ISO 15189:2022 Medical Laboratory Quality & Competence Standard
Supporting ISO 15189:2022 medical laboratory accreditation with calibration logs, Westgard multirule QC, and quality traceability.
ISO 15189:2022 Medical Laboratories — Requirements for Quality & Competence
AILS Cloud LIMS provides the complete digital quality management suite required by international medical laboratory accreditation assessors under the updated ISO 15189:2022 standard.
Automated instrument telemetry tracking, preventative maintenance logs, calibration curve verifications, and downtime incident tracking.
Universal LOINC parameter dictionaries, age/gender biological reference intervals, and real-time AI delta checking against patient historical data.
Native Westgard multirule evaluations (1-2s, 1-3s, 2-2s, R-4s, 4-1s, 10-x) with automated Levey-Jennings visual trend charts per lot.
Tamper-evident record retention, anti-fraud QR verification on reports, and automated cloud backup snapshots with 7-year audit retention.
Reagent Lot & Expiry Management
Track reagent lot numbers, open-vial stability dates, and manufacturer expiration schedules. AILS automatically alerts technicians when controls or test reagents approach expiration dates.
Proficiency Testing & EQA Tracking
Dedicated modules to log External Quality Assessment (EQA) and proficiency survey results from CAP, EQAS, and RIQAS with automated standard deviation index (SDI) calculations.
Have Specific Laboratory Accreditation Questions?
Our biomedical engineering and compliance specialists can review your laboratory SOPs and assist with LIMS validation checklists.