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The following subjects will be taught during this 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
Module 18: Key Terms and Definitions of Lead Auditor
Module 19: Lead Auditor Responsibilities
Module 20: Team Leader Skills
Module 21: ISO 13485 Clauses 1 and 2
Module 22: ISO 13485 Clauses 3 and 4
Module 23: Structure and Intent of ISO 13485
Module 24: Medical Devices, Quality, and Auditing Terminology
Module 25: Processes, Procedures, and Records
Module 26: Checklist Development
Module 27: Planning, Preparation, and Management of Audits
Module 28: Interviewing Skills
Module 29: Corrective Action and Verification
This course has been recommended for professionals who are involved in implementing and/or auditing quality management systems for medical devices, or those leading a supplier quality assurance programme.
We recommend completing the ISO 13485 Foundation certification before studying this course.
This highly interactive course enables individuals to plan, lead, and report audits within their own organisation, with their suppliers and with third-party organisations. This course will benefit our delegates by ensuring that they are able to conduct effective audits in any auditing situation. This will be achieved through the attainment of the relevant skills in planning, coordinating, reporting, and reviewing with regards to QMS auditing. By putting these skills into practice, certified individuals can improve overall organisational performance. Our expert instructors will provide informative and engaging sessions and will include a hands-on run through of the complete auditing process, including managing an audit programme and reporting the results. It is essential that our candidates understand the role of an ISO 13485 Lead Auditor and can explain their role in terms of the entire auditing process outlined in this course. At the end of the course, delegates will be required to sit an exam to become certified.
This training course includes:
ISO 13485 Lead Auditor Exam
In order to complete this ISO 13485 Lead Auditor 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
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.
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
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
"...the trainer for this course was excellent. I would definitely recommend (and already have) this course to others."
Diane Gray, Shell