{ "schemaVersion": "1.0", "item": { "slug": "quality-manager-qms-iso13485", "name": "Quality Manager Qms Iso13485", "source": "tencent", "type": "skill", "category": "安全合规", "sourceUrl": "https://clawhub.ai/alirezarezvani/quality-manager-qms-iso13485", "canonicalUrl": "https://clawhub.ai/alirezarezvani/quality-manager-qms-iso13485", "targetPlatform": "OpenClaw" }, "install": { "downloadMode": "redirect", "downloadUrl": "/downloads/quality-manager-qms-iso13485", "sourceDownloadUrl": "https://wry-manatee-359.convex.site/api/v1/download?slug=quality-manager-qms-iso13485", "sourcePlatform": "tencent", "targetPlatform": "OpenClaw", "installMethod": "Manual import", "extraction": "Extract archive", "prerequisites": [ "OpenClaw" ], "packageFormat": "ZIP package", "includedAssets": [ "SKILL.md", "references/iso13485-clause-requirements.md", "references/qms-process-templates.md", "scripts/qms_audit_checklist.py" ], "primaryDoc": "SKILL.md", "quickSetup": [ "Download the package from Yavira.", "Extract the archive and review SKILL.md first.", "Import or place the package into your OpenClaw setup." ], "agentAssist": { "summary": "Hand the extracted package to your coding agent with a concrete install brief instead of figuring it out manually.", "steps": [ "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." ], "prompts": [ { "label": "New install", "body": "I downloaded a skill package from Yavira. 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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." }, { "label": "Upgrade existing", "body": "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." } ] }, "documentation": { "source": "clawhub", "primaryDoc": "SKILL.md", "sections": [ { "title": "Quality Manager - QMS ISO 13485 Specialist", "body": "ISO 13485:2016 Quality Management System implementation, maintenance, and certification support for medical device organizations." }, { "title": "Table of Contents", "body": "QMS Implementation Workflow\nDocument Control Workflow\nInternal Audit Workflow\nProcess Validation Workflow\nSupplier Qualification Workflow\nQMS Process Reference\nDecision Frameworks\nTools and References" }, { "title": "QMS Implementation Workflow", "body": "Implement ISO 13485:2016 compliant quality management system from gap analysis through certification." }, { "title": "Workflow: Initial QMS Implementation", "body": "Conduct gap analysis against ISO 13485:2016 requirements\nDocument current state vs. required state for each clause\nPrioritize gaps by:\n\nRegulatory criticality\nRisk to product safety\nResource requirements\n\n\nDevelop implementation roadmap with milestones\nEstablish Quality Manual per Clause 4.2.2:\n\nQMS scope with justified exclusions\nProcess interactions\nProcedure references\n\n\nCreate required documented procedures — see Mandatory Documented Procedures for the full list\nDeploy processes with training\nValidation: Gap analysis complete; Quality Manual approved; all required procedures documented and trained\n\nUse the Gap Analysis Matrix template in qms-process-templates.md to document clause-by-clause current state, gaps, priority, and actions." }, { "title": "QMS Structure", "body": "LevelDocument TypeExample1Quality ManualQM-0012ProceduresSOP-02-0013Work InstructionsWI-06-0124RecordsTraining records" }, { "title": "Document Control Workflow", "body": "Establish and maintain document control per ISO 13485 Clause 4.2.3." }, { "title": "Workflow: Document Creation and Approval", "body": "Identify need for new document or revision\nAssign document number per numbering convention:\n\nFormat: [TYPE]-[AREA]-[SEQUENCE]-[REV]\nExample: SOP-02-001-01\n\n\nDraft document using approved template\nRoute for review to subject matter experts\nCollect and address review comments\nObtain required approvals based on document type\nUpdate Document Master List\nValidation: Document numbered correctly; all reviewers