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Use for ISMS design, security risk assessment, control implementation, ISO 27001 certification, security audits, incident response, and compliance verification. Covers ISO 27001, ISO 27002, healthcare security, and medical device cybersecurity.","zhangzhang-111-i\u002Fclaude-skills111","zhangzhang-111-i","https:\u002F\u002Favatars.githubusercontent.com\u002Fu\u002F251344927?v=4","01M6DRBP4NCM1ZCHTT0FW0SQHD","lixiying","01M6DRBPAMFDJSGQ69XPK9KM9J",4,"MIT","https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fra-qm-team\u002Finformation-security-manager-iso27001\u002FSKILL.md",[18],{"categoryNo":19,"categoryName":20,"taxonomyType":21,"taxonomyTypeDesc":22},"01JBSEEDCAT000000000000037","律师与法务","PROFESSION","适用职业",[24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],"security","iso27001","information security manager iso27001","design","medical","iso","control","incident","use","healthcare","certification","isms","incident response","cybersecurity","risk","compliance","verification","assessment","risk assessment","governance","2026-11-10 10:12:30",false,"---\nname: \"information-security-manager-iso27001\"\ndescription: ISO 27001 ISMS implementation and cybersecurity governance for HealthTech and MedTech companies. Use for ISMS design, security risk assessment, control implementation, ISO 27001 certification, security audits, incident response, and compliance verification. Covers ISO 27001, ISO 27002, healthcare security, and medical device cybersecurity.\n---\n\n# Information Security Manager - ISO 27001\n\nImplement and manage Information Security Management Systems (ISMS) aligned with ISO 27001:2022 and healthcare regulatory requirements.\n\n---\n\n## Table of Contents\n\n- [Trigger Phrases](#trigger-phrases)\n- [Quick Start](#quick-start)\n- [Tools](#tools)\n- [Workflows](#workflows)\n- [Reference Guides](#reference-guides)\n- [Validation Checkpoints](#validation-checkpoints)\n\n---\n\n## Trigger Phrases\n\nUse this skill when you hear:\n- \"implement ISO 27001\"\n- \"ISMS implementation\"\n- \"security risk assessment\"\n- \"information security policy\"\n- \"ISO 27001 certification\"\n- \"security controls implementation\"\n- \"incident response plan\"\n- \"healthcare data security\"\n- \"medical device cybersecurity\"\n- \"security compliance audit\"\n\n---\n\n## Quick Start\n\n### Run Security Risk Assessment\n\n```bash\npython scripts\u002Frisk_assessment.py --scope \"patient-data-system\" --output risk_register.json\n```\n\n### Check Compliance Status\n\n```bash\npython scripts\u002Fcompliance_checker.py --standard iso27001 --controls-file controls.csv\n```\n\n### Generate Gap Analysis Report\n\n```bash\npython scripts\u002Fcompliance_checker.py --standard iso27001 --gap-analysis --output gaps.md\n```\n\n---\n\n## Tools\n\n### risk_assessment.py\n\nAutomated security risk assessment following ISO 27001 Clause 6.1.2 methodology.\n\n**Usage:**\n\n```bash\n# Full risk assessment\npython scripts\u002Frisk_assessment.py --scope \"cloud-infrastructure\" --output risks.json\n\n# Healthcare-specific assessment\npython scripts\u002Frisk_assessment.py --scope \"ehr-system\" --template healthcare --output risks.json\n\n# Quick asset-based assessment\npython scripts\u002Frisk_assessment.py --assets assets.csv --output risks.json\n```\n\n**Parameters:**\n\n| Parameter | Required | Description |\n|-----------|----------|-------------|\n| `--scope` | Yes | System or area to assess |\n| `--template` | No | Assessment template: `general`, `healthcare`, `cloud` |\n| `--assets` | No | CSV file with asset inventory |\n| `--output` | No | Output file (default: stdout) |\n| `--format` | No | Output format: `json`, `csv`, `markdown` |\n\n**Output:**\n- Asset inventory with classification\n- Threat and vulnerability mapping\n- Risk scores (likelihood × impact)\n- Treatment recommendations\n- Residual risk calculations\n\n### compliance_checker.py\n\nVerify ISO 27001\u002F27002 control implementation status.