Course information

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

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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Our Vancouver venue

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To keep you comfortable during your course we offer a fully air conditioned environment.

Full IT support

IT support is on hand to sort out any unforseen issues that may arise.

Video equipment

This location has full video conferencing equipment.

­­­­Vancouver, a popular and beautiful city in the Canadian province of British Columbia, has an average population of roughly 603,500 spread across 44.39 square miles of land.  At The Knowledge Academy, we offer 50,000 classroom based training courses throughout the different areas of Vancouver, in order to enhance people’s learning in an array of subject areas.  Education in Canada is generally funded by federal, provincial, and local governments; the system is divided into primary, secondary and post-secondary education and is operated under provincial jurisdiction.  On the whole, there are 190 days in a school year, starting in September and ending towards the last Friday of June.  Some popular and highly regarded universities in Canada include: the University of Toronto (notable alumni including: William Lyon Mackenzie King, Vincent Massey, Donald Sutherland and Lesra Martin), the University of British Columbia (notable alumni including: Eddie Peng, Justin Trudeau and Nardwuar the Human Serviette), and the University of Alberta (notable alumni including: Dayo Wong, George Stanley and Beverley McLachlin).  In Vancouver, it is compulsory for residents under the age of 16 to complete compulsory schooling – from low level elementary (kindergarten + grades 1-7), to high level secondary (grades 8-12); Vancouver’s secondary schools are also commonly subdivided into two groups - starting with junior secondary and then followed by senior secondary level.  In most cases, expatriates of Vancouver will send their children to public schools.  The public schools in Vancouver are generally well-respected – scoring highly in student assessments at an international level, as well as nationally, and students normally have a reputation for positive academic success and achievements. Other residents of Vancouver opt for their children to attend private schools instead; although private schools are few-and-far-between in the area as opposed to other areas of Canada, there is still nonetheless a large private school community, most of which is largely either a religious or international institution.  

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Address

World Trade Centre
999 Canada Place
Suite 404
Vancouver
British Columbia
V6C 3E2

 

T: +1 6474932992

Ways to take this course

Experience live, interactive learning from home with The Knowledge Academy's Online Instructor-led ISO 1348 Training | ISO 13485 Foundation Training in Vancouver. 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 1348 Training | ISO 13485 Foundation Training in Vancouver, 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.

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

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Team building opportunity

Our 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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What our customers are saying

ISO 1348 Training | ISO 13485 Foundation Training in Vancouver 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 training fees for ISO 13485 Foundation certification in Vancouver starts from CAD2195
The Knowledge Academy is the Leading global training provider for ISO 13485 Foundation.
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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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