ISO 1348 Training | ISO 13485 Foundation Training in Mombasa

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ISO 13485 Training

ISO 13485 Foundation

Mombasa

Learn about the implementation stages of ISO frameworks with our ISO 13485 Training
Acquire in-depth knowledge about the ISO 13485 fundamentals for medical device quality
Gain regulatory compliance and product safety insights

Dates & Prices Dates & Prices

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: An 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: The Relationship Between ISO 13485 and ISO 9001

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

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

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 essential 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 designing, producing, or distributing 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 provides 1-day ISO 13485 Foundation Training that 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 to navigate the complex medical device quality management landscape.

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 completing 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 more substantial contribution to the sector's growth and safety.

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 Mombasa 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.

Mombasa is a city in Kenya. Its lies on the coast and is the second largest city in the country. It has a population of 1.2 million people and is the capital of Mombasa County. The Technical University of Mombasa resides in the city and provides degrees and programs in science and technology. Computer and business courses are readily available in the city and some other universities take part in student exchange programs. The two official languages of Kenya are English and Swahili. English is spoken by the vast majority in large cities and those connected with tourism or are educated. The unemployment rate of Kenya lies at around 21%. The rate of unemployment in Mombasa is slightly higher at a rate of 22.8%.

Address

Tudor Creek,
next to Nyali Bridge,
Mombasa,
Kenya

T: +44 1344 203 999

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 Mombasa. 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.

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Unlock your potential with The Knowledge Academy's ISO 1348 Training | ISO 13485 Foundation Training in Mombasa, 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.

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Experience the most sought-after learning style with The Knowledge Academy's ISO 1348 Training | ISO 13485 Foundation Training in Mombasa. 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 Mombasa sessions.

Highly experienced trainers

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

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

Small class sizes

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

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

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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.

Tailored learning experience

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

Maximise your training budget

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

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

Monitor employees progress

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

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What our customers are saying

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John was extremely knowledgeable and very thorough.

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ISO 1348 Training | ISO 13485 Foundation Training in Mombasa FAQs

What is ISO 13485?

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.

What are the benefits of taking this ISO 13485 Course?

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.

Are there any prerequisites to attend this ISO 13485 Training?

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.

What is included in this ISO 13485 Course?

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.

What is the duration of this ISO 13485 Training?

This course takes 1-day to complete during which delegates participate in intensive learning sessions that cover various course topics.

Is there an examination for this ISO 13485 Training Course?

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.

What does ISO 13485 Certification aim to achieve?

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.

What will I learn in these ISO 13485 Training Courses?

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.

What is the difficulty level of these ISO 13485 Courses?

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.

What is the significance of holding ISO 13485 Certification?

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.

Do you offer 24/7 support for this ISO 13485 Training Course?

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.

What kind of jobs can I expect based on this ISO 13485 Course Online?

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.

Do you provide self-paced ISO 13485 Courses Online?

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.

Which individuals or roles require ISO 13485 Certification?

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.

Do you provide corporate training for these ISO 13485 Medical Devices Courses?

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.

Who should attend this ISO 13485 Course?

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.

What to do after this Online ISO 13485 Course?

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.

Why should I take the ISO 13485 Training?

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.

Who should I contact if I am unable to access this ISO 13485 Certification Training?

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.

Is it necessary to have a background in other ISO 13485 Courses to take this ISO 13485 Certification Course?

What is the cost/training fees for ISO 13485 Foundation in Mombasa?

The training fees for ISO 13485 Foundationin Mombasa starts from $1595

Which is the best training institute/provider of ISO 13485 Foundation in Mombasa?

The Knowledge Academy is the Leading global training provider for ISO 13485 Foundation.

What are the best ISO 13485 Training courses in Mombasa?

Please see our ISO 13485 Training courses available in Mombasa

Why choose us

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.

Many delivery methods

Flexible delivery methods are available depending on your learning style.

High quality resources

Resources are included for a comprehensive learning experience.

"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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