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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
Experience live, interactive learning from home with The Knowledge Academy's Online Instructor-led ISO 13485 Lead Auditor. 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 Auditor, 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.
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
We may not have any package deals available including this course. If you enquire or give us a call on +852 2592 5349 and speak to our training experts, we should be able to help you with your requirements.
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