6 min read ยท Updated 22 Aug 2026
NABL accreditation assesses a medical laboratory against the applicable standard for competence and quality management. The process involves preparing a quality system, applying, undergoing document review and an on-site assessment, closing any non-conformities, and then periodic surveillance.
Read this first
This is a general outline, not authoritative guidance. Requirements, the applicable standard version, fees and timelines are set by NABL and change. Confirm everything directly with NABL before making commitments. 365LabPro is not accredited and does not certify anyone; no software can make a laboratory compliant on its own.
What accreditation is assessing
Accreditation looks at whether a laboratory can consistently produce technically valid results: competent staff, validated methods, controlled equipment and reagents, a functioning quality management system, and records that demonstrate all of it over time. It is about demonstrable consistency rather than a single inspection passing.
The broad sequence
Laboratories generally move through these stages.
- Build and run the quality management system for long enough to generate records
- Train staff and document their competence
- Validate methods and establish internal quality control
- Participate in external quality assessment programmes
- Apply, then undergo document review and an on-site assessment
- Close any non-conformities raised, then maintain through surveillance
Records are the part labs underestimate
Most of the effort is not in doing the work correctly but in being able to show that you did, months afterwards. Traceability from a reported result back through who approved it, when, on what sample and against which reference range is the kind of evidence assessment depends on.
Where software helps and where it does not
Software can hold records, enforce that approval happens before release, and keep an audit trail of changes. It cannot validate your methods, train your staff, calibrate your instruments or write your quality manual. Any vendor claiming their product makes you NABL compliant is overstating what software does.