Getting it into your agent
One page per mod, every tool's command on it. A separate URL per tool would split the same page into five that compete with each other.
npx skills add x-cmd/skill --skill iso-13485-certificationgit clone --depth 1 https://github.com/x-cmd/skillWrote this? Show the measurements
A badge with what this costs and how it scanned, read live from this page, so it follows the numbers instead of freezing them. Markdown for a README, HTML for a documentation site or a project page.
[](https://agentmods.dev/skills/x-cmd/skill/iso-13485-certification)<a href="https://agentmods.dev/skills/x-cmd/skill/iso-13485-certification"><img src="https://agentmods.dev/badge/skills/x-cmd/skill/iso-13485-certification/github.svg" alt="Measured on agentmods" height="20"></a>Or the 80×15 button, for a site that already has a row of RSS and ATOM ones. Only the verdict fits; the numbers stay here.
<a href="https://agentmods.dev/skills/x-cmd/skill/iso-13485-certification"><img src="https://agentmods.dev/badge/skills/x-cmd/skill/iso-13485-certification.svg" alt="Reviewed on agentmods" width="80" height="20"></a>What it costs to keep this loaded
Counted locally with the o200k_base tokenizer, which is exact for GPT models; Claude uses its own tokenizer and its counts differ. Treat this as one consistent yardstick across the catalogue rather than a bill. Prices are per million input tokens.
| Model | Per session | Once invoked |
|---|---|---|
| Fable 5.1 | $0.00126 | $0.05458 |
| Opus 5.5 | $0.00050 | $0.02183 |
| Sonnet 5.5 | $0.00025 | $0.01092 |
| Haiku 4.5 | $0.00013 | $0.00546 |
Grade A, and why
iso-13485-certification scanned grade A with 0 findings against 26 rules in 11 categories — prompt injection, anti-refusal, data exfiltration, privilege escalation, supply chain, agent snooping, system-prompt leakage, SSRF and excessive agency — measured 1mo ago.
A static scan of the body, not an audit. Every finding is printed with the line that produced it so you can judge whether it matters here. A mod is markdown that instructs an agent; that is exactly why what it instructs is worth reading.
Nothing flagged
None of the 26 patterns this scan looks for appear in this file: no shell pipes, no recursive deletes, no credential paths, no hidden text, no instruction-override or anti-refusal phrasing, no agent-config snooping. That is not a guarantee, it is the absence of the things that are checkable.
This is a copy
92% identical to iso-13485-certification — 2 lines differ, which has more behind it and is treated as the original. This page carries a canonical link to it rather than competing with it.
How it starts
The opening of the file, as written. The whole thing — 680 lines — stays where its author put it; the contents beside it link to each section on GitHub.
ISO 13485 Certification Documentation Assistant
Overview
This skill helps medical device manufacturers prepare comprehensive documentation for ISO 13485:2016 certification. It provides tools, templates, references, and guidance to create, review, and gap-analyze all required Quality Management System (QMS) documentation.
What this skill provides:
- Gap analysis of existing documentation
- Templates for all mandatory documents
- Comprehensive requirements guidance
- Step-by-step documentation creation
- Identification of missing documentation
- Compliance checklists
When to use this skill:
- Starting ISO 13485 certification process
- Conducting gap analysis against ISO 13485
- Creating or updating QMS documentation
- Preparing for certification audit
- Transitioning from FDA QSR to QMSR
- Harmonizing with EU MDR requirements
Core Workflow
1. Assess Current State (Gap Analysis)
When to start here: User has existing documentation and needs to identify gaps
Process:
-
Collect existing documentation:
- Ask user to provide directory of current QMS documents
- Documents can be in any format (.txt, .md, .doc, .docx, .pdf)
- Include any procedures, manuals, work instructions, forms
-
Run gap analysis script:
python scripts/gap_analyzer.py --docs-dir <path_to_docs> --output gap-report.json -
Review results:
- Identify which of the 31 required procedures are present
- Identify missing key documents (Quality Manual, MDF, etc.)
- Calculate compliance percentage
- Prioritize missing documentation
-
Present findings to user:
- Summarize what exists
- Clearly list what's missing
- Provide prioritized action plan
- Estimate effort required
Output: Comprehensive gap analysis report with prioritized action items
2. Understand Requirements (Reference Consultation)
When to use: User needs to understand specific ISO 13485 requirements
Available references:
references/iso-13485-requirements.md- Complete clause-by-clause breakdownreferences/mandatory-documents.md- All 31 required procedures explainedreferences/gap-analysis-checklist.md- Detailed compliance checklistreferences/quality-manual-guide.md- How to create Quality Manual
What ships with it
8 files beside SKILL.md in the same directory: the scripts, references and assets a skill reads on demand. Not counted in the per-session cost; read them before you install if any of them is executable.
- assets/templates/procedures/CAPA-procedure-template.md 15 KB
- assets/templates/procedures/document-control-procedure-template.md 18 KB
- assets/templates/quality-manual-template.md 20 KB
- references/gap-analysis-checklist.md 27 KB
- references/iso-13485-requirements.md 25 KB
- references/mandatory-documents.md 21 KB
- references/quality-manual-guide.md 26 KB
- scripts/gap_analyzer.py 15 KB runs code
What this file has done since we first saw it
Hashed on every crawl. A supply-chain change to an agent config is a question of when, not whether, so the history is kept rather than the latest state alone.
- 1mo ago First seen · 680 lines · 126 tokens per session scan A 8f339225162a
iso-13485-certification is a skill published in the GitHub repository x-cmd/skill (26 stars, last pushed 3mo ago), licensed Apache-2.0. It adds 126 tokens to every session and 5,458 once invoked, about $0.0005 per session on Opus 5.5. A static security scan graded it A with 0 findings. It is 92% identical to iso-13485-certification, differing in 2 lines, and is treated as a copy.
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