Quality-Safe AI for ISO 9001

This used to be two thin, overlapping documents — a short field guide and a free "ebook" that mostly described the value it wasn't delivering. We merged them into one real book, because a quality manager five weeks from a surveillance audit doesn't need a menu; she needs the meal.

What's actually inside

• The clause-to-control map — nine ISO 9001:2015 clauses AI touches (7.5, 8.5.1, 9.x, 10.2 and more), what each requires, how a controlled AI step satisfies it, and the record that proves it.
• Two fully worked scenarios — an auditor asking about an AI-drafted work instruction, evidence trail included; and a nonconformity where an AI draft introduced an error, followed all the way to a closed CAPA.
• Three templates you can adopt this week — an AI-use procedure (SOP), a "where AI is/isn't used" statement, and a document-control checklist for every AI-assisted output.
• A vendor & tool assessment rubric and a ten-question audit rehearsal — the exact evidence you show for each likely question.
• A 5-week readiness checklist and the honest bright lines: exactly where AI must never be trusted in a quality management system.

The through-line is the one we hold ourselves to everywhere: AI drafts, a named human decides, and the record proves it. Do that, and AI strengthens your quality system instead of threatening it.

Get the full ebook

Use the Download button on this page for the complete, ~28-page PDF — cover to back, nothing held back for a paid tier. If you'd rather read the short, free-standing orientation first, start with Adding AI without breaking your ISO 9001 audit — the same download sits at the bottom of that page too.