Does ISO 15189 require calibration?

Yes. Clause 6.5.2 requires procedures for calibrating equipment that directly or indirectly affects examination results, and clause 6.5.3 requires metrological traceability of measurement results. Where a higher-order reference is not possible, the standard accepts other means of providing confidence, such as reference measurement procedures.

Can a laboratory rely on the manufacturer for traceability under ISO 15189?

Yes, with a limit. Traceability information from the manufacturer of an examination system is acceptable only when that system and its calibration procedures are used without modification. Once you modify the procedure, that route no longer applies.

Is the ISO 15189 transition over?

Yes. ISO 15189:2022 was published with a three-year transition set by ILAC Resolution GA 26.08, which ended in December 2025. After that, accreditation to the 2012 edition, and to ISO 22870 alongside it for point-of-care testing, is no longer recognized under the ILAC Arrangement.

Does Axiospec replace quality control or method verification?

No. Axiospec keeps the instrument register and calibration records. Method verification, internal quality control, external quality assessment and decisions about patient results stay in the laboratory's own quality system.

Can a small medical laboratory use Axiospec?

Yes. The free plan covers up to 50 active instruments with unlimited users, and a new workspace starts with 45 days on Professional for up to 1,500 active instruments. We load existing records for you at no charge on every plan. Axiospec keeps the records and does not certify conformance to ISO 15189.

Does Axiospec force technicians to fill in every required field?

Yes, by default. When you select a standard, the fields that standard requires are marked on the calibration form and the save is blocked until they are filled. Enforcement is on for every workspace unless an admin turns it off in Settings. There is one deliberate exception. A brand new workspace is not held to the standard fields until it has logged its first calibration, so a first run is never trapped behind a form it cannot save. Full strictness applies from the second calibration onward. The public REST API enforces the same requirements on write.

For medical laboratories

ISO 15189 calibration requirements for medical laboratory equipment

ISO 15189:2022 requires a medical laboratory to control the equipment that can influence its results (clause 6.4) and to calibrate it under written procedures with metrological traceability of results (clause 6.5). Clause 6.5.2 also asks for a defined response when a calibration goes out of control. The checklist below breaks those clauses into what an assessor checks, and Axiospec keeps the instrument register and calibration records in one system, while method verification, quality control and interpretation of patient results stay with the laboratory.

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ISO 15189 clauses 6.4 and 6.5 calibration checklist

6.4.2: Identify equipment and keep a register

Give each item that can influence laboratory activities a unique label or other identification, and keep a register of it. The standard treats instrument software, measuring systems and laboratory information systems as equipment too.

6.4.3: Verify before use

Confirm that equipment meets its acceptance criteria before it goes into service or returns to service. Measuring equipment has to reach the measurement accuracy or measurement uncertainty that a valid result needs.

6.4.5: Maintenance and defective equipment

Follow a preventive maintenance program based on the manufacturer's instructions. Take defective equipment, or equipment outside its specified requirements, out of service, mark it until it is shown to work correctly, and examine the effect on earlier results.

6.4.7: Equipment records

Keep records for each item that influences results. They cover identification including software and firmware, receipt and acceptance, location, maintenance, damage or repair, calibration or verification reports with dates, times and results, and current status such as in service, out of service or quarantined.

6.5.1: Specify calibration and traceability

Set the calibration and traceability requirements that keep the reporting of examination results consistent. Qualitative methods specify the characteristic assessed and what is needed for reproducibility over time.

6.5.2: Written calibration procedures

Have procedures for calibrating equipment that directly or indirectly affects results. They cover the manufacturer's calibration instructions, recording traceability, checking accuracy and system function at set intervals, recording calibration status and the recalibration date, updating correction factors, and what to do when a calibration goes out of control.

6.5.3: Metrological traceability of results

Maintain a documented, unbroken chain of calibrations to an appropriate reference, reaching the highest possible level of traceability and the SI through a competent laboratory or a competent reference material producer. Where that is not possible, apply other means of confidence such as reference measurement procedures. Genetic examinations trace to genetic reference sequences.

8.4: Control of records

Create records when the work is done. Keep original and amended data together with the date, the change and the person who made it, and protect records from unauthorized access and change for the retention period you set.

