Qms Audit Expert

What it does

When your agent uses it

• Planning internal audits
• Executing audits
• Classifying findings
• Preparing for external audits

Example prompts

• “/qms-audit-expert”

Requirements

• Python 3

Workflow steps

8 steps, taken from the first numbered list in SKILL.md.

1. 1List all QMS processes requiring audit
2. 2Assign risk level to each process (High/Medium/Low)
3. 3Review previous audit findings and trends
4. 4Determine audit frequency by risk level
5. 5Assign qualified auditors (verify independence)
6. 6Create annual audit schedule
7. 7Communicate schedule to process owners
8. 8Validation: All ISO 13485 clauses covered within cycle

What it can do on your machine

Read from SKILL.md and the folder at commit 19392f7. It shows what the files ask for, not the result of running them.

• Tool permissions

  Pre-approves nothing: there is no allowed-tools line, so your agent's usual permission prompts apply.

  From allowed-tools in the SKILL.md frontmatter.

• Runs code

  Ships 1 file in scripts/ (Python), which the agent can run.

  Shell commands in SKILL.md call:

  • python

  From the folder's file list and the shell code blocks in SKILL.md.

• Network

  No URLs in SKILL.md.

  From URLs in SKILL.md, links to its own repository left out.

• Credentials

  Names no API keys, tokens, secrets or passwords.

  From names ending in _API_KEY, _TOKEN, _SECRET, _KEY or _PASSWORD in SKILL.md.

Context cost

Qms Audit Expert loads about 2.4k tokens when it runs, and up to ~9.4k if it reads all its reference files. Until then it costs about 75 tokens; SKILL.md has 838 words of instructions outside code blocks.

Always · name and description, kept in context so the agent knows when to use it

~75

When it runs · the whole SKILL.md, loaded when a task matches

~2.4k

With references · SKILL.md plus every file in references/, read only if the agent opens them

~9.4k

Estimates: characters ÷ 4, the usual rule of thumb; real counts depend on the model's tokenizer. Scripts and assets cost tokens only if the agent reads them.

Safety

Automated static check — not a guarantee. Review scripts before installing. It scans the text of SKILL.md for risky patterns (piping downloads into a shell, reading credential files, hidden Unicode, destructive commands); the scripts in this folder are not scanned.

SKILL.md

The full file from alirezarezvani/claude-skills at commit 19392f7, republished under its MIT licence (© alirezarezvani). 838 words, ~2,406 tokens.

name

qms-audit-expert

description

ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use when planning internal audits, executing audits, classifying findings, preparing for external audits, or managing an audit program.

triggers

ISO 13485 audit, internal audit, QMS audit, audit planning, nonconformity classification, CAPA verification, audit checklist, audit finding, external audit…

Requirement: [Specific ISO 13485 clause or procedure]
Evidence: [What was observed, reviewed, or heard]
Gap: [How evidence fails to meet requirement]

Requirement: ISO 13485:2016 Clause 7.6 requires calibration
at specified intervals.

Evidence: Calibration records for pH meter (EQ-042) show
last calibration 2024-01-15. Calibration interval is
12 months. Today is 2025-03-20.

Gap: Equipment is 2 months overdue for calibration,
representing a gap in calibration program execution.

Is required element absent or failed?
├── Yes → Systematic (multiple instances)? → MAJOR
│   └── No → Could affect product safety? → MAJOR
│       └── No → MINOR
└── No → Deviation from procedure?
    ├── Yes → Recurring? → MAJOR
    │   └── No → MINOR
    └── No → Improvement opportunity? → OBSERVATION

# Generate optimized audit schedule
python scripts/audit_schedule_optimizer.py --processes processes.json

# Interactive mode
python scripts/audit_schedule_optimizer.py --interactive

# JSON output for integration
python scripts/audit_schedule_optimizer.py --processes processes.json --output json

{
  "processes": [
    {
      "name": "Design Control",
      "iso_clause": "7.3",
      "risk_level": "HIGH",
      "last_audit_date": "2024-06-15",
      "previous_findings": 2
    },
    {
      "name": "Document Control",
      "iso_clause": "4.2",
      "risk_level": "MEDIUM",
      "last_audit_date": "2024-09-01",
      "previous_findings": 0
    }
  ]
}

© alirezarezvani, MIT. Rendered from Markdown: HTML in the file is shown as text, images as links, and headings moved down two levels. Raw file

Files

SKILL.md and 4 other files (scripts, references) in ra-qm-team/skills/qms-audit-expert of alirezarezvani/claude-skills.

• SKILL.md
• references/iso13485-audit-guide.md
• references/iso13485_audit_playbook.md
• references/nonconformity-classification.md
• scripts/audit_schedule_optimizer.py

Open the folder on GitHubat commit 19392f7

Used in 1 other repository

We found 1 copy of this SKILL.md (exact, near-identical or edited) in other folders, from 1 other GitHub owner. This page covers the copy in alirezarezvani/claude-skills, which our catalogue first saw on October 7, 2026.

• LeoYeAI/openclaw-master-skillsskills/qms-audit-expert