ISO 13485 Medical Devices Quality Management Lead Implementer

Module 1: Introduction to ISO 13485

• ISO 13485 overview
• Purpose and scope
• Medical device QMS
• Quality management principles
• Regulatory environment
• Organisational benefits

Module 2: Understanding ISO 13485 Requirements

• Standard structure
• QMS requirements
• Management responsibility
• Resource management
• Product realisation
• Measurement and improvement

Module 3: Medical Device Regulatory Context

• Regulatory requirements
• Applicable requirements
• Customer requirements
• Regulatory responsibilities
• Medical device lifecycle
• Compliance considerations

Module 4: Lead Implementer Responsibilities

• Implementation leadership
• Project ownership
• Stakeholder engagement
• Resource coordination
• Communication
• Implementation governance

Module 5: QMS Implementation Planning

• Implementation objectives
• Project scope
• Implementation phases
• Responsibilities
• Resources
• Implementation timeline

Module 6: Organisational Context & QMS Scope

• Organisational activities
• Products and services
• QMS boundaries
• Outsourced processes
• Regulatory considerations
• Scope documentation

Module 7: ISO 13485 Gap Analysis

• Current-state assessment
• Requirement comparison
• Identifying gaps
• Prioritising actions
• Gap analysis reporting
• Implementation roadmap

Module 8: Process Identification & Mapping

• QMS processes
• Process interactions
• Inputs and outputs
• Process owners
• Process controls
• Process mapping

Module 9: QMS Documentation Structure

• Quality manual
• Policies
• Procedures
• Work instructions
• Forms and templates
• Medical device files

Module 10: Document & Record Control

• Document creation
• Review and approval
• Revision control
• Distribution
• Record retention
• Record protection

Module 11: Management Responsibility

• Management commitment
• Customer focus
• Quality policy
• Quality objectives
• Responsibilities and authority
• Management representative

Module 12: Resource Management

• Human resources
• Competence requirements
• Training
• Infrastructure
• Work environment
• Resource planning

Module 13: Risk Management Integration

• Risk management principles
• Risk identification
• Risk evaluation
• Risk controls
• Risk documentation
• Lifecycle integration

Module 14: Product Realisation Planning

• Product requirements
• Quality objectives
• Process requirements
• Verification activities
• Validation activities
• Required records

Module 15: Customer-Related Processes

• Customer requirements
• Product requirements
• Requirement review
• Customer communication
• Changes to requirements
• Customer records

Module 16: Design & Development Controls

• Design planning
• Design inputs
• Design outputs
• Design reviews
• Verification and validation
• Design changes

Module 17: Supplier Management

• Supplier selection
• Supplier evaluation
• Supplier approval
• Supplier monitoring
• Supplier re-evaluation
• Supplier performance

Module 18: Purchasing Controls

• Purchasing requirements
• Purchasing information
• Product specifications
• Verification activities
• Supplier documentation
• Purchasing records

Module 19: Production & Service Controls

• Production planning
• Controlled conditions
• Work instructions
• Equipment requirements
• Product cleanliness
• Servicing activities

Module 20: Process Validation

• Validation requirements
• Validation planning
• Acceptance criteria
• Equipment qualification
• Validation records
• Revalidation

Module 21: Identification & Traceability

• Product identification
• Traceability requirements
• Product status
• Batch and lot records
• Distribution records
• Traceability documentation

Module 22: Infrastructure & Contamination Control

• Facility requirements
• Equipment
• Maintenance
• Work environment
• Contamination prevention
• Cleanliness controls

Module 23: Customer Feedback & Complaint Handling

• Feedback collection
• Complaint receipt
• Complaint evaluation
• Investigation
• Complaint records
• Regulatory reporting considerations

Module 24: Control of Nonconforming Product

• Nonconformity identification
• Segregation
• Evaluation
• Disposition
• Concessions
• Nonconformity records

Module 25: Corrective Action

• Problem identification
• Root cause analysis
• Corrective action planning
• Implementation
• Effectiveness verification
• Preventing recurrence

Module 26: Monitoring, Measurement & Data Analysis

• Process monitoring
• Product monitoring
• Quality indicators
• Data collection
• Trend analysis
• Performance evaluation

Module 27: Internal Audit Programme

• Audit planning
• Audit criteria
• Auditor selection
• Audit execution
• Audit findings
• Follow-up activities

Module 28: Management Review

• Management review planning
• Review inputs
• QMS performance
• Customer feedback
• Quality objectives
• Review outputs

Module 29: QMS Maintenance & Improvement

• Performance monitoring
• Corrective actions
• Process improvements
• Change management
• QMS updates
• Maintaining effectiveness

Module 30: Complete ISO 13485 Implementation

• Gap analysis
• Implementation planning
• Process development
• Documentation
• Implementation monitoring
• QMS readiness review