Templates and records · ISO 17025 · Clause 6.4 y 6.5
ISO 17025 equipment file and calibration plan
The history of every instrument that influences a result: what it is, where it is, when it was calibrated and with what traceability, which intermediate checks it passes and what faults it has had.
In one sentence
The equipment file in an accredited laboratory identifies the equipment and its software or firmware version, its manufacturer, serial number and location, the evidence that it meets specifications, the dates, results, adjustments, acceptance criteria and next due date of each calibration, the reference materials, the maintenance plan and work done, and any damage or repairs, because clause 6.4.13 of ISO/IEC 17025 lists that content and requires it to be retained.
- Where the standard requires it
- ISO 17025 · Clause 6.4 y 6.5 Clauses are cited using the numbering of ISO/IEC 17025:2017, the current edition and the same one the Academy uses.
- Type of information
- Mandatory record Records for equipment that can influence laboratory activities (6.4.13)
- Who fills it in
- Equipment or metrology lead Whoever uses the equipment performs the intermediate checks and logs any issues
- When
- On receipt and throughout its working life Calibrations according to the programme; intermediate checks at the defined frequency
- How long it is kept
- Set by the laboratory The standard requires a retention time to be defined for each record, consistent with contractual and legal obligations (8.4.2). Covering at least the accreditation cycle lets you show the history at every reassessment.
What the standard requires
What ISO 17025 demands and what it leaves to your judgement
Equipment is calibrated when its accuracy or uncertainty affects the validity of results or when calibration is needed to establish metrological traceability. The laboratory keeps a calibration programme, which it reviews and adjusts to maintain confidence in the equipment’s status.
Metrological traceability (6.5) is demonstrated through an unbroken chain of calibrations back to the International System of Units, usually via accredited calibration laboratories. ILAC policy P10 describes how accreditation bodies assess it.
The standard adds what ISO 9001 does not ask for: intermediate checks where needed, management of correction factors after calibration and a record of the software or firmware version. Equipment giving questionable results is taken out of service and its effect is analysed as nonconforming work.
Structure
Fields the template should include
- Unique identification, type, manufacturer and serial number
- Software and firmware version
- Current location
- Acceptance check against specifications
- Calibrations: date, laboratory, result, uncertainty, adjustments
- Acceptance criterion and fitness decision
- Correction factors and how they are applied
- Calibration interval and next due date
- Intermediate checks and their frequency
- Associated reference materials
- Maintenance plan, faults, repairs and modifications
Example
Example: file for an analytical balance
Company, people and figures are fictitious: the example only shows what a properly completed record looks like.
| Field | Content |
|---|---|
| Equipment | BAL-03 · analytical balance 220 g × 0.1 mg · invented serial number 40213 |
| Firmware | 2.07 |
| Location | Weighing room, anti-vibration table |
| Calibration | 14 February 2026 · accredited laboratory · uncertainty at 100 g: 0.2 mg (k = 2) |
| Criterion | Error + uncertainty ≤ 0.5 mg across the range · fit for use |
| Interval | 12 months · next due February 2027 |
| Intermediate check | Daily with a 100 g class E2 weight · tolerance ±0.3 mg |
| Issue | 3 June: check out of tolerance after the table was moved · taken out of use and nonconforming work TNC-2026-09 |
At the audit
Mistakes auditors commonly flag
- Calibration certificates filed with no fitness decision against a criterion.
- Intermediate checks defined in the procedure but never recorded.
- Correction factors from the certificate that never reach the calculation of results.
- Calibrations by laboratories with no accreditation or any other demonstrated traceability.
- Equipment software updates that go unrecorded.
In Kimobox
How this record is kept in Kimobox
- 1The equipment calibration schedule is set up with automatic alerts before each due date.
- 2Each instrument’s metrological traceability is linked to its file.
- 3The environmental conditions relevant to each method are documented in the same system.
- 4Equipment found out of tolerance is recorded as nonconforming work, with its impact assessment on earlier results.
Frequently asked questions
What people ask us before getting started
What is an intermediate check?
A check between calibrations to confirm that the equipment remains in the state in which it was calibrated: a standard weight on a balance, a reference thermometer in an oven. ISO/IEC 17025 requires it when needed to maintain confidence in the equipment.
How does it differ from the ISO 9001 calibration record?
ISO 9001 asks you to keep evidence that measuring equipment is fit for purpose. ISO/IEC 17025 specifies the content of the file, requires demonstrated metrological traceability and adds intermediate checks, correction factors and software control.
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Sources
Where each figure comes from
References to the official text in force. If a standard is revised, this page is updated and the review date says so.
- ISO/IEC 17025:2017 — General requirements for the competence of testing and calibration laboratories ISO/IEC · November 2017
- ILAC Policy Series (P9 on proficiency testing, P10 on metrological traceability) ILAC · Current editions
- Entidad Nacional de Acreditación (Spain’s national accreditation body): laboratory accreditation criteria and documents ENAC · Official website, consulted in October 2026