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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
We recommend completing the ISO 13485 Foundation certification before studying this course.
ISO 13485 establishes quality management system requirements for organisations that must consistently demonstrate their capacity to supply medical devices and relevant services that meet customer and applicable regulatory requirements. The lead implementer of this standard is responsible for developing, implementing, maintaining, and monitoring a quality management system for medical devices and enhancing an organisation's overall performance. Studying this training allows learners to implement a quality management system for medical devices and strategies for mitigating the risk associated with them. Adding management skills for medical devices to the profile will help individuals to get high-profile jobs in globally recognised corporations and claim upgraded earnings.
This 3-day ISO 13485 Lead Implementer Training course provides delegates with a thorough understanding of managing quality and implementation of respective systems. During this training, delegates will become familiar with the auditing process for obtaining audit evidence and evaluating it objectively. They will also get acquainted with the control of nonconforming products detected through the inspection process. Our highly skilled and professional trainer with years of experience teaching ISO courses will conduct this training.
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.
This training course includes:
ISO 13485 Lead Implementer Exam
In order to complete this ISO 13485 Lead Implementer training course, delegates will need to pass the associated examination. The exam is:
Why choose us
Our easy to use Virtual platform allows you to sit the course from home with a live instructor. You will follow the same schedule as the classroom course, and will be able to interact with the trainer and other delegates.
Our fully interactive online training platform is compatible across all devices and can be accessed from anywhere, at any time. All our online courses come with a standard 90 days access that can be extended upon request. Our expert trainers are constantly on hand to help you with any questions which may arise.
This is our most popular style of learning. We run courses in 1200 locations, across 200 countries in one of our hand-picked training venues, providing the all important ‘human touch’ which may be missed in other learning styles.
All our trainers are highly qualified, have 10+ years of real-world experience and will provide you with an engaging learning experience.
We only use the highest standard of learning facilities to make sure your experience is as comfortable and distraction-free as possible
We limit our class sizes to promote better discussion and ensuring everyone has a personalized experience
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This is the same great training as our classroom learning but carried out at your own business premises. This is the perfect option for larger scale training requirements and means less time away from the office.
Our courses can be adapted to meet your individual project or business requirements regardless of scope.
Cut unnecessary costs and focus your entire budget on what really matters, the training.
This gives your team a great opportunity to come together, bond, and discuss, which you may not get in a standard classroom setting.
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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