Research basis: 2026-07-26. Read this before preparing evidence for any standard in this skill. Most substantive errors in readiness work are lane confusion, not missing documents: an output that is correct for one lane is wrong, and sometimes a false claim, in another.
Every lane below is decided by a different body, against a different basis, producing a different artifact with a different scope. None of them is a substitute for another, and this skill produces none of them.
| Lane | Who decides | Basis | Artifact | Applies to |
|---|---|---|---|---|
| Management-system certification | Certification body under ISO/IEC 17021-1 | Authorized standard + certification scheme | Certificate, scoped | ISO 13485 |
| Laboratory accreditation | Accreditation body under ISO/IEC 17011 | Authorized standard + scheme rules | Accreditation + scope schedule | ISO/IEC 17025, ISO 15189 |
| Regulator inspection | National regulator | That jurisdiction's law | Inspection outcome, enforcement | FDA QMSR, CLIA, national regimes |
| Mandatory certification/licensure | Government or its agent | Statute | Certificate/licence to operate | CLIA |
| Regulatory audit programme | Recognized Auditing Organization | Programme audit model | Audit report used by participating regulators | MDSAP |
| Conformity assessment | Notified body / manufacturer per route | Product regulation | Product certificate, declaration of conformity | EU MDR/IVDR |
| Assessed-inside-another-lane | Whoever runs the host lane | The standard, as evidence | No artifact of its own | ISO 14971 |
This is the most frequent wording error in readiness documents.
"ISO 17025 certified" and "ISO 15189 certified" are category errors. So is treating an accreditation schedule as if it covered the whole organization: an accreditation scope is per location and per activity or examination, and work outside it must carry no accreditation claim.
Since 2026-01-01, Global Accreditation Cooperation Incorporated has replaced the former ILAC and IAF and operates a single Multilateral Recognition Arrangement. Certificates and accredited results issued under the former IAF MLA / ILAC MRA remain recognized during the transition. Before reproducing any recognition claim, logo, or document designation, verify the current wording — legacy phrasing may be transitional rather than current.
Hold these apart in every output:
Whatever the lane, the artifact is bounded. Record the boundaries explicitly, because a claim that quietly exceeds them is the failure mode:
Classification, intended purpose and claims, software and cybersecurity, clinical or performance evidence, biocompatibility, electrical safety, sterilization, UDI, registration, personnel qualification, reporting, and payer conditions each require separate authorized analysis. A management-system or laboratory-competence readiness output says nothing about any of them.
Before evidence work starts, name the lane or lanes in the intake, with an owner for
each applicability decision. The bundled checks record what humans declared; they never
infer a lane from a document set. Where a lane is undetermined, the intake check raises
HUMAN_DECISION_REQUIRED as a blocker — leave it as a blocker.
Manifest audit_context.purpose accepts one declared purpose per manifest:
internal-audit, iso-certification-readiness,
accreditation-assessment-readiness, fda-inspection-readiness,
national-regulatory-inspection-readiness, mdsap-audit-readiness, or
eu-conformity-assessment-readiness. Preparing for two lanes means two manifests with
two scopes and two sets of limitations, not one manifest with a blended purpose.
Never title an output "certificate," "accreditation," "compliance report," "audit pass," "deemed status," or "ready for inspection." Use Draft evidence review for authorized human assessment, and state which lane the evidence was prepared for.
references/source-ledger.md — dated official sources for every claim above