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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Mississauga is the sixth largest city in Canada. It is in the south of the province of Ontario in the region of peel. The city is estimated to have a population of around 715,000 people. The rapid growth of this city is attributed to its proximity to Toronto. It was originally built as suburb of Toronto. Education in Canada is mostly free and publicly funded. It is overseen by the federal, provincial and local governments, with the education within provincial jurisdiction and the curriculum overseen by the province. Education is compulsory in most provinces up to the age of 16. Mississauga is served by the Peel District School Board, which operates the secular English speaking public schools. There is also a school board that runs the local catholic schools and a board that runs the French speaking schools in the area, one for the secular French schools and one for the catholic French schools. There are a number of schools in the area that offer specialised programs. These include the French immersion schools such as Clarkson Secondary School and Streetsville Secondary School. There are three schools in the areas that off a Regional Arts Program and two that offer a specialist sci-tech program for students who are gifted in these areas. There is also two schools that offer support for those studying for the international baccalaureate plus numerous other programs. Canada’s higher has a very good reputation. However there is no formal ranking system and students will often choose colleges and universities bases on geographic convenience and the reputation of a particular course. Mississauga is home to one of the three campuses run by the University of Toronto. This university is ranked as the 34th best university in the world and is the second highest ranked Canadian university in the rankings. The campus was established in 1967 and is the universities second largest division. It is home to 12,000 students. They have 15 academic departments and pupils can choose from 148 programs to participate in from 89 areas of study. Students can study both undergraduate and graduate programs on this campus. This campus also has an excellent research environment that has helped the staff and researchers become internationally recognised for their work. The university includes Institutes for Management and Innovation, and Communication, Culture, Information and Technology.

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Address

Robert Speck 2
2 Robert Speck Parkway
Suite 750
Mississauga
Ontario
L4Z 1H8

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

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Team building opportunity

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What our customers are saying

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

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