Mastering Internal & Supplier Audits in Medical Devices

What you'll learn
This course is designed for anyone involved in the medical device industry. It's especially valuable for: Internal auditors who want to strengthen their skills
Quality Assurance and Regulatory Affairs beginner or professionals (QA/RA) who need to ensure ongoing compliance with ISO 13485 or ISO 19011
Suppliers and subcontractors who are subject to audits and want to better understand what auditors are looking for
And even for project managers, engineers, and consultants who want to build a practical understanding of how audits work in a regulated environment
Whether you're preparing for your 1st audit or looking to improve your current audit program, this course will give you the knowledge and tools to succeed
You'll learn how to plan, conduct, report, and follow up on audits-whether you're auditing internally or visiting a supplier's site
The goal? To make sure that your audit program adds value, mitigates risk, and supports compliance
By the end of this training, you'll feel confident in your ability to lead audits, communicate findings clearly
and contribute to a robust QMS that stands up to inspections and delivers safe, effective medical devices.
Requirements
No prior experience in auditing is required to take this course.
This training is designed to be accessible to beginners while still offering practical depth for professionals.
Whether you're just starting out in the medical device industry or looking to improve your auditing skills, you're in the right place.
All you need is: A basic understanding of how medical device companies operate A willingness to learn and apply quality and regulatory concepts Access to a computer or device to view the course and download materials Everything else - including audit templates, real-world examples, and clear explanations of ISO 13485 and ISO 19011 - will be provided inside the course. Let's make auditing simple, practical, and valuable - no stress, just progress.
Description
Are you responsible for quality audits in the medical device industry or looking to become an expert in auditing processes?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 auditsWhether you're preparing for a new role, supporting ISO certification, or ensuring supplier reliability, this course provides the knowledge, tools, and confidence you need to succeed.Enroll today and become an expert in auditing for medical devices!
Who this course is for
This course is for anyone involved in the medical device industry who want learn more about Audit
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