ISO 13485 Lead Auditor Training

The ISO 13485 Lead Auditor Course provides in-depth training to conduct, lead, and manage audits of QMS for medical devices. Learners gain the expertise to assess compliance, evaluate system performance, and support certification processes under ISO 13485 requirements.

Key Topics Covered 

• ISO 13485 Overview: Structure, clauses, and regulatory intent 

• Audit Planning and Execution: Scheduling, roles, and process audits 

• Nonconformity and Reporting: Classifying, documenting, and corrective action 

• Regulatory Context: Understanding MDR, FDA, and global frameworks 

• Auditor Responsibilities: Ethics, objectivity, and continual improvement

Course Benefits 

• Career Enhancement: Ideal for Quality Managers, Auditors, and Regulatory Consultants 

• Global Relevance: Aligned with international medical device requirements 

• Practical Focus: Real-life audit scenarios and reporting tasks 

• Immediate Impact: Strengthen quality, safety, and regulatory readiness 

The ISO 13485 Lead Auditor Course provides the knowledge and skills required to conduct audits of medical device Quality Management Systems against the requirements of ISO 13485. This course can be beneficial for professionals, including: 

• Lead Auditors 

• Quality Control Managers 

• Regulatory Affairs Managers 

• Compliance Officers 

• Manufacturing Managers 

• Quality Assurance Professionals 

• Internal Auditors 

Module 1: Introduction to ISO 13485:2016

• Introduction
• What is ISO 13485:2016?
• Benefits of Implementing ISO 13485
• Applications of ISO 13485
• First Steps to ISO 13485:2016 Compliance
• What is a Medical Device?
• Purpose of a Quality Management System
• Importance of ISO 13485
• Basic Principles of ISO 13485
• 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
• Clause 4.1 General Requirements
• Clause 4.2 Document Requirements
• Exercise

Module 4: Requirements and Quality Systems

• Requirements and Quality Systems
• Clause 5 - Management Responsibilities
• Clause 6 - Resource Management
• Clause 7 - Product Realisation
• Clause 8 - Measurement, Analysis, and Improvement
• Exercise

Module 5: Overview of ISO 13485:2016 Requirements

• Requirements of ISO 13485:2016
• General Requirements
• Documentation Requirements
• Management Responsibility
• Resources
• Product Realisation
• Infrastructure
• Risk Management

Module 6: Implementation Phases of the ISO 13485 Frameworks

• Stages to Implementation
• Gap Analysis
• Process Mapping

Module 7: Conducting an ISO 13485 Certification Audit

• Certification Audits
• Exercise

Module 8: Relationship Between ISO 13485 and ISO 9001

• Scope
• Focus
• Continual Improvement
• Terminology
• Differences Between the Standards
• Similarities Between the Standards

Module 9: Internal Auditing

• Internal Auditing
• Internal Audit Objectives
• Auditing Skills
• Steps in Internal Auditing
• Planning, Preparation, and Management of Audits
• Internal Audit – PDCA Cycle
• Types of Audit
• Audit Techniques
• Exercise

Module 10: Internal Audit Plan

• Audit Plan
• Criteria

Module 11: Audit Process

• Audit Process
• Conducting Process Audits
• Scope
• Criteria
• Reporting Audit Findings

Module 12: Internal Audit Evidence and Findings

• Internal Audit Evidence and Findings
• Classification
• Closing Report
• Nonconformities
• Documented Procedure
• Exercise

Module 13: Roles and Responsibilities

• Internal Auditor Responsibilities
• Closing Meetings

Module 14: Resource Management and Product Realisation

• Provision of Resources
• Infrastructure
• Planning and Development of Products

Module 15: ISO 13485 and Quality Management Systems

• ISO 13485
• Quality Management Systems (QMS)
• Exercise

Module 16: Principles of Quality Management System

• Principles of QMS
• Exercise

Module 17: Fundamentals of Quality Management Systems

• Fundamentals of Quality Management Systems

Module 18: Measurement, Analysis, and Improvement

• Measurement, Analysis, and Improvement
• General Requirements
• Monitoring and Measurement
• Control of Nonconforming Product
• Performance of QMS
• Analysis of Data
• Improvement
• Corrective Action
• Preventive Action
• Identification of Improvement Opportunities

Module 19: Risk Management

• Risk Management
• Risk Management Principle
• Risk Management Process
• Risk Lifecycle
• Risk Management Tools
• Risk Management Culture
• Assessments and Control of Risk Management
• Exercise

Module 20: Key Terms and Definitions of Lead Auditor

• Key Terms Definitions

Module 21: Lead Auditor Responsibilities

• Lead Auditor Responsibilities
• Auditing Organisation
• Auditees

Module 22: Team Leader Skills

• Team Leader Skills
• Exercise

Module 23: Structure and Intent of ISO 13485

• Structure and Intent
• Clause 5 – Management Responsibility
• Clause 6 – Resource Management
• Clause 7 – Product Realisation
• Clause 8 – Measurement, Analysis, and Improvement

Module 24: Medical Devices, Quality, and Auditing Terminology

• Medical Devices
• Quality Management System
• Auditing Terminology
• Exercise

Module 25: Processes, Procedures, and Records

• Processes
• Procedure
• Records

Module 26: Checklist Development

• Purpose
• Completed Checklist Provides
• Process Based Audits
• Checklist
• Process Checklist

Module 27: Planning, Preparation, and Management of Audits

• Planning
• Preparation
• Management of Audits
• Exercise

Module 28: Interviewing Skills

• Key Interviewing Skills
• Star Technique

Module 29: Corrective Action and Verification

• Overview
• Corrective Action
• Documented Procedure
• Process

Module 30: Preventative Action

• Overview
• Preventive Action: Process
• Exercise and Questions

By the end of the course, learners will be able to:

• Lead full ISO 13485 QMS audits for medical device organisations
• Evaluate compliance and detect areas for process improvement
• Document audit findings and provide actionable recommendations
• Apply ISO 19011 auditing principles effectively
• Support organisations preparing for regulatory and certification audits

To achieve the ISO 13485 Lead Auditor, candidates will need to sit for an examination. The exam format is as follows: 

• Question Type: Multiple Choice
• Total Questions: 30
• Total Marks: 30 Marks
• Pass Mark: 50%, or 15/30 Marks
• Duration: 40 Minutes  
• Open Book/ Closed Book: Closed Book