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The ISO 13485 Lead Auditor Course provides the knowledge and skills required to conduct audits of medical device Quality Management Systems against the requirements of ISO 13485. This course can be beneficial for professionals, including:
There are no formal prerequisites for this ISO 13485 Lead Auditor Course. However, some knowledge of quality management systems, auditing techniques, and regulatory requirements, along with practical experience in medical device manufacturing, would greatly benefit the delegates.
ISO 13485 sets the standards for a Quality Management System (QMS) in scenarios where organisations need to consistently demonstrate their ability to provide medical devices and related services that meet customer and regulatory requirements. This training equips learners with the skills required for implementing a quality management system for medical devices and conducting audits to ensure organisational performance.
Acquiring knowledge from this training benefits organisations by streamlining processes and reducing operational challenges. Individuals pursuing this training can enhance their expertise and capabilities, opening new career opportunities and potential income growth. Professionals in roles that are responsible for quality management systems, should aspire to master ISO 13485 Lead Auditor training.
The Knowledge Academy's 5-day ISO 13485 Lead Auditor Training Course offers a comprehensive understanding of quality management and the art of auditing systems. Delegates will delve into the implementation phases of ISO frameworks and gain expertise in gap analysis to support various clauses. They will also explore risk management, learning how to map identified risks and monitor continuous improvement.
Course Objectives:
After completing 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 take on responsibilities associated with auditing authority for the management and performance of all audit activities.
ISO 13485 Lead Auditor Exam Information
To achieve the ISO 13485 Lead Auditor, 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.