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Equipment Calibration and Metrological Traceability Record

Required by: ISO 15189:2022 Cl. 6.5 — Metrological traceability of measurement results

Evidence that every measuring system is calibrated against material traceable to SI units, with certificates on file.

Checked against NABL 112A (Issue 01, 18-Dec-2024) · page updated 23 September 2026

Layout of a compliant equipment calibration and metrological traceability record for an Indian medical laboratory, showing every field required under ISO 15189:2022 Cl. 6.5 — Metrological traceability of measurement results
What a compliant equipment calibration and metrological traceability record looks like. Every field shown is required — an assessor reads the record, not the intention behind it.

How often it must be recorded

Per the defined calibration interval and after any repair affecting measurement.

Every field this record must carry

An assessor reads the record, not the intention behind it. A field left off the form is a finding, however well the work was actually done.

  • Equipment identity and location
  • Calibration date and next due date
  • Calibrator / reference material and lot
  • Traceability certificate reference
  • Calibrating agency
  • Acceptance criteria and result
  • Action where out of specification
  • Authorising signature

What NABL 112A actually says

NABL 112A requires the laboratory to employ suitable reference material traceable to SI units for calibration of measuring systems, and to obtain traceability certificates for calibrators from kit suppliers. NABL 112A refers the reader to NABL 142 on this point.

Source: NABL 112A — Specific Criteria for Accreditation of Medical Laboratories, Issue 01, 18-Dec-2024, 108pp. Downloaded from nabl-india.org 2026-09-23. Paraphrased with attribution. ISO 15189:2022 clause numbers and titles are cited as references; the standard's text is copyrighted and is not reproduced here.

What an assessor actually asks for

Reasoning from the clause, not from a published checklist — NABL does not publish assessor scripts. Treat this as how the requirement is normally evidenced.

  1. The record itself, for a period they choose — not a blank template.
  2. Completeness across the period. Gaps are the finding; a perfect January and an empty March reads worse than a consistently modest record.
  3. Who recorded and who verified, with dates. An unsigned record is not evidence that the work was checked.
  4. The linked procedure — the SOP that says this record must exist, at this frequency, in this format.
  5. What happened when it went wrong. Every record above has a failure path, and the action taken is usually the part that is missing.

Records this one depends on

Where the software fits

HealthFlow is lab software, not an accreditation body. It is not NABL accredited and using it does not make a laboratory accredited or compliant — the records above are the laboratory's own responsibility.

What it does do is produce some of this evidence as a by-product of normal work: turnaround time is measured per test on the owner dashboard, reports are versioned and locked on authorisation with dual signatures, every report access is written to an append-only audit trail enforced at the database, retained two years, and all of it exports at any time.

Ask what it records for you See all 22 records →

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