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.
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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.
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Using "qms-audit-expert". Create a risk-based audit plan for design controls, purchasing, production, and CAPA.
Expected outcome:
Using "qms-audit-expert". Help document a nonconformity for incomplete design verification records.
Expected outcome:
Using "qms-audit-expert". Plan a follow-up audit for a training CAPA.
Expected outcome:
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.
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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[](https://skillstore.io/skills/alirezarezvani-qms-audit-expert?utm_source=security_passport_badge)<a href="https://skillstore.io/skills/alirezarezvani-qms-audit-expert?utm_source=security_passport_badge"><img src="https://skillstore.io/badges/skills/alirezarezvani-qms-audit-expert/security.svg" alt="Skillstore security assessment" loading="lazy"></a><iframe src="https://skillstore.io/embed/skills/alirezarezvani-qms-audit-expert.html" title="Skillstore Security Assessment" sandbox="allow-popups allow-popups-to-escape-sandbox" loading="lazy" referrerpolicy="no-referrer" width="420" height="180"></iframe>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@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}
}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"
Each author remains a separate installable skill. The recommended variant is ranked by Skillstore evidence.
Why this variant is first
davila7-qms-audit-expert
2026-08-21
alirezarezvani-qms-audit-expert
2026-08-21
Create a risk-based schedule, define process scope, and assign auditors by competency and independence.
Turn ISO 13485 clauses and internal procedures into focused questions, evidence targets, and interview topics.
Plan follow-up evidence collection to confirm that audit findings were corrected and recurrence risk was reduced.
Create an ISO 13485 internal audit plan for these processes: [list processes]. Include scope, criteria, timing, and expected evidence.
Prepare audit questions for ISO 13485 clause [clause]. Include objective evidence, interview prompts, and common nonconformity examples.
Classify these audit observations as major, minor, observation, or best practice: [paste observations]. Explain the requirement and evidence for each.
Design a follow-up audit for this CAPA: [describe CAPA]. Include sampling, records to review, interviews, and effectiveness criteria.
Author
alirezarezvaniLicense
MIT
Skillstore revision
r1
Version notice
The author did not declare a version.
Ref
c1fdca50ff516318f65fed0d7f9e82797c5171dc
Maintenance freshness
7/18/2026
Usage
16 downloads · 178 views
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