\n\n**Usage:**\n\n```bash\n# Check all ISO 27001 controls\npython scripts\u002Fcompliance_checker.py --standard iso27001\n\n# Gap analysis with recommendations\npython scripts\u002Fcompliance_checker.py --standard iso27001 --gap-analysis\n\n# Check specific control domains\npython scripts\u002Fcompliance_checker.py --standard iso27001 --domains \"access-control,cryptography\"\n\n# Export compliance report\npython scripts\u002Fcompliance_checker.py --standard iso27001 --output compliance_report.md\n```\n\n**Parameters:**\n\n| Parameter | Required | Description |\n|-----------|----------|-------------|\n| `--standard` | Yes | Standard to check: `iso27001`, `iso27002`, `hipaa` |\n| `--controls-file` | No | CSV with current control status |\n| `--gap-analysis` | No | Include remediation recommendations |\n| `--domains` | No | Specific control domains to check |\n| `--output` | No | Output file path |\n\n**Output:**\n- Control implementation status\n- Compliance percentage by domain\n- Gap analysis with priorities\n- Remediation recommendations\n\n---\n\n## Workflows\n\n### Workflow 1: ISMS Implementation\n\n**Step 1: Define Scope and Context**\n\nDocument organizational context and ISMS boundaries:\n- Identify interested parties and requirements\n- Define ISMS scope and boundaries\n- Document internal\u002Fexternal issues\n\n**Validation:** Scope statement reviewed and approved by management.\n\n**Step 2: Conduct Risk Assessment**\n\n```bash\npython scripts\u002Frisk_assessment.py --scope \"full-organization\" --template general --output initial_risks.json\n```\n\n- Identify information assets\n- Assess threats and vulnerabilities\n- Calculate risk levels\n- Determine risk treatment options\n\n**Validation:** Risk register contains all critical assets with assigned owners.\n\n**Step 3: Select and Implement Controls**\n\nMap risks to ISO 27002 controls:\n\n```bash\npython scripts\u002Fcompliance_checker.py --standard iso27002 --gap-analysis --output control_gaps.md\n```\n\nControl categories:\n- Organizational (policies, roles, responsibilities)\n- People (screening, awareness, training)\n- Physical (perimeters, equipment, media)\n- Technological (access, crypto, network, application)\n\n**Validation:** Statement of Applicability (SoA) documents all controls with justification.\n\n**Step 4: Establish Monitoring**\n\nDefine security metrics:\n- Incident count and severity trends\n- Control effectiveness scores\n- Training completion rates\n- Audit findings closure rate\n\n**Validation:** Dashboard shows real-time compliance status.\n\n### Workflow 2: Security Risk Assessment\n\n**Step 1: Asset Identification**\n\nCreate asset inventory:\n\n| Asset Type | Examples | Classification |\n|------------|----------|----------------|\n| Information | Patient records, source code | Confidential |\n| Software | EHR system, APIs | Critical |\n| Hardware | Servers, medical devices | High |\n| Services | Cloud hosting, backup | High |\n| People | Admin accounts, developers | Varies |\n\n**Validation:** All assets have assigned owners and classifications.\n\n**Step 2: Threat Analysis**\n\nIdentify threats per asset category:\n\n| Asset | Threats | Likelihood |\n|-------|---------|------------|\n| Patient data | Unauthorized access, breach | High |\n| Medical devices | Malware, tampering | Medium |\n| Cloud services | Misconfiguration, outage | Medium |\n| Credentials | Phishing, brute force | High |\n\n**Validation:** Threat model covers top-10 industry threats.