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AF quality-manager-qms-iso13485

ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support. Use when working with medical device quality systems, preparing for ISO 13485 audits, managing regulatory compliance documentation, setting up corrective actions, or building audit preparation programs. Useful for quality management, audit preparation, regulatory compliance, medical device documentation, and corrective action workflows.

alirezarezvani/claude-skills Agent Skills author: alirezarezvani MIT 4 files body ≈ 4 225 tokens Open the sourcegithub.com↗ analyzed 2 d ago

ISO 13485 Quality Management System implementation and maintenance for medical device organizations.

As a process F 42/100 · Will not run — References files that are not bundled: ../quality-manager-qmr/, ../capa-officer/, ../qms-audit-expert/

ProcedureQuality controltype and topics are labelled automatically from the skill text
Runs in: Claude / Claude Code ChatGPT / Codex Gemini CLI Cursor GitHub Copilot / VS Code Qwen Code Kimi Code CLI Z.ai (GLM) DeepSeek (Deep Code) Mistral Vibe LangChain (deepagents) OpenClaw Goose OpenCode
JSON
Technical rating
A
91/100
safety, quality, tests
Safety 60%
100
Quality 40%
78
Run on models
none yet
Process rating
F
42/100
Will not run
References files that are not bundled: ../quality-manager-qmr/, ../capa-officer/, ../qms-audit-expert/
Tools and files w 18
0
Failures and branches w 10
0
Progress reporting w 2
0
the three weakest of ten parameters · all ten

How to improve

  1. The text references files that are not there: add them or drop the references.
For the model run — optional
  • Your own cases (evals/evals.json, 4–6 real requests with expected answers): the full check would then run those instead of a model-drafted suite.
  • A spec.yaml with trigger phrases and assertions — a behaviour contract for CI; `skilltest init` writes a template.

Guard findings · 0

✓ No critical or high findings

Files scanned: 4. Evidence is masked. Grey chips explain why severity was lowered.

Against the Agent Skills spec

  • warning missing-ref reference to a missing file: ../quality-manager-qmr/
  • warning missing-ref reference to a missing file: ../capa-officer/
  • warning missing-ref reference to a missing file: ../qms-audit-expert/
  • warning missing-ref reference to a missing file: ../quality-documentation-manager/
  • warning missing-ref reference to a missing file: ../risk-management-specialist/
  • note frontmatter-key unknown frontmatter key "triggers"
  • note edit-residue the text marks something as outdated (lines 308, 310, 312, 313, 314, 315): check that old rules are not kept next to new ones — the full check reads the text for contradictions

Process rating: all ten parameters 42/100

Will not run. References files that are not bundled: ../quality-manager-qmr/, ../capa-officer/, ../qms-audit-expert/
  • 0Tools and files. 5 referenced file(s) missing: ../quality-manager-qmr/, ../capa-officer/, ../qms-audit-expert/
  • 0Failures and branches. Linear process with no failure handling
  • 0Progress reporting. Says nothing while it works
  • 20When it triggers. No condition that starts the skill
  • 30Running it twice. 3 mutating operations with no state check
  • 40Result and completion. Does not say what the result is
  • 70Inputs and preconditions. Inputs and preconditions are listed
  • 70Execution cost. Instruction body is 4225 tokens
  • 85Steps. 104 steps, 1 vague phrases
  • 100Consistency. Name and required fields are in place
  • low 10 top-level sections: this looks like several domains in one skill

Everything here is measured from the skill text rather than judged by a model, so the numbers are checkable. A parameter weighs more when it is a more common reason for the process to stall.

Quality signals

  • +5Description has no quoted example phrases that should trigger the skill
  • +4Description does not say when NOT to use the skill (false activations)
  • +3Output format is not stated: the model decides each time
  • +1No license
  • +2Single-language instructions
  • +3Description length 546: enough signal without eating the budget
  • +4Structure: 38 headings
  • +3Step-by-step instructions: 104 items
  • +4Has examples (1 code blocks)
  • +4Reference files are cited in the instructions (2 of 2)
  • +3All 1 scripts are documented

Quality base 70; lint remarks subtract, signals add up to 100. Result: 78.