PCA / ISO 17025 accreditation: how to prepare your equipment register

The PCA (Polish Centre for Accreditation) auditor sits down in your lab, opens the accreditation folder and asks for the equipment register. That question comes in the first hour. The answer they get largely decides the audit outcome — because the equipment register is the heart of ISO/IEC 17025:2017 clause 6.4 (Equipment).

This article is for lab managers of small and medium accredited laboratories (or those preparing for accreditation), method-validation technologists and quality-management leads. We show exactly what PCA expects in the equipment register, what fields are required, how to document calibration and maintenance, and the most common reasons labs fail to obtain or lose accreditation.

What ISO 17025 clause 6.4 actually requires

Clause 6.4 has 13 sub-points on equipment. The register-relevant ones:

**6.4.1** — The lab must have access to equipment (measurement, software, reference standards, reference materials, reagents, consumables, auxiliary apparatus) needed for its work.

**6.4.4** — Equipment must be verified to meet specifications before being placed or returned to service.

**6.4.6** — Measurement equipment must be calibrated when measurement accuracy affects a reported result. Calibration must have metrological traceability.

**6.4.7** — The lab must have a calibration programme, reviewed and adjusted to maintain confidence in calibration status.

**6.4.13** — Records of equipment that affects the lab's activities. Records must include (a) identification including software/firmware version; (b) manufacturer, type, serial number or other unique ID; (c) verification evidence; (d) current location; (e) calibration dates, results, corrections, acceptance criteria, next calibration date; (f) reference materials documentation; (g) preventive maintenance plan and results; (h) damage, malfunction, modification and repair details.

That clause 6.4.13 (a)-(h) is the list PCA expects in the register. Eight points. No fewer.

Minimum register fields for ISO 17025

Drawn directly from 6.4.13:

For reagents and reference materials (6.4.13 f): manufacturer lot, receipt date + opened date, manufacturer certificate, expiry, current quantity.

How PCA audits the register in practice

5 most common reasons for failed first audits

How [Asseto](/for/labs) handles ISO 17025 equipment registers

Asseto captures all 13 fields required by 6.4.13 as first-class data: internal ID, manufacturer, type, serial, software version, location, responsible person, calibration dates with history, acceptance criteria, maintenance plan with history, damage and repair history.

Reagent register: lot per receipt with dates (received / opened), expiry, manufacturer certificate, current quantity. Alerts before expiry (90 / 60 / 30 / 7 days). Multi-location (fridges, freezers, benches) by design.

PDF exports in the format PCA expects: full equipment register with calibration history, upcoming calibration schedule, repair history per item — three documents for the accreditation folder.

Roles: lab manager = full access; specialists = view and record; PCA auditor = read-only (optional). Change audit log per user and date — automatic.

**What Asseto does not do (honestly):** method validation records, measurement uncertainty calculations, sample chain-of-custody. If you need those, look at LabWare, LabVantage or a dedicated LIMS. Asseto covers equipment + reagents + audit trail — what the PCA auditor asks about in the first hour.

Before your PCA audit

Inventory everything used in measurements — not just measurement instruments but balances, thermometers, pipettes, references. Verify every item against the 13 fields in 6.4.13. Check calibration due dates — nothing can be overdue on audit day. Move paper documentation to a system with a change audit trail. Run practice questions with your team the week before — the auditor asks random people about random items.

Migration from Excel + paper folders to a system with an audit trail takes 3-7 days for a typical lab with 15-30 instruments and 50-100 reagent items. Far cheaper than a failed audit or a postponed re-accreditation.

[Try Asseto free](/signup) — free plan handles 50 items, Pro (from 39 zł/mo) handles unlimited equipment, reagents, users and accreditation-folder PDF exports.