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QMS ISO 13485 Specialist

Implement and maintain ISO 13485 quality management systems for medical devices — gap analysis, process design, procedure writing, and certification readiness.

Built for: Founders

What this skill does

Get your medical device company audit-ready by implementing a complete ISO 13485 quality management system without hiring a specialist. You can generate essential documentation like quality manuals and procedures while managing corrective actions and internal audits, making it ideal for launching a new product or streamlining regulatory compliance.

@alirezarezvani · Compliance
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name: “quality-manager-qms-iso13485” description: 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. triggers:

  • ISO 13485
  • QMS implementation
  • quality management system
  • document control
  • internal audit
  • management review
  • quality manual
  • CAPA process
  • process validation
  • design control
  • supplier qualification
  • quality records

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

Implement ISO 13485:2016 compliant quality management system from gap analysis through certification.

Workflow: Initial QMS Implementation

  1. Conduct gap analysis against ISO 13485:2016 requirements
  2. Document current state vs. required state for each clause
  3. Prioritize gaps by:
    • Regulatory criticality
    • Risk to product safety
    • Resource requirements
  4. Develop implementation roadmap with milestones
  5. Establish Quality Manual per Clause 4.2.2:
    • QMS scope with justified exclusions
    • Process interactions
    • Procedure references
  6. Create required documented procedures — see Mandatory Documented Procedures for the full list
  7. Deploy processes with training
  8. 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 TypeExample
1Quality ManualQM-001
2ProceduresSOP-02-001
3Work InstructionsWI-06-012
4RecordsTraining records

Document Control Workflow

Establish and maintain document control per ISO 13485 Clause 4.2.3.

Workflow: Document Creation and Approval

  1. Identify need for new document or revision
  2. Assign document number per numbering convention:
    • Format: [TYPE]-[AREA]-[SEQUENCE]-[REV]
    • Example: SOP-02-001-01
  3. Draft document using approved template
  4. Route for review to subject matter experts
  5. Collect and address review comments
  6. Obtain required approvals based on document type
  7. Update Document Master List
  8. Validation: Document numbered correctly; all reviewers signed; Master List updated

Document Numbering Convention

PrefixDocument TypeApproval Authority
QMQuality ManualManagement Rep + CEO
POLPolicyDepartment Head + QA
SOPProcedureProcess Owner + QA
WIWork InstructionSupervisor + QA
TFTemplate/FormProcess Owner
SPECSpecificationEngineering + QA

Area Codes

CodeAreaExamples
01Quality ManagementQuality Manual, policy
02Document ControlThis procedure
03TrainingCompetency procedures
04DesignDesign control
05PurchasingSupplier management
06ProductionManufacturing
07Quality ControlInspection, testing
08CAPACorrective actions

Document Change Control

Change TypeApproval LevelExamples
AdministrativeDocument ControlTypos, formatting
MinorProcess Owner + QAClarifications
MajorFull review cycleProcess changes
EmergencyExpedited + retrospectiveSafety issues

Document Review Schedule

Document TypeReview PeriodTrigger for Unscheduled Review
Quality ManualAnnualOrganizational change
ProceduresAnnualAudit finding, regulation change
Work Instructions2 yearsProcess change
Forms2 yearsUser feedback

Internal Audit Workflow

Plan and execute internal audits per ISO 13485 Clause 8.2.4.

Workflow: Annual Audit Program

  1. Identify processes and areas requiring audit coverage
  2. Assess risk factors for audit frequency:
    • Previous audit findings
    • Regulatory changes
    • Process changes
    • Complaint trends
  3. Assign qualified auditors (independent of area audited)
  4. Develop annual audit schedule
  5. Obtain management approval
  6. Communicate schedule to process owners
  7. Track completion and reschedule as needed
  8. 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

