iso-13485-certification

iso-13485-certification is a skill for Claude Code, Codex from foryourhealth111-pixel/Vibe-Skills. It costs 126 tokens per session (5,298 once invoked), scanned A, original, Apache-2.0.

A documentation toolkit for preparing ISO 13485 quality-management documents for medical-device companies. ISO 13485 is an international standard used to show that a medical-device quality system is properly managed.

In plain words
What is it for?
Use it for documentation gap analysis, quality manuals, procedures, compliance checklists, and preparation for ISO 13485 certification or audits.
Why use it?
It helps identify missing documents and prepare evidence for certification audits and related regulatory requirements.

Skill for Claude CodeCodex

Written for no agent in particular: nothing here depends on one.

Good fit Use it for documentation gap analysis, quality manuals, procedures, compliance checklists, and preparation for ISO 13485 certification or audits.

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Install with agentmods
npx agentmods add skills/foryourhealth111-pixel/vibe-skills/iso-13485-certification
About the project

Vibe-Skills is a collection and routing system that helps AI agents discover, select, and coordinate specialized skills for completing tasks. It is intended for agents that need to organize workflows across many installed capabilities. The catalogue entries are skills and an agent belonging to this system.

foryourhealth111-pixel/Vibe-Skills · 3,252 stars · on GitHub

Install

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.

Any agent
npx skills add foryourhealth111-pixel/Vibe-Skills --skill iso-13485-certification
Clone the repo
git clone --depth 1 https://github.com/foryourhealth111-pixel/Vibe-Skills

Made for: Claude Code, Codex.

Wrote 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.

agentmods badge for iso-13485-certification

README.md
[![agentmods](https://agentmods.dev/badge/skills/foryourhealth111-pixel/vibe-skills/iso-13485-certification/github.svg)](https://agentmods.dev/skills/foryourhealth111-pixel/vibe-skills/iso-13485-certification)
Your own site
<a href="https://agentmods.dev/skills/foryourhealth111-pixel/vibe-skills/iso-13485-certification"><img src="https://agentmods.dev/badge/skills/foryourhealth111-pixel/vibe-skills/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.

agentmods 80×15 button for iso-13485-certification

Your own site · 80×15
<a href="https://agentmods.dev/skills/foryourhealth111-pixel/vibe-skills/iso-13485-certification"><img src="https://agentmods.dev/badge/skills/foryourhealth111-pixel/vibe-skills/iso-13485-certification.svg" alt="Reviewed on agentmods" width="80" height="20"></a>
Per session 126 Skills are progressive disclosure: only the name and description are preloaded; the body loads when the skill is used.
When invoked 5,298 The whole file, excluding the scripts and references it only reads on demand.
Security scan A 0 findings. A grade says what 26 rules found in the file — not that it is safe. Third-party audits
  • NVIDIA SkillSpector warn 7 Sept 2026
SkillSpector: 1 finding, up to high

These are SkillSpector’s own severities. On a checked sample its high-severity flags on skills were ~96% false positives — a documented command, a public API, a “never do X” rule — so we show them as a caution to read, not a verdict. Why →

  • high Anti-Refusal · line 657
    Skill instructs the agent to never refuse or to always comply. Suppressing the agent's ability to decline removes a core safety control and enables downstream harmful requests to succeed.
    Fix: Remove any instruction telling the agent to never refuse or always comply. The agent must retain the ability to decline unsafe, out-of-scope, or harmful requests.
How audits are shown
Origin original No closer match found in the catalogue.
Token cost

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.

ModelPer sessionOnce invoked
Fable 5.1 $0.00126 $0.05298
Opus 5 $0.00063 $0.02649
Sonnet 5 $0.00025 $0.01060
Haiku 4.5 $0.00013 $0.00530

Measured 9d ago against content hash 5e1265308aca, method: parsed. Prices are Anthropic first-party input rates as of 2026-09-12, from the pricing page.

Security

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 9d ago.

The scan reads SKILL.md. This mod also ships 1 executable file (scripts/gap_analyzer.py), listed below but not scanned — reading those needs a real analyzer, not pattern matching.

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.

Origin

Copies of this mod

8 near-identical copies found in the catalogue:

bundled/skills/iso-13485-certification/SKILL.md · 678 lines

How it starts

The opening of the file, as written. The whole thing — 678 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:

  1. 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
  2. Run gap analysis script:

    python scripts/gap_analyzer.py --docs-dir <path_to_docs> --output gap-report.json
    
  3. 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
  4. 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 breakdown
  • references/mandatory-documents.md - All 31 required procedures explained
  • references/gap-analysis-checklist.md - Detailed compliance checklist
  • references/quality-manual-guide.md - How to create Quality Manual

Read the full file on GitHub · 678 lines

Changes

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.

  1. 9d ago First seen · 678 lines · 126 tokens per session scan A 5e1265308aca

Subscribe to this mod's changes

iso-13485-certification is a skill published in the GitHub repository foryourhealth111-pixel/Vibe-Skills (3,252 stars, last pushed 12d ago), licensed Apache-2.0. It adds 126 tokens to every session and 5,298 once invoked, about $0.0006 per session on Opus 5. A static security scan graded it A with 0 findings. No closer match exists in the catalogue, so it is treated as the original; first seen 2026-09-03.

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