# Send Qms Audit Expert to your agent Hand the extracted package to your coding agent with a concrete install brief instead of figuring it out manually. ## Fast path - Download the package from Yavira. - Extract it into a folder your agent can access. - Paste one of the prompts below and point your agent at the extracted folder. ## Suggested prompts ### New install ```text I downloaded a skill package from Yavira. Read SKILL.md from the extracted folder and install it by following the included instructions. Tell me what you changed and call out any manual steps you could not complete. ``` ### Upgrade existing ```text I downloaded an updated skill package from Yavira. Read SKILL.md from the extracted folder, compare it with my current installation, and upgrade it while preserving any custom configuration unless the package docs explicitly say otherwise. Summarize what changed and any follow-up checks I should run. ``` ## Machine-readable fields ```json { "schemaVersion": "1.0", "item": { "slug": "qms-audit-expert", "name": "Qms Audit Expert", "source": "tencent", "type": "skill", "category": "安全合规", "sourceUrl": "https://clawhub.ai/alirezarezvani/qms-audit-expert", "canonicalUrl": "https://clawhub.ai/alirezarezvani/qms-audit-expert", "targetPlatform": "OpenClaw" }, "install": { "downloadUrl": "/downloads/qms-audit-expert", "sourceDownloadUrl": "https://wry-manatee-359.convex.site/api/v1/download?slug=qms-audit-expert", "sourcePlatform": "tencent", "targetPlatform": "OpenClaw", "packageFormat": "ZIP package", "primaryDoc": "SKILL.md", "includedAssets": [ "SKILL.md", "references/iso13485-audit-guide.md", "references/nonconformity-classification.md", "scripts/audit_schedule_optimizer.py" ], "downloadMode": "redirect", "sourceHealth": { "source": "tencent", "status": "healthy", "reason": "direct_download_ok", "recommendedAction": "download", "checkedAt": "2026-04-23T16:43:11.935Z", "expiresAt": "2026-04-30T16:43:11.935Z", "httpStatus": 200, "finalUrl": "https://wry-manatee-359.convex.site/api/v1/download?slug=4claw-imageboard", "contentType": "application/zip", "probeMethod": "head", "details": { "probeUrl": "https://wry-manatee-359.convex.site/api/v1/download?slug=4claw-imageboard", "contentDisposition": "attachment; filename=\"4claw-imageboard-1.0.1.zip\"", "redirectLocation": null, "bodySnippet": null }, "scope": "source", "summary": "Source download looks usable.", "detail": "Yavira can redirect you to the upstream package for this source.", "primaryActionLabel": "Download for OpenClaw", "primaryActionHref": "/downloads/qms-audit-expert" }, "validation": { "installChecklist": [ "Use the Yavira download entry.", "Review SKILL.md after the package is downloaded.", "Confirm the extracted package contains the expected setup assets." ], "postInstallChecks": [ "Confirm the extracted package includes the expected docs or setup files.", "Validate the skill or prompts are available in your target agent workspace.", "Capture any manual follow-up steps the agent could not complete." ] } }, "links": { "detailUrl": "https://openagent3.xyz/skills/qms-audit-expert", "downloadUrl": "https://openagent3.xyz/downloads/qms-audit-expert", "agentUrl": "https://openagent3.xyz/skills/qms-audit-expert/agent", "manifestUrl": "https://openagent3.xyz/skills/qms-audit-expert/agent.json", "briefUrl": "https://openagent3.xyz/skills/qms-audit-expert/agent.md" } } ``` ## 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? ├── Yes → Systematic (multiple instances)? → MAJOR │ └── No → Could affect product safety? → MAJOR │ └── No → MINOR └── No → Deviation from procedure? ├── Yes → Recurring? → MAJOR │ └── No → MINOR └── No → Improvement opportunity? → 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 ## Trust - Source: tencent - Verification: Indexed source record - Publisher: alirezarezvani - Version: 2.1.1 ## Source health - Status: healthy - Source download looks usable. - Yavira can redirect you to the upstream package for this source. - Health scope: source - Reason: direct_download_ok - Checked at: 2026-04-23T16:43:11.935Z - Expires at: 2026-04-30T16:43:11.935Z - Recommended action: Download for OpenClaw ## Links - [Detail page](https://openagent3.xyz/skills/qms-audit-expert) - [Send to Agent page](https://openagent3.xyz/skills/qms-audit-expert/agent) - [JSON manifest](https://openagent3.xyz/skills/qms-audit-expert/agent.json) - [Markdown brief](https://openagent3.xyz/skills/qms-audit-expert/agent.md) - [Download page](https://openagent3.xyz/downloads/qms-audit-expert)