ISO 13485 Lead Auditor

• Professional Background: While no prior auditing experience is necessary, it is beneficial for learners to have a foundational understanding of quality management systems or the medical device industry. This will enhance the overall learning experience. 

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

• Interest in Auditing: The course is ideal for individuals looking to advance their auditing career, deepen their knowledge of ISO 13485, or take on leadership roles in audit teams. 

• Master ISO 13485 Auditing Principles: Develop a thorough understanding of ISO 13485 standards, including the principles, requirements, and procedures for auditing quality management systems in the medical device industry. 

• Conduct Audits with Confidence: Learn how to effectively plan, execute, and report on audits of quality management systems, including both internal and external audits, ensuring compliance and identifying areas for improvement. 

• Enhance Audit Leadership Skills: Gain the skills necessary to lead audit teams, manage audit processes, and communicate findings in a professional and constructive manner. 

• Improve Risk Management and Compliance: Learn to identify and evaluate risks, ensuring that audits assess not only compliance with ISO 13485 but also the effectiveness of quality management systems in mitigating risks. 

The ISO 13485 Lead Auditor course is specifically designed for professionals involved in quality management, auditing, and regulatory compliance within the medical device industry. Below are the individuals who will benefit from this course: 

• Quality Managers 

• Compliance Officers 

• Regulatory Affairs Professionals 

• Internal Auditors 

• Lead Auditors 

• Medical Device Manufacturers 

• Auditing Consultants 

• Risk Management Specialists 

• Medical Device Industry 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
   

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