Equipment register format for ISO 15189:2022
The eleven equipment records clause 6.4.7 asks for, column by column, with a worked example and the four mistakes assessors raise most often.
Last reviewed August 11, 2026
Equipment is where assessments slow down, and it is rarely because the lab is doing bad work. It is because the evidence of good work is spread across a service engineer's job cards, a WhatsApp thread, a drawer of calibration certificates and a spreadsheet that stopped being updated when someone left. The register is the thing that pulls it together.
What the standard actually asks for
ISO 15189:2022 clause 6.4.7 lists the records to be maintained for each item of equipment that influences examination results. National schemes are built on it — Malaysia assesses against MS ISO 15189, and Dubai's health authority accepts accreditation to ISO 15189 by any ILAC-MRA signatory — so this list is the one to work from wherever you are. Eleven items, in the standard's own order, required where relevant:
- a
Identity of the equipment, including software and firmware version
The name you call it plus a unique asset number. The software version matters on anything that computes a result — an analyser after a firmware update is not quite the instrument it was before.
- b
Manufacturer's name, model, and serial number or other unique identification
Straight off the plate on the back. The serial number is what a service engineer and a recall notice both work from.
- c
Contact information for the supplier or manufacturer
Who you call when it stops. Worth holding the engineer's direct number, not only the head-office line.
- d
Date of receiving and date of placing into service
Two separate dates, and assessors do notice when they are identical for every instrument in the register.
- e
Location
Department and bench. Enough that someone who has never been in your lab could walk to it.
- f
Condition when received
New, used, reconditioned or on loan. Rarely filled in, routinely asked about for second-hand instruments.
- g
Manufacturer's instructions
The manual, or a note of where the manual is. A scanned PDF against the asset counts; a cupboard in the store room does not, if nobody can find it.
- h
Records of performance that confirm suitability for use
Acceptance testing before first use, then calibration and verification records afterwards. This is the row that proves the instrument was fit to report patient results.
- i
Maintenance carried out and the preventive maintenance schedule
Both the plan and the completed jobs — a schedule with no completion records is the most common gap in the whole clause.
- j
Damage, malfunction, modification or repair
Every breakdown, what was found, what was done, and what happened to results that may have been affected.
- k
Equipment status
In use, out of service, quarantined or retired. Must be current — a withdrawn instrument still showing as in use is a serious finding.
A register format that covers it
Below is a column set that satisfies the clause without becoming a form nobody fills in. Twenty-one columns sounds like a lot; in practice about eight are typed once when the instrument is registered and the rest accumulate on their own as work is done.
| Column | Example | Note |
|---|---|---|
| Asset number | BIO-001 | Yours, unique, never reused. Printed on the tag stuck to the instrument. |
| Equipment name | Fully automated biochemistry analyser | What staff actually call it. |
| Category | Biochemistry analyzer | Drives the maintenance and calibration defaults. |
| Make / manufacturer | Roche | |
| Model | Cobas c311 | |
| Serial number | C311-88421 | From the instrument, not the invoice. |
| Software / firmware version | 3.2.1 | Only where the instrument computes or reports. |
| Department | Biochemistry | |
| Location | Main lab, bench 2 | |
| Supplier / service provider | Gulf Medical Instruments LLC | Linked to a supplier record with the SLA and contact. |
| Date received | 2024-02-11 | |
| Date placed in service | 2024-02-19 | After acceptance testing passed, not before. |
| Condition when received | New | |
| Criticality | Critical | Decides how hard a missed date is chased. |
| Status | In use | In use / under repair / quarantined / withdrawn. |
| PM interval and next due | 30 days · 2026-08-28 | The plan. |
| Last PM completed | 2026-07-29 | The evidence. A different column on purpose. |
| Calibration interval and next due | 180 days · 2026-11-02 | |
| Last calibration and certificate | 2026-05-06 · CAL/2026/0412 | With the standard it was traceable to. |
| Contract type and expiry | Comprehensive · 2027-03-31 | Warranty, service contract, comprehensive or none. |
| Custodian | R. Menon | The named person responsible today. |
The four mistakes that cost labs findings
Planned dates presented as completed work
The most damaging one, and almost always accidental. A register column headed “Last calibration” filled by a formula that adds twelve months to the previous date is not a record of anything — it is a prediction wearing the clothes of evidence. Keep the plan and the evidence in different columns, and leave the evidence column empty when nothing has happened. An empty cell is an honest finding. A confident wrong date is a much worse one.
Status that has gone stale
An instrument withdrawn from service in March that still reads “in use” in August tells an assessor the register is not maintained, and invites them to check whether anything was reported on it in between. Status has to change at the moment the instrument does.
No acceptance record for older instruments
Instruments bought before the lab started thinking about accreditation often have no acceptance testing record at all. You cannot invent one. What you can do is record a performance verification now, dated now, and note that it was carried out retrospectively — that is a defensible position, and back-dating is not.
Repairs with no impact assessment
Clause 6.4.5 expects you to examine the effect of a malfunction on earlier examinations. When an analyser is found out of tolerance, the question is not only “when was it fixed” but “what did it report before we noticed, and did any of it need recalling”. A single sentence recorded against the breakdown answers it. Nothing recorded leaves the assessor to ask.
Common questions
What is an equipment master list?
It is the single register of every instrument the laboratory owns or uses, with enough identity and status information to find any one of them and know whether it is fit for use. Under ISO 15189:2022 it is the index into the individual equipment records required by clause 6.4.7.
Does the equipment register have to be software, or is a spreadsheet acceptable?
A spreadsheet is acceptable. Nothing in ISO 15189 requires software. What it does require is that records are legible, retrievable, protected from unauthorised change, and traceable to who changed them — which is where an uncontrolled shared spreadsheet usually falls down, not at the format.
How long do equipment records have to be kept?
The laboratory defines the retention period, and it must at minimum cover the lifetime of the instrument in service. In practice most labs keep the full equipment file for the life of the instrument plus the period they retain patient results for, because a query about an old result may need the instrument's condition at that time.
What is the difference between the master list and the equipment file?
The master list is one row per instrument — identity, location, status, due dates. The equipment file is everything held about one instrument: acceptance, manual, service history, calibration certificates, breakdowns and status changes. Assessors usually start at the list, pick two or three instruments, and then ask for their files.