ISO 17025 calibration software is software that helps a calibration lab keep the records ISO/IEC 17025 expects: equipment and reference standards, readings, uncertainty, reviewed results, certificates and a history of changes. It does not make a lab accredited, and no software can be “ISO 17025 certified” in place of the lab. NABL accredits laboratories, not software.
This guide maps what the standard says about records and information systems to questions you can ask in a software demo. WebUncles sells calibration management software, priced after a demo, so we also list what it does not cover yet.
What ISO 17025 calibration software can and cannot do
Accreditation is a decision about a laboratory. NABL describes its accreditation as voluntary and covering testing, calibration and medical laboratories, among others. Assessors look at your people, methods, equipment and records, whichever tools you use.
Software can make good practice easier to follow and easier to show. It can enforce a second-person review, block an expired reference standard and keep a change history. It cannot decide your decision rule, write your procedures or replace the technical judgement of your staff.
What ISO/IEC 17025 expects from your records
The table is our paraphrase, based on an accreditation body’s briefing on clauses 7.4 and 7.11, its briefing on records control and the ISO/IEC 17025:2017 catalogue entry. Read the exact words in your own copy of the standard.
| Topic (clause) | What the standard asks, in short | Question for the software |
|---|---|---|
| Equipment records (6.4.13) | Keep records for equipment that affects results: identity and software or firmware version, maker and serial number, location, calibration dates and next due date, maintenance, damage and repairs. | Is there one record per instrument and reference standard with these fields and dates? |
| Traceability (topic) | Results link to a suitable reference through an unbroken chain of calibrations. | Can you store each standard’s certificate, uncertainty and traceability, and does the tool stop an expired one being used? |
| Technical records (7.5) | Records hold enough detail to repeat the work. Changes must be traceable to the original, with both versions kept, plus date, what changed and who changed it. | Does every change show who, when, before and after? Are original readings kept? |
| Reporting of results (topic) | A calibration certificate reports measurement uncertainty and the conditions and traceability behind the result. | Do certificates carry these, and can you see where each value came from? |
| Information systems (7.11.2) | Systems are validated for their functions before use. Changes to configuration or to off-the-shelf software are authorised, documented and validated first. Off-the-shelf software used within its designed range is generally considered validated. | What did the vendor test? What will you test yourself? |
| Protection (7.11.3) | Protect systems against unauthorised access, tampering and loss, and record failures with the action taken. | Roles, permissions, backups and failure alerts: what exists? |
| Outside provider (7.11.4) | If an outside party hosts or maintains the system, it must still meet the requirements. | Who hosts it, and who can reach the data? |
| Calculations (7.11.6) | Calculations and data transfers are checked in a systematic way. | Can you recalculate a past result by hand and match it? |
| Control of records (8.4) | Identify, store, protect, back up, retain and dispose of records; keep them legible and available. | Where are backups kept, and how long are certificates retained? |
How to check an ISO 17025 calibration software before you trust it
Clause 7.11.2 puts the validation duty on the laboratory, not the vendor. A simple, written check is usually more convincing than a long document. Here is a plan a small lab can run:
- Pick five past certificates covering different instrument types and uncertainty levels.
- Enter the original readings, environment data and reference standards into the software.
- Compare the calculated error, expanded uncertainty and pass or fail result with the old certificate. Record any difference and explain it.
- Test the controls: try to approve your own job, use an expired standard, and edit a locked result. Note what the software allows.
- Make a change to a result through the proper re-issue route, and confirm the old certificate and the reason are kept.
- Restore a backup on another machine and open it.
- Write down what you tested, the date, who checked and the outcome. File it with your records.
- Repeat a shorter version after any software update or configuration change.
This follows the idea in the standard that configuration changes and updates are authorised, documented and validated. Your assessor decides what is enough for your scope.
Demo questions mapped to the standard
- Who reviews? Can the person who did the readings approve the same result? What locks at review?
- Uncertainty. Which components are included, and can you see the working for one result?
- Standards. Does the tool show certificate, spec, uncertainty and traceability, and warn before expiry?
- Re-issue. What happens to the old certificate when a corrected one is issued?
- History. Can you export who changed what, and when, for a given job?
- Backups. How often, where, and who gets a failure alert?
