Our advice
Summary of Changes to ISO 9001

Quality initiatives are often equated with efforts aimed at ensuring compliance with regulations, standards, and customer requirements… This is indeed one of the historical aspects of such initiatives, reinforced in particular by certifications such as ISO 9001.

When the 2015 editions were released—ten years ago—we wrote: “The expansion and deepening of the ‘Strategy’ and ‘Human’ dimensions, complementing the ‘Technical’ and ‘Management’ dimensions, open the door to new practices and call for appropriate methods and tools.”

As we begin 2026, it is clear—both in practice and in the proposed revisions to ISO 9001—that the strategic alignment of the QMS and its processes, on the one hand, and the proper recognition...