ISO 13485:2016 Medical Device Training Courses
The Kelmac Group® Academy Medical Devices Quality Management Systems Training Courses focus on familiarizing our learners to understand and engage with MD-QMS in any situation. Our courses are designed with the following in mind – clarity on the concepts, their relationship with the business processes, and a practical approach. Our courses are approved by leading accreditation bodies such as CQI-IRCA
COURSE OVERVIEW
Our Fundamental Courses comprehensively introduce Learners to Quality Management Systems and provide them with a highly insightful introduction to the purpose, intent, and requirements of ISO 13485:2016, plus the business case for adopting ISO 13485:2016.
The focus of the Internal Auditor Courses is on assisting and verifying the competencies & capabilities of the Learner to be able to effectively audit a process, activity, or department/function of a QMS based on ISO 13485:2016 requirements with specific emphasis on 1st Party auditing [Internal audits].
The Lead Auditor Courses are based on assisting and verifying the competencies/capabilities of the Learner to be able to effectively audit a complete QMS [MD] based on ISO 13485:2016 requirements and Medical Device Single Audit Program (MDSAP) requirements with a specific emphasis on 2nd Party auditing [Customer/Supplier audits] and 3rd Party auditing. Others train Followers. We train Leaders.™
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WHO NEEDS ISO 13485:2016 AUDITOR CERTIFICATION TRAINING?
The ISO 13485 Auditor certification training course can be attended by medical device quality testing professionals such as:
- Management Representatives
- Quality Directors, Managers and Engineers
- Senior Departmental Management and Area/Process Owners.
- Supply Chain Professionals
- Persons who want to become a qualified Internal Auditor, Supplier or Lead Auditor
- Staff involved in designing, implementing or managing Medical Device Quality Management Systems
- Staff who have responsibility for internal, external and cross-audits
- Quality Managers/Engineers/Coordinators
- Those wishing to apply for CQI IRCA MDQMS Auditor Certification
- Departmental Managers and Supervisory staff, (e.g. Design, Engineering, Purchasing and Materials)
- Sub-Contractors and Suppliers who wish to gain an insight into customer audits (2nd Party audits) and how they can prepare for and facilitate these audits.
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ISO 13485:2016 MD-QMS Training Courses
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ABOUT THE KELMAC GROUP® ACADEMY
We help equip learners with the needed skills to achieve and sustain transformational impact and help them accelerate their careers with trusted and flexible learning delivery options. We also help organizations accelerate performance and unlock value through ISO Certification Management System and Regulatory Compliance, leadership development and capability building at scale.
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WHY CHOOSE US
Choose Kelmac Group® Academy to be the guide in your quality and compliance journey. Our clients across the globe see us as the stepping stone to the next chapter of their careers. We instruct our learners in the complexities of achieving conformity to ISO standard and compliance to customer and regulatory requirement in todays fast-changing world. If you are serious about your career, do not let the opportunity pass you by. Our Fundamentals, Internal, Lead Auditor, and Specialised Training courses are based on todays reality and deliver practical knowledge and proven insights delivered by our Expert consultants.
CQI & IRCA CERTIFIED
Courses that are accredited (CQI & IRCA), interactive, and are led by our consultants, auditors and crisis managers
EXPERT CONSULTANTS
We have built our reputation on attracting and developing exceptional Experts who are passionate about helping people enhance their talents and reaching their full potential in management systems and auditing
COURSE MATERIAL DESIGN
Course material is instructionally designed by a combination of Experts, Instructional Designers, Media Technologists and Editor. Access to all course material upon registration and up to 12 months post course delivery with at least 1 update to keeping you current with best international practice
INCREDIBLE VALUE
You receive market-leading training at an extremely competitive price.
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46 Countries
Learners
50K Clients
10 Schemes
21 Certified Courses
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Frequently Asked Questions
If you are a new learner, and here for the first time, you will have to register [open a learner account] yourself as a new learner by following this link. https://www.kelmacgroup.com/registration
To complete the registration process you will be asked to verify with a one-time verification email. Once you have successfully registered with the Kelmac Group Academy, you can login as aregister account holder and proceed with booking your seat for any of the Kelmac Group Academy courses. If you are an existing learner/account holder with the Kelmac Group Academy, please log in to your learner account portal and proceed with booking your seat for any of our courses.
Once you have successfully booked your seat for one of the Kelmac Group Academy courses, you will receive all the relevant copies of the digital course material via the Kelmac Group Academy DRM application, Mimeo. You will also have access to these digital course materials up to 12 months after completing the course.
You can use our chat bot and get answers to all your queries. Or you can write to or call our
support team –
Call: +353 61 49122
Email: rsoni@kelmacgroup.com, gquandt@kelmacgroup.com
CQI and IRCA stands for the Chartered Quality Institute and the International Register of Certificated Auditors. The CQI is a globally recognised brand and their specialist division IRCA is a market leader with its Management Systems auditing training – approved by employers and the industry. With 18,000 members in 100 countries, they are the partner of choice for management system practitioners.
With CQI-IRCA accredited training you can expect the following benefits:
• CQI and IRCA Certified Training is mapped to our unique Competency Framework so you learn the relevant, up-to-date skills employers have told us they want
• Our certified training courses offers you infinite development opportunities and is an invaluable way of gaining professional recognition for your expertise and commitment.
These are what the Kelmac Group® Academy recommends–
- A current-generation laptop or desktop computer. The laptop or desktop computer should have the latest web browser installed and handle multiple software running simultaneously. (Note: A tablet or mobile device is not suitable for this training).
- HD Webcam — built-in or USB plug-in.
- Speakers and a microphone — built-in or USB plug-in. We highly recommend a headset for optimal audio quality.
- Internet connection — Minimum of 2.5 Mbps download, 3.0 Mbps upload.
- Two display monitors are highly recommended:
- One for joining the virtual classroom and, if applicable, viewing e-Course documentation
- The other for completing class exercises/assignment
You will receive all communication updates including your exam results and certificates through your Kelmac Group® Academy learner account.