Module 1: Introduction to ISO 13485:2016
Module 2: An Overview of ISO 13485:2016 Requirements
Module 3: Implementation Phases of the ISO 13485 Frameworks
Module 4: Conducting an ISO 13485 Certification Audit
Module 5: The Relationship Between ISO 13485 and ISO 9001
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:
There are no formal prerequisites for this ISO 13485 Foundation Course.
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
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.
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:
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Experience live, interactive learning from home with The Knowledge Academy's Online Instructor-led ISO 1348 Training | ISO 13485 Foundation Training in Chester. 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 Chester, 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 Chester. 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 Chester sessions.
Boost your skills with our expert trainers, boasting 10+ years of real-world experience, ensuring an engaging and informative training experience
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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John was extremely knowledgeable and very thorough.
He is having complete hold on this subject and proper understanding, Explanation and methodology is there
You won't find better value in the marketplace. If you do find a lower price, we will beat it.
Flexible delivery methods are available depending on your learning style.
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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