iso-standards-readiness

SUMMARY

What it does

Evidence-bound capability profile for the iso-standards-readiness Agent Skill. The skill prepares and structurally reviews readiness evidence for ISO management-system and laboratory-competence standards (ISO 13485, ISO 14971, ISO/IEC 17025, ISO 15189). It provides deterministic local CLI checks and templates for organizing declared scope, controlled documents, risk-management files, scope of accreditation, traceability, CAPA, external-provider controls, and bounded local evidence manifests. It explicitly separates ISO certification from laboratory accreditation, FDA QMSR inspection, CLIA certification, MDSAP, and EU MDR/IVDR evidence boundaries. The skill contains no clause text and performs no audit, certification, or accreditation decisions. It is a router: SKILL.md holds the boundary, lane discipline, shared workflow, and CLI contract; per-standard depth lives in references/. All bundled CLIs use only the Python standard library, perform no network requests, accept bounded local JSON/Markdown, and produce deterministic sorted JSON. The skill is licensed under MIT and is part of the K-Dense-AI/scientific-agent-skills repository (commit 1e5eeffbdad3749125afe7ab48a39694e27f181c).