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Tencent SkillHub ยท Security & Compliance
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.
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ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support.
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- SKILL.md, references/iso13485-clause-requirements.md, references/qms-process-templates.md, scripts/qms_audit_checklist.py
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- 2.1.1
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Documentation
Quality Manager - QMS ISO 13485 Specialist
ISO 13485:2016 Quality Management System implementation, maintenance, and certification support for medical device organizations.
Table of Contents
QMS Implementation Workflow Document Control Workflow Internal Audit Workflow Process Validation Workflow Supplier Qualification Workflow QMS Process Reference Decision Frameworks Tools and References
QMS Implementation Workflow
Implement ISO 13485:2016 compliant quality management system from gap analysis through certification.
Workflow: Initial QMS Implementation
Conduct gap analysis against ISO 13485:2016 requirements Document current state vs. required state for each clause Prioritize gaps by: Regulatory criticality Risk to product safety Resource requirements Develop implementation roadmap with milestones Establish Quality Manual per Clause 4.2.2: QMS scope with justified exclusions Process interactions Procedure references Create required documented procedures โ see Mandatory Documented Procedures for the full list Deploy processes with training Validation: Gap analysis complete; Quality Manual approved; all required procedures documented and trained Use the Gap Analysis Matrix template in qms-process-templates.md to document clause-by-clause current state, gaps, priority, and actions.
QMS Structure
LevelDocument TypeExample1Quality ManualQM-0012ProceduresSOP-02-0013Work InstructionsWI-06-0124RecordsTraining records
Document Control Workflow
Establish and maintain document control per ISO 13485 Clause 4.2.3.
Workflow: Document Creation and Approval
Identify need for new document or revision Assign document number per numbering convention: Format: [TYPE]-[AREA]-[SEQUENCE]-[REV] Example: SOP-02-001-01 Draft document using approved template Route for review to subject matter experts Collect and address review comments Obtain required approvals based on document type Update Document Master List Validation: Document numbered correctly; all reviewers signed; Master List updated
Document Numbering Convention
PrefixDocument TypeApproval AuthorityQMQuality ManualManagement Rep + CEOPOLPolicyDepartment Head + QASOPProcedureProcess Owner + QAWIWork InstructionSupervisor + QATFTemplate/FormProcess OwnerSPECSpecificationEngineering + QA
Area Codes
CodeAreaExamples01Quality ManagementQuality Manual, policy02Document ControlThis procedure03TrainingCompetency procedures04DesignDesign control05PurchasingSupplier management06ProductionManufacturing07Quality ControlInspection, testing08CAPACorrective actions
Document Change Control
Change TypeApproval LevelExamplesAdministrativeDocument ControlTypos, formattingMinorProcess Owner + QAClarificationsMajorFull review cycleProcess changesEmergencyExpedited + retrospectiveSafety issues
Document Review Schedule
Document TypeReview PeriodTrigger for Unscheduled ReviewQuality ManualAnnualOrganizational changeProceduresAnnualAudit finding, regulation changeWork Instructions2 yearsProcess changeForms2 yearsUser feedback
Internal Audit Workflow
Plan and execute internal audits per ISO 13485 Clause 8.2.4.
Workflow: Annual Audit Program
Identify processes and areas requiring audit coverage Assess risk factors for audit frequency: Previous audit findings Regulatory changes Process changes Complaint trends Assign qualified auditors (independent of area audited) Develop annual audit schedule Obtain management approval Communicate schedule to process owners Track completion and reschedule as needed Validation: All processes covered; auditors qualified and independent; schedule approved Use 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).
Workflow: Individual Audit Execution
Prepare audit plan with scope, criteria, and schedule Notify auditee minimum 1 week prior Review procedures and previous audit results Prepare audit checklist Conduct opening meeting Collect evidence through: Document review Record sampling Process observation Personnel interviews Classify findings: Major NC: Absence or breakdown of system Minor NC: Single lapse or deviation Observation: Risk of future NC Conduct closing meeting Issue audit report within 5 business days Validation: All checklist items addressed; findings supported by evidence; report distributed
Auditor Qualification Requirements
CriterionRequirementTrainingISO 13485 awareness + auditor trainingExperienceMinimum 1 audit as observerIndependenceNot auditing own work areaCompetenceUnderstanding of audited process
Finding Classification Guide
ClassificationCriteriaResponse TimeMajor NCSystem absence, total breakdown, regulatory violation30 days for CAPAMinor NCSingle instance, partial compliance60 days for CAPAObservationPotential risk, improvement opportunityTrack in next audit
Process Validation Workflow
Validate special processes per ISO 13485 Clause 7.5.6.
