Choosing calibration software
ISO 13485 Calibration Software: Clause 7.6 Evidence and Software Validation
We make calibration software, so read this with that in mind. ISO 13485 clause 7.6 asks a medical device maker to calibrate its measuring equipment against traceable standards, keep its status visible, protect it and act when it is found out of calibration. The standard also asks you to validate the software you use for these jobs. This guide maps clause 7.6 to the evidence an auditor checks, shows where it should live in software, and is plain about the validation work that stays with you.
On this page
What ISO 13485 clause 7.6 asks of your equipment
- Calibrate or verify at specified intervals, or before use, against standards traceable to international or national measurement standards. Where none exist, record the basis used.
- Adjust equipment when needed and record the adjustment.
- Identify the calibration status of each item.
- Protect equipment from adjustments that would invalidate results, and from damage during handling, maintenance and storage.
- When equipment is found out of calibration, assess and record the validity of earlier results and act on the equipment and any affected product.
- Keep records of calibration and verification results.
The evidence an auditor checks, and where it lives
Device auditors and notified bodies tend to follow one instrument used in a production or inspection step. The table maps each requirement to what they check and to where it sits in calibration software. The right-hand column describes Axiospec. Any tool you consider should answer each row.
| Requirement | What the auditor checks | Where it lives in calibration software |
|---|---|---|
| Traceable calibration at intervals | The certificate, the interval and the chain to a national standard. | The calibration record with the certificate attached, a link to the reference standard used, and the interval on the instrument. |
| Adjustments recorded | What was adjusted and the readings before and after. | As-found and as-left readings on the calibration record. |
| Calibration status | That status is identifiable at the point of use. | A live status on the instrument and printable QR labels with the due date. |
| Safeguarding | How unauthorised adjustment and damage are prevented. | A tamper-evident audit trail, quarantine for equipment pulled from use, and supervisor approval on the instruments you choose. |
| Out-of-calibration findings | The recorded assessment of earlier results and the action taken. | An automatic out-of-tolerance check on as-found readings, and a reverse trace from a drifted standard to each calibration it supported. |
| Records | Calibration and verification results, signed and retrievable. | Records kept with the instrument, e-signatures you can require on calibrations, and an audit pack export. |
Validating the calibration software itself
ISO 13485 asks you to validate computer software used in the quality management system (clause 4.1.6) and software used for monitoring and measurement (clause 7.6), before first use and after changes, in proportion to the risk. A calibration management tool falls under that.
Axiospec does not supply a validation package. Plan to validate it for your intended use as you would any other quality system software. Your validation records stay in your quality system.
What to look for in ISO 13485 calibration software
- Records nobody can silently change, with signatures tied to the person who signed.
- As-found readings kept as data, so the validity of earlier results can be assessed.
- A reverse trace from a reference standard to the calibrations it supported.
- Visible status at the point of use, for example a label you can scan.
- Exports you can hand an auditor, and all your data available to take with you.
- Enough clarity about how the tool works to support your own validation.
Trying it with your own instruments
The live demo runs a working calibration program on sample data with no signup. To try it with your own instruments, create a free account. It runs the full platform for its first 45 days with no card and then stays free for up to 50 instruments.
You do not have to retype your list. Send us whatever your current system gives you and we load it for you at no cost, usually within a couple of business days.
Common questions
- Does ISO 13485 require calibration software?
- No. Clause 7.6 requires calibrated, traceable equipment with visible status and kept records. It names no tool. If you do use software for this, the standard asks you to validate it.
- Do I have to validate calibration management software under ISO 13485?
- Yes. Clause 4.1.6 covers software used in the quality management system and clause 7.6 covers software used for monitoring and measurement. Validation is proportionate to the risk and is done before first use and after changes.
- Does Axiospec provide a validation package?
- No. You validate Axiospec for your intended use, as you would any quality system software, and keep the validation records in your own system.
- What should happen when a gauge is found out of calibration under ISO 13485?
- You assess and record whether earlier measurement results are still valid, and act on the equipment and any affected product. Calibration software helps by keeping the as-found reading and showing which calibrations a drifted standard supported.
Put it into practice
Got a gage list? Send it over and we load it for you, usually in a couple of business days. Free on every plan. Then log every calibration to a tamper-evident audit trail and produce records on demand.
Axiospec is a documentation and workflow tool. It helps you keep clean, traceable, audit-ready records. Certification depends on your own processes, scope and assessor.
Take the audit-prep checklist with you
First the checklist, with each item phrased the way an auditor asks it. Then four short emails with practical tips. You can unsubscribe in one click.
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