ISO 13485 does most of the work. The 2026 ISO 9001 revision shifts where the rest lives
This story is from 2026-09-25. It is preserved in the archive; the latest stories are on the live feed.
The audit prep spreadsheet for our dual-cert surveillance has six rows for ISO 13485 and two for ISO 9001. That ratio has been roughly stable for the four years I have been at my current role, and it reflects a reality most medical device QMS people know: 13485 carries the load, 9001 is the standar…
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- 2026-09-25 10:21 · DEV Community — AI
ISO 13485 does most of the work. The 2026 ISO 9001 revision shifts where the rest lives