Build ISO 13485 QMS Programs
Medical device teams need controlled QMS processes that match ISO 13485 expectations. This skill helps plan documentation, audits, reviews, CAPA work, and certification readiness.
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Review the Skillstore skill "quality-manager-qms-iso13485" from https://skillstore.io/skills/alirezarezvani-quality-manager-qms-iso13485.md and its manifest at https://skillstore.io/api/skills/alirezarezvani-quality-manager-qms-iso13485/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 "quality-manager-qms-iso13485". Need to prepare a document control procedure for ISO 13485.
Expected outcome:
A structured procedure outline covering document creation, review, approval, release, distribution, change control, retention, and obsolete document handling.
Using "quality-manager-qms-iso13485". Need a management review for the next quarter.
Expected outcome:
An agenda, input checklist, decision log outline, action tracker, and follow-up verification plan for leadership review.
Using "quality-manager-qms-iso13485". Need an internal audit schedule for the next year.
Expected outcome:
A risk-based audit calendar with process priorities, audit criteria, auditor assignments, reporting expectations, and CAPA follow-up checkpoints.
All 16 static findings are false positives caused by Markdown fences, inline resource names, and ordinary QMS terms. I found no executable command invocation, environment access, prompt injection text, or data exfiltration intent in the reviewed files.
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https://skillstore.io/skills/alirezarezvani-quality-manager-qms-iso13485/audits/6?utm_source=security_passport&utm_medium=share&utm_campaign=versioned_report[](https://skillstore.io/skills/alirezarezvani-quality-manager-qms-iso13485?utm_source=security_passport_badge)<a href="https://skillstore.io/skills/alirezarezvani-quality-manager-qms-iso13485?utm_source=security_passport_badge"><img src="https://skillstore.io/badges/skills/alirezarezvani-quality-manager-qms-iso13485/security.svg" alt="Skillstore security assessment" loading="lazy"></a><iframe src="https://skillstore.io/embed/skills/alirezarezvani-quality-manager-qms-iso13485.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). quality-manager-qms-iso13485 security audit report (audit version 6) [Author version unspecified]. Skillstore. https://skillstore.io/skills/alirezarezvani-quality-manager-qms-iso13485/audits/6@techreport{alirezarezvani-alirezarezvani-quality-manager-qms-iso13485-2026,
author = {alirezarezvani},
title = {quality-manager-qms-iso13485 security audit report (audit version 6)},
institution = {Skillstore},
year = {2026},
number = {6},
url = {https://skillstore.io/skills/alirezarezvani-quality-manager-qms-iso13485/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: "quality-manager-qms-iso13485 security audit report (audit version 6)"
version: "unspecified"
type: report
authors:
- name: "alirezarezvani"
date-released: "2026-07-06"
url: "https://skillstore.io/skills/alirezarezvani-quality-manager-qms-iso13485/audits/6"
identifiers:
- type: other
value: "skillstore:alirezarezvani-quality-manager-qms-iso13485: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-quality-manager-qms-iso13485
2026-08-21
alirezarezvani-quality-manager-qms-iso13485
2026-08-21
Build a phased ISO 13485 implementation roadmap with gap priorities, documentation needs, training actions, and process metrics.
Prepare internal audit scopes, evidence checklists, management review inputs, and certification follow-up actions.
Organize nonconformity handling, root cause analysis, corrective actions, and effectiveness verification across QMS processes.
Create an ISO 13485 QMS gap analysis plan for a small medical device company. Include evidence to collect and priority levels.
Draft a document control workflow for SOPs, work instructions, and forms. Include approval steps, version control, distribution, retention, and change control.
Prepare a management review agenda and input checklist for ISO 13485 clause 5.6. Include metrics, decisions, and action tracking.
Build a risk-based internal audit plan for the next year. Include process priorities, auditor needs, CAPA follow-up, and effectiveness checks.
Author
alirezarezvaniLicense
MIT
Skillstore revision
r1
Version notice
The author did not declare a version.
Repository
https://github.com/alirezarezvani/claude-skills/tree/main/ra-qm-team/quality-manager-qms-iso13485Ref
c1fdca50ff516318f65fed0d7f9e82797c5171dc
Maintenance freshness
7/18/2026
Usage
24 downloads · 215 views
File structure
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