Press esc to close
Press esc to close
Fill out your contact details below and our training experts will be in touch.
If you wish to make any changes to your course, please log a ticket and choose the category ‘booking change’
Back to Course Information
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
Module 20: Key Terms and Definitions of Lead Auditor
Module 21: Lead Auditor Responsibilities
Module 22: Team Leader Skills
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
Module 30: Preventative Action
There are no formal prerequisites for attending this ISO 13485 Lead Auditor Training course.
This course is designed for everyone who wishes to advance their knowledge of implementing quality management systems for medical devices and managing auditing to improve the overall performance of an organisation.
ISO 13485 defines the requirements for a Quality Management System (QMS) in situations where an organisation must demonstrate its ability to consistently offer medical devices and related services that fulfil customer and applicable regulatory requirements. Studying this training provides learners with the implementation of a quality management system for medical devices and methods to conduct auditing activities to ensure the overall performance of an organisation. Obtaining knowledge of this training assists organisations in eliminating problems and reducing the work burden. Individuals who pursue this training can better acquire the knowledge and abilities that will ultimately expand their employment options and raise their income.
The Knowledge Academy’s 5-day ISO 13485 Lead Auditor Training course provides delegates with comprehensive knowledge of quality management and how to audit the system. During this training, delegates will learn about the implementation phases of ISO frameworks and the gap analysis for support information for several clauses. They will also learn about risk management for mapping identified risks and monitoring continuous improvement. This course will be led by our highly skilled and knowledgeable instructor with years of experience teaching ISO courses.
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.
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.
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