Skills qms-audit-expert

📦

qms-audit-expert

Name: qms-audit-expert
Author: davila7

Content revision r2 Safe ⚙️ External commands🔑 Env variables

Plan ISO 13485 Quality Audits

Medical device teams need consistent ISO 13485 audit planning, evidence review, finding classification, and follow-up. This skill provides structured guidance for risk-based audits, CAPA verification, auditor competency, and external audit readiness.

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/davila7-qms-audit-expert.md and its manifest at https://skillstore.io/api/skills/davila7-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/davila7-qms-audit-expert.md Signed manifest GET /api/skills/davila7-qms-audit-expert/manifest Signed lockfile GET /api/skills/davila7-qms-audit-expert/lockfile

Test it

Using "qms-audit-expert". Create a focused audit plan for design controls after two late CAPAs and a major procedure change.

Expected outcome:

Priority: High because recent CAPA delays and process changes increase audit risk.
Scope: Design planning, inputs, outputs, reviews, verification, validation, transfer, and change control.
Evidence: Procedures, design history records, risk files, review minutes, traceability, training, and CAPA effectiveness records.
Follow-up: Assign owners and dates for evidence gaps before fieldwork begins.

Using "qms-audit-expert". Classify an isolated missing training signature when other records show completed training.

Expected outcome:

Suggested classification: Minor nonconformity, subject to the organization's approved criteria and additional evidence.
Rationale: The record is isolated, but it does not demonstrate full compliance with the training procedure.
Next step: Confirm training completion, assess related records, and determine whether a broader system failure exists.

Using "qms-audit-expert". Prepare a four-week readiness sequence for a certification body audit.

Expected outcome:

Four weeks before: Close overdue internal audit actions and confirm requested records.
Two weeks before: Conduct a mock audit and resolve document access or role gaps.
Audit week: Manage requests, evidence logs, daily summaries, escalation, and response approvals.
Afterward: Review findings, initiate CAPAs, assign owners, and schedule effectiveness checks.

Security Audit

Safe

v9 • 7/23/2026 Open versioned report

All 32 static findings are false positives caused by Markdown fences, inline filenames, and ordinary quality management terminology. The reviewed files contain no external command execution, environment access, network reconnaissance, prompt injection, or data exfiltration behavior.

Files scanned

319

Lines analyzed

Review items

False positives ignored

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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Academic citations (APA · BibTeX · CFF)

APA citation

davila7. (2026). qms-audit-expert security audit report (audit version 9) [Author version unspecified]. Skillstore. https://skillstore.io/skills/davila7-qms-audit-expert/audits/9

BibTeX citation

@techreport{davila7-davila7-qms-audit-expert-2026,
  author = {davila7},
  title = {qms-audit-expert security audit report (audit version 9)},
  institution = {Skillstore},
  year = {2026},
  number = {9},
  url = {https://skillstore.io/skills/davila7-qms-audit-expert/audits/9},
  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 9)"
version: "unspecified"
type: report
authors:
  - name: "davila7"
date-released: "2026-07-23"
url: "https://skillstore.io/skills/davila7-qms-audit-expert/audits/9"
identifiers:
  - type: other
    value: "skillstore:davila7-qms-audit-expert:audit:9"
    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 Current

davila7-qms-audit-expert

Skillstore Score 83

Evidence Confidence High

Skillstore usage 22

Updated

2026-08-21

alirezarezvani

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

Prioritize an annual audit program

Build an annual internal audit program that prioritizes processes using risk, prior results, CAPA performance, complaints, and operational changes.

Prepare a process audit

Prepare a process audit plan with scope, evidence sources, interview topics, finding criteria, and follow-up requirements.

Coordinate external audit readiness

Organize a readiness assessment, mock audit, document review, staff roles, issue escalation, and CAPA verification before an external assessment.

Try These Prompts

Create a basic checklist

Create an internal ISO 13485 audit checklist for [process]. Include objectives, scope, evidence sources, interview questions, and relevant clause areas.

Plan a risk-based schedule

Build a risk-based annual audit schedule for [organization]. Use process criticality, prior findings, changes, complaints, and CAPA performance. Explain each frequency and scope decision.

Evaluate findings and CAPA

Review these audit observations: [observations]. Classify each as a major nonconformity, minor nonconformity, observation, or best practice. Identify evidence gaps and CAPA follow-up needs.

Prepare for an external audit

Design an external audit readiness program for [audit type] scheduled on [date]. Include a mock audit, document review, role assignments, escalation, CAPA verification, and daily coordination. Highlight unresolved risks and required evidence.

Best Practices

Provide current procedures, process maps, metrics, prior findings, CAPA status, complaints, and recent changes before requesting an audit plan.
Separate objective evidence, applicable requirements, finding statements, risk judgments, and recommended actions in every audit record.
Confirm cited clauses and regulatory expectations against current official sources before approving audit criteria or responses.

Avoid

Do not assign finding severity from assumptions or incomplete evidence.
Do not treat generic guidance as a certification decision, regulatory conclusion, or legal opinion.
Do not rely on named resources that are absent from the installed skill.

Frequently Asked Questions

Does this skill conduct a certification audit?

No. It supports planning and preparation, but only an authorized certification body can perform certification activities.

Can it classify audit findings?

Yes. Provide the requirement, objective evidence, process context, and approved classification criteria for a supported assessment.

Does the package include audit scripts and templates?

No. The named specialized resources are absent, and the bundled script, reference, and asset files are placeholders.

Can it support regulatory inspection readiness?

Yes. It can organize document review, mock audits, staff roles, evidence handling, escalation, and follow-up planning.

What information produces the strongest audit plan?

Provide scope, processes, applicable requirements, procedures, metrics, changes, complaints, prior findings, CAPA status, timing, and available auditors.

Does it replace auditor independence and competence controls?

No. The organization must assign qualified, independent auditors and approve the final scope, evidence, findings, and corrective actions.