\n\n**Step 3: Vulnerability Assessment**\n\n```bash\npython scripts\u002Frisk_assessment.py --scope \"network-infrastructure\" --output vuln_risks.json\n```\n\nDocument vulnerabilities:\n- Technical (unpatched systems, weak configs)\n- Process (missing procedures, gaps)\n- People (lack of training, insider risk)\n\n**Validation:** Vulnerability scan results mapped to risk register.\n\n**Step 4: Risk Evaluation and Treatment**\n\nCalculate risk: `Risk = Likelihood × Impact`\n\n| Risk Level | Score | Treatment |\n|------------|-------|-----------|\n| Critical | 20-25 | Immediate action required |\n| High | 15-19 | Treatment plan within 30 days |\n| Medium | 10-14 | Treatment plan within 90 days |\n| Low | 5-9 | Accept or monitor |\n| Minimal | 1-4 | Accept |\n\n**Validation:** All high\u002Fcritical risks have approved treatment plans.\n\n### Workflow 3: Incident Response\n\n**Step 1: Detection and Reporting**\n\nIncident categories:\n- Security breach (unauthorized access)\n- Malware infection\n- Data leakage\n- System compromise\n- Policy violation\n\n**Validation:** Incident logged within 15 minutes of detection.\n\n**Step 2: Triage and Classification**\n\n| Severity | Criteria | Response Time |\n|----------|----------|---------------|\n| Critical | Data breach, system down | Immediate |\n| High | Active threat, significant risk | 1 hour |\n| Medium | Contained threat, limited impact | 4 hours |\n| Low | Minor violation, no impact | 24 hours |\n\n**Validation:** Severity assigned and escalation triggered if needed.\n\n**Step 3: Containment and Eradication**\n\nImmediate actions:\n1. Isolate affected systems\n2. Preserve evidence\n3. Block threat vectors\n4. Remove malicious artifacts\n\n**Validation:** Containment confirmed, no ongoing compromise.\n\n**Step 4: Recovery and Lessons Learned**\n\nPost-incident activities:\n1. Restore systems from clean backups\n2. Verify integrity before reconnection\n3. Document timeline and actions\n4. Conduct post-incident review\n5. Update controls and procedures\n\n**Validation:** Post-incident report completed within 5 business days.\n\n---\n\n## Reference Guides\n\n### When to Use Each Reference\n\n**references\u002Fiso27001-controls.md**\n- Control selection for SoA\n- Implementation guidance\n- Evidence requirements\n- Audit preparation\n\n**references\u002Frisk-assessment-guide.md**\n- Risk methodology selection\n- Asset classification criteria\n- Threat modeling approaches\n- Risk calculation methods\n\n**references\u002Fincident-response.md**\n- Response procedures\n- Escalation matrices\n- Communication templates\n- Recovery checklists\n\n---\n\n## Validation Checkpoints\n\n### ISMS Implementation Validation\n\n| Phase | Checkpoint | Evidence Required |\n|-------|------------|-------------------|\n| Scope | Scope approved | Signed scope document |\n| Risk | Register complete | Risk register with owners |\n| Controls | SoA approved | Statement of Applicability |\n| Operation | Metrics active | Dashboard screenshots |\n| Audit | Internal audit done | Audit report |\n\n### Certification Readiness\n\nBefore Stage 1 audit:\n- [ ] ISMS scope documented and approved\n- [ ] Information security policy published\n- [ ] Risk assessment completed\n- [ ] Statement of Applicability finalized\n- [ ] Internal audit conducted\n- [ ] Management review completed\n- [ ] Nonconformities addressed\n\nBefore Stage 2 audit:\n- [ ] Controls implemented and operational\n- [ ] Evidence of effectiveness available\n- [ ] Staff trained and aware\n- [ ] Incidents logged and managed\n- [ ] Metrics collected for 3+ months\n\n### Compliance Verification\n\nRun periodic checks:\n\n```bash\n# Monthly compliance check\npython scripts\u002Fcompliance_checker.py --standard iso27001 --output monthly_$(date +%Y%m).md\n\n# Quarterly gap analysis\npython scripts\u002Fcompliance_checker.py --standard iso27001 --gap-analysis --output quarterly_gaps.md\n```\n\n---\n\n## Worked Example: Healthcare Risk Assessment\n\n**Scenario:** Assess security risks for a patient data management system.