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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
The ISO 13485 Internal Auditor Course is a programme that allows professionals to conduct ISO 13485-based medical device Quality Management System (QMS) Internal Audits. This course can be beneficial for professionals, including:
There are no formal prerequisites for this ISO 13485 Internal Auditor Course.
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. An ISO 13485 audit helps to identify the present state and health of your QMS and processes. It includes an independent and systematic process audit to determine QMS's conformity or nonconformity.
This training session will provide delegates with auditing techniques for Quality Management Systems following ISO 13485 and ISO 19011. Individuals with excellent auditing skills in medical devices will quickly get higher designations and expand their professional networks. Professionals in roles such as Quality Managers, Regulatory Affairs Specialists, Quality Control Officers, and individuals involved in internal quality audits in the medical device industry should aim to master the ISO 13485 Internal Auditor Training Course.
In this 2-day ISO 13485 Internal Auditor Training course, delegates will gain comprehensive knowledge of Quality Management Systems and how to conduct internal auditing. They will also learn about management's responsibilities for making policy and financial decisions to support QMS, how to plan a medical device, quality process audit, and documentation requirements.
Course Objectives
After attending this training, delegates can promote awareness of regulations and review the management to identify improvements and regulatory requirements. They will also be able to evaluate the effectiveness of the Quality Management System and document each test during processing.
Why choose us
Experience live, interactive learning from home with The Knowledge Academy's Online Instructor-led ISO 13485 Internal 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 Internal 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 Internal 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 Internal 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 Internal 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 Internal 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
John was extremely knowledgeable and very thorough.
He is having complete hold on this subject and proper understanding, Explanation and methodology is there
Knowledgeable, thorough, friendly
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 +0800 780004 and speak to our training experts, we should be able to help you with your requirements.
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