ISO 1348 Training | ISO 13485 Foundation Training in Nottingham

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ISO 13485 Training

ISO 13485 Foundation

Nottingham

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: 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

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.

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 Nottingham 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.

Nottingham is a city in Nottinghamshire, England and is around 30 miles south of Sheffield. Nottingham is most famous for its affiliation with Robin Hood and for its industries of bike and lace making and tobacco. Its population is around 310,000 people making it the second largest city in the Midlands. Schools in Nottingham are governed by the unitary authority of Nottingham and the Nottingham City Council. There are a large number of primary and secondary schools in Nottingham, including Alderman White School, The Holgate Academy, Rushcliffe School, Tuxford Academy, Serlby Park Academy and The Oakwood Academy.

There are several colleges, most of which were formed by the merging of lots of different smaller colleges. For example, Central College was formed when South Nottingham College and Castle College merged and New College was created when four small colleges joined together. There are several smaller academies and sixth-form colleges for educational purposes also. Independent schools also thrive in Nottingham; Nottingham High School was founded in 1513 and is the city’s oldest educational institute. There are two universities in Nottingham, the Nottingham Trent University and the University of Nottingham. These universities have a combined student population of around 61,000. Nottingham Trent University was founded in 1843 but only became a university in 1992 when the Nottingham Government School of Design was established. It is split over three different campuses across Nottingham.

The University of Nottingham is a public research university was founded in 1881 and has a variety of campuses in and around Nottingham, as well as some in China and Malaysia. It is most famous for its teaching in economics, law and pharmaceuticals as well as its teaching hospital, the Queen’s Medical Centre which is located outside Nottingham but still in the same county. Notable alumni include David Ross, co-founder of Carphone Warehouse, actress Ruth Wilson, actor Theo James and Nobel Prize winner Sir Clive Granger.

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Address

Nottingham

T: 01344203999

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 Nottingham. 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.

Learn more in our FAQs

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

Learn more in our FAQs

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

The trainer was excellent. She was very knowledgeable, made the course content interesting (as it could have come across as death by PowerPoint) and very approachable,

Andrea Blowers

I would like to provide positive feedback regarding the Lead Audit Certification ISO training, specifically highlighting the exceptional skills and expertise of the trainer, John. The training program was truly enlightening and informative. John's ability to convey complex concepts in a clear and concise manner was commendable. He demonstrated a deep understanding of ISO standards and effectively guided us through the entire auditing process. John's patience and willingness to answer all our questions made the training experience even more valuable. His interactive teaching style kept us engaged throughout the sessions, making it easier for us to grasp the practical application of the ISO standards. Furthermore, John's extensive industry experience was apparent in the real-life examples and case studies he shared, adding relevance and context to the topics discussed. His ability to relate to our specific industry challenges was highly appreciated.

Misa Milosevic

Very interactive session

Vijaykumar Putchakayala

ISO 1348 Training | ISO 13485 Foundation Training in Nottingham FAQs

What does ISO 13485 mean?

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.

What is the purpose of ISO 13485 Training?

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.

What are the benefits of this ISO 13485 Training Certification?

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.

What are the prerequisites needed for this ISO 13485 Course?

There are no formal prerequisites for this ISO 13485 Foundation Course.

What is included in this 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.

What is the duration of this ISO 13485 Training?

The duration of this course is 1 day.

Is there an examination for this ISO 13485 Training Course?

Yes, delegates will need to pass the associated examination to complete this ISO 13485 Training.

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

The training fees for ISO 13485 Foundation certification in Nottingham starts from £1295

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

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

What are the best ISO 13485 Training courses in Nottingham?

Please see our ISO 13485 Training courses available in Nottingham

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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