ISO 13485 §6.3 treats your buildings, equipment, and supporting systems as part of the quality system — not background scenery. Define the infrastructure you need, maintain it on a schedule you actually wrote down, and keep the records to prove it.
A common QMSR procedure scopes §7.5.9.2 out with “we don’t make implants.” That justification works under ISO 13485 alone. Under the QMSR’s §820.10(d) cross-reference, it doesn’t hold up if your device supports or sustains life. Here’s the trap, the definition, and how to write a non-applicability statement that survives an FDA inspection.
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
Section 820.50 is gone from the QMSR — quietly retired into “Reserved” status. ISO 13485 §7.4 took over, with three subclauses, more risk language, and supplier audit reports that FDA can finally read. Here’s what changed and what to fix in your procedures.
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 §7.3 keeps the design controls discipline you knew from §820.30 — but threads risk management through every step, treats V&V plans as actual deliverables, and renames your DHF in the process. Here’s what changed and what to do about it.
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.