Iso 13485:2016 Medical Device Internal Auditor Training

ISO13485:2016 Training

What you'll learn

Understand the ISO13485 requirements with examples and Conduct Internal Audits.

Evaluate QMS Effectiveness,Review Compliance with Regulatory Requirements

Identify and Report Nonconformities; Recommend Corrective and Preventive Actions (CAPA)

Audit Documentation and Reporting; Promote Continuous Improvement

Ensure Auditor Independence and Objectivity

Requirements

No Prior Auditing Experience Required. This course is suitable for both beginners and experienced professionals. We provide all the foundational knowledge needed to conduct internal audits for medical device quality management systems.

Recommended Skills & Background (Optional but Helpful): Basic Understanding of ISO 13485:2016 – Familiarity with the standard’s structure and requirements will be beneficial but is not mandatory.

Quality Management Knowledge – Some experience with quality management systems (QMS) or medical device regulations is helpful. Attention to Detail & Analytical Thinking – Auditors need to identify compliance gaps and assess processes effectively.

Tools & Equipment Required: Computer or Tablet – For online courses, learners will need a device with internet access to view course materials and participate in virtual training.

Notepad & Pen – Useful for taking notes during the training.

To enhance the learning experience, the entire training is recorded using AI voice technology. This approach eliminates variations in accents and pronunciation, ensuring clarity and ease of understanding for all learners.

Since the slides move quickly, it is essential to engage with the material actively. To get the most out of this training, we recommend the following approach:   Read the related section in the ISO 13485 standard before watching the module. This will provide context and a better grasp of the requirements being discussed.

Pause the video when needed to review the material thoroughly. This will help reinforce key concepts and allow you to take notes on important points.

Take breaks between sections to absorb the information effectively. This prevents cognitive overload and enhances retention of critical concepts.

Engage with the examples provided as they are designed to clarify complex concepts and help you apply them in real world situations.

Learning Checklist: Read the relevant ISO 13485:2016 sections before watching the module. Watch and listen carefully to the AI-voiced explanations. Pause the training video to review slides and take notes. Identify key points and compare them with real-world applications. Review nonconformities and CAPA examples to understand how to handle audit findings.

Lowering the Barrier for Beginners: No need to worry if you’re new to auditing or ISO 13485! This course is structured to guide you step by step, ensuring you gain the necessary knowledge and confidence to perform internal audits effectively. Whether you’re an aspiring auditor, a quality professional, or a medical device manufacturer, this course will equip you with the skills to audit ISO 13485:2016 compliance efficiently..

Description

The ISO 13485:2016 Medical Device Internal Auditor Training course is designed to provide participants with the knowledge and skills required to conduct effective internal audits of a Quality Management System (QMS) in compliance with ISO 13485:2016. This training ensures that medical device organizations meet regulatory and customer requirements while maintaining a strong focus on product quality and patient safety.Through a combination of theoretical instruction, real-world case studies, and hands-on exercises, learners will develop expertise in audit planning, execution, reporting, and follow-up actions. The course follows the principles of ISO 19011: Guidelines for Auditing Management Systems and emphasizes risk-based thinking, process auditing, and regulatory compliance.This training is ideal for professionals working in quality assurance, regulatory affairs, manufacturing, and compliance roles, helping them enhance their ability to evaluate, improve, and maintain ISO 13485-compliant QMS processes.Who Should Take This Course?This course is designed for:- Quality Assurance (QA) & Regulatory Affairs (RA) Professionals- Internal Auditors & Compliance Officers- Medical Device Manufacturers & Suppliers- Production & Operations Managers- Engineers & R&D Professionals- Consultants & Regulatory Specialists- Anyone involved in ISO 13485 compliance & QMS auditingNo prior auditing experience is required, but a basic understanding of ISO 13485:2016 is beneficial.Course FormatDelivery Mode: Online / Self-PacedDuration: 2–3 Days (Flexible Learning Options Available)Training Materials: Course slides, audit templates

Overview

Section 1: Introduction

Lecture 1 Introduction

Section 2: Structure & Key Requirements of ISO 13485:2016

Lecture 2 Structure & Key Requirements of ISO 13485:2016

Section 3: Risk-Based Thinking & Process Approach in Auditing

Lecture 3 Risk-Based Thinking & Process Approach in Auditing

Section 4: ISO13485:2016 Clauses 4,5,6

Lecture 4 Review ISO13485 Clauses: Clauses 4,5,6

Section 5: Review ISO 13485 Clause 7

Lecture 5 Review ISO13485 Clause: Clause 7.

Section 6: Review ISO13485. Clauses: Clause 8.1; 8.2;

Lecture 6 Review ISO13485 Clause: Clause 8

Section 7: Review ISO13485 Clauses: Clause 8.3, 8.4, 8.5, Audit Practice & Final Assessment

Lecture 7 Risk Assessment and Internal Auditor Competency

The ISO 13485:2016 Internal Auditor Training Course is designed for individuals who are involved in medical device quality management systems (QMS) and want to develop the skills necessary to conduct internal audits effectively. This course is ideal for: - Quality Assurance (QA) & Regulatory Affairs (RA) Professionals – Those responsible for ensuring compliance with ISO 13485, FDA, MDR (EU), and other medical device regulations. - Internal Auditors & Compliance Officers – Professionals who conduct or plan to conduct internal audits to assess compliance with ISO 13485:2016. - Medical Device Manufacturers & Suppliers – Organizations that need to maintain an ISO 13485-certified QMS and ensure ongoing compliance. - Production & Operations Managers – Those involved in manufacturing, process validation, and quality control who want to understand audit requirements and improve system efficiency. -Engineers & R&D Teams – Product designers, development teams, and technical personnel working in the medical device industry who need to understand quality and regulatory compliance. - New Auditors or Professionals Transitioning into Quality & Compliance Roles – Individuals looking to expand their career opportunities in quality management, medical device regulations, and compliance auditing. - Consultants & Regulatory Specialists – Those advising companies on regulatory compliance, ISO 13485 implementation, and audit readiness. Why Take This Course? Whether you are a beginner or an experienced professional, this course provides comprehensive, step-by-step training on ISO 13485 internal auditing, equipping you with the skills to assess, report, and improve compliance within a medical device organization. This course will help you advance your career, improve quality processes, and contribute to patient safety by ensuring regulatory compliance.