ISO 13485 Internal Auditor

• Professional Background: No prior experience in auditing or ISO 13485 is required. However, a basic understanding of quality management systems (QMS) and the medical device industry will enhance the learning experience. 

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

• Interest in Auditing: This course is ideal for individuals looking to develop their internal auditing skills to support quality management and regulatory compliance in the medical device sector. 

• Master ISO 13485 Standards: Gain a comprehensive understanding of the ISO 13485 standard, its requirements, and how to interpret and apply these standards within an organisation to ensure compliance with regulatory requirements. 

• Conduct Effective Internal Audits: Learn the techniques and best practices for planning, conducting, and reporting internal audits, including how to assess the effectiveness of a quality management system. 

• Improve Audit Reporting Skills: Develop the ability to create clear and accurate audit reports, documenting audit findings, non-conformities, and recommendations for improvement to enhance quality management processes. 

• Understand Corrective and Preventive Actions (CAPA): Learn to assess and recommend corrective and preventive actions to address audit findings and ensure continuous improvement within the organisation. 

The ISO 13485 Internal Auditor Course is tailored for professionals in the medical device sector looking to improve their internal auditing capabilities to ensure quality management system compliance and continuous improvement. Below are the individuals who can benefit from this course: 

• Quality Assurance Managers 

• Internal Auditors 

• Regulatory Affairs Professionals 

• Compliance Officers 

• Operations Managers 

• Production Managers 

• Medical Device Manufacturers 

• Consultants in Quality Management Systems 

• Training Coordinators 

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