Agent Skills Index

Directory / Scientific Agent Skills (K-Dense) / iso-standards-readiness

iso-standards-readiness

skill Science, research & learning

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.
Description from the SKILL.md front matter.

Information source

Copied from the Scientific Agent Skills (K-Dense) catalog (K-Dense-AI/scientific-agent-skills), maintained by K-Dense Inc..

Links are pinned to commit 593377b (2026-10-19), the version we synced. Not reviewed by us.

Install

GitHub CLI v2.90+ (Copilot by default)
gh skill install K-Dense-AI/scientific-agent-skills iso-standards-readiness
For Claude Code
gh skill install K-Dense-AI/scientific-agent-skills iso-standards-readiness --agent claude-code
For Codex
gh skill install K-Dense-AI/scientific-agent-skills iso-standards-readiness --agent codex

Commands follow each host's documentation (Any Agent Skills host (Claude Code, Codex, Cursor, Gemini CLI, Copilot…) docs). gh skill needs GitHub CLI 2.90 or later and is in public preview.

Listed from K-Dense Inc.'s catalog, not reviewed by us. Read the source before installing.

Catalog
Scientific Agent Skills (K-Dense)
Information source
SKILL.md in K-Dense-AI/scientific-agent-skills
Author
K-Dense Inc.
Source code
K-Dense-AI/scientific-agent-skills
License
MIT
Repository stars
52,882 for K-Dense-AI/scientific-agent-skills (the whole catalog repo)
Version
1.3
Added to catalog
Not tracked for this source
Last change
2026-10-19 (last push to the repo)

What it contains

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