Workflow: Process Validation Protocol
Identify processes requiring validation: Output cannot be verified by inspection Deficiencies appear only in use Sterilization, welding, sealing, software Form validation team with subject matter experts Write validation protocol including: Process description and parameters Equipment and materials Acceptance criteria Statistical approach Execute IQ: verify equipment installed correctly and document specifications Execute OQ: test parameter ranges and verify process control Execute PQ: run production conditions and verify output meets requirements Write validation report with conclusions Validation: IQ/OQ/PQ complete; acceptance criteria met; validation report approved
Validation Documentation Requirements
PhaseContentEvidenceProtocolObjectives, methods, criteriaApproved protocolIQEquipment verificationInstallation recordsOQParameter verificationTest resultsPQPerformance verificationProduction dataReportSummary, conclusionsApproval signatures
Revalidation Triggers
TriggerAction RequiredEquipment changeAssess impact, revalidate affected phasesParameter changeOQ and PQ minimumMaterial changeAssess impact, PQ minimumProcess failureFull revalidationPeriodicPer validation schedule (typically 3 years)
Special Process Examples
ProcessValidation StandardCritical ParametersEO SterilizationISO 11135Temperature, humidity, EO concentration, timeSteam SterilizationISO 17665Temperature, pressure, timeRadiation SterilizationISO 11137Dose, dose uniformitySealingInternalTemperature, pressure, dwell timeWeldingISO 11607Heat, pressure, speed
Supplier Qualification Workflow
Evaluate and approve suppliers per ISO 13485 Clause 7.4.
Workflow: New Supplier Qualification
Identify supplier category: Category A: Critical (affects safety/performance) Category B: Major (affects quality) Category C: Minor (indirect impact) Request supplier information: Quality certifications Product specifications Quality history Evaluate supplier based on: Quality system (ISO certification) Technical capability Quality history Financial stability For Category A suppliers: Conduct on-site audit Require quality agreement Calculate qualification score Make approval decision: 80: Approved 60-80: Conditional approval <60: Not approved Add to Approved Supplier List Validation: Evaluation criteria scored; qualification records complete; supplier categorized
Supplier Evaluation Criteria
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
Supplier Category Requirements
CategoryQualificationMonitoringAgreementA - CriticalOn-site auditAnnual reviewQuality agreementB - MajorQuestionnaireSemi-annual reviewQuality requirementsC - MinorAssessmentIssue-basedStandard terms
Supplier Performance Metrics
MetricTargetCalculationAccept Rate>98%(Accepted lots / Total lots) ร 100On-Time Delivery>95%(On-time / Total orders) ร 100Response Time<5 daysAverage days to resolve issuesDocumentation100%(Complete CoCs / Required CoCs) ร 100
QMS Process Reference
For detailed requirements and audit questions for each ISO 13485:2016 clause, see iso13485-clause-requirements.md.
Management Review Required Inputs (Clause 5.6.2)
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
Record Retention Requirements
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
Exclusion Justification (Clause 4.2.2)
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
Nonconformity Disposition Decision Tree
Nonconforming Product Identified โ โผ Can it be reworked? โ YesโโโดโโNo โ โ โผ โผ Is rework Can it be used procedure as is? available? โ โ YesโโโดโโNo YesโโดโNo โ โ โ โ โผ โผ โผ โผ Concession Scrap or Rework Create approval return to per SOP rework needed? supplier procedure โ YesโโดโNo โ โ โผ โผ Customer Use as is approval with MRB approval
CAPA Initiation Criteria
SourceAutomatic CAPAEvaluate for CAPACustomer complaintSafety-relatedAll othersExternal auditMajor NCMinor NCInternal auditMajor NCRepeat minor NCProduct NCField failureTrend exceeds thresholdProcess deviationSafety impactRepeated deviations
Scripts
ToolPurposeUsageqms_audit_checklist.pyGenerate audit checklists by clause or processpython qms_audit_checklist.py --help Audit Checklist Generator Features: Generate clause-specific checklists (e.g., --clause 7.3) Generate process-based checklists (e.g., --process design-control) Full system audit checklist (--audit-type system) Text or JSON output formats Interactive mode for guided selection
References
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
Quick Reference: Mandatory Documented Procedures
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
Related Skills
SkillIntegration Pointquality-manager-qmrManagement review, quality policycapa-officerCAPA system managementqms-audit-expertAdvanced audit techniquesquality-documentation-managerDHF, DMR, DHR managementrisk-management-specialistISO 14971 integration
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-clause-requirements.md
- references/qms-process-templates.md
- scripts/qms_audit_checklist.py