{"slug":"k-dense-ai-iso-standards-readiness","source_name":"k-dense-ai/iso-standards-readiness","name":"K Dense AI/Iso Standards Readiness","description":"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 fro","version":1,"lift":{"pass_rate_delta_pts":45.45,"pass_rate_pct":95.5,"total_cases":22,"passed_cases":21,"tokens_delta_pct":157.5,"turns_delta_pct":0,"verdict":"mixed","benchmark_model":"gemini-3.6-flash","grading_method":"judged","completed_at":"2026-08-09T06:03:23.158866+00:00"},"skill_score":null,"benchmark_models":[{"model":"gemini-3.6-flash","headline":true,"delta_pts":45.45,"with_pass_pct":95.5,"without_pass_pct":50,"tokens_delta_pct":157.5,"turns_delta_pct":0,"total_cases":22,"cases_aggregated":22,"verdict":"mixed","never_hurt":false,"completed_at":"2026-08-09T06:03:23.158866+00:00","run_id":"2260b795-5898-41ab-8656-2c5ebbf9715f","version_number":1,"is_latest_version":true,"gate":null}],"trust":{"skill_safety":"passed","safety_status":"clean","intent_verdict":"safe","content_status":"clean","indexable":true},"license":"MIT","install_count":0,"manifest_hash":"778252a2801508e04da5a94477c4785707635af60e21329fcaa6997a63e4e980","raw_url":"https://app.decimal.ai/s/k-dense-ai-iso-standards-readiness/SKILL.md","scorecard_url":"https://app.decimal.ai/skills/k-dense-ai-iso-standards-readiness"}