Individual skill
iso-standards-readiness
Prepares and structurally reviews readiness evidence for ISO management-system and laboratory-competence standards - ISO 13485 medical device QMS, ISO 14971 device risk management, ISO/IEC 17025 testing and calibration laboratories, and ISO 15189 medical laboratories. Use when organizing declared scope, controlled documents, risk-management files, scope of accreditation, traceability, CAPA, external-provider controls, or bounded local evidence manifests, and when separating ISO certification from laboratory accreditation, FDA QMSR inspection, CLIA certification, MDSAP, and EU MDR/IVDR evidence boundaries. Not for legal applicability, compliance, certification, or accreditation decisions; contains no clause text.
backend/cli/skills/other/iso-standards-readiness/SKILL.md
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- Network or broad shell
- Last checked
- Nov 2, 2026
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- 4,350
- Repository last updated
- Nov 4, 2026
- License
- Apache-2.0
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SKILL.mdcore · 17,523 bytesSKILL.mdcore · 17,523 bytesSKILL.mdcore · 17,523 bytesSKILL.mdcore · 17,523 bytesSKILL.mdcore · 17,523 bytesSKILL.mdcore · 17,523 bytesSKILL.mdcore · 17,523 bytesSKILL.mdcore · 17,523 bytesSKILL.mdcore · 17,523 bytesSKILL.mdcore · 17,523 bytesSKILL.mdcore · 17,523 bytesSKILL.mdcore · 17,523 bytesSKILL.mdcore · 17,523 bytesassets/templates/capa-record-template.jsonasset · 2,979 bytesassets/templates/document-register-template.jsonasset · 2,122 bytesassets/templates/evidence-manifest-template.jsonasset · 2,018 bytesassets/templates/laboratory-scope-intake-template.jsonasset · 3,422 bytesassets/templates/medical-laboratory-scope-intake-template.jsonasset · 3,536 bytesassets/templates/procedures/CAPA-procedure-template.mddoc · 6,517 bytesassets/templates/procedures/document-control-procedure-template.mddoc · 6,934 bytesassets/templates/qmsr-transition-template.jsonasset · 9,622 bytesassets/templates/quality-manual-template.mddoc · 9,372 bytesassets/templates/scope-intake-template.jsonasset · 2,975 bytesassets/templates/supplier-controls-template.jsonasset · 4,323 bytesassets/templates/traceability-matrix-template.jsonasset · 4,439 bytesreferences/assurance-lanes.mddoc · 7,053 bytesreferences/evidence-architecture.mddoc · 13,644 bytesreferences/gap-analysis-checklist.mddoc · 19,354 bytesreferences/iso-13485.mddoc · 12,165 bytesreferences/iso-14971.mddoc · 9,124 bytesreferences/iso-15189.mddoc · 11,718 bytesreferences/iso-17025.mddoc · 11,307 bytesreferences/quality-manual-guide.mddoc · 11,572 bytesreferences/source-ledger.mddoc · 19,582 bytesscripts/_catalog.pyruns · 7,732 bytesscripts/_common.pyruns · 16,379 bytesscripts/audit_document_records.pyruns · 5,518 bytesscripts/check_capa.pyruns · 8,909 bytesscripts/check_qmsr_transition.pyruns · 5,719 bytesscripts/check_supplier_controls.pyruns · 5,746 bytesscripts/check_traceability.pyruns · 5,646 bytesscripts/gap_analyzer.pyruns · 5,243 bytesscripts/validate_evidence_manifest.pyruns · 8,446 bytesscripts/validate_scope_intake.pyruns · 7,268 bytes
Read excerpt
# ISO Standards Readiness Evidence Preparation
## Purpose
Use this skill to organize declared scope, controlled documents, implementation
records, traceability, and readiness evidence for substantive human review against a
named standard. It summarizes process workflows and provides deterministic local
checks. It contains no clause text and performs no audit.
This is a router. `SKILL.md` holds the boundary, the lane discipline, the shared
workflow, and the CLI contract. Per-standard depth lives in `references/`.
## Non-negotiable boundary
