How does Medical Device Quality Management System benefit from ISO 13485?
ISO 13485 Foundation Certification offers a fundamental understanding of the ISO standard. Individuals pursuing this certification gain an understanding of the ISO 13485:2016 standard to instill a Medical Device Quality Management System (MDQMS). The ISO 13485 Standard specifies the requirements that have to be met by organizations while providing medical devices and related services. The standard is applicable to every organization irrespective of its size and industry. Organizations are required to follow the policies and procedures as specified in the 2016 version of ISO 13485. Professionals certified with ISO 13485 Foundation Certification are recognized by such organizations.
ISO 13485 Foundation Certification Training
The ISO 13485 Foundation Exam emphasizes on the processes involved in managing and implementing MDQMS. Candidates pursuing the Foundation Exam of ISO 13485 standard gain an in-depth understanding of the standard and its requirements. This assists in applying the standard to the organizational framework. Individuals willing to broaden their scope of ISO 13485 can enroll in ISO 13485 Foundation Training offered by Unichrone across various countries. Our highly qualified experts in the field provide practical insights into the standard. This in turn helps professionals to clear the exam and obtain the certification without any hassles.
Key Features of ISO 13485 Training
ISO 13485 Foundation Certification has gained popularity across the globe. Professionals enrolling for the training session of ISO 13485 Foundation are prepared to apply best practices followed in the field. Our trainers encourage candidates to participate in case studies and discussions. In addition, participants receive hands-on experience through real-life examples provided by our qualified trainers. This makes it easier for professionals to understand ISO 13485 Standard comprehensively.
- 1 Day Interactive Instructor –led Online Classroom or Group Training
- Course study materials designed by subject matter experts
- Mock Tests to prepare in a best way
- Highly qualified & accredited trainers with vast experience
- Enrich with Industry best practices and case studies
- ISO 13485 Foundation Course adhered with International Standards
- End-to-end support via phone, mail, and chat
- Convenient Weekday/Weekend ISO 13485 Foundation Training Course schedule
Corporate Group Training
- Customized Training
- Live Instructor-led
- Onsite / Online
- Flexible Dates
|ISO 13485 Foundation Exam Format|
|Exam Name||ISO 13485 Foundation|
|Exam Cost||Included in Training Fee|
|Exam Format||Multiple Choice|
|Total Questions||30 Questions|
|Passing Score||70% passing marks|
|Exam Duration||1 hour|
ISO 13485 Foundation Training Course Curriculum
1.Introduction to ISO 13485:2016
- · What is ISO 13485:2016?
- · Importance of ISO 13485 for an organisation
2.An Overview of ISO 13485:2016 Requirements
- · General requirements
- · Documentation requirements
- · Management responsibility
- · Resources
- · Product realisation
- · Infrastructure
- · Risk management
3.Implementation Phases of the ISO 13485 Frameworks
- · Stages to implementation
- · Gap analysis
- · Process mapping
4.Conducting ISO 13485 Certification Audit
- · Certification audits
5.The relationship between ISO 13485 and ISO 9001
- · Scope
- · Focus
- · Continual improvement
- · Terminology
- · Differences between the standards
- · Similarities between ISO 13485 and ISO 9001
ISO 13485 Foundation Certification Benefits
Frequently Asked Questions
Why should I take up ISO 13485 Foundation Training?
Enrolling in ISO 13485 Foundation Training course enables individuals to acquire a deeper understanding of the standard. During the course, our highly qualified trainers engage in conducting practical exercises. This further helps candidates to grasp the complex terminologies of the standard and clear the exam in the first attempt.
What is provided during the course if ISO 13485 Foundation Training?
During ISO 13485 Foundation course, candidates can access extensive training material, case studies, and mock tests.
Can I take up online ISO 13485 Foundation Certification Training?
Yes, at Unichrone we offer live online instructor-led sessions and in-classroom sessions. Candidates can choose their desired mode of ISO 13485 Foundation Training while enrolling in the course.
How long is the ISO 13485 Foundation Course?
The ISO 13485 Foundation Training is conducted for a day across various nations.
How is ISO 13485 Foundation Exam conducted?
The ISO 13485 Foundation Exam is required to attempt 30 multiple choice questions within 1 hour. Professionals who clear the exam are awarded ISO 13485 Foundation Certification.
Who offers the ISO 13485 Foundation Exam?
The ISO 13485 Foundation Exam is governed Unichrone which is globally recognized.
What is the passing score to clear ISO 13485 Foundation Exam?
Candidates need to obtain 70% or more to clear ISO 13485 Foundation Exam.
What is ISO 13485?
ISO 13485:2016 Standard specifies the requirements for maintaining the quality of medical devices and related services. ISO 13485 is the international standard established for managing the quality management system. Organizations that need to be certified under this standard need to demonstrate their ability in manufacturing medical devices. These medical devices are manufactured in accordance with the standard.
How does an organization benefit from ISO 13485?
An organization that is certified with ISO 13485 standard gains recognition and access to markets worldwide. Organizations holding the certification of ISO 13485 showcase that their medical devices are safer and in accordance with the quality standard. In addition, certified organizations can increase the efficiency of the process involved in manufacturing medical devices.
Why should individuals pursue ISO 13485 Foundation Certification?
Professionals certified with ISO 13485 Foundation Certification stand out from the crowd of regular professionals. Such professionals possess basic knowledge of the standard and its requirements. Organizations hire such professionals to assist them in implementing the standard within the structure. Recruiting certified professionals gains the trust of customers looking for standardized medical devices and related services.
Is there any prerequisite to take up ISO 13485 Certification?
No, there are no prerequisites for pursuing ISO 13485 Foundation Certification. Individuals who have an interest in pursuing a career in this field can enroll for the course and pursue the certification.
ISO 13485 Foundation Examination Procedure
Attend intense 1 day ISO 13485 Foundation Training offered by Unichrone. Fulfil all the requirements before the examination.
Apply for the Exam, conducted by Unichrone, whilst filling up all necessary details. Attend the exam scheduled at the end of the training session.
Get certified after clearing the exam. You will receive an email confirming the status, after which you can check for certification.
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Very engaging course with real world context and wonderful examples. Helped to expand my knowledge as a direct result of it.
Super awesome faculty! The best part of the training was lots of real time case studies and interactive sessions. Learnt many new concepts.
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Interesting, Focused, Real life case studies. The material was a comprehensive presentation of Lean principles and Six Sigma.
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Really interesting, a lot of knowledge about processes, in many areas and departments, helped to understand the subjects easily.
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Faculty and Mentors
Our certified and highly experienced trainers are handpicked from various industries to assist aspirants with practical insights into the field, thereby providing a comprehensive understanding of fundamentals and complex terminologies