climate-related issues — a clear signal that broader societal challenges are finding their way into quality standards. But this was only the beginning.
A significant revision of ISO 9001 is now in motion. In August 2025, the Draft International Standard (DIS) was released to ISO member states for review. If the timeline holds, a completely new edition — ISO 9001:2026 — will be published in September 2026. Organizations will then be granted a transition period of a maximum of three (3) years, meaning the revised standard will become mandatory for certification around late 2029. While the final details are still under discussion, it is already evident that (i) sustainability, (ii) digital transformation, and (iii) the ability to anticipate stakeholder expectations will become core themes. For medical technology companies, this is not simply a matter of updating a certificate. It is about redefining how quality systems can both ensure compliance and create strategic value in a rapidly changing healthcare environment.
Running in parallel is ISO 13485, the quality standard tailored for medical devices and in vitro diagnostics. This standard has been the cornerstone for demonstrating compliance with regulatory frameworks such as the EU MDR/IVDR, UK MDR, Swiss regulations, and the US FDA’s QSR. The current edition dates back to 2016, and although it remains valid, the standard is under active review. While no firm timeline has yet been announced, industry committees are exploring revisions in the coming years to align ISO 13485 more closely with ISO 9001:2026 while preserving its essential regulatory rigor.
For medtech manufacturers, the implications are significant. Two standards, each vital in its own right, are moving towards an updated vision of quality management. The likely outcome will be more emphasis on sustainability, risk-based thinking, and digital integration. Companies will be challenged to adapt — but those who do so proactively will not only secure compliance; they will strengthen their resilience and credibility in a competitive market.
At QNET, we see these revisions as opportunities. They offer medical technology companies a chance to step beyond a compliance-driven mindset and embed quality as a genuine driver of trust, safety, and innovation. The countdown to 2026 has already begun, and the organizations that prepare today will be the ones that lead tomorrow.
Want to know how the upcoming revisions to ISO 9001 and ISO 13485 will affect your medical technology business? Contact us — we help manufacturers worldwide align their quality systems with evolving standards and regulatory requirements.
ISO 9001:2026 Transition Timeline
- February 2024: Amendment published (climate aspects)
- August 2025: Draft International Standard (DIS) released
- September 2026: Final ISO 9001:2026 publication expected
- 2026 – 2029: Transition period (max. 3 years)
- Late 2029: ISO 9001:2015 certificates expire