\n\n### Step 1: Define Assets\n\n```bash\npython scripts\u002Frisk_assessment.py --scope \"patient-data-system\" --template healthcare\n```\n\n**Asset inventory output:**\n\n| Asset ID | Asset | Type | Owner | Classification |\n|----------|-------|------|-------|----------------|\n| A001 | Patient database | Information | DBA Team | Confidential |\n| A002 | EHR application | Software | App Team | Critical |\n| A003 | Database server | Hardware | Infra Team | High |\n| A004 | Admin credentials | Access | Security | Critical |\n\n### Step 2: Identify Risks\n\n**Risk register output:**\n\n| Risk ID | Asset | Threat | Vulnerability | L | I | Score |\n|---------|-------|--------|---------------|---|---|-------|\n| R001 | A001 | Data breach | Weak encryption | 3 | 5 | 15 |\n| R002 | A002 | SQL injection | Input validation | 4 | 4 | 16 |\n| R003 | A004 | Credential theft | No MFA | 4 | 5 | 20 |\n\n### Step 3: Determine Treatment\n\n| Risk | Treatment | Control | Timeline |\n|------|-----------|---------|----------|\n| R001 | Mitigate | Implement AES-256 encryption | 30 days |\n| R002 | Mitigate | Add input validation, WAF | 14 days |\n| R003 | Mitigate | Enforce MFA for all admins | 7 days |\n\n### Step 4: Verify Implementation\n\n```bash\npython scripts\u002Fcompliance_checker.py --controls-file implemented_controls.csv\n```\n\n**Verification output:**\n\n```\nControl Implementation Status\n=============================\nCryptography (A.8.24): IMPLEMENTED\n  - AES-256 at rest: YES\n  - TLS 1.3 in transit: YES\n\nAccess Control (A.8.5): IMPLEMENTED\n  - MFA enabled: YES\n  - Admin accounts: 100% coverage\n\nApplication Security (A.8.26): PARTIAL\n  - Input validation: YES\n  - WAF deployed: PENDING\n\nOverall Compliance: 87%\n```\n","# Information Security Manager - ISO 27001\n\nImplement and manage Information Security Management Systems (ISMS) aligned with ISO 27001:2022 and healthcare regulatory requirements.\n\n---\n\n## Table of Contents\n\n- [Trigger Phrases](#trigger-phrases)\n- [Quick Start](#quick-start)\n- [Tools](#tools)\n- [Workflows](#workflows)\n- [Reference Guides](#reference-guides)\n- [Validation Checkpoints](#validation-checkpoints)\n\n---\n\n## Trigger Phrases\n\nUse this skill when you hear:\n- \"implement ISO 27001\"\n- \"ISMS implementation\"\n- \"security risk assessment\"\n- \"information security policy\"\n- \"ISO 27001 certification\"\n- \"security controls implementation\"\n- \"incident response plan\"\n- \"healthcare data security\"\n- \"medical device cybersecurity\"\n- \"security compliance audit\"\n\n---\n\n## Quick Start\n\n### Run Security Risk Assessment\n\n```bash\npython scripts\u002Frisk_assessment.py --scope \"patient-data-system\" --output risk_register.json\n```\n\n### Check Compliance Status\n\n```bash\npython scripts\u002Fcompliance_checker.py --standard iso27001 --controls-file controls.csv\n```\n\n### Generate Gap Analysis Report\n\n```bash\npython scripts\u002Fcompliance_checker.py --standard iso27001 --gap-analysis --output gaps.md\n```\n\n---\n\n## Tools\n\n### risk_assessment.py\n\nAutomated security risk assessment following ISO 27001 Clause 6.1.2 methodology.