How Axiospec helps ISO 15189 teams

Calibration status on every analyzer and instrument

Each instrument carries a live status (in tolerance, due, overdue, or quarantined) so staff can confirm equipment is fit for use before relying on a result.

Traceability captured per instrument

Record the reference standard or material and certificate behind each calibration so traceability is visible on the asset.

Intervals that surface before they lapse

Set a calibration interval per instrument and let Axiospec flag what is due and overdue, with reminders before each date. Axiospec does not lock out or prevent use of any instrument.

Retained, attributable records

Every calibration is written to a tamper-evident ledger with who, when, and the readings, ready to export as an audit pack.

Out-of-tolerance results ask for an impact

An accepted Fail or Damaged quarantines the instrument, and the record asks for the impact to be written. A Pass with as-found readings out of tolerance needs an impact too, and unrecorded ones show in Needs attention.

Calibration software for ISO 15189 clauses 6.4 and 6.5

ISO 15189 puts equipment control in clause 6.4 and calibration and metrological traceability in clause 6.5. For a medical laboratory that means a register of the items that influence results, acceptance before use, maintenance, and written calibration procedures with recorded traceability and status. The standard names no software. The practical question is which system keeps that file current without a spreadsheet someone has to remember to update.

Axiospec gives each instrument an identifier, an interval and a live status. Calibrations are logged with as-found and as-left readings and the reference standard or material and its certificate, then written to a tamper-evident ledger. With ISO 15189 selected as your standard, the form requires the reference standard, certificate, tolerance, as-found reading, measurement uncertainty and traceability certificate number. The Due Calendar shows what is due and overdue, with reminders before each date.

Axiospec does not verify examination methods, run internal quality control or external quality assessment, or handle patient results. It has no separate record type for checks between calibrations. The free plan covers up to 50 active instruments, and we load existing records at no charge on every plan. Axiospec keeps the records; conformity is decided by your laboratory and your accreditation body.

ISO 15189 calibration: common questions

Does ISO 15189 require calibration?

Yes. Clause 6.5.2 requires procedures for calibrating equipment that directly or indirectly affects examination results, and clause 6.5.3 requires metrological traceability of measurement results. Where a higher-order reference is not possible, the standard accepts other means of providing confidence, such as reference measurement procedures.
What must a calibration procedure cover under ISO 15189 clause 6.5.2?

Six things: the manufacturer's conditions of use and calibration instructions, recording traceability, checking accuracy and function at set intervals, recording calibration status and the recalibration date, updating correction factors after recalibration, and handling a calibration that goes out of control so the risk to the service and to patients stays low.
Can a laboratory rely on the manufacturer for traceability under ISO 15189?

Yes, with a limit. Traceability information from the manufacturer of an examination system is acceptable only when that system and its calibration procedures are used without modification. Once you modify the procedure, that route no longer applies.
Is the ISO 15189 transition over?

Yes. ISO 15189:2022 was published with a three-year transition set by ILAC Resolution GA 26.08, which ended in December 2025. After that, accreditation to the 2012 edition, and to ISO 22870 alongside it for point-of-care testing, is no longer recognized under the ILAC Arrangement.
Does Axiospec replace quality control or method verification?

No. Axiospec keeps the instrument register and calibration records. Method verification, internal quality control, external quality assessment and decisions about patient results stay in the laboratory's own quality system.
Can a small medical laboratory use Axiospec?

Yes. The free plan covers up to 50 active instruments with unlimited users, and a new workspace starts with 45 days on Professional for up to 1,500 active instruments. We load existing records for you at no charge on every plan. Axiospec keeps the records and does not certify conformance to ISO 15189.
Does Axiospec force technicians to fill in every required field?

Yes, by default. When you select a standard, the fields that standard requires are marked on the calibration form and the save is blocked until they are filled. Enforcement is on for every workspace unless an admin turns it off in Settings. There is one deliberate exception. A brand new workspace is not held to the standard fields until it has logged its first calibration, so a first run is never trapped behind a form it cannot save. Full strictness applies from the second calibration onward. The public REST API enforces the same requirements on write.

Axiospec is a documentation and workflow tool. It helps you produce clean, traceable records that support ISO 15189 compliance; certification depends on your own processes, scope, and assessor.

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