signed; Master List updated" }, { "title": "Document Numbering Convention", "body": "PrefixDocument TypeApproval AuthorityQMQuality ManualManagement Rep + CEOPOLPolicyDepartment Head + QASOPProcedureProcess Owner + QAWIWork InstructionSupervisor + QATFTemplate/FormProcess OwnerSPECSpecificationEngineering + QA" }, { "title": "Area Codes", "body": "CodeAreaExamples01Quality ManagementQuality Manual, policy02Document ControlThis procedure03TrainingCompetency procedures04DesignDesign control05PurchasingSupplier management06ProductionManufacturing07Quality ControlInspection, testing08CAPACorrective actions" }, { "title": "Document Change Control", "body": "Change TypeApproval LevelExamplesAdministrativeDocument ControlTypos, formattingMinorProcess Owner + QAClarificationsMajorFull review cycleProcess changesEmergencyExpedited + retrospectiveSafety issues" }, { "title": "Document Review Schedule", "body": "Document TypeReview PeriodTrigger for Unscheduled ReviewQuality ManualAnnualOrganizational changeProceduresAnnualAudit finding, regulation changeWork Instructions2 yearsProcess changeForms2 yearsUser feedback" }, { "title": "Internal Audit Workflow", "body": "Plan and execute internal audits per ISO 13485 Clause 8.2.4." }, { "title": "Workflow: Annual Audit Program", "body": "Identify processes and areas requiring audit coverage\nAssess risk factors for audit frequency:\n\nPrevious audit findings\nRegulatory changes\nProcess changes\nComplaint trends\n\n\nAssign qualified auditors (independent of area audited)\nDevelop annual audit schedule\nObtain management approval\nCommunicate schedule to process owners\nTrack completion and reschedule as needed\nValidation: All processes covered; auditors qualified and independent; schedule approved\n\nUse the Audit Program Template in qms-process-templates.md to schedule audits by clause and quarter across processes such as Document Control (4.2.3/4.2.4), Management Review (5.6), Design Control (7.3), Production (7.5), and CAPA (8.5.2/8.5.3)." }, { "title": "Workflow: Individual Audit Execution", "body": "Prepare audit plan with scope, criteria, and schedule\nNotify auditee minimum 1 week prior\nReview procedures and previous audit results\nPrepare audit checklist\nConduct opening meeting\nCollect evidence through:\n\nDocument review\nRecord sampling\nProcess observation\nPersonnel interviews\n\n\nClassify findings:\n\nMajor NC: Absence or breakdown of system\nMinor NC: Single lapse or deviation\nObservation: Risk of future NC\n\n\nConduct closing meeting\nIssue audit report within 5 business days\nValidation: All checklist items addressed; findings supported by evidence; report distributed" }, { "title": "Auditor Qualification Requirements", "body": "CriterionRequirementTrainingISO 13485 awareness + auditor trainingExperienceMinimum 1 audit as observerIndependenceNot auditing own work areaCompetenceUnderstanding of audited process" }, { "title": "Finding Classification Guide", "body": "ClassificationCriteriaResponse TimeMajor NCSystem absence, total breakdown, regulatory violation30 days for CAPAMinor NCSingle instance, partial compliance60 days for CAPAObservationPotential risk, improvement opportunityTrack in next audit" }, { "title": "Process Validation Workflow", "body": "Validate special processes per ISO 13485 Clause 7.5.6." }, { "title": "Workflow: Process Validation Protocol", "body": "Identify processes requiring validation:\n\nOutput cannot be verified by inspection\nDeficiencies appear only in use\nSterilization, welding, sealing, software\n\n\nForm validation team with subject matter experts\nWrite validation protocol including:\n\nProcess description and parameters\nEquipment and materials\nAcceptance criteria\nStatistical approach\n\n\nExecute IQ: verify equipment installed correctly and document specifications\nExecute OQ: test parameter ranges and verify process control\nExecute PQ: run production