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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
Fundamentals of Quality Management Systems
Module 18: Measurement, Analysis, and Improvement
Identification of Improvement Opportunities
Module 19: Risk Management
Module 20: Key Terms and Definitions of Lead Auditor
Key Terms Definitions
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
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, regulatory requirements, and practical experience in medical device manufacturing would significantly benefit the delegates.
ISO 13485 sets the standards for a Quality Management System (QMS) in scenarios where organisations must 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 to implement a Quality Management System for medical devices and conduct audits to ensure organisational performance. Acquiring knowledge from this training benefits organisations by streamlining processes and lowering operational challenges. Delegates pursuing this training can improve their expertise and capabilities, opening new career opportunities and potential income growth. Professionals responsible for Quality Management Systems will find mastering ISO 13485 Lead Auditor Training highly advantageous.
The Knowledge Academy provides a 5-day ISO 13485 Lead Auditor Training Course that 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 to map identified risks and monitor continuous improvement.
Course Objectives
After completing this training, delegates can 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.
Join a scheduled class with a live instructor and other delegates.
Engage in activities, and communicate with your trainer and peers.
We handpick from a global pool of expert trainers for our Online Instructor-led courses.
With 10+ years of quality, instructor-led training, we equip professionals with lasting skills for success.
With classes running in all timezones, access any of our courses and course material from anywhere, anytime.
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.
Experience the most sought-after learning style with The Knowledge Academy's ISO 13485 Lead Auditor. Available in 490+ locations across 190+ countries, our hand-picked Classroom venues offer an invaluable human touch. Immerse yourself in a comprehensive, interactive experience with our expert-led ISO 13485 Lead Auditor sessions.
Boost your skills with our expert trainers, boasting 10+ years of real-world experience, ensuring an engaging and informative training experience
We only use the highest standard of learning facilities to make sure your experience is as comfortable and distraction-free as possible
Our Classroom courses with limited class sizes foster discussions and provide a personalised, interactive learning environment
Achieve certification without breaking the bank. Find a lower price elsewhere? We'll match it to guarantee you the best value
Streamline large-scale training requirements with The Knowledge Academy’s In-house/Onsite ISO 13485 Lead Auditor at your business premises. Experience expert-led classroom learning from the comfort of your workplace and engage professional development.
Leverage benefits offered from a certification that fits your unique business or project needs
Cut unnecessary costs and focus your entire budget on what really matters, the training.
Our ISO 13485 Lead Auditor offers a unique chance for your team to bond and engage in discussions, enriching the learning experience beyond traditional classroom settings
The course know-how will help you track and evaluate your employees' progression and performance with relative ease
I will definitely recommend
John was extremely knowledgeable and very thorough.
He is having complete hold on this subject and proper understanding, Explanation and methodology is there
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 +352 8002-6867 and speak to our training experts, we should be able to help you with your requirements.
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