The instrument passed every test.
The certificate had expired six days earlier.

How a calibration gap put 140 medical power supplies in limbo — and what Vestfold Power AS did about it.

Production as usual

Vestfold Power AS manufactures AC/DC power supplies for medical, maritime, and industrial customers from their facility in Horten, Vestfold. Their medical PSU line operates under ISO 13485 and IEC 60601-1 — every unit tested before it leaves the factory.

Production testing relies on calibrated instruments. One of them , the primary current reference for end-of-line load testing — had a 12-month calibration interval tracked manually in a shared Excel file.

The due date passed. The Excel file was not opened. Production continued.

Discovery

Six days after the due date, an internal QMS calendar review caught it. By then, 140 units of PSU-MED-24-10 had been tested on an instrument with unknown calibration status. Fifty were already at Medi-Nordic AS — sitting in their incoming inspection area.

ISO 13485 clause 7.6 is unambiguous: when measuring equipment is found out of calibration, you must assess the validity of every result produced since the last known-good calibration. That means a decision: wait for the instrument to be re-calibrated, compare the as-found condition against tolerance, then either release the batches or initiate a recall.

Calibration → Equipment — Henrik Lindqvist, quality manager, sees this on a Monday morning. Device 63204 shows OVERDUE in red. Two Rigol multimeters are DUE SOON in amber. No investigation required — the system tells you the status of every instrument, at every site, in real time.

Containment

The containment was clean. The device was removed from bench T03 immediately — red tag, do not use. Munich contacted the same day, emergency calibration appointment booked. Medi-Nordic AS notified the following morning per SOP-QA-CUST-003. Batch CH-VFP-2026-008 (50 units at the customer) placed on quality hold. Batches CH-VFP-2026-006 and CH-VFP-2026-007 (90 units in finished goods) quarantined.

PSU-MED-24-10 production temporarily suspended.

NCR-VFP-2026-001 — the non-conformance report opened the same day as discovery. Severity: critical. Status: investigation. Quantity affected: 140. Batch numbers on record. Everything traceable — from the instrument to the batch to the customer.

Root cause

The root cause was not the instrument. It was the system.

This is the gap ISO 13485 auditors find. Not because manufacturers are careless — but because tracking calibration manually at any scale is genuinely hard to do reliably.

RISK-VFP-002 — the risk "ISO 13485 calibration gap — repeat finding at next Nemko audit" is directly linked to NCR-VFP-2026-001 (caused_by) and to ISO 13485 clause 7.6. The risk existed already — as an audit observation from 2025. The NCR confirmed it.

Outcome

The Device 63204 came back from Munich in June: found in tolerance. All test results produced during the overdue window were retrospectively validated per ISO 13485 clause 7.6. The batches were released. Medi-Nordic AS lifted the quality hold.

The corrective action

CycleQA replaced the Excel file with instrument-level tracking: calibration due dates, automated alerts at 30 and 7 days before the due date, and a live status indicator — OVERDUE / DUE SOON / CURRENT — visible on every instrument record. Both the production supervisor and quality manager receive alerts. No instrument operates past its due date without a deliberate decision.

CA-VFP-2026-001-01 — the corrective action is traceable, assigned, and time-bound. Due: 1 July 2026. Linked to NCR-VFP-2026-001 and RISK-VFP-002. The Nemko ISO 13485 surveillance audit is in Q4 — this action must be closed before then.

The Nemko ISO 13485 surveillance audit is in Q4 2026. This time, calibration management will not be an observation.