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Module 1: Introduction to ISO 13485:2016
Module 2: 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: 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.
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.
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.
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:
Why choose us
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.
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.
Experience the most sought-after learning style with The Knowledge Academy's ISO 13485 Foundation. 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 13485 Foundation 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
Our Classroom courses with limited class sizes foster discussions and provide a personalised, interactive learning environment
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 ISO 13485 Foundation at your business premises. Experience expert-led classroom learning from the comfort of your workplace and engage professional development.
Leverage benefits offered from a certification that fits your unique business or project needs
Cut unnecessary costs and focus your entire budget on what really matters, the training.
Our ISO 13485 Foundation offers a unique chance for your team to bond and engage in discussions, enriching the learning experience beyond traditional classroom settings
The course know-how will help you track and evaluate your employees' progression and performance with relative ease
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,
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.
Very interactive session
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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