\n\n**Usage:**\n\n```bash\n# Full risk assessment\npython scripts\u002Frisk_assessment.py --scope \"cloud-infrastructure\" --output risks.json\n\n# Healthcare-specific assessment\npython scripts\u002Frisk_assessment.py --scope \"ehr-system\" --template healthcare --output risks.json\n\n# Quick asset-based assessment\npython scripts\u002Frisk_assessment.py --assets assets.csv --output risks.json\n```\n\n**Parameters:**\n\n| Parameter | Required | Description |\n|-----------|----------|-------------|\n| `--scope` | Yes | System or area to assess |\n| `--template` | No | Assessment template: `general`, `healthcare`, `cloud` |\n| `--assets` | No | CSV file with asset inventory |\n| `--output` | No | Output file (default: stdout) |\n| `--format` | No | Output format: `json`, `csv`, `markdown` |\n\n**Output:**\n- Asset inventory with classification\n- Threat and vulnerability mapping\n- Risk scores (likelihood × impact)\n- Treatment recommendations\n- Residual risk calculations\n\n### compliance_checker.py\n\nVerify ISO 27001\u002F27002 control implementation status.\n\n**Usage:**\n\n```bash\n# Check all ISO 27001 controls\npython scripts\u002Fcompliance_checker.py --standard iso27001\n\n# Gap analysis with recommendations\npython scripts\u002Fcompliance_checker.py --standard iso27001 --gap-analysis\n\n# Check specific control domains\npython scripts\u002Fcompliance_checker.py --standard iso27001 --domains \"access-control,cryptography\"\n\n# Export compliance report\npython scripts\u002Fcompliance_checker.py --standard iso27001 --output compliance_report.md\n```\n\n**Parameters:**\n\n| Parameter | Required | Description |\n|-----------|----------|-------------|\n| `--standard` | Yes | Standard to check: `iso27001`, `iso27002`, `hipaa` |\n| `--controls-file` | No | CSV with current control status |\n| `--gap-analysis` | No | Include remediation recommendations |\n| `--domains` | No | Specific control domains to check |\n| `--output` | No | Output file path |\n\n**Output:**\n- Control implementation status\n- Compliance percentage by domain\n- Gap analysis with priorities\n- Remediation recommendations\n\n---\n\n## Workflows\n\n### Workflow 1: ISMS Implementation\n\n**Step 1: Define Scope and Context**\n\nDocument organizational context and ISMS boundaries:\n- Identify interested parties and requirements\n- Define ISMS scope and boundaries\n- Document internal\u002Fexternal issues\n\n**Validation:** Scope statement reviewed and approved by management.\n\n**Step 2: Conduct Risk Assessment**\n\n```bash\npython scripts\u002Frisk_assessment.py --scope \"full-organization\" --template general --output initial_risks.json\n```\n\n- Identify information assets\n- Assess threats and vulnerabilities\n- Calculate risk levels\n- Determine risk treatment options\n\n**Validation:** Risk register contains all critical assets with assigned owners.\n\n**Step 3: Select and Implement Controls**\n\nMap risks to ISO 27002 controls:\n\n```bash\npython scripts\u002Fcompliance_checker.py --standard iso27002 --gap-analysis --output control_gaps.md\n```\n\nControl categories:\n- Organizational (policies, roles, responsibilities)\n- People (screening, awareness, training)\n- Physical (perimeters, equipment, media)\n- Technological (access, crypto, network, application)\n\n**Validation:** Statement of Applicability (SoA) documents all controls with justification.\n\n**Step 4: Establish Monitoring**\n\nDefine security metrics:\n- Incident count and severity trends\n- Control effectiveness scores\n- Training completion rates\n- Audit findings closure rate\n\n**Validation:** Dashboard shows real-time compliance status.\n\n### Workflow 2: Security Risk Assessment\n\n**Step 1: Asset Identification**\n\nCreate asset inventory:\n\n| Asset Type | Examples | Classification |\n|------------|----------|----------------|\n| Information | Patient records, source code | Confidential |\n| Software | EHR system, APIs | Critical |\n| Hardware | Servers, medical devices | High |\n| Services | Cloud hosting, backup | High |\n| People | Admin accounts, developers | Varies |\n\n**Validation:** All assets have assigned owners and classifications.