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 Mumbai 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 Mumbai 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 Mumbai 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 Mumbai 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 Mumbai, 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 Mumbai 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.

Mumbai is situated within the West Coast of India, as well as it being the capital of Maharashtra, it plays an important part within the global economics system. Bombay as the city was previously known as, up until 1995 is also known as an alpha world city and has the largest number of millionaires and billionaires across India, with it therefor being noted as the wealthiest city in India. Mumbai is home to around 18.4 million people and is regarded as the second largest metropolitan population within India as of the record in 2011 with 20.7 million people. Schools and Colleges within Mumbai can be found within the city as well as the suburbs and are either run privately, by the government or the Brihanmumbai Municipal Corporation. Secondary schools are operated by the MCGM primary education system to which it is schooling around 485,531 students in 1,188 primary schools and around 55,576 students in 49 secondary schools within eight different languages these being English, Hindi, Urdu, Kannada, Marathi, Tamil, Gujarati and Telugu. Colleges offer students opportunities to participate within Junior college level, undergraduate level, BCom, BSc and BA courses. As stated by the 10+2+3/4 plan students complete ten years at school to then go on to a junior college and study either science, commerce or arts and they complete that over a two year period. University courses at a degree level are offered in a wide range of different subjects such as engineering, law, media, applied arts and architecture, management, dental, pharmacy as well as Commerce and Science. There are a few universities and colleges within Mumbai and these are the University Institute of Chemical Technology, Indian Institute of Technology (Bombay), SNDT Women’s University, Government Law college, Veermata Jijabai Technological Institute, Narsee Monejee Institute of Management Studies, Sir J. J. School of Art which is the oldest art institution within Mumbai along the Thadomal Shahani Engineering College which is also the oldest private engineering college and the first of its kind to join up with the University of Mumbai to be able to give students the chance to learn about the biomedical engineering, computer engineering, biotechnology and information technology. The University of Mumbai is regarded to be one of the premier universities within India with achievements such as being placed within the top 50 engineering schools of the world ranking at 41 by the American Business Insider within 2013 as well as excelling as the 3rd best multi-disciplinary university within the QS university rankings within India.   

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Address

Safal Institute 
613, Corporate Centre
Nirmal Lifestyles Mall
LBS Marg
Mulund (W)
Mumbai 400080

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 Mumbai. 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 Mumbai, 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 Mumbai. 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 Mumbai 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 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 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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ISO 1348 Training | ISO 13485 Foundation Training in Mumbai 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 Mumbai starts from INR3295
The Knowledge Academy is the Leading global training provider for ISO 13485 Foundation.
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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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