---
title: "ISO 15189:2022 — Medical laboratories — Requirements for quality and competence — KYE Protocol™ coverage"
description: "ISO 15189:2022 — Medical laboratories — Requirements for quality and competence coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it."
url: https://kyeprotocol.com/compliance/iso-15189/
lang: en
source: "KYE Protocol"
---

> ISO 15189:2022 — Medical laboratories — Requirements for quality and competence coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.

ISO 15189:2022 — Medical laboratories — Requirements for quality and competence

# ISO 15189:2022 — Medical laboratories — Requirements for quality and competence — 100% of in-scope requirements covered.

6 requirements · 5 in scope (5 enforced) · 1 out-of-scope (outside KYE™’s authority layer). The 100% is weighted over the in-scope base.

**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.v1` **engines**: `internal` **constitution\_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.v1` **engines**: `internal` **worm\_tables**: `evidence_events` **constitution\_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.v1` **engines**: `internal` **constitution\_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.v1` **engines**: `internal` **constitution\_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.v1` **engines**: `internal` **constitution\_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)_ |

Canonical KYE™ surfaces referenced on this page: [KYE Protocol™](https://kyeprotocol.com/).