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

by Chad Kymal,William Kovacich,Frankie Breedlove published on November 07, 2025

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 webinar recording 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.

Speaker

Chad Kymal

Chad Kymal is the CTO and Founder of Omnex Inc. He is the author of seven books and more than 100 papers including several on integrated management systems. Chad is currently on the writing committees for several standards including TC 22/ SC 32/WG 8 for ISO 26262 (Functional Safety), ISO/TC 176 for ISO 9001:2015 (Quality Management), ISO/TC 207 for ISO 14001:2015 (Environmental Management), and PC283 for ISO 45001 (Health and Safety Management Systems). He founded and was the CEO of an Automotive registrar for over 10 years and is familiar with conducting audits, being witnessed for audits, and also evaluating auditors and assessors. He authored and teaches a course for 3rd Party Auditors for Automotive Registrars on behalf of International Automotive Certification Bodies Association (IACBA). This course explains how 3rd Party Auditors audit IATF 16949 in an environment that includes ASPICE, Functional Safety and Product Cybersecurity. He is currently rolling out the course to global 3rd Party Auditors for IATF 16949. Chad has spent over 20 years in system, hardware and software development in various capacities. He assesses and works in automotive system, hardware and software for Agile, ASPICE, and Functional Safety ISO 26262. Chad is also currently an intacsTM certified Principal Assessor for Automotive SPICE.

William Kovacich

Willim Kovacich Bill Kovacich, a retired metallurgist and senior quality engineer from Caterpillar Inc., dedicated 38 years to advancing manufacturing and quality systems, following his graduation from the University of Missouri-Rolla with a degree in metallurgical engineering and later earning a master’s in management. His expertise spans metal casting, welding, heat treatment, powder metallurgy, and quality systems, and he holds a patent for powder metallurgy sinter brazing. A certified Six Sigma Black Belt and IRCA-certified QMS Principal Auditor, Bill played a key role in transitioning Caterpillar to ISO 9001:2015 and trained over 700 internal auditors across multiple continents. He has received prestigious honors, including the ISO Excellence Award and US TAG Colleague of Distinction Award. Bill also contributed to the development of ISO 10013:2021 as a convenor for TC 176.