  1. Prepare audit plan with scope, criteria, and schedule
  2. Notify auditee minimum 1 week prior
  3. Review procedures and previous audit results
  4. Prepare audit checklist
  5. Conduct opening meeting
  6. Collect evidence through:
    • Document review
    • Record sampling
    • Process observation
    • Personnel interviews
  7. Classify findings:
    • Major NC: Absence or breakdown of system
    • Minor NC: Single lapse or deviation
    • Observation: Risk of future NC
  8. Conduct closing meeting
  9. Issue audit report within 5 business days
  10. Validation: All checklist items addressed; findings supported by evidence; report distributed

Auditor Qualification Requirements

CriterionRequirement
TrainingISO 13485 awareness + auditor training
ExperienceMinimum 1 audit as observer
IndependenceNot auditing own work area
CompetenceUnderstanding of audited process

Finding Classification Guide

ClassificationCriteriaResponse Time
Major NCSystem absence, total breakdown, regulatory violation30 days for CAPA
Minor NCSingle instance, partial compliance60 days for CAPA
ObservationPotential risk, improvement opportunityTrack in next audit

Process Validation Workflow

Validate special processes per ISO 13485 Clause 7.5.6.

Workflow: Process Validation Protocol

  1. Identify processes requiring validation:
    • Output cannot be verified by inspection
    • Deficiencies appear only in use
    • Sterilization, welding, sealing, software
  2. Form validation team with subject matter experts
  3. Write validation protocol including:
    • Process description and parameters
    • Equipment and materials
    • Acceptance criteria
    • Statistical approach
  4. Execute IQ: verify equipment installed correctly and document specifications
  5. Execute OQ: test parameter ranges and verify process control
  6. Execute PQ: run production conditions and verify output meets requirements
  7. Write validation report with conclusions
  8. Validation: IQ/OQ/PQ complete; acceptance criteria met; validation report approved

Validation Documentation Requirements

PhaseContentEvidence
ProtocolObjectives, methods, criteriaApproved protocol
IQEquipment verificationInstallation records
OQParameter verificationTest results
PQPerformance verificationProduction data
ReportSummary, conclusionsApproval signatures

Revalidation Triggers

TriggerAction Required
Equipment changeAssess impact, revalidate affected phases
Parameter changeOQ and PQ minimum
Material changeAssess impact, PQ minimum
Process failureFull revalidation
PeriodicPer validation schedule (typically 3 years)

Special Process Examples

ProcessValidation StandardCritical Parameters
EO SterilizationISO 11135Temperature, humidity, EO concentration, time
Steam SterilizationISO 17665Temperature, pressure, time
Radiation SterilizationISO 11137Dose, dose uniformity
SealingInternalTemperature, pressure, dwell time
WeldingISO 11607Heat, pressure, speed

Supplier Qualification Workflow

Evaluate and approve suppliers per ISO 13485 Clause 7.4.

Workflow: New Supplier Qualification

  1. Identify supplier category:
    • Category A: Critical (affects safety/performance)
    • Category B: Major (affects quality)
    • Category C: Minor (indirect impact)
  2. Request supplier information:
    • Quality certifications
    • Product specifications
    • Quality history
  3. Evaluate supplier based on:
    • Quality system (ISO certification)
    • Technical capability
    • Quality history
    • Financial stability
  4. For Category A suppliers:
    • Conduct on-site audit
    • Require quality agreement
  5. Calculate qualification score
  6. Make approval decision:
    • 80: Approved

    • 60-80: Conditional approval
    • <60: Not approved
  7. Add to Approved Supplier List
  8. Validation: Evaluation criteria scored; qualification records complete; supplier categorized

Supplier Evaluation Criteria

CriterionWeightScoring
Quality System30%ISO 13485=30, ISO 9001=20, Documented=10, None=0
Quality History25%Reject rate: <1%=25, 1-3%=15, >3%=0
Delivery20%On-time: >95%=20, 90-95%=10, <90%=0
Technical Capability15%Exceeds=15, Meets=10, Marginal=5
Financial Stability10%Strong=10, Adequate=5, Questionable=0

