ISO 13485 quality management system for medical devices
ISO 13485 Foundation Certification in Indonesia 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 Indonesia 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 Indonesia
ISO 13485 Foundation Training is offered by Unichrone across various cities of Indonesia. Aspirants acquire a comprehensive understanding of ISO 13485 standard and its requirements. The ISO 13485 Foundation Training in Indonesia 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 Indonesia
ISO 13485 Foundation Certification Training in Indonesia 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 Indonesia?
The ISO 13485 Foundation Training in Indonesia is conducted in live online instructor-led method and in-class method by Unichrone.
Why do I need ISO 13485 Foundation Training in Indonesia?
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 Indonesia?
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 Indonesia?
The ISO 13485 Foundation Training session is conducted for a day across various cities of Indonesia.
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 Indonesia?
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.
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 Indonesia?
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 Indonesia?
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 Indonesia?
Aspirants need not fulfill any prerequisites for pursuing ISO 13485 Foundation Certification in Indonesia.
ISO 13485 Foundation Examination Procedure
Attend intense 1 day ISO 13485 Foundation Training offered by Unichrone. Fulfil all the requirements specified by the TUV-SUD (Globally Recognized and Accepted) 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.
What our customers say
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.
I opted for Instructor led Online Session. The training was very well executed. It was awesome and exceeded my expectations.
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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