ISO 13485 Foundation Training
Understand the core principles of ISO 13485 and its role in quality management for medical devices. This course introduces learners to regulatory requirements, documentation practices, and compliance frameworks essential for medical device manufacturing and distribution.
ISO 13485 Foundation Training Course is accredited by global certification board
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ISO 13485 Foundation Training Overview
The ISO 13485 Foundation Course offers essential training in Quality Management Systems (QMS) for medical devices. Learners explore the structure and purpose of ISO 13485, including documentation, regulatory alignment, and risk-based thinking for quality assurance in medical device industries.
Key Topics Covered
Introduction to ISO 13485: Scope, structure, and importance
QMS Principles: Risk-based thinking and process orientation
Documentation Requirements: Policies, procedures, and records
Regulatory Requirements: Aligning with international medical device laws
Continual Improvement: Corrective actions and performance monitoring
Course Benefits
Foundation-Level Knowledge: Ideal for those new to medical device QMS
Industry Relevance: Aligned with global regulatory expectations
Career Entry Point: Suitable for quality, compliance, and regulatory roles
Practical Focus: Builds familiarity with documentation and quality concepts
The ISO 13485 Foundation Course is designed to provide a fundamental understanding of the ISO 13485 standard, which pertains to Quality Management Systems for medical device manufacturers and suppliers. It benefits a wide range of professionals from this course, including:
Quality Managers
Regulatory Affairs Professionals
Product Managers
Compliance Officers
Manufacturing Managers
Quality Assurance Professionals
Consultants
Internal Auditors
Healthcare Professionals
ISO 13485 Foundation Training Outline
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
What You’ll Learn in this Course
By the end of the course, learners will be able to:
- Understand the structure and purpose of ISO 13485
- Identify key QMS components and documentation needs
- Recognise compliance obligations for medical devices
- Explain the role of risk and control measures
- Support preparation for audits and certifications
What’s Included
ISO 13485 Foundation Examination
World-Class Training Sessions from Experienced Instructors
ISO 13485 Foundation Certificate
Digital Delegate Pack
ISO 13485 Foundation Training Exam Details
To achieve the ISO 13485 Foundation, candidates will need to sit for an examination. The exam format is as follows:
Question Type: Multiple Choice
Total Questions: 30
Total Marks: 30 Marks
Pass Mark: 50%, or 15/30 Marks
Duration: 40 Minutes
Open Book/ Closed Book: Closed Book
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The ISO 9001 Internal Auditor Training gave me practical insight into quality systems and how to apply audit techniques effectively. The sessions were clear and approachable, even without prior auditing experience. I now feel confident reviewing documentation, identifying nonconformities, and contributing to continuous improvement. The real-world examples and audit scenarios helped me understand the practical side of compliance and how it fits into our daily operations.
Completing the ISO 45001 Foundation Training provided me with a solid understanding of occupational health and safety standards. The training clarified legal requirements, hazard identification, and risk control measures. I’ve applied this knowledge to improve our incident response protocols and reinforce safety culture within the team. It’s also made me more effective at communicating compliance expectations and supporting ongoing H&S initiatives.
The ISO 22301 Foundation Training helped deepen my knowledge of business continuity planning and risk preparedness. The course content was practical and focused on real implementation challenges, which I could immediately relate to my role. I now play a more active part in reviewing continuity plans and coordinating recovery strategies. The training has improved how we manage operational risks and strengthened our overall resilience.
I registered my team in the ISO 9001 Lead Implementer Training, and the improvements were visible right away. The training gave us the tools to standardise workflows, enhance documentation, and build a consistent quality management system. The team has taken ownership of processes and is now more proactive in identifying areas for improvement. It’s significantly enhanced how we align with best practices and deliver results with greater reliability.
Our team participated in the ISO 45001 Lead Auditor Training to reinforce our internal safety and compliance framework. The training not only improved our auditing skills but also helped us critically assess our workplace health and safety practices. We’ve since implemented stronger controls and improved reporting structures. The shift in awareness and engagement has been very positive, especially in high-risk areas.
Frequently Asked Questions
What is the ISO 13485 Foundation Course about?
This course introduces learners to ISO 13485, covering QMS principles, regulatory compliance, and documentation for medical devices. It helps build foundational knowledge essential for understanding the structure, scope, and application of ISO 13485 in real-world environments.
Do I need experience before taking this course?
No prior experience is needed. The course is suitable for beginners looking to enter medical device quality or compliance roles and aims to familiarise them with ISO 13485 structure, terminology, and core documentation requirements.
Who should attend this course?
Ideal for Quality Associates, Regulatory Assistants, and Compliance professionals. Anyone new to medical device quality management or seeking to understand ISO 13485 requirements can benefit from this foundational training course.
Does the course include documentation practice?
Yes, the course introduces learners to essential QMS documentation such as policies, procedures, and quality records. It helps understand how documentation supports regulatory compliance and overall effectiveness of ISO 13485-based quality systems.
What is the duration of the ISO 13485 Foundation Course?
The course is delivered in 1 day and includes instructor-led lessons, discussions, and practical examples. It offers a clear and concise introduction to ISO 13485 requirements for medical device quality systems.
