This page maps the clauses of ISO 15189:2022 (and the NABL 112 specific criteria that build on it) to the QCnomics module that provides the evidence for each. It is written for quality managers and assessors who want to know what the software actually covers before they rely on it. Nothing here claims that NABL, or any accreditation body, endorses the software: accreditation is granted to laboratories, and QCnomics is the tool that keeps their evidence in order.
How to read the status column. Supported: the clause has a dedicated module and the records it produces are what an assessor asks for. Partly: the module covers the records but not every requirement of the clause (the gap is stated). Planned: on the roadmap. Not covered: the laboratory needs another system or a paper record.
| Clause | Requirement | What QCnomics does | Module | Status |
|---|---|---|---|---|
| 4.1–4.3 | Impartiality, confidentiality, patient-centred | Per-laboratory data isolation, role-based access, audit trail of every record; patient feedback module. | Audit Trail · Users & Access · Patient Feedback | Supported |
| 5.1–5.3 | Legal entity, laboratory director, laboratory activities | Legal licence register with expiry reminders (Clinical Establishments Act, BMW authorisation, PCPNDT, NABL certificate, agreements); scope of activities per section. | Legal Compliance · Lab Setup | Supported |
| 5.5 / 8.1 | Management system requirements | Quality manual, policies and SOPs under document control with versions, approvals and read-acknowledgement. | Document Control · Controlled Manuals | Supported |
| 6.2 | Personnel: competence, authorisation, training, records | Personnel records, job descriptions, qualification documents, competence assessment, training (LMS) with certificates, vaccination / health records. | Personnel (HRM) · Training (LMS) | Supported |
| 6.3 | Facilities and environmental conditions | Room and refrigerator temperature / humidity logs with limits, missed-reading alerts and e-mail reminders. | Environmental Monitoring | Supported |
| 6.4 | Equipment: acquisition, acceptance, use, maintenance, repair, records | Equipment master with history, daily/weekly checklists linked to analyzers, calibration and verification records with due dates, breakdown and maintenance events, condemnation. | Equipment & Calibration · Equipment Checklist | Supported |
| 6.4.5 / 7.3.7.1 | Equipment calibration and metrological traceability | Instrument calibration records; reagent/analyte calibration log with calibrator lot, factor, QC-after check, correlation with IQC and EQAS, 6-monthly verification reminders (CLIA 493.1255). | Calibration & Correlation | Supported |
| 6.5 | Equipment calibration and traceability of measurement results | Calibrator lot and traceability statement per calibration; measurement uncertainty from IQC. | Calibration & Correlation · Sigma QC | Partly |
| 6.6 | Reagents and consumables: reception, storage, acceptance testing, inventory | QC material and reagent lot records with open-vial stability and expiry; lot-to-lot verification (NABL 112A) per CLSI EP26; reagent lot change correlated with QC and calibration. | QC / Reagent Lots · Calibration & Correlation | Supported |
| 6.7 | Service agreements | Agreements and MoUs (referral lab, AMC, courier, CBWTF) with signed-copy upload and renewal reminders. | Legal Compliance | Supported |
| 6.8 | Externally provided products and services | Referral laboratory agreements; supplier records. | Legal Compliance | Partly |
| 7.2 | Pre-examination processes | Sample rejection log with reasons and quality indicators; collection centre management; critical-value reporting log. | Sample Rejection · Collection Centres · Critical Values | Partly |
| 7.3.1–7.3.3 | Examination processes: verification and validation of methods | Method validation / verification studies (precision, bias, linearity, reference interval), carry-over study, inter-instrument comparison, LIS verification. | Method Validation · Carry-over Study · Inter-instrument · LIS Verification | Supported |
| 7.3.4 | Measurement uncertainty | MU from IQC imprecision and EQAS bias per analyte, U (k=2) compared with TEa; MU calculator. | Sigma QC · Calibration & Correlation | Supported |
| 7.3.7.2 | Internal quality control | Daily QC entry or automatic capture from analyzers (ASTM / HL7 / serial / file), Levey-Jennings, Westgard multirules, sigma-based rule selection, run review, repeat tracking, QC due alerts, monthly review of mean/SD. | QC Entry · Auto QC (HL7) · Levey-Jennings · Violations & CAPA · Sigma QC | Supported |
| 7.3.7.3 | External quality assessment (EQA / proficiency testing) | EQAS programme calendar, result entry, bias / SDI, unacceptable-result CAPA opened automatically, correlation with calibration and IQC. | EQA / Proficiency Testing | Supported |
