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:
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Video Content
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eLearning Materials
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Study Resources
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Completion Certificate
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Tutor Support
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Interactive Quizzes
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.