ISO 13485 Medical Devices Quality Management Lead Auditor

Module 1: Introduction to ISO 13485

• ISO 13485 overview
• Purpose and scope
• Medical device QMS
• Regulatory environment
• Process approach
• QMS effectiveness

Module 2: ISO 13485 Requirements

• Quality management system
• Management responsibility
• Resource management
• Product realisation
• Measurement and analysis
• Improvement requirements

Module 3: Medical Device Regulatory Environment

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

Module 4: QMS Documentation Requirements

• Quality manual
• Procedures
• Medical device files
• Work instructions
• Document control
• Record control

Module 5: Risk Management in Medical Device QMS

• Risk-based approach
• Risk identification
• Risk evaluation
• Risk controls
• Lifecycle risk considerations
• Risk management evidence

Module 6: Fundamentals of Management System Auditing

• Audit terminology
• Audit objectives
• Audit scope
• Audit criteria
• Audit evidence
• Audit findings

Module 7: Principles of Auditing

• Integrity
• Fair presentation
• Due professional care
• Confidentiality
• Independence
• Evidence-based approach

Module 8: Risk-Based Auditing

• Audit risks
• Process risks
• Regulatory risks
• Risk prioritisation
• Audit focus
• Risk-based decision-making

Module 9: Audit Programme Management

• Programme objectives
• Audit schedules
• Responsibilities
• Resources
• Programme risks
• Programme monitoring

Module 10: Lead Auditor Responsibilities

• Audit leadership
• Team coordination
• Professional conduct
• Communication
• Decision-making
• Audit accountability

Module 11: Establishing Audit Objectives, Scope & Criteria

• Audit objectives
• Audit boundaries
• Audit criteria
• Regulatory considerations
• Process coverage
• Audit feasibility

Module 12: Audit Planning

• Audit plan
• Audit timetable
• Process allocation
• Resource requirements
• Audit methods
• Communication arrangements

Module 13: Audit Team Selection & Management

• Auditor competence
• Team selection
• Technical expertise
• Task allocation
• Team briefings
• Performance coordination

Module 14: Pre-Audit Document Review

• QMS documentation
• Procedures
• Medical device files
• Risk documentation
• Previous findings
• Performance information

Module 15: Developing Audit Checklists

• Process-based questions
• Requirement-based questions
• Audit trails
• Evidence requirements
• Sampling
• Checklist flexibility

Module 16: Opening Meeting

• Introductions
• Confirming objectives
• Confirming scope
• Audit methodology
• Communication channels
• Audit arrangements

Module 17: Interview & Communication Techniques

• Open questions
• Closed questions
• Probing questions
• Active listening
• Professional communication
• Managing difficult interviews

Module 18: Collecting & Verifying Audit Evidence

• Documents
• Records
• Interviews
• Observations
• Sampling
• Evidence verification

Module 19: Auditing Management & Resource Processes

• Management commitment
• Quality policy
• Quality objectives
• Responsibilities
• Competence and training
• Infrastructure

Module 20: Auditing Design & Development

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

Module 21: Auditing Risk Management

• Risk documentation
• Hazard identification
• Risk evaluation
• Risk controls
• Risk-related records
• Lifecycle considerations

Module 22: Auditing Suppliers & Purchasing

• Supplier selection
• Supplier evaluation
• Purchasing requirements
• Supplier monitoring
• Purchased product verification
• Supplier records

Module 23: Auditing Production & Process Validation

• Production controls
• Process parameters
• Validation requirements
• Equipment controls
• Process records
• Validation evidence

Module 24: Auditing Identification & Traceability

• Product identification
• Traceability requirements
• Product status
• Batch and lot information
• Distribution records
• Product preservation

Module 25: Auditing Feedback & Complaint Handling

• Customer feedback
• Complaint handling
• Complaint investigation
• Complaint records
• Regulatory reporting considerations
• Trend analysis

Module 26: Nonconformities & Audit Findings

• Conformity
• Nonconformity
• Objective evidence
• Finding statements
• Classification principles
• Improvement opportunities

Module 27: Corrective Action Evaluation

• Root cause analysis
• Correction
• Corrective action
• Action plans
• Effectiveness verification
• Recurrence prevention

Module 28: Closing Meeting & Audit Reporting

• Presenting findings
• Audit conclusions
• Closing meeting management
• Audit report structure
• Report preparation
• Report distribution

Module 29: Audit Follow-Up & Team Leadership

• Follow-up activities
• Corrective action status
• Verification
• Follow-up audits
• Team performance
• Audit programme improvement

Module 30: Complete ISO 13485 Audit Simulation

• Audit preparation
• Team allocation
• Document review
• Evidence collection
• Findings and conclusions
• Reporting and follow-up