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AC qms-audit-expert

ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use for internal audit planning, audit execution, finding classification, external audit preparation, or audit program management.

modbender/skill-library-mcp Agent Skills author: modbender MIT 4 files body ≈ 2 346 tokens Open the sourcegithub.com↗ analyzed 2 d ago

ISO 13485 internal audit expertise for medical device QMS.

As a process C 50/100 · Has gaps — weak spots: result and completion, when it triggers, inputs and preconditions

AnalyzerQuality controltype and topics are labelled automatically from the skill text
Runs in: OpenClaw 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) Goose OpenCode
JSON
Technical rating
A
96/100
safety, quality, tests
Safety 60%
100
Quality 40%
90
Run on models
none yet
Process rating
C
50/100
Has gaps
Result and completion w 14
0
Inputs and preconditions w 11
0
Failures and branches w 10
0
the three weakest of ten parameters · all ten

How to improve

    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

    • note frontmatter-key unknown frontmatter key "triggers"

    Process rating: all ten parameters 50/100

    • 0Result and completion. Does not say what the result is
    • 0Inputs and preconditions. Does not say what the process needs to start
    • 0Failures and branches. Linear process with no failure handling
    • 20When it triggers. No condition that starts the skill
    • 30Running it twice. 1 mutating operations with no state check
    • 85Steps. 87 steps, 1 vague phrases
    • 100Tools and files. No external tools needed
    • 100Consistency. Name and required fields are in place
    • 100Execution cost. Instruction body is 2346 tokens
    • 100Progress reporting. Reports progress

    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 276: enough signal without eating the budget
    • +4Structure: 24 headings
    • +3Step-by-step instructions: 87 items
    • +4Has examples (5 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: 90.