Supplier Category Requirements

CategoryQualificationMonitoringAgreement
A - CriticalOn-site auditAnnual reviewQuality agreement
B - MajorQuestionnaireSemi-annual reviewQuality requirements
C - MinorAssessmentIssue-basedStandard terms

Supplier Performance Metrics

MetricTargetCalculation
Accept Rate>98%(Accepted lots / Total lots) × 100
On-Time Delivery>95%(On-time / Total orders) × 100
Response Time<5 daysAverage days to resolve issues
Documentation100%(Complete CoCs / Required CoCs) × 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 By
Audit resultsInternal and external auditsQA Manager
Customer feedbackComplaints, surveysCustomer Quality
Process performanceProcess metricsProcess Owners
Product conformityInspection data, NCsQC Manager
CAPA statusCAPA systemCAPA Officer
Previous actionsPrior review recordsQMR
Changes affecting QMSRegulatory, organizationalRA Manager
RecommendationsAll sourcesAll Managers

Record Retention Requirements

Record TypeMinimum RetentionRegulatory Basis
Device Master RecordLife of device + 2 years21 CFR 820.181
Device History RecordLife of device + 2 years21 CFR 820.184
Design History FileLife of device + 2 years21 CFR 820.30
Complaint RecordsLife of device + 2 years21 CFR 820.198
Training RecordsEmployment + 3 yearsBest practice
Audit Records7 yearsBest practice
CAPA Records7 yearsBest practice
Calibration RecordsEquipment life + 2 yearsBest practice

Decision Frameworks

Exclusion Justification (Clause 4.2.2)

ClausePermissible ExclusionJustification Required
6.4.2Contamination controlProduct not affected by contamination
7.3Design and developmentOrganization does not design products
7.5.2Product cleanlinessNo cleanliness requirements
7.5.3InstallationNo installation activities
7.5.4ServicingNo servicing activities
7.5.5Sterile productsNo sterile products

Nonconformity Disposition Decision Tree

Nonconforming Product Identified


    Can it be reworked?

       Yes──┴──No
        │       │
        ▼       ▼
    Is rework     Can it be used
    procedure     as is?
    available?        │
        │        Yes──┴──No
    Yes─┴─No     │       │
     │    │     ▼       ▼
     ▼    ▼  Concession  Scrap or
  Rework  Create    approval    return to
  per SOP  rework    needed?    supplier
          procedure     │
                    Yes─┴─No
                     │    │
                     ▼    ▼
                 Customer  Use as is
                 approval  with MRB
                          approval

CAPA Initiation Criteria

SourceAutomatic CAPAEvaluate for CAPA
Customer complaintSafety-relatedAll others
External auditMajor NCMinor NC
Internal auditMajor NCRepeat minor NC
Product NCField failureTrend exceeds threshold
Process deviationSafety impactRepeated deviations

Tools and References

Scripts

ToolPurposeUsage
qms_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

DocumentContent
iso13485-clause-requirements.mdDetailed requirements for each ISO 13485:2016 clause with audit questions
qms-process-templates.mdReady-to-use templates for gap analysis, audit program, document control, CAPA, supplier, training

Quick Reference: Mandatory Documented Procedures

ProcedureClauseKey Elements
Document Control4.2.3Approval, distribution, obsolete control
Record Control4.2.4Identification, retention, disposal
Internal Audit8.2.4Program, auditor qualification, reporting
NC Product Control8.3Identification, segregation, disposition
Corrective Action8.5.2Root cause, implementation, verification
Preventive Action8.5.3Risk identification, implementation

SkillIntegration Point
quality-manager-qmrManagement review, quality policy
capa-officerCAPA system management
qms-audit-expertAdvanced audit techniques
quality-documentation-managerDHF, DMR, DHR management
risk-management-specialistISO 14971 integration

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npx skills add alirezarezvani/claude-skills --skill ra-qm-team/quality-manager-qms-iso13485
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Details

Category
Compliance
License
MIT
Source file
show path ra-qm-team/quality-manager-qms-iso13485/SKILL.md
ISO-13485 QMS medical-device quality certification