ISO 15189:2022 — Medical laboratories — Requirements for quality and competence
ISO 15189:2022 — Medical laboratories — Requirements for quality and competence — 83% covered.
6 requirements · 5 enforced · 0 designed · 0 advisory · 0 deferred.
Source: ISO 15189:2022 specifies requirements for quality and competence in medical laboratories, including patient-safety risk management. KYE Protocol™ governs the §7.6 reporting-integrity and §8.4 record-control slices, the §5 impartiality/authority slice, and the §8.5 risk/patient-safety evidence slice where a medical laboratory uses AI-supported or automated decisioning. KYE™ does not perform examinations, validate examination procedures, manage biological reference intervals, or assess personnel competence. · License: ISO — clause text is copyrighted; KYE registry paraphrases each clause's intent and cites the official identifier for mapping purposes only.
By category
| Category | Reqs | Enforced | Designed | Advisory | Deferred | Coverage |
|---|---|---|---|---|---|---|
| Reporting of results & integrity of the report (7.4-7.6) | 1 | 1 | 0 | 0 | 0 | 100% |
| Control of records & audit trail (8.4) | 1 | 1 | 0 | 0 | 0 | 100% |
| Information management & data integrity (7.6, 8.4) | 1 | 1 | 0 | 0 | 0 | 100% |
| Impartiality & authorised decision-making (5.1, 6.2) | 1 | 1 | 0 | 0 | 0 | 100% |
| Risk management & patient-safety evidence (8.5) | 1 | 1 | 0 | 0 | 0 | 100% |
| Examination processes & technical competence (6, 7.3) | 1 | 0 | 0 | 0 | 0 | 0% |
Every requirement → the KYE™ artefact that enforces it
| ID | Title | Status | KYE™ enforcement |
|---|---|---|---|
iso-15189.7.4-report-integrity |
7.4-7.6 — Examination results are reported accurately and any amended report is traceable | enforced | audit_events: kye.evidence.decision_map.v1, kye.replay.context_seal.v1engines: internalconstitution_refs: constitution/13-RESILIENCE-LOOP.md |
iso-15189.8.4-record-control |
8.4 — Records are retained, legible and protected from unauthorised alteration | enforced | audit_events: kye.evidence.pack.v1engines: internalworm_tables: evidence_eventsconstitution_refs: constitution/30-AUDIT-WORM-RETENTION.md |
iso-15189.7.6-data-integrity |
7.6 — Laboratory information systems preserve the integrity of examination data | enforced | audit_events: kye.evidence.tool_call.v1, kye.replay.proof.v1engines: internalconstitution_refs: constitution/13-RESILIENCE-LOOP.md |
iso-15189.5.1-impartiality-authority |
5.1 / 6.2 — Impartial, authorised personnel (or governed agents) make laboratory decisions | enforced | audit_events: kye.purpose.request.v1, kye.purpose.admissibility.v1engines: internalconstitution_refs: constitution/12-PURPOSE-PERMISSION.md |
iso-15189.8.5-risk-patient-safety |
8.5 — Risk to patient safety from an AI-supported step is assessed and evidenced | enforced | audit_events: kye.resilience.drift_event.v1, kye.resilience.loop_iteration.v1engines: internalconstitution_refs: constitution/13-RESILIENCE-LOOP.md |
iso-15189.6-examination-competence |
Clause 6 / 7.3 — Examination processes, validation and technical competence | out-of-scope | (no enforcement cited) |