# Build an ISO 13485 Quality Management System

Medical device teams need structured quality processes that align with ISO 13485. This skill provides practical guidance for QMS design, audits, CAPA, and reviews.

## Install

```bash
npx skillstore add davila7/quality-manager-qms-iso13485
```

## Metadata

- Status: approved
- Slug: davila7-quality-manager-qms-iso13485
- Skillstore revision: r2
- Version status: missing
- Tree hash: 1de2e5f1549f7aa903e0efc09d3c7f19415d78b8204861251464777b8c7bb50f
- Author: davila7
- GitHub username: davila7
- License: MIT
- Repository: https://github.com/davila7/claude-code-templates/tree/main/cli-tool/components/skills/enterprise-communication/quality-manager-qms-iso13485
- Ref: c43861a65bb95efcae259cd161c9d6f4dc7eec6f
- Supported tools: Claude, Codex, Claude Code
- Audit status: complete
- Agent install advisory: allowed
- Manual install advisory: allowed
- Artifact signature: available
- Audit attestation: unavailable
- Human verification: not\_verified
- Risk factors: external\_commands, env\_access
- Quality score: 84
- Quality tier: gold
- Public page: https://skillstore.pages.dev/skills/davila7-quality-manager-qms-iso13485
- Manifest: https://skillstore.pages.dev/api/skills/davila7-quality-manager-qms-iso13485/manifest

## Capabilities

- Structures ISO 13485 gap analyses and implementation roadmaps.
- Outlines document control workflows for approval, distribution, revision, retention, and disposal.
- Plans management reviews using required inputs, decisions, actions, and effectiveness follow-up.
- Designs risk-based internal audit programs and audit follow-up activities.
- Connects design controls, ISO 14971 risk management, supplier quality, and QMS monitoring.
- Defines quality indicators for complaints, audits, CAPA, training, and process performance.

## Use Cases

- Plan a QMS implementation: Create a prioritized ISO 13485 gap assessment and implementation roadmap for a growing medical device organization.
- Prepare an internal audit: Develop a risk-based audit scope, criteria, schedule, interview plan, and follow-up process.
- Organize management review: Compile QMS performance inputs, decisions, assigned actions, and effectiveness checks for leadership review.

## Prompt Templates

### Create a QMS checklist

```
Create a beginner-friendly ISO 13485 QMS checklist for [organization type]. Cover documents, responsibilities, training, audits, CAPA, and management review.
```

### Assess document control

```
Review this document control process: [process summary]. Identify gaps in approval, access, revision, retention, external documents, and obsolete document handling.
```

### Design an audit program

```
Design a risk-based internal audit program for [QMS scope]. Include priorities, frequency, auditor competence, evidence, reporting, CAPA, and effectiveness verification.
```

### Develop an integrated improvement plan

```
Analyze these QMS metrics and findings: [data]. Propose priorities integrating ISO 13485, ISO 14971, supplier controls, CAPA, and management review.
```

## Limitations

- It provides guidance and draft structures, not legal advice or certification approval.
- Users must verify current standards, regulations, and jurisdiction-specific requirements.
- Referenced scripts, templates, and supporting documents may not be available in the installed skill.
- Outputs require review against the organization, device class, products, and established procedures.

## Best Practices

- Provide the organization scope, device types, markets, current procedures, and known quality issues.
- Request traceable outputs that identify applicable clauses, evidence, owners, due dates, and effectiveness checks.
- Review every draft with qualified quality, regulatory, process, and product stakeholders before controlled release.

## Anti Patterns

- Do not treat generated content as certification, legal advice, or regulatory approval.
- Do not create generic procedures without matching actual responsibilities, systems, records, and product risks.
- Do not close audit findings or CAPAs without objective evidence and effectiveness verification.

## Security Audit

- Audited at: 2026-07-23T13:53:48.221\+00:00
- Summary: All 16 static findings are false positives caused by Markdown code fences, inline filenames, and ordinary quality-management text. No command execution, environment access, prompt injection, or other semantic security concern was found.

## Stats

- Views: 204
- Downloads: 7
- Favorites: 0
- Popularity score: 0