Sector · testing and medical laboratories
Equipment calibrated on schedule, staff with competence evidenced per technique, proficiency tests recorded and uncertainty documented where it belongs. What the accreditation body reviews, available without preparing anything.
An accredited laboratory rests its competence on four records: equipment calibrated in time, staff authorised per technique, validated methods with estimated uncertainty, and evidence that results remain valid — proficiency tests, internal controls, comparisons. When those four live in separate sheets maintained by one person, accreditation becomes an operational risk: if that person is away, nobody knows what has expired.
Calibrations and verifications with the interval watched and the certificate linked to each instrument.
+ infoStaff authorisation for a specific test, with its qualification record and its expiry.
+ infoTest reports built from the recorded results, not transcribed from somewhere else.
+ infoProficiency tests, interlaboratory comparisons and internal controls with their follow-up.
+ infoRecord of nonconforming work, its impact assessment and the notification to the customer where applicable.
+ infoProcedures and methods with their current version, in the cloud the laboratory already uses.
+ infoWhat it solves
Sector standards
Real examples
Water laboratory
Before Calibrations are tracked on a separate sheet. The assessor finds two instruments with expired certificates and tests signed using them.
After The interval is watched automatically and expired equipment stops counting as fit. A test cannot be signed with an out-of-date instrument.
Medical laboratory
Before There is a list of technicians, but it does not say who is qualified for each technique or since when.
After A matrix per technique with the evidence of qualification and its expiry. Signing the report is restricted to those authorised.
Materials laboratory
Before The laboratory takes part in interlaboratory testing, but when a result comes back questionable nothing is opened.
After Unsatisfactory performance opens its action with an owner and a deadline, and effectiveness is verified in the next round.
Frequently asked questions
It depends on how the result is used: if it serves to diagnose or treat a specific patient, ISO 15189; for testing materials, water, food or calibration, ISO/IEC 17025. Since the 2022 edition they share a structure, so a laboratory doing both can run one system.
No. ISO 9001 certifies the management system but does not accredit technical competence: it says nothing about whether the laboratory can measure. They are different, and many customers ask for accreditation, not certification.
It is estimated per method and documented. What gets neglected most is the decision rule: how that uncertainty is accounted for when declaring conformity for a result sitting right on the limit.
Yes, with the same mechanism as preventive maintenance: interval, advance warning and blocking of expired equipment. An instrument past its date in use is one of the most frequent findings.
It is run as a competence matrix per technique, not per job title. Anyone without the qualification for a specific test stops showing as authorised to sign it.
Yes, with its planning, its result and the action when performance is unsatisfactory. It is clause 7.7 of ISO/IEC 17025 and the assessor always looks at it.
Yes, and it is a frequent case. Even without seeking accreditation, an in-house laboratory has to demonstrate the reliability of its results to the ISO 9001 auditor or to the relevant food protocol.
ENAC, the national accreditation body, both for ISO/IEC 17025 and for ISO 15189.
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Sources
References to the official text in force. If a standard is revised, this page is updated and the review date says so.
Kimobox is quality software for laboratories covering what an accreditation assessor reviews: the equipment inventory with its calibration and status, staff authorisation per technique, version control of methods and procedures, and the record of nonconforming work.
It serves both accreditation under ISO/IEC 17025 in testing and calibration laboratories and ISO 15189 in medical laboratories, which since its 2022 edition shares a structure with the former.
