ISO 13485 quality management system for medical devices
ISO 13485 Foundation Certification in Japan is awarded to individuals well-versed in developing a quality management system for medical devices. The ISO 13485 Standard emphasizes on implementing Medical Device Quality Management System as per the requirements. Businesses that manufacture medical devices are necessitated to implement the ISO standard. Organizations that are certified with ISO 13485 execute the MDQMS to showcase the required quality of medical devices. Professionals certified with ISO 13485 Foundation Certification in Japan demonstrate their skills in managing the MDQMS instilled within the organization. The ISO certification is internationally recognized, offering ample opportunities for professionals pursuing a career in this field. Any individual can pursue the ISO 13485 Foundation Certification as there are no prerequisites.
ISO 13485 Foundation Certification Training in Japan
ISO 13485 Foundation Training is offered by Unichrone across various cities of Japan. Aspirants acquire a comprehensive understanding of ISO 13485 standard and its requirements. The ISO 13485 Foundation Training in Japan helps aspirants to master the processes involved in developing and maintaining an MDQMS. In addition, aspirants learn about the policies, procedures, performance measurements and continual improvement for MDQMS. Professionals who are involved in medical device quality management can pursue the certification and enhance their knowledge. Furthermore, certified ISO 13485 professionals can enhance their career options with the certification. The ISO 13485 Foundation Certification holders are highly sought-after in the medical device industry.
Key Features of ISO 13485 Training in Japan
ISO 13485 Foundation Certification Training in Japan is conducted through various methods. Professionals can choose either the online method or the in-class method and attend the sessions at their convenience. Expert trainers engage in offering real-time insights into the field. In addition, aspirants analyze the standard and its correlation with other frameworks. Furthermore, aspirants master the approaches and techniques for managing the MDQMS. On completion of the training sessions, aspirants are required to attempt the ISO 13485 Foundation Exam. Professionals who clear the exam can attain their ISO 13485 Certification.
- 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, Open Book Exam|
|Total Questions||30 Questions|
|Passing Score||70% passing marks|
|Exam Duration||1 hour|
ISO 13485 Foundation Certification Benefits
With this renowned credential, aspirants earn higher salary packages when compared to non-certified professionals in the field
Aspirants can look for higher career prospects at an early stage in their life with the most esteemed certification
Owning the certification makes it easier to earn the trust and respect of professionals working in the same field
Rigorous study plan
The course content is prescribed as per the exam requirements, covering the necessary topics to ace the exam in the first attempt
Diverse job roles
Attaining the certification enhances the spirit of individuals to pursue diverse job roles in the organization
With this certification, individuals acquire refined skills and techniques required to play their part in an organization
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
Frequently Asked Questions
How is the ISO 13485 Foundation Training conducted in Japan?
The ISO 13485 Foundation Training in Japan is conducted in live online instructor-led method and in-class method by Unichrone.
Why do I need ISO 13485 Foundation Training in Japan?
The ISO 13485 Foundation Training is hosted by expert trainers. Aspirants can reap the benefits of practical insights and apply the best practices. This in turn helps businesses to implement and manage MDQMS without any hassles.
Why should I opt for online ISO 13485 Foundation Training in Japan?
The online ISO 13485 Foundation Training is conducted in a live manner. Aspirants, as well as trainers, log in at the same time for the session. This helps aspirants to attend the program from their homes or office rather than traveling to the training venue.
What is the duration of ISO 13485 Foundation Training in Japan?
The ISO 13485 Foundation Training session is conducted for a day across various cities of Japan.
Is there any certification provided for ISO 13485 Foundation Certification Training?
Yes, candidates get a course completion certificate after completing ISO 13485 Foundation Certification Training.
Is self-study better than live online instructor-led training for ISO 13485 Foundation Certification?
It is difficult for candidates to understand the concepts of ISO 13485 through self-paced learning. However, live Online training offers candidates the opportunity to interact with instructors and clear their doubts. This assists candidates in a better understanding of ISO 13485 standards.
How many levels are there in ISO 13485 course?
There are three levels in ISO 13485 course: ISO 13485 Foundation course, ISO 13485 Lead Auditor course, and ISO 13485 Lead Implementer course.
Do you provide a mock test for ISO 13485 Foundation Certification Training in Japan?
Yes, Unichrone provides a mock test for ISO 13485 Foundation Certification Training in Japan.
What is the skill set acquired during ISO 13485 Foundation Certification Training?
Candidates will gain skills in implementing ISO 13485 standards and establishing a Medical Devices Quality Management System. Furthermore, candidates gain knowledge in analyzing and monitoring the functioning of MDQMS.
What companies need ISO 13485 standard?
Organizations specialized in designing, manufacturing, installing, and servicing various medical devices need ISO 13485 standards.
What countries do not apply ISO 13485:2016 standards?
