• Proceedings of the Safety Management and Science Conference
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• 2007.11a
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• pp.299-303
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• 2007

This paper deals with conformity assessments requirements for accreditation and certification bodies. This study also introduces conformity guidances of product certification and code of good practice. This paper presents general requirements for accreditation, recognition and registration bodies of environmental quality system and product certification.

• Korean Journal of Clinical Laboratory Science
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• v.53 no.1
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• pp.68-80
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• 2021

An uncertified facility is a facility not certified, as defined in the Biological Agents and Toxins Act (BATA) in Singapore, but has met the requirements of the Ministry of Health to possess First and Fifth Schedule biological agents and toxins. This type of facility is also known as a Biosafety Level 2 Plus (BSL 2+) facility. Registration as an uncertified facility or a BSL 2+ facility requires a certain process and procedure to be sought with the Biosafety Branch of the ministry. This review, shares first-hand knowledge on the journey to achieving registration of the authors' facility. The procedure involved considerable preparation, setting up facility requirements, biosafety precautions, procedures and practices, and training and competence of laboratory users. The ministry conducted a thorough onsite facility audit to ensure that the facility requirements and biosafety procedures and practices were in place. It then issued an approval letter of possession for the first-time use of biological agents and registered the laboratory as an uncertified facility. The expectation is that the comprehensive information shared may be of great benefit to other facilities with similar interests.

• Korean Journal of Clinical Pharmacy
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• v.11 no.2
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• pp.68-77
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• 2001

Herbal medicines have been used since ancient times as medicines to treat and relieve the symptoms of many different human diseases. However, so far, relatively few herbal medicines have been evaluated scientifically to prove their safety, potential benefits and effectiveness. This study was conducted to provide the groundwork for improving the current registration regulations for herbal medicines in distinction from synthetic medicines. The study was performed based on the literature research and individual interviews with 5 experts who had extensive experience in registration of herbal medicines. When compared with synthetic drugs, herbal medicines exhibit some marked differences, namely the active principles are frequently unknown, standardization, stability and quality control are not easy, they are usually mixtures of complex compounds. Second, the current regulations for herbal medicines are reviewed by comparison of foreign regulation systems like the one in China. The regulation requirements of herbal medicine in China are in distinction from synthetic drugs. The authors conclude that new registration requirements for the herbal medicines should be changed as follows; the toxicity and efficacy data should be submitted as mixed herbal preparation and the documents and other research on the reproduction and generation toxicity need to be shown for the proof of reproduction and generation toxicity, if needed.

• Environmental Analysis Health and Toxicology
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• v.30 no.sup
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• pp.4.1-4.7
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• 2015

Objectives Approximately 2000 phase-in substances are subject to registration according to the Act on the Registration and Evaluation, etc. of Chemical Substances (K-REACH), and the expected testing cost is 2.06 trillion Korean won assuming all the test data required for registration are acquired. The extent to which these enormous test costs can be reduced depends on the availability of existing data that can be used to meet the requirements of the K-REACH we examined the current availability of test data that can be used for chemical substance registration. Methods We analyzed the possibility of utilizing the existing test data obtained from 16 reference databases for 369 of 518 kinds of phase-in substances subject to registration that were reported in last October 2014. Results The physical and chemical properties were available for 57.1% of substances, whereas data regarding human hazards and environmental hazards were available at considerably lower rates, 8.5% and 11.8%, respectively. Conclusions Physical and chemical properties were available for a fairly high proportion, whereas human hazards and environmental hazards were reported for considerably fewer substances.

