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ISO 13485 Foundation Overview
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
Ways to take this course
Experience live, interactive learning from home with The Knowledge Academy's Online Instructor-led ISO 13485 Foundation. 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.
Live classes
Join a scheduled class with a live instructor and other delegates.
Interactive
Engage in activities, and communicate with your trainer and peers.
Global Pool of the Best Trainers
We handpick from a global pool of expert trainers for our Online Instructor-led courses.
Expertise
With 10+ years of quality, instructor-led training, we equip professionals with lasting skills for success.
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With classes running in all timezones, access any of our courses and course material from anywhere, anytime.
Unlock your potential with The Knowledge Academy's ISO 13485 Foundation, 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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ISO 13485 Foundation 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 Hong Kong starts from HKD8995
The Knowledge Academy is the Leading global training provider for ISO 13485 Foundation.
Please see our ISO 13485 Training courses available in Hong Kong
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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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ISO 13485 Foundation in Hong Kong
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