NABL accreditation: equipment and records checklist
Assessors do not only look at results. They ask for the paper trail behind every analyzer, pipette and refrigerator. This checklist covers the equipment side of accreditation.
- IdentifyEvery item listed
- VerifyChecked before use
- CalibrateTraceable and in date
- MaintainService records kept
- ProveQC and EQA results
What equipment records does NABL accreditation need?
For each item of equipment a laboratory needs a unique identity, evidence that it was installed and verified before use, a calibration record traceable to a recognised laboratory, a maintenance and repair history, and daily quality control and external quality assessment results for the tests run on it. These follow ISO 15189:2022 clauses on equipment, calibration and traceability, and the detail in NABL 112A.
How the accreditation cycle works
NABL accreditation is valid for four years, with annual surveillance and a reassessment every two years. A laboratory has 30 days to close non-conformities raised at assessment, and must apply for renewal at least six months before expiry. NABL says a well-prepared laboratory can complete the process in about 90 days.
Smaller laboratories running basic routine tests can start with the entry-level M(EL)T programme, which is valid for one three-year cycle and still expects valid calibration or maintenance contracts and at least one proficiency testing programme a year.
What assessors expect for equipment
| Requirement | What to keep |
|---|---|
| Installation | Installation, operational and performance qualification records |
| Verification before use | Performance checked on site before patient samples |
| Calibration of balances, centrifuges, pipettes, thermometers | Certificate every year from an accredited calibration laboratory |
| Electrical safety | All points verified every six months |
| Internal quality control | Two levels on the day of testing, one level every shift |
| External quality assessment | Participation in each discipline |
See our guides on daily quality control and preparing your site.
Equipment records checklist
Equipment list
Name, model, serial number, location and a unique ID for every item.
Installation file
Installation report, qualification records and the first verification runs.
Calibration file
Certificates in date, with traceability shown.
Maintenance log
Daily, weekly and monthly user maintenance signed off.
Service reports
Every preventive and breakdown visit, and checks after repair.
Operator training
Who is trained and authorised to use each analyzer.
How Milap helps
Installation records
An installation report and first-run verification for the systems we commission.
Service reports
A written report after every preventive and breakdown visit.
AMC and CMC
Scheduled maintenance so the log never has a gap.
Training records
Application training for your operators at handover.
Sources
NABL 112A, Specific criteria for accreditation of medical laboratories.
NABL 100B, General information brochure.
NABL, frequently asked questions.
NABL 128, M(EL)T programme.
Frequently asked questions
It is voluntary, though many hospitals, insurers and tenders ask for it.
ISO 15189, now in its 2022 edition, together with NABL 112A.
A contract helps, but assessors look for the records: service reports, checks after repair and your own maintenance log.
Analyzers are calibrated with the manufacturer’s calibrators and checked with controls. Measuring devices such as pipettes, balances and thermometers need certificates.
We provide the installation, training and service records for the equipment we supply. The quality system itself belongs to the laboratory.
Planning for NABL accreditation?
Tell us which analyzers you have and we will help you put the service and installation records in order.