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Module 1: Introduction to ISO 13485:2016
Module 2: ISO 13485 Clauses 1 and 2
Module 3: ISO 13485 Clauses 3 and 4
Module 4: Requirements and Quality Systems
Module 5: Overview of ISO 13485:2016 Requirements
Module 6: Implementation Phases of the ISO 13485 Frameworks
Module 7: Conducting an ISO 13485 Certification Audit
Module 8: Relationship Between ISO 13485 and ISO 9001
Module 9: Internal Auditing
Module 10: Internal Audit Plan
Module 11: Audit Process
Module 12: Internal Audit Evidence and Findings
Module 13: Roles and Responsibilities
Module 14: Resource Management and Product Realisation
Module 15: ISO 13485 and Quality Management Systems
Module 16: Principles of Quality Management System
Module 17: Fundamentals of Quality Management Systems
Module 18: Measurement, Analysis, and Improvement
Module 19: Risk Management
The ISO 13485 Lead Implementer Course programme gives employees the knowledge and skills they need to lead the implementation and management of an ISO 13485-based Quality Management System for medical devices. Below are some professionals who can benefit from this course:
There are no formal prerequisites for this ISO 13485 Lead Auditor Course. However, prior experience in medical device manufacturing or regulatory compliance will greatly benefit the delegates
ISO 13485 Lead Implementer Training is a course that introduces delegates to the aspects of managing quality in the medical device industry. ISO 13485 Certification is a globally recognised standard that establishes quality management system requirements for organisations that produce medical devices. Understanding its relevance is crucial, as it ensures that organisations consistently meet customer and regulatory requirements in the medical device field.
Mastering ISO 13485 is essential for anyone responsible for implementing and managing quality management systems in the medical device industry. It provides a valuable credential for individuals dedicated to quality assurance and regulatory compliance, opening opportunities for high-profile jobs and enhanced earnings. Its importance lies in its ability to enhance an organisation's overall performance and mitigate risks associated with medical devices.
The 3-day ISO 13485 Lead Implementer Training Course equips delegates with the necessary knowledge and skills to implement a quality management system for medical devices effectively. Participants will gain an in-depth understanding of the auditing process, enabling them to obtain audit evidence and evaluate it objectively. They will also learn how to control nonconforming products identified during the inspection process.
At the end of this training, delegates will be able to implement this ISO standard by specifying company requirements and the scope of medical devices. They will also be able to analyse the data and implement identified opportunities for improvement.
ISO 13485 Lead Implementer Exam Information
To achieve the ISO 13485 Lead Implementer, 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 Lead Implementer. 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 Lead Implementer, 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 Lead Implementer. 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 Lead Implementer 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 Lead Implementer 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 Lead Implementer 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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