quality-manager-qms-iso13485

quality-manager-qms-iso13485 is a skill for Claude Code from robertbstillwell/marketing-skills. It costs 43 tokens per session (4,273 once invoked), scanned A, original, no licence file.

A guide to building and maintaining an ISO 13485 quality-management system for medical-device organisations. It covers system design, controlled documentation, internal audits, corrective and preventive actions (CAPA), and certification preparation.

In plain words
What is it for?
Use it for QMS design, document control, internal auditing, CAPA management, and certification support.
Why use it?
It helps organisations create repeatable quality processes and prepare their system for certification.

Skill for Claude Code

Written for Claude Code: shipped in a Claude Code plugin.

Part of the ra-qm-skills plugin — 12 skills shipped together

Good fit Use it for QMS design, document control, internal auditing, CAPA management, and certification support.

Compare 6 skills from other repositories ↓
Install with agentmods
npx agentmods add skills/robertbstillwell/marketing-skills/quality-manager-qms-iso13485
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 robertbstillwell/marketing-skills --skill quality-manager-qms-iso13485
Clone the repo
git clone --depth 1 https://github.com/robertbstillwell/marketing-skills

Made for: Claude Code.

Or install ra-qm-skills, the plugin that ships this one along with the rest of its 12 skills.

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 quality-manager-qms-iso13485

README.md
[![agentmods](https://agentmods.dev/badge/skills/robertbstillwell/marketing-skills/quality-manager-qms-iso13485/github.svg)](https://agentmods.dev/skills/robertbstillwell/marketing-skills/quality-manager-qms-iso13485)
Your own site
<a href="https://agentmods.dev/skills/robertbstillwell/marketing-skills/quality-manager-qms-iso13485"><img src="https://agentmods.dev/badge/skills/robertbstillwell/marketing-skills/quality-manager-qms-iso13485/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 quality-manager-qms-iso13485

Your own site · 80×15
<a href="https://agentmods.dev/skills/robertbstillwell/marketing-skills/quality-manager-qms-iso13485"><img src="https://agentmods.dev/badge/skills/robertbstillwell/marketing-skills/quality-manager-qms-iso13485.svg" alt="Reviewed on agentmods" width="80" height="20"></a>
Per session 43 Skills are progressive disclosure: only the name and description are preloaded; the body loads when the skill is used.
When invoked 4,273 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.
Origin unknown 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 $0.00043 $0.04273
Opus 5.5 $0.00017 $0.01709
Sonnet 5.5 $0.00009 $0.00855
Haiku 4.5 $0.00004 $0.00427

Measured 1mo ago against content hash 97a3a8796584, method: parsed. Prices are Anthropic first-party input rates as of 2026-10-07, from the pricing page.

Security

Grade A, and why

quality-manager-qms-iso13485 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.

The scan reads SKILL.md. This mod also ships 1 executable file (scripts/qms_audit_checklist.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.

alirezarezvani/ra-qm-team/quality-manager-qms-iso13485/SKILL.md · 494 lines

The source is not reproduced here

No licence file

A repository with no LICENSE is all rights reserved by default, so the body is not copied here. The metadata, the measurements and the link are.

Read it on GitHub

Files

What ships with it

3 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.

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. 1mo ago First seen · 494 lines · 43 tokens per session scan A 97a3a8796584

Subscribe to this mod's changes

quality-manager-qms-iso13485 is a skill published in the GitHub repository robertbstillwell/marketing-skills (29 stars, last pushed 8mo ago), with no licence file. It adds 43 tokens to every session and 4,273 once invoked, about $0.0002 per session on Opus 5.5. 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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