Skill · em Documentar e entregar

quality-manager-qms-iso13485

ISO 13485 Quality Management System specialist for medical device companies. Provides QMS implementation, maintenance, process optimization, and compliance expertise. Use for QMS design, documentation control, management review, internal auditing, corrective actions, and ISO 13485 certification…

Procedência

Origem: davila7/claude-code-templates
Caminho: cli-tool/components/skills/enterprise-communication/quality-manager-qms-iso13485
Versão fixada: 57f899e5394bb8ca166f38eacae8f0853cbfe033
Licença: MIT
Espelhado em 25/09/2026
nenhum download no Claude Code Templates (lido em 25/09/2026)

Antes de instalar

4 arquivos · 9,8 KB · inclui 1 script que executa: scripts/example.py

Instalar na sua CLI

O comando baixa a versão fixada (commit 57f899e) direto da origem, para a pasta que a CLI lê. Precisa de curl (macOS e Linux); no Windows não há comando, porque o Rook Labs é para macOS.

Claude Code

Neste projeto: instala em .claude/skills/quality-manager-qms-iso13485/.

d=".claude/skills/quality-manager-qms-iso13485"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/quality-manager-qms-iso13485"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/api_reference.md" "$u/references/api_reference.md" \
  -o "$d/scripts/example.py" "$u/scripts/example.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Global: instala em ~/.claude/skills/quality-manager-qms-iso13485/.

d="$HOME/.claude/skills/quality-manager-qms-iso13485"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/quality-manager-qms-iso13485"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/api_reference.md" "$u/references/api_reference.md" \
  -o "$d/scripts/example.py" "$u/scripts/example.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Codex

Neste projeto: instala em .agents/skills/quality-manager-qms-iso13485/.

d=".agents/skills/quality-manager-qms-iso13485"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/quality-manager-qms-iso13485"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/api_reference.md" "$u/references/api_reference.md" \
  -o "$d/scripts/example.py" "$u/scripts/example.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Global: instala em ~/.agents/skills/quality-manager-qms-iso13485/.

d="$HOME/.agents/skills/quality-manager-qms-iso13485"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/quality-manager-qms-iso13485"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/api_reference.md" "$u/references/api_reference.md" \
  -o "$d/scripts/example.py" "$u/scripts/example.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Antigravity

Neste projeto: instala em .agents/skills/quality-manager-qms-iso13485/.

d=".agents/skills/quality-manager-qms-iso13485"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/quality-manager-qms-iso13485"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/api_reference.md" "$u/references/api_reference.md" \
  -o "$d/scripts/example.py" "$u/scripts/example.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Global: instala em ~/.gemini/antigravity-cli/skills/quality-manager-qms-iso13485/.

d="$HOME/.gemini/antigravity-cli/skills/quality-manager-qms-iso13485"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/quality-manager-qms-iso13485"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/api_reference.md" "$u/references/api_reference.md" \
  -o "$d/scripts/example.py" "$u/scripts/example.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Peça ao Rook

Já usa o Rook Labs? Cole no chat do Rook: instale a skill https://rooklabs.sh/marketplace/cct.quality-manager-qms-iso13485

Prévia do SKILL.md

---
name: quality-manager-qms-iso13485
description: ISO 13485 Quality Management System specialist for medical device companies. Provides QMS implementation, maintenance, process optimization, and compliance expertise. Use for QMS design, documentation control, management review, internal auditing, corrective actions, and ISO 13485 certification activities.
---

# Senior Quality Manager - QMS ISO 13485 Specialist

Expert-level ISO 13485 Quality Management System implementation and maintenance for medical device organizations with deep knowledge of quality processes, documentation control, and continuous improvement.

## Core QMS Competencies

### 1. ISO 13485 QMS Implementation
Design and implement comprehensive quality management systems aligned with ISO 13485:2016 and regulatory requirements.

**Implementation Workflow:**
1. **Gap Analysis and Planning**
- Current state assessment against ISO 13485 requirements
- Gap identification and prioritization
- Implementation roadmap development
- Resource allocation and timeline planning

2. **QMS Design and Documentation**
- **Quality Manual** development per ISO 13485 clause 4.2.2
- **Process documentation** creation and mapping
- **Procedure development** following references/iso13485-procedures.md
- **Work instruction** standardization

3. **Process Implementation**
- Cross-functional training and competency development
- Process deployment and monitoring
- Performance metrics establishment
- Feedback loop integration

### 2. Document Control System (ISO 13485 Clause 4.2.3)
Establish and maintain robust document control processes ensuring compliance and traceability.

**Document Control Framework:**
```
DOCUMENT LIFECYCLE MANAGEMENT
├── Document Creation and Approval
…

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