ISO 13485 Foundation Overview

ISO 13485 Foundation Course Outline

Module 1: Introduction to ISO 13485:2016

  • Introduction
  • What is ISO 13485:2016?
  • Importance of ISO 13485

Module 2: 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: Relationship Between ISO 13485 and ISO 9001

  • Scope
  • Focus
  • Continual Improvement
  • Terminology
  • Differences Between the Standards
  • Similarities Between the Standards

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Who should attend this ISO 13485 Foundation Course?

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

Prerequisites of the ISO 13485 Foundation Course

There are no formal prerequisites for this ISO 13485 Foundation Course.

ISO 13485 Foundation Course Overview

The ISO 13485 sets the standards for quality management systems that are crucial for organisations supplying medical devices and related services. It ensures compliance with customer and regulatory requirements, making it an indispensable framework for the medical device industry. This ISO 13485 Foundation Course offers a comprehensive introduction to the vital topic of ISO 13485 and its relevance in the healthcare industry.

Understanding ISO 13485 is of paramount importance for professionals in various roles. Quality managers, regulatory affairs specialists, auditors, manufacturing supervisors, and individuals involved in the design, production, or distribution of medical devices should aim to master ISO 13485. This knowledge empowers them to ensure product quality, safety, and compliance, leading to career advancement and opportunities in the industry.

The Knowledge Academy's 1-day ISO 13485 Foundation Training equips delegates with essential knowledge. It covers the requirements of medical devices, the phases of implementation, and the intricacies of conducting an ISO certification audit. Delegates will gain the skills needed to navigate the complex landscape of medical device quality management.

Course Objectives:

  • To evaluate the expectations and requirements of the customers
  • To raise the quality of medical devices manufactured in a company
  • To enhance the organisational ability and meet customer requirements
  • To promote harmonisation of regulatory requirements for manufacturers
  • To improve the credibility and image of a company to represent compliance

Upon completion of this course, delegates will benefit from a deep understanding of ISO 13485, enhancing their competence in quality management and compliance within the medical device industry. This knowledge will open doors to career progression and a stronger contribution to the sector's growth and safety.

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What’s included in this ISO 13485 Foundation Course?

  • ISO 13485 Foundation Examination
  • World-Class Training Sessions from Experienced Instructors 
  • ISO 13485 Foundation Certificate
  • Digital Delegate Pack

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ISO 13485 Foundation Exam Information

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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Why choose us

Ways to take this course

Experience live, interactive learning from home with The Knowledge Academy's Online Instructor-led ISO 13485 Foundation. Engage directly with expert instructors, mirroring the classroom schedule for a comprehensive learning journey. Enjoy the convenience of virtual learning without compromising on the quality of interaction.

Unlock your potential with The Knowledge Academy's ISO 13485 Foundation, accessible anytime, anywhere on any device. Enjoy 90 days of online course access, extendable upon request, and benefit from the support of our expert trainers. Elevate your skills at your own pace with our Online Self-paced sessions.

Experience the most sought-after learning style with The Knowledge Academy's ISO 13485 Foundation. Available in 490+ locations across 190+ countries, our hand-picked Classroom venues offer an invaluable human touch. Immerse yourself in a comprehensive, interactive experience with our expert-led ISO 13485 Foundation sessions.

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Highly experienced trainers

Boost your skills with our expert trainers, boasting 10+ years of real-world experience, ensuring an engaging and informative training experience

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State of the art training venues

We only use the highest standard of learning facilities to make sure your experience is as comfortable and distraction-free as possible

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Small class sizes

Our Classroom courses with limited class sizes foster discussions and provide a personalised, interactive learning environment

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Great value for money

Achieve certification without breaking the bank. Find a lower price elsewhere? We'll match it to guarantee you the best value

Streamline large-scale training requirements with The Knowledge Academy’s In-house/Onsite ISO 13485 Foundation at your business premises. Experience expert-led classroom learning from the comfort of your workplace and engage professional development.

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Tailored learning experience

Leverage benefits offered from a certification that fits your unique business or project needs

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Maximise your training budget

Cut unnecessary costs and focus your entire budget on what really matters, the training.

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Team building opportunity

Our ISO 13485 Foundation offers a unique chance for your team to bond and engage in discussions, enriching the learning experience beyond traditional classroom settings

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Monitor employees progress

The course know-how will help you track and evaluate your employees' progression and performance with relative ease

What our customers are saying

ISO 13485 Foundation FAQs

ISO 13485 defines the quality management system requirements for organisations that must demonstrate their capacity to supply medical devices and relevant services that meet customer and applicable regulatory requirements consistently. Demonstrate your proficiency of the standard by acquiring The Knowledge Academy’s ISO 13485 Certification.
In the medical device industry, ISO 13485 Training provides professionals with the required knowledge and skills to create, maintain, and continually improve a quality management system. This training ensures compliance with international standards and regulatory requirements, ultimately enhancing the safety and quality of medical devices.
This ISO 13485 Certification offers benefits like regulatory compliance, improved product quality, competitive advantage, risk management, operational efficiency, global market access, customer trust, and professional development, making it valuable for organisations and individuals in the medical device industry.
There are no formal prerequisites for this ISO 13485 Foundation Course.
The ISO 13485 Foundation Course includes the ISO 13485 Foundation Examination, world-class training sessions led by experienced instructors, an ISO 13485 Foundation Certificate, and a digital delegate pack.
The duration of this course is 1 day.
Yes, delegates will need to pass the associated examination to complete this ISO 13485 Training.
The price for ISO 13485 Foundation certification in Philippines starts from $1595
The Knowledge Academy is the Leading global training provider for ISO 13485 Foundation.
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Why choose us

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Best price in the industry

You won't find better value in the marketplace. If you do find a lower price, we will beat it.

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Many delivery methods

Flexible delivery methods are available depending on your learning style.

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High quality resources

Resources are included for a comprehensive learning experience.

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"Really good course and well organised. Trainer was great with a sense of humour - his experience allowed a free flowing course, structured to help you gain as much information & relevant experience whilst helping prepare you for the exam"

Joshua Davies, Thames Water

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ISO 13485 Foundation in Philippines

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