Auditors don’t collect what you say you do — they collect objective evidence: the records, the observations, the proof. Here’s how the three sources of evidence work, why every audit is really a sampling exercise, and how to think like an auditor before one shows up.
Suppliers are quietly using AI tools to draft procedures and protocols from customer drawings and specifications. Here’s what that puts at risk — confidentiality, export compliance, and product quality — and the controls both customers and suppliers should have in place.
ISO 13485 §6.4.1 wants more than a tidy bench and a thermostat. Document the environmental conditions your product actually needs, monitor them, react when they drift — and yes, the gowning rules have to be written down too.
Internal audits exist so you find your own problems before someone with a badge does. Here’s what ISO 13485 §8.2.4 actually asks of you, why “pass the audit” is the wrong goal, and why the QMSR makes honest auditing more important than ever.
An internal audit program isn’t a calendar with one entry on it. Here’s what ISO 13485 §8.2.4 and ISO 19011 actually expect from a risk-based audit schedule — and why FDA can now check whether yours is real.
Annex A.2 is the control that asks your organisation to do something it has spent two years carefully avoiding: write down, in an approved and reviewable document, what it actually thinks about AI. Art Meta walks A.2.2, A.2.3, and A.2.4 — the AI policy, its alignment with everything else, and the obligation to keep reading it.
Annex A of ISO/IEC 42001:2023 is where ten clauses of philosophy finally collapse into a list — 38 controls, 9 sections, one mandatory Statement of Applicability. Art Meta walks the structure, what is genuinely new, and why your audit will live or die by a spreadsheet.
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.
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.