This course will guide you through the complete audit lifecycle in compliance with ISO 13485:2016 and ISO 19011:2018, from planning to follow-up, including supplier and subcontractor audits. Whether you’re a quality professional, regulatory affairs specialist, auditor, or aspiring consultant, this course equips you with practical tools, templates, and real-world scenarios to confidently conduct audits that ensure compliance and mitigate risk.
This course includes real-life case studies, checklists, and templates to make your audits effective and compliant. Are you working in the medical device industry and need to strengthen your audit skills? This course is designed for quality professionals/beginners, auditors, and regulatory compliance specialists/beginners who want to excel in internal audits and supplier audits in accordance with ISO 13485:2016 and ISO 19011:2018.
In this course, you will gain a deep understanding of the audit process, from planning to execution and follow-up. We begin with an overview of ISO 13485 and its critical requirements for quality management systems in medical devices. Next, we explore ISO 19011 guidelines to ensure a risk-based, efficient, and professional auditing approach.
You will learn how to plan an audit, develop checklists, conduct interviews, and manage evidence collection. We also cover report writing, classifying nonconformities, and implementing corrective actions, ensuring you can add value beyond compliance. Special attention is given to supplier audits—a crucial aspect for managing risks and ensuring the integrity of your supply chain.
You will be able to confidently perform internal audits and second-party audits, contribute to regulatory compliance, and enhance your organization’s quality system performance.
By the end of this course, you will:
- Understand the requirements of ISO 13485 and ISO 19011 for auditing
- Learn audit planning, execution, and reporting techniques
- Master how to handle nonconformities and follow-ups
- Gain insights into supplier audits and subcontractor control
- Be prepared to drive continuous improvement through audits
