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获取原文件references/assurance-lanes.md
Research basis: 2026-10-01. 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.
Six assurance lanes and the risk-evidence role
| 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 |
| Risk evidence within a declared lane | Whoever runs the declared lane | The standard, as evidence | Supporting evidence; no assurance result from this skill | ISO 14971 |
Certification and accreditation are not synonyms
This is the most frequent wording error in readiness documents.
- Organizations and management systems are certified by a certification body. ISO 13485 is a certification lane.
- Laboratories, inspection bodies, proficiency-testing providers, and reference-material producers are accredited by an accreditation body, for a defined technical scope. ISO/IEC 17025 and ISO 15189 are accreditation lanes.
- Accreditation bodies themselves are peer-evaluated through the international recognition arrangement; they are not certified.
"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.
A certificate never displaces a regulator
Hold these apart in every output:
- ISO 13485 certification does not exempt a manufacturer from FDA inspection, and FDA does not issue ISO 13485 certificates. FDA assesses applicable FDA requirements; QMSR has been effective and enforced since 2026-02-02, and FDA uses Compliance Program 7382.850 rather than the retired QSIT.
- ISO 15189 accreditation does not satisfy CLIA. CLIA certification by CMS is required for applicable clinical testing, subject to the exceptions and exemptions in 42 CFR 493.3. Research-only testing without patient-specific clinical reporting is an explicit exception. The authorized owner must resolve applicability. Deemed status comes from an approved CLIA program, not ISO 15189 by itself.
- An MDSAP audit is not generic ISO certification, and an FDA inspection does not follow the MDSAP audit plan.
- Accreditation or certification alone is not notified-body designation. Verify a notified body's current legislation, task, and designation-code scope in NANDO.
- EU conformity assessment covers product, technical documentation, post-market, vigilance, and economic-operator requirements well beyond generic management-system documentation.
What a scope statement limits
Whatever the lane, the artifact is bounded. Record the boundaries explicitly, because a claim that quietly exceeds them is the failure mode:
- named legal organization and the specific sites or locations;
- activities, and for laboratories the specific methods, measurands, or examinations with ranges and uncertainty basis;
- the product or technical areas covered;
- the standard edition and any amendment basis, and the scheme applied;
- validity dates and current status, including suspension or withdrawal; and
- the issuing body and its own accreditation or designation status.
Product- and jurisdiction-specific controls sit outside all of this
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.
Lane declaration is a required input, not an inference
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.
Titling rule
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.
Sources
references/source-ledger.md— dated official sources for every claim above- GLOBAC launch
- Specifying use of GLOBAC accreditation
- FDA QMSR
- CMS CLIA
- MDSAP Audit Approach
- NANDO