ISO 13485 Lead Implementer​ Training

The ISO 13485 Lead Implementer Course provides comprehensive guidance on planning, implementing, and maintaining a QMS based on ISO 13485. Learners gain practical knowledge to support regulatory compliance, risk management, and continuous improvement across medical device development and manufacturing processes.

Key Topics Covered 

• ISO 13485 Structure: Principles, clauses, and documentation 

• Implementation Planning: Policies, objectives, and compliance frameworks 

• Risk-Based Controls: Product safety and regulatory integration 

• Internal Performance Monitoring: Metrics, audits, and management review 

• Process Improvement: CAPA and change management practices 

Course Benefits 

• Regulatory Readiness: Ensure ISO 13485 implementation meets global requirements 

• Strategic Implementation Skills: Learn end-to-end system planning 

• Industry Focus: Ideal for quality, compliance, and manufacturing leads 

• Practical Impact: Real-world scenarios and hands-on implementation exercises 

The ISO 13485 Lead Implementer Course gives employees the knowledge and skills they need to lead the implementation and management of an ISO 13485-based Quality Management System for medical devices. Below are some professionals who can benefit from this course: 

• Quality Managers 

• Regulatory Affairs Professionals 

• Product 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

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

• Develop and implement ISO 13485-compliant QMS
• Align medical device processes with regulatory requirements
• Establish documentation, risk controls, and improvement actions
• Prepare organisations for audit and certification
• Manage stakeholder expectations and compliance needs

To achieve the ISO 13485 Lead Implementer, 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