\n\n**Step 2: Threat Analysis**\n\nIdentify threats per asset category:\n\n| Asset | Threats | Likelihood |\n|-------|---------|------------|\n| Patient data | Unauthorized access, breach | High |\n| Medical devices | Malware, tampering | Medium |\n| Cloud services | Misconfiguration, outage | Medium |\n| Credentials | Phishing, brute force | High |\n\n**Validation:** Threat model covers top-10 industry threats.\n\n**Step 3: Vulnerability Assessment**\n\n```bash\npython scripts\u002Frisk_assessment.py --scope \"network-infrastructure\" --output vuln_risks.json\n```\n\nDocument vulnerabilities:\n- Technical (unpatched systems, weak configs)\n- Process (missing procedures, gaps)\n- People (lack of training, insider risk)\n\n**Validation:** Vulnerability scan results mapped to risk register.\n\n**Step 4: Risk Evaluation and Treatment**\n\nCalculate risk: `Risk = Likelihood × Impact`\n\n| Risk Level | Score | Treatment |\n|------------|-------|-----------|\n| Critical | 20-25 | Immediate action required |\n| High | 15-19 | Treatment plan within 30 days |\n| Medium | 10-14 | Treatment plan within 90 days |\n| Low | 5-9 | Accept or monitor |\n| Minimal | 1-4 | Accept |\n\n**Validation:** All high\u002Fcritical risks have approved treatment plans.\n\n### Workflow 3: Incident Response\n\n**Step 1: Detection and Reporting**\n\nIncident categories:\n- Security breach (unauthorized access)\n- Malware infection\n- Data leakage\n- System compromise\n- Policy violation\n\n**Validation:** Incident logged within 15 minutes of detection.\n\n**Step 2: Triage and Classification**\n\n| Severity | Criteria | Response Time |\n|----------|----------|---------------|\n| Critical | Data breach, system down | Immediate |\n| High | Active threat, significant risk | 1 hour |\n| Medium | Contained threat, limited impact | 4 hours |\n| Low | Minor violation, no impact | 24 hours |\n\n**Validation:** Severity assigned and escalation triggered if needed.\n\n**Step 3: Containment and Eradication**\n\nImmediate actions:\n1. Isolate affected systems\n2. Preserve evidence\n3. Block threat vectors\n4. Remove malicious artifacts\n\n**Validation:** Containment confirmed, no ongoing compromise.\n\n**Step 4: Recovery and Lessons Learned**\n\nPost-incident activities:\n1. Restore systems from clean backups\n2. Verify integrity before reconnection\n3. Document timeline and actions\n4. Conduct post-incident review\n5. Update controls and procedures\n\n**Validation:** Post-incident report completed within 5 business days.\n\n---\n\n## Reference Guides\n\n### When to Use Each Reference\n\n**references\u002Fiso27001-controls.md**\n- Control selection for SoA\n- Implementation guidance\n- Evidence requirements\n- Audit preparation\n\n**references\u002Frisk-assessment-guide.md**\n- Risk methodology selection\n- Asset classification criteria\n- Threat modeling approaches\n- Risk calculation methods\n\n**references\u002Fincident-response.md**\n- Response procedures\n- Escalation matrices\n- Communication templates\n- Recovery checklists\n\n---\n\n## Validation Checkpoints\n\n### ISMS Implementation Validation\n\n| Phase | Checkpoint | Evidence Required |\n|-------|------------|-------------------|\n| Scope | Scope approved | Signed scope document |\n| Risk | Register complete | Risk register with owners |\n| Controls | SoA approved | Statement of Applicability |\n| Operation | Metrics active | Dashboard screenshots |\n| Audit | Internal audit done | Audit report |\n\n### Certification Readiness\n\nBefore Stage 1 audit:\n- [ ] ISMS scope documented and approved\n- [ ] Information security policy published\n- [ ] Risk assessment completed\n- [ ] Statement of Applicability