ISO/IEC 17025:2017 calibration laboratory software
ISO 17025 calibration software, clause by clause.
The standard, and what the software does about it
Fourteen requirements, each with its mechanism.
The clauses an assessor tests in a calibration laboratory, what each asks for, and the specific thing CalibraWorks does — most of them a refusal enforced by the database, not a reminder on a screen.
§6.2.5 · §6.2.6
Records of who is competent and authorised for which activity, on what evidence, from when.
A certificate can be issued only by an authorised signatory holding a current competence record for that method. The database refuses anyone else, so the competence register is complete for every certificate ever signed. A laboratory of one names an external assessor rather than assessing itself.
§6.4.6 · §6.5
Reference standards calibrated, traceable, and in calibration when they are used.
A calibration run cannot use a reference standard whose own calibration has lapsed — a hard block, not a warning. Every run records the masters it used, so “which certificates depend on this master?” is a query rather than a week of reconstruction.
§6.4.13
Equipment records, including anything that happened to the equipment and its effect.
A damage or overload record has to state its effect on work already issued and cannot be deleted. The history of every master stays with it.
§7.1 · §7.1.3
The request reviewed, and the decision rule agreed with the customer before the work.
The decision rule can be set for the laboratory, a customer, a quote or a job, and the one that applied is printed on the certificate.
§7.2 · §8.3.2
Methods selected and verified, and documents approved for adequacy before issue.
Each instrument type is tied to an approved procedure under document control, with its author, approver and revision recorded. Work cannot reach the bench on a type with no approved procedure.
§7.5
Technical records sufficient to repeat the activity, with who did it and when.
Raw readings, the calculation template and its version, the engine version, the masters, the technician and the time on the bench are stored with every run.
§7.6
Measurement uncertainty evaluated for every calibration.
A GUM budget per calibration point, with Welch–Satterthwaite effective degrees of freedom and the coverage factor that follows. Uncertainty is never a setting that can be switched off. The free uncertainty calculator on this site runs the same engine.
§7.8.2 · §7.8.4
Everything a certificate must state, from the unique identification to the uncertainty.
Certificates are generated from the records, so a required item is present because the record behind it exists. Each carries page numbering, the signatory, the traceability statement and a random verification code with a QR code.
§7.8.6
A documented decision rule, and the rule stated wherever conformity is.
The software refuses a statement of conformity without a decision rule. Simple acceptance or a guard band, named after ILAC-G8, chosen by the laboratory and printed.
§7.8.8
Amendments identified, the original retained, and the reason recorded.
An issued certificate is immutable. An amendment is a new linked revision with its reason; the original is kept, and its verification code starts saying it was amended.
§7.9 · §7.10 · §8.7
Complaints, nonconforming work and corrective action handled and recorded.
Registers written by the work rather than beside it: a complaint is a record when a customer raises one, a nonconformance when a result fails review, and a nonconformity's decision can withdraw the certificates it affects.
§7.11.2
Laboratory information management systems — spreadsheets included — validated for their use.
The calculation engine is deterministic and reproduces byte for byte. At issue it recomputes from the stored raw readings and refuses on any mismatch. The engine has a validation record against the standards it implements; the laboratory confirms it fits its own use.
§8.3 · §8.4 · §8.4.2
Documents and records controlled, protected and retained for a defined period.
Every change is in an audit trail that cannot be deleted. Issued certificates are stored with their SHA-256 hash. A laboratory exports everything at any time, and nothing is aged out on a schedule the laboratory did not declare.
§8.8 · §8.9 · §8.5
Internal audits, management reviews and actions on risks, with records of each.
Each is a register in the same system as the work, so the complaints, nonconformances and proficiency results it reviews are already there rather than assembled the week before the visit.
Clause numbers are ISO/IEC 17025:2017. The full record of what the software does, written from the code, is on the capabilities page; what a certificate has to contain is in the ISO 17025 calibration certificate requirements guide.
Why calibration needs its own software
A testing LIMS with a spreadsheet beside it is two systems to validate.
ISO 17025 covers testing and calibration laboratories alike, and most software sold under the name was built for samples. A calibration laboratory's hard parts are somewhere else.
The arithmetic is the record
In calibration the result is computed: a fit through the readings, an error at each point, an uncertainty budget, a grade, a pass or fail against a tolerance. If that arithmetic lives in a workbook beside the LIMS, the workbook is the system an assessor asks you to validate under ISO/IEC 17025 §7.11.2. CalibraWorks computes every number on a certificate in one deterministic engine — five calculation families covering force and jacks under AS 2193, load cells, direct-reading force under Appendix H, pressure gauges under DKD-R 6-1, and a tolerance-band sheet for everything else — and no language model is anywhere near it.
The laboratory's own equipment is the other half
A testing LIMS tracks samples. A calibration laboratory also has to track its own masters — their calibration dates, their uncertainty, what happened to them, and every result that relied on them. That is ISO/IEC 17025 §6.4 and ISO/IEC 17025 §6.5, and it is where the hard block on an out-of-calibration standard lives.