conditions and verify output meets requirements\nWrite validation report with conclusions\nValidation: IQ/OQ/PQ complete; acceptance criteria met; validation report approved" }, { "title": "Validation Documentation Requirements", "body": "PhaseContentEvidenceProtocolObjectives, methods, criteriaApproved protocolIQEquipment verificationInstallation recordsOQParameter verificationTest resultsPQPerformance verificationProduction dataReportSummary, conclusionsApproval signatures" }, { "title": "Revalidation Triggers", "body": "TriggerAction RequiredEquipment changeAssess impact, revalidate affected phasesParameter changeOQ and PQ minimumMaterial changeAssess impact, PQ minimumProcess failureFull revalidationPeriodicPer validation schedule (typically 3 years)" }, { "title": "Special Process Examples", "body": "ProcessValidation StandardCritical ParametersEO SterilizationISO 11135Temperature, humidity, EO concentration, timeSteam SterilizationISO 17665Temperature, pressure, timeRadiation SterilizationISO 11137Dose, dose uniformitySealingInternalTemperature, pressure, dwell timeWeldingISO 11607Heat, pressure, speed" }, { "title": "Supplier Qualification Workflow", "body": "Evaluate and approve suppliers per ISO 13485 Clause 7.4." }, { "title": "Workflow: New Supplier Qualification", "body": "Identify supplier category:\n\nCategory A: Critical (affects safety/performance)\nCategory B: Major (affects quality)\nCategory C: Minor (indirect impact)\n\n\nRequest supplier information:\n\nQuality certifications\nProduct specifications\nQuality history\n\n\nEvaluate supplier based on:\n\nQuality system (ISO certification)\nTechnical capability\nQuality history\nFinancial stability\n\n\nFor Category A suppliers:\n\nConduct on-site audit\nRequire quality agreement\n\n\nCalculate qualification score\nMake approval decision:\n\n\n\n80: Approved\n\n\n60-80: Conditional approval\n<60: Not approved\n\n\nAdd to Approved Supplier List\nValidation: Evaluation criteria scored; qualification records complete; supplier categorized" }, { "title": "Supplier Evaluation Criteria", "body": "CriterionWeightScoringQuality System30%ISO 13485=30, ISO 9001=20, Documented=10, None=0Quality History25%Reject rate: <1%=25, 1-3%=15, >3%=0Delivery20%On-time: >95%=20, 90-95%=10, <90%=0Technical Capability15%Exceeds=15, Meets=10, Marginal=5Financial Stability10%Strong=10, Adequate=5, Questionable=0" }, { "title": "Supplier Category Requirements", "body": "CategoryQualificationMonitoringAgreementA - CriticalOn-site auditAnnual reviewQuality agreementB - MajorQuestionnaireSemi-annual reviewQuality requirementsC - MinorAssessmentIssue-basedStandard terms" }, { "title": "Supplier Performance Metrics", "body": "MetricTargetCalculationAccept Rate>98%(Accepted lots / Total lots) × 100On-Time Delivery>95%(On-time / Total orders) × 100Response Time<5 daysAverage days to resolve issuesDocumentation100%(Complete CoCs / Required CoCs) × 100" }, { "title": "QMS Process Reference", "body": "For detailed requirements and audit questions for each ISO 13485:2016 clause, see iso13485-clause-requirements.md." }, { "title": "Management Review Required Inputs (Clause 5.6.2)", "body": "InputSourcePrepared ByAudit resultsInternal and external auditsQA ManagerCustomer feedbackComplaints, surveysCustomer QualityProcess performanceProcess metricsProcess OwnersProduct conformityInspection data, NCsQC ManagerCAPA statusCAPA systemCAPA OfficerPrevious actionsPrior review recordsQMRChanges affecting QMSRegulatory, organizationalRA ManagerRecommendationsAll sourcesAll Managers" }, { "title": "Record Retention Requirements", "body": "Record TypeMinimum RetentionRegulatory BasisDevice Master RecordLife of device + 2 years21 CFR 820.181Device History RecordLife of device + 2 years21 CFR 820.184Design History FileLife of device + 2 years21 CFR 820.30Complaint RecordsLife of device + 2 years21 CFR 820.198Training RecordsEmployment + 3 yearsBest practiceAudit Records7 yearsBest practiceCAPA Records7 yearsBest practiceCalibration RecordsEquipment life + 2 yearsBest practice" }, { "title": "Exclusion Justification (Clause 4.2.2)", "body": "ClausePermissible ExclusionJustification Required6.4.2Contamination controlProduct not affected by contamination7.3Design and developmentOrganization does not design products7.5.2Product cleanlinessNo cleanliness requirements7.5.3InstallationNo installation activities7.5.4ServicingNo servicing activities7.5.5Sterile productsNo sterile products" }, { "title": "Nonconformity Disposition Decision Tree", "body": "Nonconforming Product Identified\n │\n ▼\n Can it be reworked?\n │\n Yes──┴──No\n │ │\n ▼ ▼\n Is rework Can it be used\n procedure as is?\n available? │\n │ Yes──┴──No\n Yes─┴─No │ │\n │ │ ▼ ▼\n ▼ ▼ Concession Scrap or\n Rework Create approval return to\n per SOP rework needed? supplier\n procedure │\n Yes─┴─No\n │ │\n ▼ ▼\n Customer Use as is\n approval with MRB\n approval" }, { "title": "CAPA Initiation Criteria", "body": "SourceAutomatic CAPAEvaluate for CAPACustomer complaintSafety-relatedAll othersExternal auditMajor NCMinor NCInternal auditMajor NCRepeat minor NCProduct NCField failureTrend exceeds thresholdProcess deviationSafety impactRepeated deviations" }, { "title": "Scripts", "body": "ToolPurposeUsageqms_audit_checklist.pyGenerate audit checklists by clause or processpython qms_audit_checklist.py --help\n\nAudit Checklist Generator Features:\n\nGenerate clause-specific checklists (e.g., --clause 7.3)\nGenerate process-based checklists (e.g., --process design-control)\nFull system audit checklist (--audit-type system)\nText or JSON output formats\nInteractive mode for guided selection" }, { "title": "References", "body": "DocumentContentiso13485-clause-requirements.mdDetailed requirements for each ISO 13485:2016 clause with audit questionsqms-process-templates.mdReady-to-use templates for gap analysis, audit program, document control, CAPA, supplier, training" }, { "title": "Quick Reference: Mandatory Documented Procedures", "body": "ProcedureClauseKey ElementsDocument Control4.2.3Approval, distribution, obsolete controlRecord Control4.2.4Identification, retention, disposalInternal Audit8.2.4Program, auditor qualification, reportingNC Product Control8.3Identification, segregation, dispositionCorrective Action8.5.2Root cause, implementation, verificationPreventive Action8.5.3Risk identification, implementation" }, { "title": "Related Skills", "body": "SkillIntegration Pointquality-manager-qmrManagement review, quality policycapa-officerCAPA system managementqms-audit-expertAdvanced audit techniquesquality-documentation-managerDHF, DMR, DHR managementrisk-management-specialistISO 14971 integration" } ], "body": "Quality Manager - QMS ISO 13485 Specialist\n\nISO 13485:2016 Quality Management System implementation, maintenance, and certification support for medical device organizations.\n\nTable of Contents\nQMS Implementation Workflow\nDocument Control Workflow\nInternal Audit Workflow\nProcess Validation Workflow\nSupplier Qualification Workflow\nQMS Process Reference\nDecision Frameworks\nTools and References\nQMS Implementation Workflow\n\nImplement ISO 13485:2016 compliant quality management system from gap analysis through certification.\n\nWorkflow: Initial QMS Implementation\nConduct gap analysis against ISO 13485:2016 requirements\nDocument current state vs. required state for each clause\nPrioritize gaps by:\nRegulatory criticality\nRisk to product safety\nResource requirements\nDevelop implementation roadmap with milestones\nEstablish Quality Manual per Clause 4.2.2:\nQMS scope with justified exclusions\nProcess interactions\nProcedure references\nCreate required documented procedures — see Mandatory Documented Procedures for the full list\nDeploy processes with training\nValidation: Gap analysis complete; Quality Manual approved; all required procedures documented and trained\n\nUse the Gap Analysis Matrix template in qms-process-templates.md to document clause-by-clause current state, gaps, priority, and actions.