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 
• Tools
  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