Quality Manager Qms Iso13485

⬇ 1,440 downloads

Low Risk

ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support.

H:0 D:0 A:0 C:1

📋 Capabilities

Execution

❌ Shell execution
❌ Code execution
❌ Install dependencies
❌ Persistence
Privilege: user

Filesystem

❌ Read workspace
❌ Write workspace
❌ Read home
❌ Write home
❌ Read system
❌ Delete

Network

Egress: none
❌ Ingress

Credentials

❌ Environment vars
❌ Credential files
❌ Browser data
❌ Keychain

Actions

❌ send messages❌ post public❌ purchase❌ transfer money❌ deploy❌ delete external

🔒 Containment

Level: none

Recommended:

LOG_ACTIONS: Audit trail for all actions

⚡ Risks

Social engineering indicators: SOCIAL_ENG_VAGUE_DESCRIPTION low

Mitigation: Provide clear, detailed description of skill functionality

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🚨 Incident Response

Kill switch: Stop the agent process

Containment: Review logs for unexpected actions

Recovery: Depends on skill capabilities

📄 Raw SSDS JSON click to expand

{
  "meta": {
    "document_id": "ssds:auto:quality-manager-qms-iso13485:1.0.0",
    "ssds_version": "0.2.0",
    "scanner_version": "0.4.0+fe6fd9123d50",
    "created_at": "2026-03-05T11:01:57.620Z",
    "created_by": {
      "agent": "safeagentskills-cli/generate-ssds"
    },
    "language": "en",
    "notes": "Auto-generated SSDS. Manual review recommended."
  },
  "skill": {
    "name": "Quality Manager Qms Iso13485",
    "version": "1.0.0",
    "format": "agent_skill",
    "description": "ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support.",
    "publisher": "ClawHub",
    "source": {
      "channel": "clawhub",
      "slug": "quality-manager-qms-iso13485",
      "owner": "alirezarezvani",
      "downloads": 1440,
      "stars": 0
    },
    "artifact": {
      "sha256": "20c6c9db17c294959cdeb115d306a98e4b2d9178d0e1b8015dc68017694a4853",
      "hash_method": "files_sorted"
    }
  },
  "capabilities": {
    "execution": {
      "can_exec_shell": false,
      "can_exec_code": false,
      "privilege_level": "user",
      "can_install_deps": false,
      "can_persist": false
    },
    "filesystem": {
      "reads_workspace": false,
      "reads_user_home": false,
      "reads_system": false,
      "writes_workspace": false,
      "writes_user_home": false,
      "writes_system": false,
      "can_delete": false
    },
    "network": {
      "egress": "none",
      "ingress": false
    },
    "credentials": {
      "reads_env_vars": false,
      "reads_credential_files": false,
      "reads_browser_data": false,
      "reads_keychain": false
    },
    "services": [],
    "actions": {
      "can_send_messages": false,
      "can_post_public": false,
      "can_purchase": false,
      "can_transfer_money": false,
      "can_deploy": false,
      "can_delete_external": false
    },
    "prompt_injection_surfaces": [],
    "content_types": [
      "general"
    ]
  },
  "hazards": {
    "hdac": {
      "H": 0,
      "D": 0,
      "A": 0,
      "C": 1
    },
    "flags": [],
    "custom_flags": [
      {
        "code": "SOCIAL_ENGINEERING",
        "name": "Social Engineering Risk",
        "description": "SOCIAL_ENG_VAGUE_DESCRIPTION: Skill description is too vague or missing"
      }
    ],
    "confidence": {
      "level": "medium",
      "basis": [
        "static_analysis"
      ],
      "notes": "Detected 1 security patterns (1 vendored rule hits). Review recommended."
    },
    "rationale": {
      "H": "H0: No host access",
      "D": "D0: No sensitive data access",
      "A": "A0: No side effects detected",
      "C": "C1: General content"
    }
  },
  "containment": {
    "level": "none",
    "required": [],
    "recommended": [
      {
        "control": "LOG_ACTIONS",
        "reason": "Audit trail for all actions"
      }
    ],
    "uncontained_risk": "Risk level depends on manual review of actual capabilities."
  },
  "risks": {
    "risks": [
      {
        "risk": "Social engineering indicators: SOCIAL_ENG_VAGUE_DESCRIPTION",
        "severity": "low",
        "mitigation": "Provide clear, detailed description of skill functionality"
      }
    ],
    "limitations": [
      "Static analysis only - runtime behavior not verified"
    ]
  },
  "incident_response": {
    "kill_switch": [
      "Stop the agent process"
    ],
    "containment": [
      "Review logs for unexpected actions"
    ],
    "recovery": [
      "Depends on skill capabilities"
    ]
  },
  "evidence": [
    {
      "evidence_id": "EV:file-1",
      "type": "file_excerpt",
      "title": "_meta.json",
      "file_path": "_meta.json"
    },
    {
      "evidence_id": "EV:file-2",
      "type": "file_excerpt",
      "title": "SKILL.md",
      "file_path": "SKILL.md"
    },
    {
      "evidence_id": "EV:file-3",
      "type": "file_excerpt",
      "title": "scripts/qms_audit_checklist.py",
      "file_path": "scripts/qms_audit_checklist.py"
    },
    {
      "evidence_id": "EV:cisco-1",
      "type": "file_excerpt",
      "title": "SOCIAL_ENG_VAGUE_DESCRIPTION [LOW] SKILL.md:1: ---",
      "file_path": "SKILL.md"
    }
  ]
}