What is ISO 13485 Foundation?

The ISO 13485 Foundation Course provides Learners with a solid understanding of the ISO 13485 standard, which specifies requirements for quality management systems (QMS) in the medical device industry. This course introduces the fundamental principles, key clauses, and implementation guidelines to ensure compliance with regulatory and customer requirements.

Learners will gain insights into the scope, structure, and benefits of ISO 13485 and its relationship to other quality standards and regulations. The training focuses on practical applications, preparing learners to support developing and maintaining a compliant QMS.

This comprehensive 1-day ISO 13485 Foundation Course by Oakwood International prepares professionals to contribute effectively to the medical device sector's quality assurance and regulatory compliance.
 

Course Objectives
 

  • To understand the fundamentals of ISO 13485 and its purpose in the medical device industry

  • To learn the structure and critical requirements of the ISO 13485 standard

  • To gain insights into the Plan-Do-Check-Act (PDCA) cycle for QMS

  • To explore the relationship between ISO 13485 and other regulatory requirements

  • To understand risk-based approaches to quality management

  • To learn how to support developing, implementing, and maintaining an ISO 13485-compliant QMS

  • To prepare for further certification courses in ISO 13485

Learners will have the foundational knowledge to contribute to quality management initiatives and ISO 13485 implementation upon completion.

Course Outline

ISO 13485 Foundation

Module 1: Introduction to ISO 13485:2016

  • Introduction

  • What is ISO 13485:2016?

  • Importance of ISO 13485
     

Module 2: An Overview of ISO 13485:2016 Requirements

  • Requirements of ISO 13485:2016

  • General Requirements

  • Documentation requirements

  • Management Responsibility

  • Resources

  • Product Realisation

  • Infrastructure

  • Risk Management
     

Module 3: Implementation Phases of the ISO 13485 Frameworks

  • Stages to Implementation

  • Gap Analysis

  • Process Mapping
     

Module 4: Conducting an ISO 13485 Certification Audit

  • Certification Audits
     

Module 5: The Relationship Between ISO 13485 and ISO 9001

  • Scope

  • Focus

  • Continual Improvement

  • Terminology

  • Differences Between the Standards

  • Similarities Between the Standards

Included

Included

  • No course includes are available.

Offered In This Course:

  • vedio Video Content
  • elearning eLearning Materials
  • exam Study Resources
  • certificate Completion Certificate
  • study Tutor Support
  • workbook Interactive Quizzes
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Learning Options

Discover a range of flexible learning options designed to meet your needs. Select the format that best supports your personal growth and goals.

Online Instructor-Led Training

  • Live virtual classes led by experienced trainers, offering real-time interaction and guidance for optimal learning outcomes.

Online Self-Paced Training

  • Flexible learning at your own pace, with access to comprehensive course materials and resources available anytime, anywhere.

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Frequently Asked Questions

Q. What topics are covered in the ISO 13485 Foundation Course?

The course covers the fundamentals, structure, requirements, risk-based management, and implementation guidelines of ISO 13485.

Q. How can this training benefit my career?

ISO 13485 knowledge enhances your expertise in quality management for medical devices, making you a valuable asset in the regulatory and compliance field.

Q. Is ISO 13485 applicable globally?

Yes, ISO 13485 is recognised internationally and aligns with various global medical device regulations.

Q. What support is provided during the training?

Learners receive comprehensive study materials, practical examples, and expert instructor guidance to ensure a thorough understanding of ISO 13485.

Q. Is this course suitable for beginners?

Yes, the course is designed for professionals with little or no prior knowledge of ISO 13485 and offers a strong foundation in QMS for medical devices.

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