finalized\n- [ ] Internal audit conducted\n- [ ] Management review completed\n- [ ] Nonconformities addressed\n\nBefore Stage 2 audit:\n- [ ] Controls implemented and operational\n- [ ] Evidence of effectiveness available\n- [ ] Staff trained and aware\n- [ ] Incidents logged and managed\n- [ ] Metrics collected for 3+ months\n\n### Compliance Verification\n\nRun periodic checks:\n\n```bash\n# Monthly compliance check\npython scripts\u002Fcompliance_checker.py --standard iso27001 --output monthly_$(date +%Y%m).md\n\n# Quarterly gap analysis\npython scripts\u002Fcompliance_checker.py --standard iso27001 --gap-analysis --output quarterly_gaps.md\n```\n\n---\n\n## Worked Example: Healthcare Risk Assessment\n\n**Scenario:** Assess security risks for a patient data management system.\n\n### Step 1: Define Assets\n\n```bash\npython scripts\u002Frisk_assessment.py --scope \"patient-data-system\" --template healthcare\n```\n\n**Asset inventory output:**\n\n| Asset ID | Asset | Type | Owner | Classification |\n|----------|-------|------|-------|----------------|\n| A001 | Patient database | Information | DBA Team | Confidential |\n| A002 | EHR application | Software | App Team | Critical |\n| A003 | Database server | Hardware | Infra Team | High |\n| A004 | Admin credentials | Access | Security | Critical |\n\n### Step 2: Identify Risks\n\n**Risk register output:**\n\n| Risk ID | Asset | Threat | Vulnerability | L | I | Score |\n|---------|-------|--------|---------------|---|---|-------|\n| R001 | A001 | Data breach | Weak encryption | 3 | 5 | 15 |\n| R002 | A002 | SQL injection | Input validation | 4 | 4 | 16 |\n| R003 | A004 | Credential theft | No MFA | 4 | 5 | 20 |\n\n### Step 3: Determine Treatment\n\n| Risk | Treatment | Control | Timeline |\n|------|-----------|---------|----------|\n| R001 | Mitigate | Implement AES-256 encryption | 30 days |\n| R002 | Mitigate | Add input validation, WAF | 14 days |\n| R003 | Mitigate | Enforce MFA for all admins | 7 days |\n\n### Step 4: Verify Implementation\n\n```bash\npython scripts\u002Fcompliance_checker.py --controls-file implemented_controls.csv\n```\n\n**Verification output:**\n\n```\nControl Implementation Status\n=============================\nCryptography (A.8.24): IMPLEMENTED\n  - 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Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use when user mentions risk management, ISO 14971, risk analysis, FMEA, fault tree analysis, hazard identification, risk control, risk matrix, benefit-risk analysis, residual risk, risk acceptability, or post-market risk.","https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fra-qm-team\u002Frisk-management-specialist\u002FSKILL.md",[],[38,117,118,119,120,121,122,123,124,125,126,127,32,128,129,130,30,29,28,131],"risk management specialist","management","risk management","risk analysis","risk evaluation","product","Evaluation","Production","lifecycle","analysis","user","risk matrix","Market","device","iso 14971",{"skillNo":133,"name":134,"nameZh":6,"description":135,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":136,"categories":137,"keywords":138,"publishedAt":44},"01M6DSNSRBGVZWS23TK0ZQ52QC","regulatory-affairs-head","Senior Regulatory Affairs Manager for HealthTech and MedTech companies. 