| 7.3.7.4 | Comparability of examination results | Inter-instrument comparison studies; peer comparison of QC across laboratories. | Inter-instrument · Peer Compare | Supported |
| 7.4 | Post-examination: reporting, release, retention of samples | Retained sample register; critical-value log; auto-verification rules documentation. | Retained Sample · Critical Values · Auto-verification | Partly |
| 7.5 | Nonconforming work | Daily nonconformance log, incident reports, QC rejections with run review and hold on patient results. | Daily NC · Incident Report · Violations & CAPA | Supported |
| 7.6 | Control of data and information management | Cloud hosting with daily backups, version history of every change, audit trail, LIS verification records. | Audit Trail · LIS Verification | Supported |
| 7.7 | Complaints | Patient feedback and complaint log with resolution tracking. | Patient Feedback | Supported |
| 7.8 | Continuity and emergency preparedness | Not covered by a dedicated module; risk register can hold the plan. | Risk Management | Not covered |
| 8.2–8.4 | Management system documentation, control of documents and records | Document control with approval workflow, obsolete-document control, record retention periods. | Document Control | Supported |
| 8.5 | Risk and opportunities for improvement | Risk register with likelihood/impact scoring and treatment; quality indicators with targets. | Risk Management · Quality Indicators | Supported |
| 8.6 | Improvement | Quality indicator dashboard, patient feedback, improvement actions. | Quality Indicators | Supported |
| 8.7 | Nonconformities and corrective actions | CAPA register with the five mandatory steps, automatic CAPA on QC rejection and EQAS failure, effectiveness check after 10 in-control runs, root-cause tools. | Violations & CAPA · CAPA Register | Supported |
| 8.8 | Evaluations: internal audit, quality indicators, EQA review | Internal audit with clause-wise checklist, findings and follow-up; indicator review; EQA review. | Internal Audit · Quality Indicators | Supported |
| 8.9 | Management review | Management review meeting with the ISO 15189 input list pre-filled from the modules, decisions and actions tracked. | Management Review | Supported |
| NABL 112 Cl. ii | Laboratory size classification | Lab size recorded at sign-up; plan by number of analytes. | Lab Setup | Supported |
| NABL 112 Cl. 6(d) | Reagent / calibrator records | Calibrator lot and expiry on every calibration; reagent lot records. | Calibration & Correlation · QC / Reagent Lots | Supported |
| NABL 112A | Lot-to-lot verification, QC frequency | Lot-to-lot verification workflow and EP26 judgment limits; QC frequency plans per section. | QC / Reagent Lots · Lab Setup | Supported |
| NABL 153 / 155 | Application and assessment forms | Readiness assessment with clause-wise score; evidence pack export per clause. | NABL Compliance | Partly |
| POCT (ISO 22870 / NABL) | Point-of-care testing | POCT device register, operator competence and QC. | POCT | Partly |
Evidence an assessor can ask for
Each module exports its records as PDF with the laboratory name, a generated timestamp, page numbers and a reviewed-by line: Levey-Jennings charts with Westgard violations, monthly QC review, calibration and correlation reports with sigma metrics, EQAS summaries, CAPA records with effectiveness evidence, equipment history, training and competence records, internal audit reports and management review minutes. The audit trail records who changed what and when for every record.
What QCnomics does not do
It is not a laboratory information system: it does not register patients, print patient reports or bill. It reads the QC results from the analyzer's LIS traffic or receives them directly, and leaves patient results alone. It does not provide proficiency-testing samples (it manages the results of the EQAS scheme the laboratory subscribes to). Continuity planning (7.8) and purchasing (6.8) have no dedicated module.
Frequently asked questions
Is QCnomics NABL approved or certified?
No software is approved or certified by NABL. NABL accredits laboratories against ISO 15189:2022 and NABL 112. QCnomics is built so that the records it keeps match what those criteria ask for, as set out in the matrix on this page.
Does QCnomics cover ISO 15189:2022 or only the 2012 edition?
The matrix, the internal audit checklist and the management review inputs follow the 2022 edition (ISO 15189:2022), including clause 7.3.7 for IQC and EQA and clause 8 for the management system.
Can a laboratory use QCnomics only for internal quality control?
Yes. Many laboratories start with QC Entry, Auto QC and Levey-Jennings and add the management-system modules later. Pricing is by the number of analytes under QC, not by module.