\n\nQMS Structure\nLevel\tDocument Type\tExample\n1\tQuality Manual\tQM-001\n2\tProcedures\tSOP-02-001\n3\tWork Instructions\tWI-06-012\n4\tRecords\tTraining records\nDocument Control Workflow\n\nEstablish and maintain document control per ISO 13485 Clause 4.2.3.\n\nWorkflow: Document Creation and Approval\nIdentify need for new document or revision\nAssign document number per numbering convention:\nFormat: [TYPE]-[AREA]-[SEQUENCE]-[REV]\nExample: SOP-02-001-01\nDraft document using approved template\nRoute for review to subject matter experts\nCollect and address review comments\nObtain required approvals based on document type\nUpdate Document Master List\nValidation: Document numbered correctly; all reviewers signed; Master List updated\nDocument Numbering Convention\nPrefix\tDocument Type\tApproval Authority\nQM\tQuality Manual\tManagement Rep + CEO\nPOL\tPolicy\tDepartment Head + QA\nSOP\tProcedure\tProcess Owner + QA\nWI\tWork Instruction\tSupervisor + QA\nTF\tTemplate/Form\tProcess Owner\nSPEC\tSpecification\tEngineering + QA\nArea Codes\nCode\tArea\tExamples\n01\tQuality Management\tQuality Manual, policy\n02\tDocument Control\tThis procedure\n03\tTraining\tCompetency procedures\n04\tDesign\tDesign control\n05\tPurchasing\tSupplier management\n06\tProduction\tManufacturing\n07\tQuality Control\tInspection, testing\n08\tCAPA\tCorrective actions\nDocument Change Control\nChange Type\tApproval Level\tExamples\nAdministrative\tDocument Control\tTypos, formatting\nMinor\tProcess Owner + QA\tClarifications\nMajor\tFull review cycle\tProcess changes\nEmergency\tExpedited + retrospective\tSafety issues\nDocument Review Schedule\nDocument Type\tReview Period\tTrigger for Unscheduled Review\nQuality Manual\tAnnual\tOrganizational change\nProcedures\tAnnual\tAudit finding, regulation change\nWork Instructions\t2 years\tProcess change\nForms\t2 years\tUser feedback\nInternal Audit Workflow\n\nPlan and execute internal audits per ISO 13485 Clause 8.2.4.\n\nWorkflow: Annual Audit Program\nIdentify processes and areas requiring audit coverage\nAssess risk factors for audit frequency:\nPrevious audit findings\nRegulatory changes\nProcess changes\nComplaint trends\nAssign qualified auditors (independent of area audited)\nDevelop annual audit schedule\nObtain management approval\nCommunicate schedule to process owners\nTrack completion and reschedule as needed\nValidation: All processes covered; auditors qualified and independent; schedule approved\n\nUse the Audit Program Template in qms-process-templates.md to schedule audits by clause and quarter across processes such as Document Control (4.2.3/4.2.4), Management Review (5.6), Design Control (7.3), Production (7.5), and CAPA (8.5.2/8.5.3).\n\nWorkflow: Individual Audit Execution\nPrepare audit plan with scope, criteria, and schedule\nNotify auditee minimum 1 week prior\nReview procedures and previous audit results\nPrepare audit checklist\nConduct opening meeting\nCollect evidence through:\nDocument review\nRecord sampling\nProcess observation\nPersonnel interviews\nClassify findings:\nMajor NC: Absence or breakdown of system\nMinor NC: Single lapse or deviation\nObservation: Risk of future NC\nConduct closing meeting\nIssue audit report within 5 business days\nValidation: All checklist items addressed; findings supported by evidence; report distributed\nAuditor Qualification Requirements\nCriterion\tRequirement\nTraining\tISO 13485 awareness + auditor training\nExperience\tMinimum 1 audit as observer\nIndependence\tNot auditing own work area\nCompetence\tUnderstanding of audited process\nFinding Classification Guide\nClassification\tCriteria\tResponse Time\nMajor NC\tSystem absence, total breakdown, regulatory violation\t30 days for CAPA\nMinor NC\tSingle instance, partial compliance\t60 days for CAPA\nObservation\tPotential risk, improvement opportunity\tTrack in next audit\nProcess Validation Workflow\n\nValidate special processes per ISO 13485 Clause 7.5.6.