A QMS built around
ISO 15189:2022, not generic quality.
ISO 15189 requires a medical lab to build a full quality management system demonstrating competence — not just a testing procedure manual. ValiCore structures its lab modules around the standard's real requirements: equipment, personnel competence, risk management, and control of records.
What is ISO 15189, and what does it actually require?
ISO 15189:2022 is the current international standard specifying requirements for quality and competence in medical laboratories. It requires a lab to demonstrate — not just claim — competence across a defined set of areas: personnel qualification and ongoing competence assessment, equipment and its calibration/metrological traceability, pre-examination processes (sample handling before testing), risk management as a structured discipline, and control of records that can withstand external assessment. In India, NABL 112/112A applies these requirements through the national accreditation process; the underlying technical standard is ISO 15189 itself.
Built for
What goes wrong without it
Equipment calibration traceability incomplete
ISO 15189 requires equipment calibration with clear metrological traceability — a certificate that doesn't clearly document the traceability chain to a recognized national standard is a common, specific assessment gap.
Personnel competence assessed once, not ongoing
A training certificate from onboarding isn't the same as demonstrated, ongoing competence — ISO 15189 expects competence assessment to continue, not conclude at hiring.
Records that can't withstand external review
Control of records is a named requirement — records scattered across paper, shared drives, and informal spreadsheets make demonstrating control to an external assessor considerably harder than it needs to be.
What ValiCore actually does here
Equipment register with metrological traceability
Calibration records with explicit traceability documentation and as-found/as-left data — exactly what ISO 15189's equipment clause expects to see.
ISO 15189:2022 · ISO/IEC 17025Ongoing personnel competence tracking
Training tied to role and document revision, with completion history that demonstrates continued competence, not a single onboarding certificate.
Structured risk management records
Risk assessment as a trackable, structured workflow — applied to real operational decisions, not confined to a one-time exercise.
Pre-examination process control
Sample intake, handling, and chain-of-custody tracked from receipt, supporting the pre-examination process controls ISO 15189 requires.
Control of records, structurally enforced
One tamper-evident system for equipment, personnel, and test records — not three disconnected exports assembled for an assessor visit.
ISO 15189:2022Regulations this addresses
Related modules
Frequently asked questions
ISO 15189 is specific to medical laboratories, incorporating requirements around clinical relevance and patient safety alongside general quality-management and technical competence requirements. ISO 17025 is the general standard for testing and calibration laboratory competence, applicable across industries — a metrology or industrial testing lab would typically pursue 17025, while a clinical/diagnostic lab pursues 15189. NABL-accredited medical labs are assessed against ISO 15189; their equipment's calibration traceability chain relies on ISO 17025-accredited calibration providers.
Not universally legally mandated for every lab, but increasingly expected by hospitals, insurers, government tenders, and referring physicians as a marker of reliable results. Labs pursuing institutional partnerships or public-sector contracts frequently find accreditation becomes a practical requirement even without a blanket legal mandate.
ISO 15189 expects a controlled document system where only the current, approved version of a procedure or policy is in active use, with a clear approval history and retrievable superseded versions. This mirrors the document-control expectations across other GxP frameworks — version locking, approval workflow, and a retained revision history are the concrete features that satisfy it.
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