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.
skills/iso-standards-readiness/SKILL.md
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- Last checked
- Nov 10, 2026
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- Repository stars (not skill ratings)
- 56,731
- Repository last updated
- Nov 9, 2026
- License
- MIT
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- ai-scientist Repository topic
- bioinformatics Repository topic
- chemoinformatics Repository topic
- claude Repository topic
- claude-skills Repository topic
- claudecode Repository topic
- clinical-research Repository topic
- computational-biology Repository topic
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SKILL.mdcore · 18,299 bytesSKILL.mdcore · 18,299 bytesSKILL.mdcore · 18,299 bytesSKILL.mdcore · 18,299 bytesSKILL.mdcore · 18,299 bytesSKILL.mdcore · 18,299 bytesSKILL.mdcore · 18,299 bytesSKILL.mdcore · 18,299 bytesSKILL.mdcore · 18,299 bytesSKILL.mdcore · 18,299 bytesSKILL.mdcore · 18,299 bytesSKILL.mdcore · 18,299 bytesSKILL.mdcore · 18,299 bytesSKILL.mdcore · 18,299 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 · 9,651 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 · 7,285 bytesreferences/evidence-architecture.mddoc · 13,659 bytesreferences/gap-analysis-checklist.mddoc · 19,472 bytesreferences/iso-13485.mddoc · 12,257 bytesreferences/iso-14971.mddoc · 9,516 bytesreferences/iso-15189.mddoc · 12,450 bytesreferences/iso-17025.mddoc · 12,286 bytesreferences/quality-manual-guide.mddoc · 11,587 bytesreferences/source-ledger.mddoc · 21,190 bytesscripts/_catalog.pyruns · 7,735 bytesscripts/_common.pyruns · 16,800 bytesscripts/audit_document_records.pyruns · 5,518 bytesscripts/check_capa.pyruns · 8,909 bytesscripts/check_qmsr_transition.pyruns · 5,660 bytesscripts/check_supplier_controls.pyruns · 5,746 bytesscripts/check_traceability.pyruns · 5,646 bytesscripts/gap_analyzer.pyruns · 5,626 bytesscripts/validate_evidence_manifest.pyruns · 8,446 bytesscripts/validate_scope_intake.pyruns · 7,268 bytes
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# 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.
`SKILL.md` holds the boundary, lane discipline, shared evidence workflow, and CLI
contract. Per-standard preparation details live in `references/`.
## Non-negotiable boundary
