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- OpenClaw
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- Extract archive
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- OpenClaw
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- SKILL.md
Tencent SkillHub ยท Security & Compliance
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.
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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.
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- Tencent SkillHub
- What's included
- SKILL.md, references/iso13485-audit-guide.md, references/nonconformity-classification.md, scripts/audit_schedule_optimizer.py
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Trust & source
Release facts
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- Tencent SkillHub
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- Indexed source record
- Version
- 2.1.1
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- alirezarezvani
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Documentation
QMS Audit Expert
ISO 13485 internal audit methodology for medical device quality management systems.
Table of Contents
Audit Planning Workflow Audit Execution Nonconformity Management External Audit Preparation Reference Documentation Tools
Audit Planning Workflow
Plan risk-based internal audit program: List all QMS processes requiring audit Assign risk level to each process (High/Medium/Low) Review previous audit findings and trends Determine audit frequency by risk level Assign qualified auditors (verify independence) Create annual audit schedule Communicate schedule to process owners Validation: All ISO 13485 clauses covered within cycle
Risk-Based Audit Frequency
Risk LevelFrequencyCriteriaHighQuarterlyDesign control, CAPA, production validationMediumSemi-annualPurchasing, training, document controlLowAnnualInfrastructure, management review (if stable)
Audit Scope by Clause
ClauseProcessFocus Areas4.2Document ControlDocument approval, distribution, obsolete control5.6Management ReviewInputs complete, decisions documented, actions tracked6.2TrainingCompetency defined, records complete, effectiveness verified7.3Design ControlInputs, reviews, V&V, transfer, changes7.4PurchasingSupplier evaluation, incoming inspection7.5ProductionWork instructions, process validation, DHR7.6CalibrationEquipment list, calibration status, out-of-tolerance8.2.2Internal AuditSchedule compliance, auditor independence8.3NC ProductIdentification, segregation, disposition8.5CAPARoot cause, implementation, effectiveness
Auditor Independence
Verify auditor independence before assignment: Auditor not responsible for area being audited No direct reporting relationship to auditee Not involved in recent activities under audit Documented qualification for audit scope
Audit Execution
Conduct systematic internal audit: Prepare audit plan (scope, criteria, schedule) Review relevant documentation before audit Conduct opening meeting with auditee Collect evidence (records, interviews, observation) Classify findings (Major/Minor/Observation) Conduct closing meeting with preliminary findings Prepare audit report within 5 business days Validation: All scope items covered, findings supported by evidence
Evidence Collection
MethodUse ForDocumentationDocument reviewProcedures, recordsDocument number, version, dateInterviewProcess understandingInterviewee name, role, summaryObservationActual practiceWhat, where, when observedRecord traceProcess flowRecord IDs, dates, linkage
Audit Questions by Clause
Document Control (4.2): Show me the document master list How do you control obsolete documents? Show me evidence of document change approval Design Control (7.3): Show me the Design History File for [product] Who participates in design reviews? Show me design input to output traceability CAPA (8.5): Show me the CAPA log with open items How do you determine root cause? Show me effectiveness verification records See references/iso13485-audit-guide.md for complete question sets.
Finding Documentation
Document each finding with: Requirement: [Specific ISO 13485 clause or procedure] Evidence: [What was observed, reviewed, or heard] Gap: [How evidence fails to meet requirement] Example: Requirement: ISO 13485:2016 Clause 7.6 requires calibration at specified intervals. Evidence: Calibration records for pH meter (EQ-042) show last calibration 2024-01-15. Calibration interval is 12 months. Today is 2025-03-20. Gap: Equipment is 2 months overdue for calibration, representing a gap in calibration program execution.
Nonconformity Management
Classify and manage audit findings: Evaluate finding against classification criteria Assign severity (Major/Minor/Observation) Document finding with objective evidence Communicate to process owner Initiate CAPA for Major/Minor findings Track to closure Verify effectiveness at follow-up Validation: Finding closed only after effective CAPA
Classification Criteria
CategoryDefinitionCAPA RequiredTimelineMajorSystematic failure or absence of elementYes30 daysMinorIsolated lapse or partial implementationRecommended60 daysObservationImprovement opportunityOptionalAs appropriate
Classification Decision
Is required element absent or failed? โโโ Yes โ Systematic (multiple instances)? โ MAJOR โ โโโ No โ Could affect product safety? โ MAJOR โ โโโ No โ MINOR โโโ No โ Deviation from procedure? โโโ Yes โ Recurring? โ MAJOR โ โโโ No โ MINOR โโโ No โ Improvement opportunity? โ OBSERVATION
CAPA Integration
Finding SeverityCAPA DepthVerificationMajorFull root cause analysis (5-Why, Fishbone)Next audit or within 6 monthsMinorImmediate cause identificationNext scheduled auditObservationNot requiredNoted at next audit See references/nonconformity-classification.md for detailed guidance.
External Audit Preparation
Prepare for certification body or regulatory audit: Complete all scheduled internal audits Verify all findings closed with effective CAPA Review documentation for currency and accuracy Conduct management review with audit as input Prepare facility and personnel Conduct mock audit (full scope) Brief personnel on audit protocol Validation: Mock audit findings addressed before external audit
Pre-Audit Readiness Checklist
Documentation: Quality Manual current Procedures reflect actual practice Records complete and retrievable Previous audit findings closed Personnel: Key personnel available during audit Subject matter experts identified Personnel briefed on audit protocol Escorts assigned Facility: Work areas organized Documents at point of use current Equipment calibration status visible Nonconforming product segregated
Mock Audit Protocol
Use external auditor or qualified internal auditor Cover full scope of upcoming external audit Simulate actual audit conditions (timing, formality) Document findings as for real audit Address all Major and Minor findings before external audit Brief management on readiness status
ISO 13485 Audit Guide
references/iso13485-audit-guide.md contains: Clause-by-clause audit methodology Sample audit questions for each clause Evidence collection requirements Common nonconformities by clause Finding severity classification
Nonconformity Classification
references/nonconformity-classification.md contains: Severity classification criteria and decision tree Impact vs. occurrence matrix CAPA integration requirements Finding documentation templates Closure requirements by severity
Audit Schedule Optimizer
# Generate optimized audit schedule python scripts/audit_schedule_optimizer.py --processes processes.json # Interactive mode python scripts/audit_schedule_optimizer.py --interactive # JSON output for integration python scripts/audit_schedule_optimizer.py --processes processes.json --output json Generates risk-based audit schedule considering: Process risk level Previous findings Days since last audit Criticality scores Output includes: Prioritized audit schedule Quarterly distribution Overdue audit alerts Resource recommendations
Sample Process Input
{ "processes": [ { "name": "Design Control", "iso_clause": "7.3", "risk_level": "HIGH", "last_audit_date": "2024-06-15", "previous_findings": 2 }, { "name": "Document Control", "iso_clause": "4.2", "risk_level": "MEDIUM", "last_audit_date": "2024-09-01", "previous_findings": 0 } ] }
Audit Program Metrics
Track audit program effectiveness: MetricTargetMeasurementSchedule compliance>90%Audits completed on timeFinding closure rate>95%Findings closed by due dateRepeat findings<10%Same finding in consecutive auditsCAPA effectiveness>90%Verified effective at follow-upAuditor utilization4 days/monthAudit days per qualified auditor
Category context
Identity, auth, scanning, governance, audit, and operational guardrails.
Source: Tencent SkillHub
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Package contents
Included in package
3 Docs1 Scripts
- SKILL.md
- references/iso13485-audit-guide.md
- references/nonconformity-classification.md
- scripts/audit_schedule_optimizer.py