iso-standards-readiness

iso-standards-readiness is a Privacy & regulatory compliance skill for AI agents, published by K-Dense-AI in the claude-scientific-skills repository on GitHub. Skillspace rates iso-standards-readiness C (72/100) and it passed the safety scan; a judge model has also reviewed it.

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.

Grade

C

Quality

72 / 100

Safety

Passed

GitHub stars

44,723

Placed #1 of 6 in the judged category final for Privacy & regulatory compliance.

Our two independent classifiers differ on this skill's category, so treat the placement as provisional.

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