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Use when users need to plan or execute FDA submissions, navigate 510(k) or PMA approval processes, achieve CE marking, prepare pre-submission meeting materials, write regulatory strategy documents, respond to agency queries, or manage compliance documentation for medical device market access.","https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fregulatory-affairs-head\u002FSKILL.md",[],[139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,28,157],"regulatory affairs head","regulatory","head","documentation","documents","packages","planning","devices","plan","access","write","strategy","evidence","standards","manage","intelligence","across","strategies","clinical",{"skillNo":159,"name":160,"nameZh":6,"description":161,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":162,"categories":163,"keywords":172,"publishedAt":44},"01M6DSNN7GNR2HZE66S4D31EP8","quality-manager-qms-iso13485","ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support. Use when working with medical device quality systems, preparing for ISO 13485 audits, managing regulatory compliance documentation, setting up corrective actions, or building audit preparation programs. Useful for quality management, audit preparation, regulatory compliance, medical device documentation, and corrective action workflows.","https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fquality-manager-qms-iso13485\u002FSKILL.md",[164,169],{"categoryNo":165,"categoryName":166,"taxonomyType":167,"taxonomyTypeDesc":168},"01JBSEEDCAT000000000000015","视觉设计","SCENARIO","使用场景",{"categoryNo":170,"categoryName":171,"taxonomyType":21,"taxonomyTypeDesc":22},"01JBSEEDCAT000000000000032","设计师",[173,174,27,175,176,177,142,178,179,39,180,181,32,140,182,183,184,30,29,28],"quality manager qms iso13485","quality","review","support","workflows","audit","actions","system","process","up","maintenance","document",{"skillNo":186,"name":187,"nameZh":6,"description":188,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":189,"categories":190,"keywords":192,"publishedAt":44},"01M6DSNE5PQM106PM4EDGPBWGZ","quality-manager-qmr","Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2.","https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fquality-manager-qmr\u002FSKILL.md",[191],{"categoryNo":19,"categoryName":20,"taxonomyType":21,"taxonomyTypeDesc":22},[193,174,175,194,195,43,196,39,197,180,118,198,140,199,200,201,29],"quality manager qmr","policy","performance","monitoring","regulatory compliance","oversight","cost","culture","leadership",{"skillNo":203,"name":204,"nameZh":6,"description":205,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":206,"categories":207,"keywords":212,"publishedAt":44},"01M6DSN7MYXB6X42TB1GH2TNSB","quality-documentation-manager","Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use for document control procedures, change control workflow, document numbering, version management, electronic signature compliance, or regulatory documentation review.","https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fquality-documentation-manager\u002FSKILL.md",[208,211],{"categoryNo":209,"categoryName":210,"taxonomyType":167,"taxonomyTypeDesc":168},"01JBSEEDCAT000000000000002","文档处理",{"categoryNo":19,"categoryName":20,"taxonomyType":21,"taxonomyTypeDesc":22},[142,213,174,175,214,215,178,125,216,180,217,218,32,219,220,221,28,222,223,224],"quality documentation manager","workflow","change","document lifecycle","change management","list","master","system management","documentation review","cfr","21 cfr part 11","change control",{"skillNo":226,"name":227,"nameZh":6,"description":228,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":229,"categories":230,"keywords":231,"publishedAt":44},"01M6DSN3R749H3R20K15QE8X8W","qms-audit-expert","ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use for internal audit planning, audit execution, finding classification, external audit preparation, or audit program management.","https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fqms-audit-expert\u002FSKILL.md",[],[178,232,233,145,40,234,235,236,118,32,237,130,29,28],"qms audit expert","expert","execution","classification","schedule","checklist"]