ISO 13485 §7.5 is the longest clause in the standard — eleven subclauses that absorbed what the old QSR scattered across Subparts F, G, L, and parts of H and K. Here’s a tour of what changed, what’s genuinely new (customer property, anyone?), and where the gaps tend to live before an FDA inspection.
ISO 13485 §6.2 doesn’t care that Janet has run the line for fifteen years — it cares whether you can prove it. Competence is a defined requirement, not a vibe.
Welcome back to the series, and to the post I have been quietly putting off since Clause 6. The AI
ISO 13485 §6.1 is two sentences long. Those two sentences quietly demand that top management actually fund the QMS — people, equipment, training, and time. “We’ll see what’s left in the budget” is not what the standard had in mind.
Welcome back to the part of the series I have been quietly looking forward to, in the same resigned way
ISO 13485 §5.6 requires top management to review the QMS at planned intervals — and no, the meeting where the CEO drops in for fifteen minutes and says “great work, team” does not count.
Clause 9 is where ISO/IEC 42001:2023 stops asking what you built and starts asking how you know it works. Monitoring, internal audit, and management review — three subclauses, all designed to surface the gap between ‘we have a policy’ and ‘we have evidence.’
§5.5.3 looks like the easiest clause in ISO 13485 — a single short paragraph about communication. It’s also the clause most likely to make your production lead say ‘I think there’s a poster in the break room?’ when the auditor asks how the QMS is communicated.
Clause 8 is where the AI management system stops being a stack of documents and starts having to run. Art Meta walks you through operational planning and control, the recurring risk assessment, risk treatment, and the genuinely novel AI system impact assessment — the one subclause in ISO 42001 that asks you to think about the humans on the other end.
Section 5.5.2 is short, simple, and surprisingly easy to fumble. Name a real member of management, give them real authority, and for heaven’s sake put it in writing before the auditor asks.