ISO/IEC 17025 and Calibration Laboratory Software: Which Records Belong in the System?

ISO/IEC 17025 is the international standard for the competence of testing and calibration laboratories. During an accreditation assessment, the assessor does not look only at the certificate; they ask for the chain of records behind it: how the request was reviewed, who did the work, which reference equipment was used and how the result was approved. This article covers the main record types the standard expects and how they can be kept together in a laboratory management system.

Note: software alone does not make a laboratory conform to ISO/IEC 17025. Conformity comes from the laboratory's management system and practice; software makes it easier to keep these records organised, accessible and traceable.

1. Review of requests, tenders and contracts

The standard expects the laboratory to review each request for capability, method and scope, and to record that review. In practice this means it is clear which devices, measurement ranges and accreditation status a quotation covers. Keeping the revision history of a quotation answers the later question "what exactly did we agree?".

2. Personnel competence

The person doing the work must be competent for it, and this must be shown by records: training, competence assessments and authorisations. When these records are linked to work assignment, technicians see only the jobs they are qualified for, and "was this person authorised?" can be answered from one screen.

3. Equipment and metrological traceability

Calibration certificates, intermediate checks and maintenance of reference equipment must be recorded, and every result must be traceable through that equipment to national or international references. Recording which reference devices were used on a certificate, and preventing an out-of-date device from being added, keeps that chain intact.

4. Technical records and measurement uncertainty

Raw data, calculations, environmental conditions and measurement uncertainty must be kept in enough detail to reproduce the result. Controlled calculation templates, certificates that are not affected when a template changes later, and raw data that is never retyped by hand all make technical records more reliable.

5. Reporting and approval of results

It must be clear who prepared a certificate, who reviewed and approved it and which version was sent to the customer. When a revision is needed, the link between the old and new certificate, the reason and the date must be kept. An electronic signature and a verification link help the customer confirm that the document in hand is the valid version.

6. Complaints and nonconforming work

Customer complaints and nonconforming work must be recorded, evaluated and, where needed, closed with corrective action. Linking these records to the related job or certificate makes it easier to trace a problem back to its source.

7. Management system records

Document control, risks and opportunities, corrective actions, internal audits, management reviews and impartiality records are part of the management system. Interlaboratory comparison and proficiency testing results are also an important part of monitoring the validity of results.

Why keep the records in one system?

All of this can be kept in separate spreadsheets and folders, but the hard part in an assessment is showing the links between records. When request, job, personnel, reference equipment, certificate and complaint are linked in one system, you can start from a certificate and follow the whole chain in a few clicks.

KALDATA Calibration Laboratory Management Software runs laboratory operations from quotation to certificate and invoice on one record, and keeps personnel competence, reference equipment, document control, corrective actions, risks, internal audits, complaints and interlaboratory comparison records in the same system.