Countries except for Europe, Canada, USA, Japan, Australia, Singapore, and Malaysia do not apply ISO 13485:2016 standards.
What is the format of ISO 13485 Foundation Exam?
The ISO 13485 Foundation exam comprises multiple-choice questions which have to be answered within 1 hour by aspirants.
How can I pass the ISO 13485 Foundation Exam in Japan?
Aspirants need to score 70% or more to pass the Foundation Exam and obtain their certification.
Is there a re-examination policy?
Yes, aspirants can retake the exam within 6 months from the date of the initial attempt.
Is there any separate fee for ISO 13485 Foundation Exam in Japan?
No, candidates do not have to pay a separate fee for ISO 13485 Foundation Exam. It is included in the ISO 13485 Foundation Training in Japan.
Is it possible to get a certificate without attempting ISO 13485 Foundation Exam?
No, candidates must attend and pass the ISO 13485 Foundation Exam to obtain ISO 13485 Foundation Certificate.
Who conducts ISO 13485 Foundation Exam in Japan?
Unichrone conducts ISO 13485 Foundation Exam at the end of the training course in the Japan.
Is ISO 13485 Foundation Exam an open book exam?
ISO 13485 Foundation Exam is an open book exam. Candidates can use reference materials while attempting ISO 13485 Foundation Exam.
How long is ISO 13485 Foundation Exam?
The ISO 13485 Foundation Exam is one hour long and consists of 30 multiple-choice questions.
What is the need for ISO 13485?
The ISO 13485 standard was launched by the international organization for standardization. This ISO standard specifies the requirements that have to be met by businesses that are involved in manufacturing medical devices. The quality of medical devices plays an important role in the health industry. As a result, organizations certified with ISO 13485 certification gain credibility and trust from stakeholders.
How can I get certified as ISO 13485 Foundation professional in Japan?
Individuals need to undergo ISO 13485 Foundation Training sessions. Thereafter, aspirants can clear the foundation exam and obtain the ISO 13485 Foundation Certification.
What is the benefit of ISO 13485 Foundation Certification in Japan?
The ISO 13485 Foundation Certification is internationally recognized. Aspirants can pursue their career options on a larger scale and earn higher salary packages. In addition, owning the certification helps aspirants to stand out from the crowd of regular professionals.
What are the prerequisites for pursuing ISO 13485 Foundation Certification in Japan?
Aspirants need not fulfill any prerequisites for pursuing ISO 13485 Foundation Certification in Japan.
What certification should I opt for after obtaining ISO 13485 Foundation Certification?
Candidates can go for ISO 13485 Lead Auditor Certification and ISO 13485 Lead Implementer Certification to broaden their knowledge of ISO 13485 standards.
Can ISO 13485 replace ISO 9001 standard?
ISO 13485 covers the ISO 9001 standard but with some additional features to fulfill the requirements of customers of Medical Device Quality Management organizations.
What is the difference between EN ISO 13485:2016 and ISO 13485:2016 standards?
ISO 13485 is an internationally recognized standard set of requirements to create a Medical Devices Quality Management System. However, EN ISO 13485 is a similar standard developed by the European Union for establishing MDQMS in the EU. It also offers various invaluable tables that align the ISO 13485:2016 standards with the EU medical device directives.
What is the validity of the ISO 13485 Foundation Certificate?
Candidates do not need to renew ISO 13485 Foundation Certificate, it is valid for a lifetime.
Will ISO 13485 Foundation Certificate help me to get a high salary?
Yes, ISO 13485 Foundation Certified professionals can earn an average salary of USD 80,000 per year according to payscale, which is high compared to non-certified professionals.
What can I do with ISO 13485 Foundation Certificate?
ISO 13485 Foundation Certificate holders can take job roles such as Quality Engineer, Quality Manager, Regulatory Affairs Specialist, Internal Auditor, Product Development Engineer, Quality Assurance Engineer, and Quality Assurance Director.
What is the ISO 13485 standard based on?
ISO 13485 is a stand-alone standard based on ISO 9001 quality management standard.
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. Choose the suitable date for the exam.
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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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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I opted for Instructor led Online Session. The training was very well executed. It was awesome and exceeded my expectations.
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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
Importance of ISO 13485 Foundation Certification in Japan
Even the slightest tampering with a medical device can result in unexpected threats to human life. Apart from becoming a leading medical equipment brand, this concern drives the need to comply with ISO 13485. Proper governance is required to fulfill the criteria of this ISO certification for device selling, repairing, or manufacturing enterprises. Most eligible for this purpose are individuals possessing ISO 13485 Foundation Certification.
How Does One Benefit from ISO 13485 Foundation Training?
ISO 13485 Foundation Training in Japan is the stepping stone to attaining the certification. It is the primary phase followed by an exam. Undertaking this training is advantageous in multiple ways:Read More