ra-qm-skills – Documents & Office skill for AI agents

Router/index for the 15 regulatory & quality-management skills bundled in this plugin (ISO 13485 QMS, EU MDR 2017/745, FDA submissions under QMSR, ISO 14971 risk, CAPA, document control, ISO 27001/ISMS, ISO 42001 AIMS, EU AI Act, GDPR/DSGVO, SOC 2, auditing). Use when a compliance request doesn't obviously match one sk

Documents & OfficeSKILL.mdClaude Code · Codex · Hermes · DeepSeek

Install the ra-qm-skills skill with one command

Pick the tool you use, copy the command and paste it in your terminal. The skill lands in that tool's skills folder and is ready in your next session.

Claude Code

mkdir -p ~/.claude/skills && curl -fsSL https://skill.dn1nguoi.com/z/ra-qm-skills-78ada.tgz | tar xz -C ~/.claude/skills

Call it in Claude Code: /ra-qm-skills – then describe the task you want done.

Codex

mkdir -p ~/.codex/skills && curl -fsSL https://skill.dn1nguoi.com/z/ra-qm-skills-78ada.tgz | tar xz -C ~/.codex/skills

Call it in Codex: $ra-qm-skills – then describe the task you want done.

Hermes Agent

mkdir -p ~/.hermes/skills && curl -fsSL https://skill.dn1nguoi.com/z/ra-qm-skills-78ada.tgz | tar xz -C ~/.hermes/skills

Call it in Hermes Agent: /ra-qm-skills – then describe the task you want done.

DeepSeek

mkdir -p ~/.deepcode/skills && curl -fsSL https://skill.dn1nguoi.com/z/ra-qm-skills-78ada.tgz | tar xz -C ~/.deepcode/skills

Call it in DeepSeek: /ra-qm-skills – then describe the task you want done.

SKILL.md content

Regulatory Affairs & Quality Management Skills — Router

This plugin bundles 15 compliance skills for HealthTech/MedTech organizations (this router is the 16th folder under ra-qm-team/skills/). Each skill is self-contained.

Routing table

Match the request, then load ra-qm-team/skills/<skill>/SKILL.md. If multiple rows match, ask one clarifying question first.

| Request signals | Skill | Path |

|---|---|---|

| Regulatory strategy, pathway selection, submissions planning | regulatory-affairs-head | skills/regulatory-affairs-head/ |

| Management review, quality KPIs, QMR governance | quality-manager-qmr | skills/quality-manager-qmr/ |

| ISO 13485 QMS implementation, process control | quality-manager-qms-iso13485 | skills/quality-manager-qms-iso13485/ |

| ISO 14971 risk analysis, FMEA, risk files | risk-management-specialist | skills/risk-management-specialist/ |

| Root cause analysis, corrective/preventive actions | capa-officer | skills/capa-officer/ |

| Document control, 21 CFR Part 11, DHF/DMR/DHR | quality-documentation-manager | skills/quality-documentation-manager/ |

| ISO 13485 internal audits, NC classification | qms-audit-expert | skills/qms-audit-expert/ |

| ISO 27001 audit planning and execution | isms-audit-expert | skills/isms-audit-expert/ |

| ISMS design, security risk assessment | information-security-manager-iso27001 | skills/information-security-manager-iso27001/ |

| EU MDR classification, technical files, PSUR | mdr-745-specialist | skills/mdr-745-specialist/ |

| FDA 510(k)/PMA/De Novo, QMSR | fda-consultant-specialist | skills/fda-consultant-specialist/ |

| GDPR/DSGVO, DPIA, data subject rights | gdpr-dsgvo-expert | skills/gdpr-dsgvo-expert/ |

| EU AI Act risk classification, obligations | eu-ai-act-specialist | skills/eu-ai-act-specialist/ |

| ISO/IEC 42001 AI management system | iso42001-specialist | skills/iso42001-specialist/ |

| SOC 2 Type I/II readiness, trust criteria | soc2-compliance | skills/soc2-compliance/ |

Quick start

# Example: route a risk-analysis request
cat ra-qm-team/skills/risk-management-specialist/SKILL.md
python3 ra-qm-team/skills/risk-management-specialist/scripts/risk_matrix_calculator.py --help

Rules

Route to exactly one skill, then follow that skill's workflow. This router ships no tools of its own.
All outputs are decision support: final compliance determinations route to the named human owner (QMR, DPO, regulatory counsel) — never auto-decide.
Verify regulatory citations against the current text (e.g., FDA QMSR effective 2026-02-02 replaced the legacy QSR subsections).

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