\n\nWorkflow: Process Validation Protocol\nIdentify processes requiring validation:\nOutput cannot be verified by inspection\nDeficiencies appear only in use\nSterilization, welding, sealing, software\nForm validation team with subject matter experts\nWrite validation protocol including:\nProcess description and parameters\nEquipment and materials\nAcceptance criteria\nStatistical approach\nExecute IQ: verify equipment installed correctly and document specifications\nExecute OQ: test parameter ranges and verify process control\nExecute PQ: run production conditions and verify output meets requirements\nWrite validation report with conclusions\nValidation: IQ/OQ/PQ complete; acceptance criteria met; validation report approved\nValidation Documentation Requirements\nPhase\tContent\tEvidence\nProtocol\tObjectives, methods, criteria\tApproved protocol\nIQ\tEquipment verification\tInstallation records\nOQ\tParameter verification\tTest results\nPQ\tPerformance verification\tProduction data\nReport\tSummary, conclusions\tApproval signatures\nRevalidation Triggers\nTrigger\tAction Required\nEquipment change\tAssess impact, revalidate affected phases\nParameter change\tOQ and PQ minimum\nMaterial change\tAssess impact, PQ minimum\nProcess failure\tFull revalidation\nPeriodic\tPer validation schedule (typically 3 years)\nSpecial Process Examples\nProcess\tValidation Standard\tCritical Parameters\nEO Sterilization\tISO 11135\tTemperature, humidity, EO concentration, time\nSteam Sterilization\tISO 17665\tTemperature, pressure, time\nRadiation Sterilization\tISO 11137\tDose, dose uniformity\nSealing\tInternal\tTemperature, pressure, dwell time\nWelding\tISO 11607\tHeat, pressure, speed\nSupplier Qualification Workflow\n\nEvaluate and approve suppliers per ISO 13485 Clause 7.4.\n\nWorkflow: New Supplier Qualification\nIdentify supplier category:\nCategory A: Critical (affects safety/performance)\nCategory B: Major (affects quality)\nCategory C: Minor (indirect impact)\nRequest supplier information:\nQuality certifications\nProduct specifications\nQuality history\nEvaluate supplier based on:\nQuality system (ISO certification)\nTechnical capability\nQuality history\nFinancial stability\nFor Category A suppliers:\nConduct on-site audit\nRequire quality agreement\nCalculate qualification score\nMake approval decision:\n\n80: Approved\n\n60-80: Conditional approval\n<60: Not approved\nAdd to Approved Supplier List\nValidation: Evaluation criteria scored; qualification records complete; supplier categorized\nSupplier Evaluation Criteria\nCriterion\tWeight\tScoring\nQuality System\t30%\tISO 13485=30, ISO 9001=20, Documented=10, None=0\nQuality History\t25%\tReject rate: <1%=25, 1-3%=15, >3%=0\nDelivery\t20%\tOn-time: >95%=20, 90-95%=10, <90%=0\nTechnical Capability\t15%\tExceeds=15, Meets=10, Marginal=5\nFinancial Stability\t10%\tStrong=10, Adequate=5, Questionable=0\nSupplier Category Requirements\nCategory\tQualification\tMonitoring\tAgreement\nA - Critical\tOn-site audit\tAnnual review\tQuality agreement\nB - Major\tQuestionnaire\tSemi-annual review\tQuality requirements\nC - Minor\tAssessment\tIssue-based\tStandard terms\nSupplier Performance Metrics\nMetric\tTarget\tCalculation\nAccept Rate\t>98%\t(Accepted lots / Total lots) × 100\nOn-Time Delivery\t>95%\t(On-time / Total orders) × 100\nResponse Time\t<5 days\tAverage days to resolve issues\nDocumentation\t100%\t(Complete CoCs / Required CoCs) × 100\nQMS Process Reference\n\nFor detailed requirements and audit questions for each ISO 13485:2016 clause, see iso13485-clause-requirements.md.