Built around what NABL
actually assesses.
Most "compliance software" treats NABL as a badge to display. ValiCore is structured around NABL 112/112A's real clause areas — equipment and calibration traceability, risk management, personnel competence, and control of records — because that's what an assessor actually opens the system to check.
What is NABL 112, and how does it relate to ISO 15189?
NABL 112 (currently Issue No. 4, with a 2024 addendum, alongside the related NABL 112A document) is the National Accreditation Board for Testing and Calibration Laboratories' specific criteria for accrediting medical laboratories in India. It's applied in conjunction with ISO 15189:2022, not as a replacement — ISO 15189 sets the international standard for quality and competence in medical laboratories, and NABL 112/112A adds India-specific accreditation criteria on top. Together they require a lab to demonstrate a full quality management system, not just a testing procedure manual.
Built for
What goes wrong without it
Equipment traceability chain has gaps
NABL-accredited calibration must trace to an unbroken chain up to India's National Physical Laboratory (NPL) — not NIST, a common and incorrect assumption. A calibration certificate without a clear traceability statement is a real assessment finding.
Risk management treated as a checkbox
NABL 112A explicitly names risk management as its own clause area — a generic "we consider risk" statement without documented, structured risk assessments doesn't satisfy an assessor looking for evidence.
Records scattered across systems that don't talk
Control of records is a named NABL 112A requirement — when equipment logs live in one place, personnel competence records in another, and test data in a third, demonstrating control means demonstrating three disconnected systems.
What ValiCore actually does here
NABL-traceable calibration register
Instrument calibration records with explicit traceability to the correct national metrology chain, plus as-found/as-left data — the exact structure NABL 112A checks for.
NABL 112A · ISO/IEC 17025Structured risk assessment records
Risk management as a first-class, documented workflow — not a narrative paragraph in an SOP nobody re-reads.
Personnel competence & training records
Training assignments tied to role and document revision, with completion records that demonstrate ongoing competence, not just a one-time certificate.
Single system of record
Equipment, calibration, personnel, and test records in one tamper-evident system — an assessor gets one login, not three disconnected exports.
NABL 112 / 112ADocument control aligned to ISO 15189
SOPs and quality manual sections version-locked with e-signature approval — control of records as a structural property, not a manual discipline.
ISO 15189:2022Regulations this addresses
Related modules
Frequently asked questions
ISO 15189:2022 is the international standard specifying quality and competence requirements for medical laboratories. NABL is the Indian national accreditation body, and NABL 112/112A is its specific criteria document — applied together with, not instead of, ISO 15189. A lab pursuing NABL accreditation is essentially demonstrating ISO 15189 compliance through NABL's specific assessment process.
Timelines vary by lab readiness and NABL's assessment scheduling, but the process typically spans several months from application through document review, on-site assessment, and any corrective actions required before accreditation is granted. Labs with an existing, well-documented quality system generally move faster through the process than those building records from scratch during the application.
Not universally mandated for every lab in India, but increasingly expected by hospitals, insurers, and referring physicians as a marker of reliability — and required for specific contexts like certain government tenders or NABL-accreditation-dependent partnerships. Labs pursuing growth or institutional contracts frequently find accreditation becomes a practical requirement even where it isn't a strict legal one.
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