T
Oct 24, 2026The 80/20 complaint about ISO 13485 audits misses the real problem
During a recent customer audit, a reviewer asked me to produce three records for one rejected...
Oct 24, 20264 min read0 reactions0 comments
Back to articles
Tag archive
#qms
Y
Oct 22, 2026Your QMS did not fail because of ISO. Leadership left change unowned.
A supplier once emailed us to say that an injection-moulding tool had been moved to a second...
Oct 22, 20264 min read0 reactions0 comments
T
Oct 21, 2026The QMSR is live, but renaming 21 CFR 820 procedures is not migration
A recent internal audit gave me the answer I did not want. I sampled a CAPA opened after a repeated...
Oct 21, 20264 min read0 reactions0 comments
O
Oct 20, 2026One-line design changes are not one-line changes
The change notification arrived with one line describing the change. "Update mating feature per DFMEA...
Oct 20, 20263 min read0 reactions1 comments
A
Oct 19, 2026AI drafted the impact list. I still own the audit answer.
The change that looked small Last month, a change request landed on my queue for a...
Oct 19, 20264 min read0 reactions0 comments
C
Oct 19, 2026Centralized hazard logs, six eQMS platforms, and one Class IIb audit
The question that started this was deceptively simple. Our design team wanted one place where the...
Oct 19, 20265 min read0 reactions0 comments
Y
Oct 18, 2026Your eQMS shortlist collapses back to forms. Here's what a real workflow engine actually does.
I spent most of last quarter evaluating eQMS platforms for a manufacturing function that handles...
Oct 18, 20264 min read0 reactions0 comments
F
Oct 17, 2026Five gaps between the AI Act high-risk criteria and our MDR QMS
A SaMD manufacturer pinged me last week asking whether the AI Act's high-risk classification...
Oct 17, 20265 min read0 reactions0 comments
T
Oct 17, 2026The standard is 80 pages. Our QA team only needed to read the workflow.
The 80 pages of ISO 13485 don't help when a CAPA owner is staring at a blank form at 4 PM on a...
Oct 17, 20264 min read0 reactions0 comments
F
Oct 16, 2026From spreadsheets to a controlled QMS: the four things the foundation must do
The first CAPA log I ever maintained lived in a shared Excel file with version numbers in the...
Oct 16, 20264 min read0 reactions0 comments
T
Oct 15, 2026The dead link in our legacy DHF ate a sprint. Now traceability is a living system.
A senior engineer pinged me one Tuesday morning: "There's a 404 in the DHF." Not a web 404. A...
Oct 15, 20264 min read0 reactions0 comments
A
Oct 15, 2026A stack of SOPs won't stop a retrained model from shifting your risk file overnight
Last spring I sat in a risk management review where someone asked the obvious thing. If our SaMD...
Oct 15, 20264 min read0 reactions0 comments