ISO 13485 Lead Implementer

• Professional Background: No prior experience with ISO 13485 is required; however, a basic understanding of quality management principles or working knowledge of the medical device industry will enhance the learning experience. 

• Language Proficiency: Delegates must have a strong command of English, as all course content, discussions, and assessments are delivered in English. 

• Interest in Quality Management Systems: This course is ideal for individuals aiming to lead ISO 13485 implementation efforts and ensure their organisations maintain compliance with industry standards for medical device manufacturing and regulation. 

• Understand ISO 13485 Standards: Gain a thorough understanding of the ISO 13485:2016 standard, including its structure, requirements, and the importance of compliance in the medical device industry. 

• Lead Implementation of QMS: Develop the skills to lead the implementation of an effective quality management system, ensuring that all processes meet the requirements of ISO 13485 and contribute to product quality and safety. 

• Internal Auditing Skills: Learn how to conduct internal audits effectively, ensuring continuous improvement within the organisation’s QMS and preparing for external audits and certifications. 

• Risk Management and Compliance: Understand the principles of risk management in medical device manufacturing and how to integrate risk-based thinking into the QMS to enhance regulatory compliance and product safety. 

The ISO 13485 Lead Implementer Course is designed for professionals who are involved in the implementation, maintenance, or management of ISO 13485-compliant quality management systems. The following individuals can benefit from this course: 

• Quality Assurance Managers 

• Quality Control Managers 

• Regulatory Affairs Professionals 

• Compliance Managers 

• Medical Device Manufacturers 

• Production Managers 

• Internal Auditors 

• Consultants specialising in medical device regulation 

• Health and Safety Managers 

• Risk Management Professionals 

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