Efixera

Checklist · Lab head

ISO/IEC 17025 lab-readiness checklist

A pre-assessment self-check against the ISO/IEC 17025 clauses an accreditation body samples most often. Each item names the clause it evidences.

Equipment & calibration (§6.4, §6.4.7)

  • [ ] Every instrument's calibration status (in-due-date vs. expired) is visible without opening a spreadsheet — a color-coded status, not a manual date comparison.
  • [ ] Calibration intervals are set from a documented method (drift history / manufacturer guidance), not a flat default applied to every instrument regardless of use.
  • [ ] No instrument with an expired calibration has an in-progress test result attached to it.

Environmental conditions (§6.3)

  • [ ] Environmental requirements (temperature/humidity bounds) are documented per test method, not assumed to be "lab standard" for every method.
  • [ ] Out-of-bound readings are flagged against the test results taken during that window, not discovered after the fact.

Test methods & measurement uncertainty (§7.2, §7.6)

  • [ ] Every accredited test method has a current uncertainty budget on file (GUM-based), not a one-time estimate never revisited.
  • [ ] Method validation records are retrievable per method, not per technician's personal notes.

Sample handling & reporting (§7.4, §7.8)

  • [ ] Sample chain-of-custody (receipt → test → review → report → archive) is traceable end to end for any sample pulled at random.
  • [ ] Calibration certificates and test reports are attached to the record they evidence, not stored separately from the equipment or sample they relate to (§7.8.4).

Document control (§8.3)

  • [ ] Lab documents (operating instructions, testing instructions, accreditation documents, per-device passports) are version-controlled with a visible current-vs-superseded state.

Proficiency testing & scope (§7)

  • [ ] Proficiency-test participation and results are on file per accredited method.
  • [ ] The accreditation scope document matches what the lab is actually testing — no drift between what's accredited and what's reported.

Why this matters

There are 114,600+ ISO/IEC 17025-accredited laboratories worldwide as of March 2025 (ILAC, 2025), and the standard itself was revised in September 2025 (ISO, 2025) — accreditation bodies now assess against the current text, not the prior edition. A lab that can answer every item above from a live register, not a pre-audit scramble, is assessing against the current standard by default rather than reconstructing evidence under time pressure.

Mechanism reference

Every item above corresponds to a real e-Lab mechanism: the equipment/calibration register with color-coded due dates, environmental-condition requirements and out-of-bound flagging, the test method catalogue with uncertainty budgets, sample-lot lifecycle tracking, and the lab document register — see 02_Products_and_SaaS/e_lab.md.

Sources

  • ILAC, March 2025 — 114,600+ accredited laboratories worldwide.
  • ISO, 2025 — ISO/IEC 17025:2025 published September 2025.
  • Clause structure: ISO/IEC 17025:2017 (as amended 2025) §6.3, §6.4, §6.4.7, §7.2, §7.4, §7.6, §7.8, §8.3.