ISO 13485 Lead Auditor Training Course Outline

Module 1: Introduction to ISO 13485:2016

• Course Overview
• Definition of ISO 13485:2016
• Advantages of Implementing ISO 13485
• Applications of ISO 13485
• Initial Steps for ISO 13485:2016 Compliance
• Understanding Medical Devices
• Purpose of a Quality Management System
• Significance of ISO 13485
• Fundamental 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
• Clause 4.1 - General Requirements
• Clause 4.2 - Document Requirements
• Practical Exercise

Module 4: Requirements and Quality Systems

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

Module 5: Overview of ISO 13485:2016 Requirements

• Key Requirements of ISO 13485:2016
• General Requirements
• Documentation Requirements
• Responsibilities of Management
• Resource Management
• Product Realization
• Infrastructure Considerations
• Risk Management

Module 6: Implementation Phases of the ISO 13485 Framework

• Steps for Implementation
• Conducting a Gap Analysis
• Process Mapping Techniques

Module 7: Conducting an ISO 13485 Certification Audit

• Overview of Certification Audits
• Practical Exercise

Module 8: Relationship Between ISO 13485 and ISO 9001

• Scope Comparison
• Areas of Focus
• Emphasis on Continual Improvement
• Key Terminology
• Differences Between the Standards
• Commonalities Between the Standards

Module 9: Internal Auditing

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

Module 10: Internal Audit Plan

• Developing an Audit Plan
• Establishing Criteria

Module 11: Audit Process

• Overview of the Audit Process
• Conducting Process Audits
• Defining Scope
• Establishing Criteria
• Reporting Audit Findings

Module 12: Internal Audit Evidence and Findings

• Gathering Evidence and Findings from Internal Audits
• Classification of Findings
• Preparing Closing Reports
• Addressing Nonconformities
• Documented Procedures
• Practical Exercise

Module 13: Roles and Responsibilities

• Responsibilities of Internal Auditors
• Conducting Closing Meetings

Module 14: Resource Management and Product Realization

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

Module 15: ISO 13485 and Quality Management Systems

• Overview of ISO 13485
• Understanding Quality Management Systems (QMS)
• Practical Exercise

Module 16: Principles of Quality Management System

• Key Principles of QMS
• Practical Exercise

Module 17: Fundamentals of Quality Management Systems

• Core Concepts of Quality Management Systems

Module 18: Measurement, Analysis, and Improvement

• Overview of Measurement, Analysis, and Improvement
• General Requirements
• Monitoring and Measurement Techniques
• Control of Nonconforming Products
• Performance Evaluation of QMS
• Data Analysis
• Improvement Strategies
• Corrective Actions
• Preventive Actions
• Identifying Opportunities for Improvement

Module 19: Risk Management

• Overview of Risk Management
• Principles of Risk Management
• Risk Management Process
• Understanding the Risk Lifecycle
• Risk Management Tools
• Cultivating a Risk Management Culture
• Assessments and Control of Risk Management
• Practical Exercise

Module 20: Key Terms and Definitions for Lead Auditors

• Definitions of Key Terms

Module 21: Lead Auditor Responsibilities

• Responsibilities of the Lead Auditor
• Interactions with the Auditing Organization
• Responsibilities towards Auditees

Module 22: Team Leader Skills

• Essential Skills for Team Leaders
• Practical Exercise

Module 23: Structure and Intent of ISO 13485

• Understanding the Structure and Intent of ISO 13485
• 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 Terminology

• Overview of Medical Devices
• Understanding Quality Management Systems
• Key Auditing Terminology
• Practical Exercise

Module 25: Processes, Procedures, and Records

• Overview of Processes
• Understanding Procedures
• Importance of Records

Module 26: Checklist Development

• Purpose of Checklists
• Benefits of a Completed Checklist
• Process-Based Audits
• Checklist Examples
• Process Checklist Development

Module 27: Planning, Preparation, and Management of Audits

• Audit Planning Techniques
• Preparation Strategies
• Management of Audits
• Practical Exercise

Module 28: Interviewing Skills

• Key Skills for Effective Interviews
• STAR Technique

Module 29: Corrective Action and Verification

• Overview of Corrective Actions
• Documented Procedures for Corrective Actions
• Processes for Implementation

Module 30: Preventive Action

• Overview of Preventive Actions
• Preventive Action Processes
• Practical Exercises and Questions 

• 5 days interactive instructor-led training 

• Training provided by highly qualified, certified, and accredited trainers fromPECB 

• Certificate of ISO 13485 Lead Auditor course by PECB 

• Certification