ISO 13485 Medical Devices Quality Management Internal Auditor

Module 1: Introduction to ISO 13485

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

Module 2: ISO 13485 Requirements

• Quality management system
• Management responsibility
• Resource management
• Product realisation
• Measurement and analysis
• QMS improvement

Module 3: Medical Device Regulatory Context

• Regulatory requirements
• Customer requirements
• Medical device lifecycle
• Regulatory documentation
• Product safety
• Compliance responsibilities

Module 4: Fundamentals of Internal Auditing

• Internal audit concepts
• Audit objectives
• Audit scope
• Audit criteria
• Audit evidence
• Audit findings

Module 5: Principles of Auditing

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

Module 6: Internal Audit Programme

• Audit programme objectives
• Audit frequency
• Audit schedules
• Auditor responsibilities
• Resource requirements
• Programme monitoring

Module 7: Risk-Based Audit Planning

• Process risks
• Regulatory risks
• Previous findings
• Process performance
• Audit priorities
• Risk-based scheduling

Module 8: Preparing an Internal Audit

• Defining objectives
• Establishing scope
• Identifying criteria
• Selecting processes
• Audit timetable
• Audit preparation

Module 9: Reviewing QMS Documentation

• Quality manual
• Procedures
• Medical device files
• Work instructions
• Quality records
• Previous audit reports

Module 10: Preparing Audit Checklists

• Process-based questions
• ISO 13485 requirements
• Audit trails
• Evidence requirements
• Sampling considerations
• Checklist preparation

Module 11: Opening Meeting

• Introductions
• Audit objectives
• Scope confirmation
• Audit methodology
• Communication arrangements
• Audit schedule

Module 12: Interviewing Techniques

• Open-ended questions
• Closed questions
• Follow-up questions
• Active listening
• Professional communication
• Recording responses

Module 13: Collecting Objective Evidence

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

Module 14: Auditing Document & Record Control

• Document approval
• Revision control
• Document availability
• Record identification
• Record retention
• Record protection

Module 15: Auditing Management & Resources

• Management commitment
• Quality objectives
• Responsibilities
• Competence
• Training
• Infrastructure

Module 16: Auditing Design & Risk Management

• Design planning
• Design inputs and outputs
• Design reviews
• Verification and validation
• Design changes
• Risk management evidence

Module 17: Auditing Suppliers & Purchasing

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

Module 18: Auditing Production & Traceability

• Production controls
• Process validation
• Identification
• Traceability
• Product preservation
• Production records

Module 19: Auditing Feedback & Complaints

• Customer feedback
• Complaint handling
• Complaint investigation
• Complaint records
• Regulatory reporting awareness
• Trend information

Module 20: Nonconformities & Audit Findings

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

Module 21: Audit Reporting & Corrective Actions

• Audit report structure
• Reporting findings
• Closing meeting
• Root cause analysis
• Corrective action
• Effectiveness verification

Module 22: Internal Audit Simulation

• Audit planning
• Document review
• Checklist application
• Evidence collection
• Developing findings
• Reporting and follow-up