- Import. Can you bring in your equipment list and old certificates?
- Limits. Which instrument types and disciplines are supported today, and which are planned?
What WebUncles calibration software covers today
The points below come from our current product page, which the team is still reviewing. It is built for calibration labs in India, including labs preparing for accreditation, and for biomedical service companies working in the lab or on site.
- Seven-step flow. Customer and service request (in-lab or on-site) with challan, PO and photos; job assignment to an engineer and a reviewing technical manager; readings on instrument templates with environmental conditions and a minimum number of repeat readings; calculation of error, uncertainty and pass or fail per test point against your decision rule; review by a different person, with results locked at review; PDF certificate; and reminders with online rebooking from a customer portal.
- Uncertainty. Type A repeatability, resolution, the uncertainty on the reference standard’s certificate and its accuracy spec are combined and expanded with a coverage factor k, using Welch–Satterthwaite effective degrees of freedom. Results are rounded only at reporting.
- Reference standards register. Certificate, spec, uncertainty and traceability. Expired or untraceable standards are blocked, with alerts before expiry.
- Certificates. Logo, signatories, a gap-free number, a ULR where it applies and a QR code for online verification. Controlled re-issue with a reason, and the old PDF is kept.
- Records. A calculation snapshot per result. Change history (who, when, before and after) for jobs, readings, results, standards, certificates and customers, exportable. Role-based permissions per module.
- Backups. Daily and weekly database backups, password-protected downloads, failure alerts and off-site copies to Google Drive or Amazon S3.
- Data. CSV import of equipment lists and past certificates; Excel reports by Indian financial year.
What it does not cover today
Be careful with any vendor, including us, that lists everything as available. Our page separates what exists from what is planned:
- Templates today cover biomedical instruments such as ECG machines and patient simulators, SpO₂ and pulse oximeters, IBP, NIBP, defibrillators, ESU, thermometers, infusion and syringe pumps, electrical safety testers and oxygen concentrators. Industrial disciplines are coming soon.
- NABL scope and CMC management, with CMC checks and PT or ILC tracking, is planned, not available.
- WhatsApp and SMS reminders, multi-branch, API, digital signatures, label printing, billing and GST, and two-step login are planned, not available.
If you are an industrial or dimensional lab, ask for the current template list in the demo before anything else.
Where this fits with other calibration guides
This post is about records and information systems. For the sheet versus software decision, read calibration tracking software vs Excel. For getting ready for an assessor, read our NABL assessment preparation guide. For what a certificate shows, read the calibration certificate format guide.
Price and rollout
Price after demo. It depends on lab size and modules, and we give figures only after we have seen your instrument types and users.
A sensible rollout for a small lab runs in four steps:
- Clean your equipment list and reference standards in a sheet, with certificate numbers and due dates.
- Import them by CSV and check a sample against the originals.
- Run the software in parallel with your current system for one or two months and compare certificates.
- Write your validation record, then switch and keep the old files read-only.
Frequently asked questions
Is there ISO 17025 certified software?
No. Laboratories are accredited against ISO/IEC 17025; software is not accredited. NABL accredits laboratories, not software. Your lab shows that its own use of the software is validated and controlled.
Do I have to validate calibration software?
The standard asks a lab to validate its information management systems before use and to authorise, document and validate changes. Off-the-shelf software used within its designed range is generally treated as validated, but the lab still checks its own configuration. Ask your accreditation body what it expects.
Can Excel meet ISO 17025?
It can, if the lab controls access, changes, calculations and backups and validates the sheets. It is harder as instruments and users grow. Our Excel vs software guide, linked above, covers the trade-offs.
Does the software calculate measurement uncertainty?
WebUncles calibration software calculates it per test point from Type A repeatability, resolution and reference standard uncertainty and spec, with a coverage factor k and Welch–Satterthwaite degrees of freedom. Ask to see the working for one result.
Does it support industrial calibration?
Not yet. Templates today are for biomedical instruments. Industrial disciplines are coming soon, so confirm the current list in the demo.
How much does it cost?
Price after demo. It depends on lab size and modules.
Next step
Bring three past certificates and your equipment list to a demo, and we will walk through them in the software. Book a free demo.
