Updates on IATF 16949, IA 9100, ISO 13485, and ISO 23485

Oct. 13, 2025 - PRLog -- Several of the most widely used sector-specific quality management standards are undergoing major updates. In automotive, IATF 16949—with over 93,000 certificates globally—and in aerospace, AS 9100 (soon to be IA 9100) with 27,000 certifications in 84 countries, are both being revised in parallel with the upcoming ISO 9001 update. These revisions aim to ensure continued alignment with ISO 9001:2025 and relevance in a rapidly changing, post-pandemic business environment. This session will review each standard, highlight anticipated changes, and outline expected publication timelines.

In the MedTech sector, ISO 13485, the foundation for medical device quality systems with more than 25,000 certifications worldwide, was recently confirmed through systematic review. While its core requirements remain unchanged, the need for stronger implementation support and regulatory harmonization has led to the development of ISO 23485, a new guidance document approved in January 2025 and expected in April 2026. This guidance will aid adoption of ISO 13485:2016, particularly in emerging areas such as Software as a Medical Device (SaMD).

Regulatory alignment is also accelerating. The FDA's Quality Management System Regulation (QMSR) will incorporate ISO 13485:2016 by reference starting in February 2026, with the EU, UK, Singapore, and others moving in the same direction through frameworks like MDSAP.

By exploring these updates across automotive, aerospace, and medical devices, this session will provide early insights to help organizations anticipate changes and prepare for the next generation of quality management standards.

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