한국어
Part 1
ISO 9001:2015 Quality Management System(QMS)
GIC provides certification services such as ISO 9001 quality management system provisional auditor, auditor, lead auditor, internal auditor, and senior auditor based on cooperation with GPC (Global Personnel Certification Co., Ltd.), an accredited personal certification body based on ISO/IEC 17024.
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ISO 9001:2015 Certification Overview
- ✤ ISO 9001 is an internationally recognized standard for Quality Management Systems (QMS). This is the most used standard worldwide, and more than 11 million certificates are issued to customers in 178 countries.
- ✤ Today many companies want not only to meet the needs of their customers, but also provide better products and services. They also want to remain competitive through cost reduction.
- ✤ They also want to remain competitive through cost reduction. Whether it’s a large or small business, they need a comprehensive solution to improve quality and price competitiveness, and ISO 9001 provides these companies with effective quality management processes.
- ✤ Software development is different from food manufacturing or providing consulting services. However, ISO 9001 can be applied to any industry. Various organizations including manufacturing companies, software development companies, trading organizations, service organizations, police stations, professional football teams and city councils have successfully applied the ISO 9001:2015 system.
- ✤ As such, the requirements of ISO 9001 are comprehensive and can be applied to any organization, regardless of the type, size, or products and services offered. Therefore, this standard is the most widely used quality management standard worldwide.
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ISO 9001 Auditor Certification Requirements
- ✤ Basic requirements
- - Educational background beyond secondary education
- - Completion of education at an accredited educational institution and acceptance of examinations
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Auditor Certification ISO 9001 Procedure
- ※ The applicant decides the grade of the examiner to apply for, completes the application, and submits the documentary evidence for the credentials. (If there is not enough evidence, it must be possible to prove it through additional evidence.)
- - Graduate Certificate and Certificate of experience
- - Audit history
- - Education certificate
- - Verification audit evaluation record
※ The applicant to be assessed, knowledge and as a character, are entitled when pass the test finished and acceptable education standards are as follows.- - Management system auditor or lead auditor training course completion certificate approved by GPC that meets the requirements of educational institutions
- - Management system auditor or lead auditor training course completion certificate provided by an educational training institution designated by an accredited institution based on ISO/IEC 17024
※ The certification is valid for 3 years from the date of issue, and maintenance fees must be paid annually in accordance with the certified cycle, and additional requirements must be met at the 3rd year in the renewal cycle.
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Part 1
ISO 14001 | Environmental Management System(EMS)
GIC provides certification services such as ISO 14001 environmental management system provisional auditor, auditor, lead auditor, internal auditor, and senior auditor based on cooperation with GPC (Global Personnel Certification), an accredited personal certification body based on ISO/IEC 17024.
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ISO 14001:2015 Certification Overview
- ✤ ISO 14001:2015 is an international standard for environmental management systems (EMS), and is a major management system standard that specifies requirements for configuring and maintaining an environmental management system. Many companies in Korea are certified for their organization's environmental management, and more than 250,000 certificates are issued worldwide.
- ✤ ISO 14001 deals with issues such as establishing, implementing, maintaining and improving environmental management systems, along with general guidelines on principles, systems and supporting technologies for environmental management systems. This controls the customer's environmental aspects, reduces environmental impact, and ensures compliance with laws and regulations.
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ISO 14001 Auditor Certification Requirements
- ✤ Basic requirements
- - Secondary education or higher
- - Completion of training and passing the exam at an accredited educational institution
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ISO 14001 Auditor Certification Requirements
- 1. The applicant decides the grade of the examiner to apply for, completes the application, and submits the documentary evidence for the credentials. (If there is not enough evidence, it must be possible to prove it through additional evidence.)
- - Graduate Certificate and Certificate of experience
- - Audit history
- - Education certificate
- - Verification audit evaluation record
- 2. Being the subjects for evaluation, applicants will be qualified only if they pass the knowledge and personality test.
- - Management system auditor or lead auditor training course completion certificate approved by GPC that meets the requirements of educational institutions
- - Management system auditor or lead auditor training course completion certificate approved by GPC that meets the requirements of educational institutions
- 3. The certification is valid for 3 years from the date of issue, and maintenance fees must be paid annually in accordance with the certified cycle, and additional requirements must be met at the 3rd year in the renewal cycle.
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Part 1
ISO 13485:2016 Medical devices — Quality management systems(MDQMS)
GIC provides certification services such as ISO 13485 medical device quality management system provisional auditor, auditor, lead auditor, internal auditor, senior auditor based on cooperation with GPC (Global Personnel Certification), an accredited personal certification body based on ISO/IEC 17024.
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ISO 13485 Certification Overview
- ✤ ISO 13485 is a standard that stipulates the requirements for the quality management system of organizations that provide medical device design and development, production, installation and additional services.
- ✤ This specification can also be applied to external organizations that provide sterilization, calibration and sales services for medical devices, providing a foundation for quality management systems for medical devices and related service delivery organizations.
