ISO 13485 Foundation Course Overview

ISO 13485 Foundation Course Overview

The ISO 13485 Foundation course is designed to introduce learners to the key concepts and requirements of the ISO 13485:2016 standard, which pertains to the Quality Management Systems (QMS) for medical devices. This course equips participants with the baseline knowledge necessary to understand and implement the standards within an organization, ensuring that medical devices meet both customer and regulatory demands.

Module 1 provides an overview of the ISO 13485:2016 standard and underscores its significance for organizations in the medical device industry, while Module 2 delves into the specific QMS requirements, including general and documentation needs, Management responsibility, Allocation of resources, Product realization, Infrastructure, and risk management.

By the end of the course, those who complete the ISO 13485 training will be well-prepared to contribute to their organization's objectives and may have the opportunity to take a certification exam to earn their ISO 13485 certification. This foundation is crucial for professionals aiming to ensure quality and compliance in the highly regulated medical device sector.

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Exam-Format Table
Exam ComponentDetails
Exam NameISO 13485 Foundation Certification Exam
Exam TypeMultiple Choice Questions (MCQs)
Total QuestionsTypically 40-60 questions (may vary by provider)
Passing ScoreGenerally around 60-70% (varies by provider)
Exam DurationApproximately 60-90 minutes depending on the provider
LanguageEnglish (other languages might be available depending on the provider)
Exam ProviderVarious certification bodies
Exam RegistrationThrough the certification body's official website or authorized centers
Certification ValidityUsually doesn't expire, but organizations may recommend updates
Recommended TrainingISO 13485 Foundation Training Course by the certification provider
ISO 13485 Foundation

Target Audience for ISO 13485 Foundation

The ISO 13485 Foundation course imparts crucial knowledge on MDQMS for professionals in the medical device sector.


  • Quality Assurance Managers and Engineers
  • Regulatory Affairs Specialists
  • R&D Engineers
  • Production Managers
  • Supply Chain and Operations Managers
  • Medical Device Consultants
  • Clinical Affairs Professionals
  • Internal and External Auditors
  • Compliance Officers
  • Individuals seeking to enter the medical device field
  • Project Managers in the Medical Device Industry
  • Manufacturing Engineers
  • Product Designers and Developers within the Medical Device Field


Learning Objectives - What you will Learn in this ISO 13485 Foundation?

Introduction to Learning Outcomes

Gain foundational insights into the ISO 13485:2016 standard, comprehend its significance for quality management in the medical device industry, and learn the key requirements for certification.

Learning Objectives and Outcomes

  • Understand the structure and key objectives of the ISO 13485:2016 standard.
  • Recognize the importance of ISO 13485 and its impact on an organization’s quality management system.
  • Identify the general requirements for establishing a Medical Devices Quality Management System (MDQMS).
  • Learn about the documentation requirements necessary to meet ISO 13485 standards.
  • Explore the roles and responsibilities of management within a MDQMS.
  • Understand the resource requirements and how to effectively manage them.
  • Grasp the processes of product realization and its critical aspects within MDQMS.
  • Comprehend infrastructure requirements as they relate to the quality management of medical devices.
  • Develop a foundational understanding of risk management principles in the context of ISO 13485.
  • Prepare for the ISO 13485 Foundation certification exam, focusing on key concepts and knowledge areas essential for compliance.

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