And how to validate it properly, with evidence that holds up.
Learn what auditors expect to see, the gaps they keep finding, and the framework that closes them – step by step.
Make the boundary physical: a conforming part, the worst still-acceptable part, and a clear reject, reviewed and signed off. Without it, "acceptable" stays an opinion that drifts from shift to shift.
Vision screening, then a structured test on known parts to a defined criterion, before anyone releases product. Capability demonstrated and recorded, never assumed, and requalified on a schedule.
Quantify agreement with Cohen's / Fleiss' kappa from three angles: an inspector against themselves, inspector against inspector, and against the known truth. "They mostly agree" becomes a number you can defend.
For each defect size, measure how often it's actually caught. The result is a detection curve, not a single pass rate. Report the a₉₀ – the smallest defect you reliably detect.
Scale the sample size to the risk of the defect, not a default AQL everyone copies. Where a miss can hurt a patient, you test more; where it can't, you stop wasting inspection on it.
Validation isn't a one-off. Keep the process in control: monitor detection on the line and requalify inspectors on a defined schedule, so the evidence stays current.
Live · 60 minutes · Free
A missed defect comes back as a complaint, a CAPA, and rework – months of corrective action behind a study you could have run once. Validation is the cheaper side of that trade.
A certificate proves attendance. It does not prove the process separates good from bad. Auditors don't want the training record – they want the study: detection, agreement, and the data behind your pass rate.
Replace judgment with data: limit samples, kappa, a detection curve, sampling tied to risk. The audit conversation becomes predictable, focused, and fact-based.
Simon is a MedTech expert and ISO 13485 Lead Auditor with over a decade auditing inspection and validation processes for medical device manufacturers, including high-risk and Class III devices.
As a TÜV SÜD Academy trainer, he trains professionals worldwide in test method validation (TMV), applied statistics, and process validation – with a focus on making regulatory requirements practical and defensible inside real production files.
In this webinar, Simon brings that field experience directly to visual inspection under ISO 13485: why it counts as a special process, the six gaps auditors keep finding, and the framework that turns inspector judgment into documented evidence.
QA/RA managers and QM heads who own the inspection validation and answer for it when the auditor asks how it was proven.
The people who run the line Validation engineers, production and inspection leads who build the limit samples, qualify inspectors, and run the studies day to day.
Manufacturers of Class III or otherwise high-risk devices, or anyone with a timeline or an open finding to close, who need the inspection to hold up end to end.
60 minutes. Free. Live Q&A with Simon Föger.
