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The following subjects will be taught during the ISO 13485 course:
Module 1: Introduction to ISO 13485:2016
Module 2: A 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
Module 6: Internal Auditing
Module 7: The Internal Audit Plan
Module 8: The Audit Process
Module 9: Internal Audit Evidence and Findings
Module 10: Roles and Responsibilities
Module 11: Resource Management and Product Realisation
Module 12: ISO 13485 and Quality Management Systems
Module 13: Principles of Quality Management System
Module 14: The Fundamentals of Quality Management Systems
Module 15: Requirements and Quality Systems
Module 16: Measurement, Analysis, and Improvement
Module 17: Risk Management
We recommend completing the ISO 13485 Foundation certification before studying this course.
This ISO course has been designed to provide participants with the knowledge to effectively implement a quality management system in line with the requirements of ISO 13485. Training will also indicate how to develop quality policies, the core characteristics of risk assessments, the significance of legislation, and how to create an efficacious management review process. By attending this ISO course, trainees will gain the capability to follow their Quality Management System and subsequently enhance business performance. Furthermore, with the knowledge gained from this 3-days training course, delegates will be able to find ways to increase efficiency and cost savings through quality management, monitor supply chains to achieve continuous improvement, and meet customer and regulatory requirements.
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.
Keep track of your employees’ progression and performance in your own workspace.
Course was run very smoothly, Richard our trainer was extremely knowledgeable and delivered the course in a succinct fashion with a twist of humour thrown in.
The course was great and the so was the trainer - brilliantly delivered and I would certainly recommend this course to my colleagues. Thanks to Richard for a great course and delivering it a tough environment virtually.
Richard was very knowledgeable and explained well
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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
"...the trainer for this course was excellent. I would definitely recommend (and already have) this course to others."
Diane Gray, Shell