ISO 13485 Lead Auditor Training Course Syllabus 

Module 1: Introduction to ISO 13485:2016  

• Overview of ISO 13485:2016 
• Purpose and Benefits of ISO 13485 Implementation 
• Applications and Initial Compliance Steps 
• Understanding Medical Devices and Quality Management Systems 
• Key Principles of ISO 13485 
• Practical Exercise 

Module 2: ISO 13485 Clauses 1 and 2  

• Clause 1: Scope 
• Clause 5: Management Responsibilities 
• Clause 6: Resource Management 
• Clause 2: Normative References 

Module 3: ISO 13485 Clauses 3 and 4  

• Clause 3: Terms and Definitions 
• Clause 4: Quality Management System  
• 4.1 General Requirements 
• 4.2 Documentation Requirements  
• Practical Exercise 

Module 4: Quality Systems and Requirements  

• Overview of Quality Systems 
• Management Responsibilities (Clause 5) 
• Resource Management (Clause 6) 
• Product Realization (Clause 7) 
• Measurement, Analysis, and Improvement (Clause 8) 
• Practical Exercise 

Module 5: ISO 13485:2016 Key Requirements  

• General and Documentation Requirements 
• Management Responsibility and Resource Allocation 
• Product Realization and Risk Management 

Module 6: ISO 13485 Implementation Stages  

• Implementation Phases 
• Conducting Gap Analysis 
• Process Mapping 

Module 7: ISO 13485 Certification Audit  

• Certification Audit Process 
• Practical Exercise 

Module 8: ISO 13485 vs. ISO 9001  

• Scope and Focus Comparison 
• Continual Improvement and Terminology Differences 
• Key Similarities and Differences 

Module 9: Internal Auditing Fundamentals  

• Objectives and Key Auditing Skills 
• Steps in Internal Auditing 
• Audit Planning, Preparation, and Execution 
• Internal Audit and PDCA Cycle 
• Audit Techniques and Types 
• Practical Exercise 

Module 10: Internal Audit Planning  

• Audit Plan Development 
• Audit Criteria and Scope 

Module 11: Audit Process Execution  

• Conducting Process Audits 
• Scope, Criteria, and Reporting Findings 

Module 12: Audit Evidence and Findings  

• Internal Audit Evidence Classification 
• Closing Reports and Nonconformities 
• Documented Procedures 
• Practical Exercise 

Module 13: Roles and Responsibilities  

• Internal Auditor Responsibilities 
• Conducting closing Meetings 

Module 14: Resource Management and Product Realization  

• Resource Allocation 
• Infrastructure and Product Development Planning 

Module 15: ISO 13485 and Quality Management Systems (QMS)  

• Understanding ISO 13485 in QMS Context 
• Practical Exercise 

Module 16: Principles of Quality Management Systems  

• Core Principles of QMS 
• Practical Exercise 

Module 17: Fundamentals of QMS  

• Essential Components of Quality Management Systems 

Module 18: Measurement, Analysis, and Improvement  

• Monitoring and Measurement Strategies 
• Handling Nonconforming Products 
• Data Analysis and QMS Performance Improvement 
• Corrective and Preventive Actions 

Module 19: Risk Management in ISO 13485  

• Principles, Process, and Lifecycle of Risk Management 
• Tool and Risk Culture Development 
• Risk Assessments and Controls 
• Practical Exercise 

Module 20: Key Lead Auditor Terms and Definitions  

• Essential Terminology for Lead Auditors 

Module 21: Lead Auditor Responsibilities  

• Key Duties of a Lead Auditor 
• Auditing Organizations and Auditees 

Module 22: Team Leadership Skills  

• Core Skills for Leading an Audit Team 
• Practical Exercise 

Module 23: ISO 13485 Structure and Intent  

• Clause 5: Management Responsibility 
• Clause 6: Resource Management 
• Clause 7: Product Realization 
• Clause 8: Measurement, Analysis, and Improvement 

Module 24: Medical Devices, Quality, and Auditing  

• Understanding Medical Devices and QMS 
• Auditing Terminology 
• Practical Exercise 

Module 25: Processes, Procedures, and Records  

• Understanding and Managing Processes, Procedures, and Records 

Module 26: Audit Checklist Development  

• Purpose and Components of an Effective Checklist 
• Process-Based Audits 

Module 27: Audit Planning and Management  

• Audit Planning, Preparation, and Execution 
• Practical Exercise 

Module 28: Interviewing Skills for Audits  

• Key Interviewing Techniques 
• STAR Technique Application 

Module 29: Corrective Actions and Verification  

• Corrective Action Planning and Execution 
• Documented Procedures and Verification 

Module 30: Preventive Actions and Continuous Improvement  

• Preventive Action Process 
• Exercises and Q&A Session  

• 5 days interactive instructor-led training 

• Training provided by highly qualified, certified, and accredited trainers from PECB 

• Certificate of ISO 13485 Lead Auditor course by PECB 

• Certification