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 Realization
  • 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 in New Delhi 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, 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 organizations 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 in New Delhi 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 New Delhi 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 Training in New Delhi 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 organizational ability and meet customer requirements
  • To promote harmonization of regulatory requirements for manufacturers
  • To improve the credibility and image of a company to represent compliance

Upon completion of this ISO 13485 Training in New Delhi, 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

Why choose us

Our New Delhi venue

Includes..

Free Wi-Fi

To make sure you’re always connected we offer completely free and easy to access wi-fi.

Air conditioned

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.

New Delhi is one of the districts within Delhi, as well as it being the capital city of India, it is also the home to the Government of the National Capital Territory of Delhi and some of the branches of the Government of India, these being the judiciary, executive and legislative branches and is also home to around 249,998 people. The capital of India - New Delhi was initiated within 1931 by Viceroy Lord Irwin however formed during 1911 by George V, who was the King of the United Kingdom as well as the Emperor of India and his British architects Sir Herbert Baker and Sir Edwin Lutyens formed the foundation stone and announced the capital city of India would be changed. The primary schools and secondary schools within New Delhi are either run privately or by the government and as of 2004 to 2005 there was around 1.5 million students going through the educational system within 2416 primary schools, 822,00 students in 715 middle schools and 669,000 students in 1576 secondary schools and around 500,000 students within 165 universities and colleges. All universities are either state, deemed or central universities, The top universities within New Delhi are the Jamia Millia Islamia, the University of Delhi, Indian Statistical Institute, National Law University, Jawaharlal Nehru University, Guru Gobind Singh Indraprastha University, Ambedkar University Delhi, Jamia Hamdard, Delhi Technological University – which is the first Engineering college within Delhi and one of the oldest in India, the Indira Gandhi National Open University is the largest national university in the world with over 4 million students, New Delhi is also home to the Indian Agricultural Research Institute, Pusa, New Delhi, Premier institute for agricultural research and education in India. The university courses and programs can offer different types of degrees such an undergraduate and post graduate courses, Bachelor courses and Scholarships, New Delhi prides itself on its premier institutions as the teaching and researching they do means that within 2011 the census recorded the literacy rate for females as 80.9% and for males it was slightly higher at 91.0% with an overall literacy rate of 86.3%. Subjects within the different universities can include, social sciences, engineering, humanities, technology, sports, law, social work, arts, management, education, computer information technology, foreign languages, mathematical science, dentistry and medical. 

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Address

Pioneer Institute of Education and Computer Studies
F322/A, 3rd Floor
Adarsh House (Above PNB Bank)
Old MB Road
Lado Sarai
New Delhi
110030

T: +91 8037244591

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 New Delhi. 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 New Delhi, 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 1348 Training | ISO 13485 Foundation Training in New Delhi. 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 1348 Training | ISO 13485 Foundation Training in New Delhi sessions.

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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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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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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 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

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ISO 1348 Training | ISO 13485 Foundation Training in New Delhi FAQs

ISO 13485 is an international standard that outlines the requirements for a quality management system specifically for organisations involved in the design, development, production, and servicing of medical devices, ensuring consistent quality and regulatory compliance.
Taking the ISO 13485 course offers benefits such as enhanced understanding of quality management systems, improved compliance with regulations, increased career opportunities, and the ability to contribute to safer medical device development.
There are no formal prerequisites to attend the ISO 13485 training; however, a basic understanding of quality management principles or experience in the medical device industry may be beneficial for delegates.
In this training course, delegates will have intensive training with our experienced instructors, a digital delegate pack consisting of important notes related to this course, and a certificate after course completion.
This course takes 1-day to complete during which delegates participate in intensive learning sessions that cover various course topics.
Yes, there is typically an examination at the end of the ISO 13485 training course to assess delegates' understanding of the material covered and their ability to apply the principles of quality management in medical devices.
ISO 13485 certification aims to ensure that organisations consistently produce safe and effective medical devices by establishing a robust quality management system that meets regulatory requirements and enhances customer satisfaction.
In ISO 13485 training courses, you will learn about quality management principles, regulatory requirements, risk management, documentation practices, and how to implement and maintain effective quality management systems for medical devices.
The ISO 13485 courses are designed to be accessible to individuals with varying experience levels, from beginners to professionals. The course content is structured to progressively build knowledge, making it manageable for most delegates.
Holding ISO 13485 certification demonstrates expertise in medical device quality management systems, ensuring compliance with regulatory standards, enhancing product safety, and increasing credibility with stakeholders and global markets.
Yes, The Knowledge Academy offers 24/7 support via phone & email before attending, during, and after the course. Our customer support team is available to assist and promptly resolve any issues you may encounter.
After completing the ISO 13485 course, you can pursue roles such as quality manager, regulatory affairs specialist, internal auditor, or compliance officer, particularly within the medical device manufacturing and healthcare sectors.
The Knowledge Academy provides flexible self-paced training for this course. Self-paced training is beneficial for individuals who have an independent learning style and wish to study at their own pace and convenience.
ISO 13485 certification is essential for quality managers, regulatory professionals, internal auditors, and personnel responsible for designing, developing, or manufacturing medical devices to ensure compliance with industry regulations and quality standards.
Yes, corporate training is available for ISO 13485 Medical Devices courses, offering tailored learning solutions to help organisations ensure compliance, improve product quality, and meet industry-specific regulatory requirements efficiently.
This ISO 13485 course is ideal for quality managers, auditors, regulatory professionals, and anyone involved in the development, implementation, or maintenance of a quality management system within the medical device industry.
After completing the online ISO 13485 course, delegates can apply their knowledge to implement or audit quality management systems, pursue advanced ISO qualifications, or enhance their role in regulatory compliance and quality assurance.
Taking ISO 13485 training ensures you understand the requirements for a quality management system in the medical device industry, helping you improve compliance, enhance product safety, and meet regulatory standards efficiently.
No prior background in other ISO 13485 courses is required to take this certification. The course is designed to provide a comprehensive introduction, making it suitable for delegates of varying experience levels.
No prior background in other ISO 13485 courses is required to take this certification. The course is designed to provide a comprehensive introduction, making it suitable for delegates of varying experience levels.
The training fees for ISO 13485 Foundationin New Delhi starts from INR3295
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"

Joshua Davies, Thames Water

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