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

This revised outline streamlines the content while keeping the details clear and structured. Let me know if you'd like further adjustments! 

1. 5 days interactive instructor-led training

2. Training provided by highly qualified, certified, and accredited trainers

from PECB

3. Certificate of ISO 27001 Lead Auditor course by PECB 

4. Certification