Skills qms-audit-expert

📦

qms-audit-expert

Name: qms-audit-expert
Author: alirezarezvani

Content revision r1 Safe ⚙️ External commands🔑 Env variables

Plan ISO 13485 QMS Audits

Medical device teams need consistent QMS audits for ISO 13485 readiness. This skill guides planning, execution, findings, and CAPA follow-up.

Supports: Claude Codex Code(CC)

🥇 83 Gold

Install with my Agent

Copy this request to your Agent. It includes the canonical Skill page and manifest.

Agent request

Review the Skillstore skill "qms-audit-expert" from https://skillstore.io/skills/alirezarezvani-qms-audit-expert.md and its manifest at https://skillstore.io/api/skills/alirezarezvani-qms-audit-expert/manifest. Verify the artifact. You may proceed after verification, subject to the environment's own policy.

Your Agent should still show its plan and request any confirmation required by the security policy.

Agent-readable resources

Use these links when an AI agent, crawler, or script needs clean context instead of reading the full page.

Markdown detail GET /skills/alirezarezvani-qms-audit-expert.md Signed manifest GET /api/skills/alirezarezvani-qms-audit-expert/manifest Signed lockfile GET /api/skills/alirezarezvani-qms-audit-expert/lockfile

Test it

Using "qms-audit-expert". Create a risk-based audit plan for design controls, purchasing, production, and CAPA.

Expected outcome:

High priority: design controls and CAPA, with deeper sampling and senior auditor assignment.
Medium priority: purchasing and production, with supplier controls and process validation evidence.
Follow-up: review prior findings, open CAPAs, complaint trends, and management review inputs.

Using "qms-audit-expert". Help document a nonconformity for incomplete design verification records.

Expected outcome:

Requirement: link the finding to the applicable ISO 13485 design control clause and procedure.
Evidence: identify affected records, product scope, missing verification, and sampled files.
Classification: assess whether the gap is systemic before assigning major or minor severity.

Using "qms-audit-expert". Plan a follow-up audit for a training CAPA.

Expected outcome:

Review revised training procedures, training records, role assignments, and completion evidence.
Interview personnel to confirm understanding of the changed process.
Check recurrence indicators through recent deviations, complaints, or process monitoring results.

Security Audit

Safe

v6 • 7/6/2026 Open versioned report

All 55 static findings were adjudicated as false positives. The cited evidence consists of Markdown fences, inline filename formatting, JSON strings, and QMS audit terminology; no command execution, environment access, reconnaissance, or prompt injection intent was found. The bundled placeholder and evaluation files may still confuse scanners and should be cleaned before publication.

Files scanned

717

Lines analyzed

Review items

False positives ignored

Risk Factors

⚙️ External commands (24)

🔑 Env variables (28)

No confirmed security findings were detected by the latest completed static and semantic audit. This does not prove the skill has no side effects.

Audited by: codex View Audit History →

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Open versioned report

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https://skillstore.io/skills/alirezarezvani-qms-audit-expert/audits/6?utm_source=security_passport&utm_medium=share&utm_campaign=versioned_report

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Academic citations (APA · BibTeX · CFF)

APA citation

alirezarezvani. (2026). qms-audit-expert security audit report (audit version 6) [Author version unspecified]. Skillstore. https://skillstore.io/skills/alirezarezvani-qms-audit-expert/audits/6

BibTeX citation

@techreport{alirezarezvani-alirezarezvani-qms-audit-expert-2026,
  author = {alirezarezvani},
  title = {qms-audit-expert security audit report (audit version 6)},
  institution = {Skillstore},
  year = {2026},
  number = {6},
  url = {https://skillstore.io/skills/alirezarezvani-qms-audit-expert/audits/6},
  note = {Author version unspecified}
}

CITATION.cff

cff-version: 1.2.0
message: "If you use this Skill, cite its author and this versioned security audit report."
title: "qms-audit-expert security audit report (audit version 6)"
version: "unspecified"
type: report
authors:
  - name: "alirezarezvani"
date-released: "2026-07-06"
url: "https://skillstore.io/skills/alirezarezvani-qms-audit-expert/audits/6"
identifiers:
  - type: other
    value: "skillstore:alirezarezvani-qms-audit-expert:audit:6"
    description: "Skillstore immutable audit report identifier"

Compare variants

2 installable variants

Each author remains a separate installable skill. The recommended variant is ranked by Skillstore evidence.

Why this variant is first

Higher Skillstore usage

Author / source Skillstore Score Evidence Confidence Skillstore usage Updated

davila7 Recommended

davila7-qms-audit-expert

Skillstore Score 83

Evidence Confidence High

Skillstore usage 22

Updated

2026-08-21

alirezarezvani Current

alirezarezvani-qms-audit-expert

Skillstore Score 83

Evidence Confidence High

Skillstore usage 21

Updated

2026-08-21

Skillstore Score

Why this score Evidence Confidence: High

Architecture

Maintainability

Content

Community

Spec Compliance

What You Can Build

Build an Annual Audit Program

Create a risk-based schedule, define process scope, and assign auditors by competency and independence.

Prepare an Audit Checklist

Turn ISO 13485 clauses and internal procedures into focused questions, evidence targets, and interview topics.

Verify Corrective Actions

Plan follow-up evidence collection to confirm that audit findings were corrected and recurrence risk was reduced.

Try These Prompts

Create a Simple Audit Plan

Create an ISO 13485 internal audit plan for these processes: [list processes]. Include scope, criteria, timing, and expected evidence.

Build a Clause Checklist

Prepare audit questions for ISO 13485 clause [clause]. Include objective evidence, interview prompts, and common nonconformity examples.

Classify Audit Findings

Classify these audit observations as major, minor, observation, or best practice: [paste observations]. Explain the requirement and evidence for each.

Design CAPA Follow-Up

Design a follow-up audit for this CAPA: [describe CAPA]. Include sampling, records to review, interviews, and effectiveness criteria.

Best Practices

Define audit criteria and evidence targets before interviews begin.
Use risk, prior findings, complaints, and process performance to set audit frequency.
Tie every finding to a requirement, objective evidence, and a clear CAPA decision.

Avoid

Do not audit only documents when process observation is needed.
Do not classify findings before reviewing requirement impact and recurrence risk.
Do not let auditors assess work where independence is not established.