Guide · ISO/IEC 17025:2017
What has to exist before a calibration laboratory is assessed for NATA accreditation
What does the assessor actually look for?
Evidence that the system is operating. A quality manual describes a laboratory; records show one. The list below is the set of records that have to exist before the visit, the clause each answers, and, importantly, who has to supply it, because most of them cannot be supplied by software, a consultant or a template. They are facts about the laboratory.
1 · ISO/IEC 17025 §6.5
A reference standard with a current calibration and an external certificate
Why it is asked for. Every result traces to it. A master with no certificate, or one past its due date, makes every certificate issued against it untraceable.
Who supplies it. The laboratory buys the calibration from an accredited provider; nothing can invent the date or the certificate number.
2 · ISO/IEC 17025 §6.2.6
An authorised signatory with a competence record for each method
Why it is asked for. The first thing an assessor tests: who signed this, and on what evidence were they authorised for this method on this date.
Who supplies it. A second person, or for a laboratory of one an external assessor named with their organisation, because §6.2.5 forbids self-assessment.
3 · ISO/IEC 17025 §8.3.2
An approved procedure for each method, approved by somebody other than its author
Why it is asked for. Work done under an unapproved procedure is work done under no procedure. Approval by the author is not approval.
Who supplies it. The laboratory writes it; a second person approves it. The method's own numbers, tolerances and points come from the laboratory's records.
4 · ISO/IEC 17025 §7.8.6
A declared decision rule
Why it is asked for. No statement of conformity can be made without one, and it must be agreed with the customer and printed on the certificate.
Who supplies it. The laboratory chooses simple acceptance or a guard band; they distribute risk differently and no default is neutral.
5 · ISO/IEC 17025 §7.6
An uncertainty budget per method, evaluated per point
Why it is asked for. The certificate must state the uncertainty, and the assessor will ask to see where each number came from.
Who supplies it. The laboratory, from its reference standard's certificate, its instruments' resolution and its own repeatability data.
6 · ISO/IEC 17025 §8.4.2
A defined retention period for records
Why it is asked for. The standard requires the period to be defined and honoured. A number nobody declared is a finding, and so is a system that deletes on a schedule nobody chose.
Who supplies it. The laboratory declares it. Nothing should be aged out until it has.
7 · ISO/IEC 17025 §6.4.13
Equipment records, including calibration status and anything that happened to the equipment
Why it is asked for. A damaged or overloaded master raises the question of every result since its last good check; the record has to state its effect on work already issued.
Who supplies it. The laboratory records events as they happen; the software keeps them from being deleted.
8 · ISO/IEC 17025 §7.11.2
Validation of the software that does the arithmetic
Why it is asked for. A spreadsheet is a laboratory information management system under the clause, and an unvalidated one is a finding. The validation has to show the calculation reproduces.
Who supplies it. The vendor supplies the dossier and the evidence; the laboratory confirms it fits its use.
9 · ISO/IEC 17025 §7.10, ISO/IEC 17025 §8.7, ISO/IEC 17025 §8.8, ISO/IEC 17025 §8.9
The registers, with entries in them
Why it is asked for. Nonconforming work, complaints, corrective action, internal audits, management review, risks and opportunities. Blank registers show a system that has been written and not run.
Who supplies it. The laboratory does the work; the registers should fill as a by-product of it rather than in the week before the visit.
What can software do, and what can it not?
It can record the evidence as a by-product of the work, so the registers fill because jobs were done rather than because a visit is coming. It can refuse the non-compliant case: a calibration run against a master past its due date, a certificate signed by somebody not authorised for the method, a statement of conformity with no decision rule, an issued certificate edited after the fact. And it can assemble a clause-by-clause dossier from the records, dated and attributed, with the gaps named.
It cannot supply the facts. It does not know the master's calibration date, who is competent, what the laboratory's retention period is, or whether the laboratory is registered for GST; a system that defaults any of those is inventing a fact about the physical world, and an assessor will find the invented one. CalibraWorks refuses to issue until each is answered, and reports which are still missing on one screen, because the honest shape of readiness is a list of what the laboratory has not yet said.
What about a laboratory of one?
A sole practitioner can be accredited. The one place the standard imposes a second person is ISO/IEC 17025 §6.2.5: a signatory cannot assess their own competence, so a laboratory of one names an external assessor, with their organisation, to make the competence record. The route exists and is used; it does not require hiring anybody. The reference standards, procedures, the decision rule and the registers a sole practitioner holds alone. Our page for laboratories working towards accreditation goes through what the first months look like.
What do laboratories most often get wrong?
- Certificates issued against an expired master. One laboratory's eight years of records held nine certificates across six customers issued against a reference standard past its due date, the worst by 455 days. None of them looked wrong. Whether to notify the customers is the laboratory's decision under ISO/IEC 17025 §7.10; whether it could happen again is the software's.
- Pass or fail with no decision rule, on every certificate that made the statement. See the decision rules guide.
- A spreadsheet nobody validated. Thirty-odd forks of one workbook, each with its own defects, several affecting the grade printed. The uncertainty guide lists what was found in them.
- Registers written the week before. A nonconformance register with one entry, dated the month of the assessment, says more than an empty one would.
NATA's own requirements and the application process are on nata.com.au. The standard is ISO/IEC 17025:2017, available from Standards Australia as AS ISO/IEC 17025:2018.
Before a NATA assessment a calibration laboratory needs a traceable reference standard, an authorised signatory with a competence record, procedures approved by someone other than their author, a declared decision rule, uncertainty budgets, a retention period and registers with entries. Software records these; it cannot supply them, and it cannot accredit anybody.
Questions about accreditation readiness
- Can software make a laboratory NATA accredited?
- No. Accreditation is granted by NATA assessing the laboratory against ISO/IEC 17025 and its own requirements. Software can make the evidence exist as a by-product of the work and refuse the cases an assessor would refuse; it cannot supply a reference standard, a competent signatory or a decision rule. Any vendor who says otherwise is selling the assessor's job.
- Can one person be the whole laboratory?
- Yes, with one limit the standard imposes. §6.2.5 forbids a signatory assessing their own competence, so a laboratory of one names an external assessor with their organisation to make the competence record, and is then an authorised signatory on the strength of it. Everything else, standards, procedures, the decision rule, a sole practitioner can hold alone.
- How long does the evidence have to exist before an assessment?
- Long enough to show the system is operating, not merely documented. An assessor wants to see work done under the procedures, records produced by it, and the registers with entries in them: a nonconformance raised and closed, an internal audit done, a management review held. Months of real work are more persuasive than a year of blank forms.
- What is the difference between NATA and ISO/IEC 17025?
- ISO/IEC 17025 is the international standard for the competence of testing and calibration laboratories. NATA is the Australian accreditation body that assesses laboratories against it and grants accreditation. A laboratory is accredited by NATA to ISO/IEC 17025; it is not certified to the standard, and a certificate of compliance from anyone else is not accreditation.
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