- ✤ Medical devices directly affect human life and health, they need to guarantee a higher level of stability than any other product. Therefore, the medical device industry has a variety of regulations that must be met, including domestic regulatory systems, international standards and other requirements.
- ✤ In order to meet the requirements of the EU Medical Device Directive, a quality system must be established, and some countries, such as Canada, require ISO 13485 certification for product sales.
- ✤ ISO 13485 Management System Certification allows medical device manufacturers to demonstrate that their organizations' systems meet comprehensive requirements for quality management systems and special requirements for medical devices.
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ISO 13485 Auditor Certification Requirements
- ✤ Basic requirements
- - Secondary education or higher
- - Completion of training and passing the exam at an accredited educational institution
- ✤ ISO 13485:2016 Auditor requirements
- - Education: University (4 years) graduation or higher
- - Majors: Biology, Microbiology, Chemistry, Biochemistry, Computer and Software Technology, Electrical, Electronics, Mechanical, Biological Engineering, Human Physiology, Pharmacy, Physics
- - Experience: Persons who have worked full-time for at least 4 years in medical devices and medical research fields
- ✤ Special requirements and technical competence :
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- 1. Basic knowledge of medical devices and an understanding of related production activities, including :
- - purpose of use
- - Classification of medical devices including risk analysis
- - Legal regulatory framework and the role of the certification body
- - Medical device risk evaluation (ISO 14971)
- - Product standards related to medical device evaluation
- - ISO 13485 certification by certification body
- - Knowledge of medical device business/technology
- 2. Statistical analysis
- - Basic knowledge of probability and statistics according to sampling and trend analysis considering reliability and standard deviation
- 3. Knowledge of :
- - Sterilization technology and verification technology
- - Microbiology and BIO-Burden monitoring
- - Biocompatibility and validation
- - Clean room operation
- - Environmental monitoring and control
- - Packaging technology
- - Stability test
- - Risk management base
- - Cleaning and disinfection
- - Biological evaluation of medical devices
- - Clinical evaluation of medical devices
- - Physical and chemical evaluation of medical devices
- - Knowledge of process validation practices
- - Software verification technology
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ISO 13485 Auditor Certification Procedure
- ✤ The applicant decides the grade of the examiner to apply for, completes the application, and submits the documentary evidence for the credentials. (If there is not enough evidence, it must be possible to prove it through additional evidence.)
- - Graduate Certificate
- - Certificate of experience
- - Audit history
- - Education certificate
- - Verification audit evaluation record
- ✤ Being the subjects for evaluation, applicants will be qualified only if they pass the knowledge and personality test.
- - Management system auditor or lead auditor training course completion certificate approved by GPC that meets the requirements of educational institutions
- - Management System Examiner/Senior Examiner Training Course Certificate provided by a designated training institution based on ISO/IEC 17024
- ✤ The certification is valid for 3 years from the date of issue, and maintenance fees must be paid annually in accordance with the certified cycle, and additional requirements must be met at the 3rd year in the renewal cycle.
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Part 1
ISO 45001:2018 Occupational Health and safety Management Systems
GIC provides certification services such as for ISO 45001 occupational health and safety management systems provisional auditor, auditor, lead auditor, internal auditor, senior auditor based on cooperation with GPC (Global Personnel Certification), an accredited personal certification body based on ISO/IEC 17024.
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ISO 45001:2018 Certification Overview
- ✤ ISO 45001 is a occupational health and safety management systems, and the existing OHSAS 18001:2007 standard was replaced by ISO 45001 in 2018. It provides a framework for managing health and safety management responsibilities through an occupational health and safety management system compatible with ISO 9001 and 14001 management systems.
- ✤ This standard was developed for international use and enables organizations to control health and safety risks and improve performance.
- ✤ ISO 45001 is suitable for over 90,000 organizations in over 127 countries. If your organization needs to show the best practice of the safety management of those responsible for it, it will be right for you.
- ✤ GIC grants certifications to various organizations in various fields, including government offices, manufacturing, service, food companies, and franchises.
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ISO 45001 Auditor Certification Requirements
- ✤ Documents to be submitted for registration as an auditor
- - Certificate of experience and Auditor certificate
- - Auditor certificate
- - Education certificate
- - Audit history log sheet writing
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ISO 45001 Auditor Certification Procedure
- ✤ The applicant decides the grade of the examiner to apply for, completes the application, and submits the documentary evidence for the credentials. (If insufficient evidence is available, additional evidence should be available.)
- ✤ Applicants are eligible for evaluation and are entitled to pass the Knowledge and Personality Test and are eligible for completion of the training as follows
- - Management system auditor or lead auditor training course completion certificate approved by GPC that meets the requirements of educational institutions
- - Management system auditor or lead auditor training course completion certificate provided by an educational training institution designated by an accredited institution based on ISO/IEC 17024
- ✤ The certification is valid for 3 years from the date of issue, and maintenance fees must be paid annually in accordance with the certified cycle, and additional requirements must be met at the 3rd year in the renewal cycle.
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