\n\nManagement Review Required Inputs (Clause 5.6.2)\nInput\tSource\tPrepared By\nAudit results\tInternal and external audits\tQA Manager\nCustomer feedback\tComplaints, surveys\tCustomer Quality\nProcess performance\tProcess metrics\tProcess Owners\nProduct conformity\tInspection data, NCs\tQC Manager\nCAPA status\tCAPA system\tCAPA Officer\nPrevious actions\tPrior review records\tQMR\nChanges affecting QMS\tRegulatory, organizational\tRA Manager\nRecommendations\tAll sources\tAll Managers\nRecord Retention Requirements\nRecord Type\tMinimum Retention\tRegulatory Basis\nDevice Master Record\tLife of device + 2 years\t21 CFR 820.181\nDevice History Record\tLife of device + 2 years\t21 CFR 820.184\nDesign History File\tLife of device + 2 years\t21 CFR 820.30\nComplaint Records\tLife of device + 2 years\t21 CFR 820.198\nTraining Records\tEmployment + 3 years\tBest practice\nAudit Records\t7 years\tBest practice\nCAPA Records\t7 years\tBest practice\nCalibration Records\tEquipment life + 2 years\tBest practice\nDecision Frameworks\nExclusion Justification (Clause 4.2.2)\nClause\tPermissible Exclusion\tJustification Required\n6.4.2\tContamination control\tProduct not affected by contamination\n7.3\tDesign and development\tOrganization does not design products\n7.5.2\tProduct cleanliness\tNo cleanliness requirements\n7.5.3\tInstallation\tNo installation activities\n7.5.4\tServicing\tNo servicing activities\n7.5.5\tSterile products\tNo sterile products\nNonconformity Disposition Decision Tree\nNonconforming Product Identified\n │\n ▼\n Can it be reworked?\n │\n Yes──┴──No\n │ │\n ▼ ▼\n Is rework Can it be used\n procedure as is?\n available? │\n │ Yes──┴──No\n Yes─┴─No │ │\n │ │ ▼ ▼\n ▼ ▼ Concession Scrap or\n Rework Create approval return to\n per SOP rework needed? supplier\n procedure │\n Yes─┴─No\n │ │\n ▼ ▼\n Customer Use as is\n approval with MRB\n approval\n\nCAPA Initiation Criteria\nSource\tAutomatic CAPA\tEvaluate for CAPA\nCustomer complaint\tSafety-related\tAll others\nExternal audit\tMajor NC\tMinor NC\nInternal audit\tMajor NC\tRepeat minor NC\nProduct NC\tField failure\tTrend exceeds threshold\nProcess deviation\tSafety impact\tRepeated deviations\nTools and References\nScripts\nTool\tPurpose\tUsage\nqms_audit_checklist.py\tGenerate audit checklists by clause or process\tpython qms_audit_checklist.py --help\n\nAudit Checklist Generator Features:\n\nGenerate clause-specific checklists (e.g., --clause 7.3)\nGenerate process-based checklists (e.g., --process design-control)\nFull system audit checklist (--audit-type system)\nText or JSON output formats\nInteractive mode for guided selection\nReferences\nDocument\tContent\niso13485-clause-requirements.md\tDetailed requirements for each ISO 13485:2016 clause with audit questions\nqms-process-templates.md\tReady-to-use templates for gap analysis, audit program, document control, CAPA, supplier, training\nQuick Reference: Mandatory Documented Procedures\nProcedure\tClause\tKey Elements\nDocument Control\t4.2.3\tApproval, distribution, obsolete control\nRecord Control\t4.2.4\tIdentification, retention, disposal\nInternal Audit\t8.2.4\tProgram, auditor qualification, reporting\nNC Product Control\t8.3\tIdentification, segregation, disposition\nCorrective Action\t8.5.2\tRoot cause, implementation, verification\nPreventive Action\t8.5.3\tRisk identification, implementation\nRelated Skills\nSkill\tIntegration Point\nquality-manager-qmr\tManagement review, quality policy\ncapa-officer\tCAPA system management\nqms-audit-expert\tAdvanced audit techniques\nquality-documentation-manager\tDHF, DMR, DHR management\nrisk-management-specialist\tISO 14971 integration" }, "trust": { "sourceLabel": "tencent", "provenanceUrl": "https://clawhub.ai/alirezarezvani/quality-manager-qms-iso13485", "publisherUrl": "https://clawhub.ai/alirezarezvani/quality-manager-qms-iso13485", "owner": "alirezarezvani", "version": "2.1.1", "license": null, 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