The certificate is a legal document
ISO/IEC 17025 §7.8 says what it must contain and ISO/IEC 17025 §7.8.8 says how it may change, which is never in place. Issued certificates here are immutable, hashed and verifiable by anybody with the code on the sticker; an amendment is a new revision that points to the old one.
The quality system has to run, not exist
An assessor reading blank registers sees a system that was written and never used. Fifteen registers here fill from the work — nonconforming work, complaints, corrective action, competence, internal audit, management review, risks, proficiency testing and the rest — so they are full on the day because they were never separate from the job. See laboratories working towards NATA accreditation and accredited laboratories still on spreadsheets.
Choosing ISO 17025 software
Eight questions to ask any vendor.
Ask them of us, and of anybody else. A yes that turns out to mean a warning on a screen is a no.
01
Will it refuse to issue a certificate against a reference standard that was out of calibration on the day?
02
Will it refuse a signatory without a current competence record for that method — in the database, not on the screen?
03
Can it recompute any certificate it ever issued from the raw readings and get the same answer?
04
Does it require a decision rule before it prints pass or fail?
05
Is an issued certificate immutable, and is an amendment a new linked revision?
06
Can you list every certificate that used a given master, in seconds?
07
Can you export everything, and does certificate verification keep working if you leave?
08
Is the price published, and is the quality system on every plan rather than an upgrade?
The longer version, with the reason behind each requirement, is the calibration lab software buyer's guide; the options side by side are on compare calibration software.
What no software can do
Accreditation is your laboratory's, and it stays that way.
It is in our terms and it is tested in our code. The software refuses a great deal that would fail an assessment; an assessor assesses the laboratory.
Facts only you can supply
A master's calibration date, who is competent to sign, your decision rule, your retention period. The software refuses to default any of them, and the readiness screen lists which are still missing from your records.
Your methods and your scope
Which procedure applies to an instrument and whether a method is fit for purpose is ISO/IEC 17025 §7.2, the laboratory's judgement. The software suggests where a mapping looks wrong and never changes it by itself.
The assessment itself
The assessment pack lays out the evidence clause by clause from your own records. Start with the NATA audit checklist for what an assessor asks to see.
Every certificate carries a random verification code — never a sequential number, which would let anyone enumerate every certificate ever issued — and verification stays public whatever happens to the laboratory's subscription.
ISO 17025 software: the questions people ask
- Is there ISO 17025 certified or accredited software?
- No. ISO/IEC 17025 accredits laboratories, not products. An accreditation body such as NATA assesses a laboratory's competence, and software is one of the things it looks at under the clause on information management. A vendor that calls its software 17025 certified or accredited is describing something the standard does not offer. What software can do is hold the records the standard asks for and refuse the cases an assessor would refuse.
- Does ISO 17025 require a laboratory to use software?
- No. The standard requires records, traceability, uncertainty, decision rules and a working quality system; it does not say how they are kept. It does require any system used to manage laboratory data — including a spreadsheet — to be validated for its use before it is relied on (§7.11.2). That is usually where spreadsheets fail an assessment: the arithmetic in a workbook that has been copied for years has never been validated.
- What should ISO 17025 calibration software do that a generic LIMS does not?
- Calibration is its own discipline. The software has to compute results and uncertainty from the readings, grade force instruments under AS 2193, apply a decision rule to a tolerance, issue a certificate with the contents §7.8.4 requires, and track the calibration status of the laboratory's own masters. A general laboratory LIMS built for testing samples usually leaves those to a spreadsheet beside it.
- Will CalibraWorks get our laboratory through a NATA assessment?
- Accreditation is the accreditation body's decision about your laboratory. The software makes the evidence exist as a by-product of the work and refuses an expired master, an unauthorised signatory and a conformity statement with no decision rule. The assessment pack it generates shows, clause by clause, the evidence that exists and the gaps that do not. It helps you prepare; it is not an assessment and not a guarantee.
- Is it only for Australian laboratories?
- ISO/IEC 17025 is the same standard everywhere, and accreditation bodies under the ILAC arrangement assess to it. CalibraWorks is built in Australia, with NATA's practice, Australian standards and data held in Sydney, and laboratories in other countries can sign up; New Zealand addresses and the NZBN are supported. Prices are in Australian dollars.
- Does it cover inspection as well as calibration?
- Yes. Test & Tag, safety equipment, lifting gear and medical safety are inspection — ISO/IEC 17020 territory, not 17025 — and the software issues an inspection report for them that asserts no measurement accuracy, carries no grade and never carries an accreditation mark. Calibration and inspection sit in one system for one customer list.
- How much does it cost?
- Prices are published: $189.00 a month for Solo and $549.00 a month for the Laboratory plan, in Australian dollars, ex GST. Every supported ISO/IEC 17025 workflow is on every plan. There is a 30-day free trial with no card.
Sources: ISO/IEC 17025:2017 as published by ISO and Standards Australia; ILAC-G8:09/2019 at ilac.org; NATA's accreditation criteria at nata.com.au.
Try it against your own laboratory.
30 days, no card. Add one reference standard and one procedure, and the readiness screen shows what an assessor would ask for next.