iso-standards-readiness agent skill by K-Dense-AI
Prepares and structurally reviews readiness evidence for ISO 13485, ISO 14971, ISO/IEC 17025, and ISO 15189 standards, covering scope, controlled documents, and risk files.
At a glance
| Publisher | K-Dense-AI |
|---|---|
| Repository | K-Dense-AI/claude-scientific-skills (177 listed skills) |
| Category | Business, Sales and Finance |
| License | MIT |
| Last commit | October 12, 2026 (repository) |
| SKILL.md | 370 lines, 2,084 words |
| Bundled files | 32 files, including references, scripts, assets or templates |
| Quality score | 91/100 · A Passes all seven graded checks |
| Security scan | Not scanned |
| README badge | Get the badges for this listing |
Before you install
Read from the skill's files at the directory's October 19, 2026 snapshot: what ships with it, what its code reads, and the terms it is published under.
- Bundled scripts: 10 script files (10 Python). Your agent may run them, so read them first.
- Tool permissions requested:
Read Write Bash Glob(theallowed-toolsfield of SKILL.md). - License: MIT, an open-source or open-content license.
Install iso-standards-readiness
The skills CLI works with Claude Code, Codex, Cursor and other agents; the other routes copy the folder by hand.
npx skills add https://github.com/K-Dense-AI/claude-scientific-skills/tree/main/skills/iso-standards-readinesstmp="$(mktemp -d)"
git clone --depth 1 https://github.com/K-Dense-AI/claude-scientific-skills.git "$tmp/repo"
mkdir -p .claude/skills
cp -R "$tmp/repo/"skills/iso-standards-readiness .claude/skills/
rm -rf "$tmp"python3 ~/.codex/skills/.system/skill-installer/scripts/install-skill-from-github.py \
--repo K-Dense-AI/claude-scientific-skills \
--path skills/iso-standards-readinessK-Dense-AI/claude-scientific-skills is third-party code. Read SKILL.md and any bundled scripts before you install it.
How the author describes 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.
From the description field of SKILL.md. Agents read this line to decide when to load the skill.
Compatibility, from SKILL.md
| Compatibility | Python 3.11+; bundled CLIs use only the standard library and bounded local JSON/Markdown files, with no network access or credentials. |
|---|
Sections in SKILL.md
- Purpose
- Non-negotiable boundary
- ISO and IEC copyright
- Standards covered
- Current baseline (read the ledger before any time-sensitive statement)
- Keep the assurance lanes separate
- Core workflow
- Step 1: Declare the standard, purpose, and authorized owners
- Step 2: Freeze source/version evidence
- Step 3: Inventory controlled documents and records
- Step 4: Review process implementation
- Step 5: Run the focused checks that apply to the lane
- Step 6: Address lane-specific regulator evidence separately
- Step 7: Assemble a bounded readiness manifest
- Step 8: Human review and controlled handoff
- CLI behavior and safety
Files in the skill folder
SKILL.mdassets/templates/capa-record-template.jsonassets/templates/document-register-template.jsonassets/templates/evidence-manifest-template.jsonassets/templates/laboratory-scope-intake-template.jsonassets/templates/medical-laboratory-scope-intake-template.jsonassets/templates/procedures/CAPA-procedure-template.mdassets/templates/procedures/document-control-procedure-template.mdassets/templates/qmsr-transition-template.jsonassets/templates/quality-manual-template.mdassets/templates/scope-intake-template.jsonassets/templates/supplier-controls-template.jsonassets/templates/traceability-matrix-template.jsonreferences/assurance-lanes.mdreferences/evidence-architecture.mdreferences/gap-analysis-checklist.mdreferences/iso-13485.mdreferences/iso-14971.mdreferences/iso-15189.mdreferences/iso-17025.mdreferences/quality-manual-guide.mdreferences/source-ledger.mdscripts/_catalog.pyscripts/_common.py
Showing 24 of 32 files. Browse the folder on GitHub.
Suede Skill Check: 91/100 · A
Report snapshot · · graded-v2
The rubric totals 100 points; published scores are capped at 99. Security scan: not scanned.
Source revision: a1043ef544e3. Report version a67272541644. Badge URLs follow the latest listing; save the report to keep this version.
Download report · Request a fresh review
What to review next
- Example request: 0 of 3 points. 3 when the description quotes an example request (3–60 characters in quotation marks).
- Description length: 3 of 5 points. 5 for 150–600 characters; 3 for 100–900; 1 for 50–1,024.
Add declarations and bundled files when they describe the skill’s actual needs. Update the source, then request a fresh review with the changed commit or PR.
iso-standards-readiness passes the required frontmatter check and all seven graded checks, which cover the SKILL.md format, a declared license and a commit in the last year. Those checks earn 56 of the score’s points; the rest come from description quality, instruction depth, bundled files, maintenance and curated-list citations. How the score works.
See the checks and points
| Check | Result |
|---|---|
| Frontmatter parses and declares a name and a description | Pass |
| Name uses lowercase letters, digits and hyphens, 64 characters or fewer | Pass |
| Name matches the skill's folder name | Pass |
| Description is between 50 and 1,024 characters | Pass |
| Description says when an agent should use the skill | Pass |
| SKILL.md body is 500 lines or fewer | Pass |
| A license is declared in the frontmatter or the repository | Pass |
| Repository has a commit in the last 12 months | Pass |
| Score component | Points |
|---|---|
| Structural checks | 56 of 56 |
| Description length | 3 of 5 |
| Boundary clause | 4 of 4 |
| Example request | 0 of 3 |
| Instruction depth | 7 of 7 |
| Reference files | 3 of 3 |
| Bundled scripts | 2 of 2 |
| Recent maintenance | 9 of 9 |
| Curated-list citations | 3 of 7 |
| Tool permissions declared | 2 of 2 |
| Compatibility declared | 2 of 2 |
Two badges for iso-standards-readiness
Choose the numeric badge, the letter badge, or both. Each links to this skill’s Suede listing; either valid linked badge can qualify for the feature offer.
[](https://skills.suedeai.ai/directory/k-dense-ai/claude-scientific-skills/iso-standards-readiness/)
[](https://skills.suedeai.ai/directory/k-dense-ai/claude-scientific-skills/iso-standards-readiness/)<a href="https://skills.suedeai.ai/directory/k-dense-ai/claude-scientific-skills/iso-standards-readiness/"><img src="https://skills.suedeai.ai/directory/k-dense-ai/claude-scientific-skills/iso-standards-readiness/score.svg" alt="Suede Skill Check: 91/100" width="160" height="175"></a>
<a href="https://skills.suedeai.ai/directory/k-dense-ai/claude-scientific-skills/iso-standards-readiness/"><img src="https://skills.suedeai.ai/directory/k-dense-ai/claude-scientific-skills/iso-standards-readiness/badge.svg" alt="Suede Skill Check: Grade A" width="160" height="175"></a>Suede Certified on the shield refers to this published structural quality check. Security scan: not scanned. Read the methodology.
Limited-time feature offer: display either the numeric or letter badge in your repository or skill README (both also qualify), then request badge verification. Eligible skills scoring 80–99 can receive a featured placement after Suede verifies at least one valid badge linked to the skill’s listing. Suede has not announced an end date.
Where this skill is cited
K-Dense-AI/claude-scientific-skills appears in 2 curated lists: BehiSecc/awesome-claude-skills, travisvn/awesome-claude-skills.