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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.
Course Objectives:
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
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
Get more bang for your buck! If you find your chosen course cheaper elsewhere, we’ll match it!
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.
Omar was a good instructor - patient, knowledgeable and kept things moving.
Jacqueline's delivery was exceptional. information was clear and concise. Would have been better in person, however that's a personal preference
Jacqueline was very professional and knowledgeable.
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
We may not have any package deals available including this course. If you enquire or give us a call on 01344203999 and speak to our training experts, we should be able to help you with your requirements.