• Journal of Korean Society of Industrial and Systems Engineering
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• v.23 no.54
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• pp.97-110
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• 2000

As more and more companies pursue ISO 9000 certification, one of the most misconceptions about ISO 9000 is that registration is necessary only for business. ISO 9000 is being driven by commercial requirements, not legal fiat. This registration can be used as evidence of compliance to the ISO 9000 to satisfy specific customer requirements. The primary objective of this research is to provide the efficient implementation process of ISO 9000 certification on the basis of total quality management concerning with ISO/CDl 9001:2000, ISO/CDl 9004:2000 and ISO/CD2 9001:2000. Based on the result of first paper in May 1999, this study has been conducted using the data collected from 312 manufacturing companies which registered ISO 9000 certification. This analysis can be applied to Korean small and medium industrial companies in establishing and maintaining the development of qualify systems. The companies should be able to benefit if they make continuous effort to improve the quality activities based on the factors suggested in this paper.

• Journal of Pharmaceutical Investigation
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• v.10 no.3
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• pp.51-77
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• 1980

A comparison of worldwide drug registration requirements on scientific data required by the different regulatory authorities for the investigational new drug and new drug application for human uses was briefly reviewed and as one of administrative processings on review and evaluation of applications, the functions of scientific advisory committees were reviewed.

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.21
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• pp.9411-9416
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• 2014

Background: Cancer registration data is used to understand the nation's cancer burden, and to provide significant baseline data for cancer control efforts, as well as, research on cancer incidence, mortality, survival, and prevalence. A system that approves, assesses, and manages the qualification of specialists, responsible for performing cancer registration, has not been developed in Korea. This study presents ways to implement a certification system designed for the qualification of tumor registrars in Korea. Materials and Methods: Requirements for implementing a certified tumor registrar qualification system were determined by reviewing the system for establishing qualifications in Korea and the American qualification system via the National Cancer Registrars Association (NCRA). Moreover, a survey was conducted on Korean medical records administrators, who had taken the U.S. Certified Tumor Registrar (CTR) examination, in order to review their opinions regarding these requirements. Results: This study verified the feasibility of a qualification examination based on the opinions of CTR specialists by determining the following: items, and the associated ratings, of the qualifications necessary to register individuals as certified tumor registrars in a private qualification system; status of human resources required for the examination or training processes; plans regarding the organization needed for management, and operation of qualifications, examination standards, subject areas, examination methods, examination qualifications, or education and training programs. Conclusions: The implementation of a certified tumor registrar qualification system will lead to enhanced job competency for specialists and a qualitative improvement of cancer registration data. It will also reliably foster human resources that will lay the groundwork needed to establish scientific and reasonable national cancer management policies.

• Journal of the Korean Institute of Navigation
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• v.18 no.1
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• pp.63-84
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• 1994

Bareboat Charter Register or Dual Registration under a Demise Charter scheme, does not in fact sanc-tion the alternative use of flags of different states, but rather it authorises the use of the flag of the coun-try where the ship is temporarily flagged only. Bareboat Charter Register is not intended to miselead third party states or persons dealing with the ship in respect of its nationality. Bareboat Charter Register gives a shipwner a more flexible and attractive package, for example mortga-ging facilities might be more attractive in one state because of its stronger laws relating to recovery of liens, whereas the manning requirements might be attractive in another state. By using Bareboat Charter Register, a shipwner/manager can avail himself of both advantage instead of settling for a compro-mise. Ships on a Bareboat charter Register would be subject to the safety, manning and anti-pollution require-ments of the second flag state and would carry that state's right to fly a flag of the original state be withd-rawn and the effect is to suspend the registration during the period of demise charter except in so far as relates to Title transactions.

• Journal of Korean Society of Industrial and Systems Engineering
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• v.17 no.32
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• pp.267-279
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• 1994

The Ministry of Transportation forecasts that the total number of automobiles in use in 1997 will be increased to about 10 million units. Until now, with the increase of domestic demand for automobiles, the customers' complaints have been raised frequently in relation with insufficient supply of auto parts for the repair and maintenance. At the same time, the industry came to face with new problems such as customers' requests of auto makers' quality services. Until now there were not any statistics on the registration of car age for each car type. So, for the auto makers' efficient aftersales management a system for collecting registration statistics was developed, and it has attributed remarkably to the improvement of the aftersales services, through easy anticipation of the requirements of parts being used for not only the small-produced but the massproduced car types. And a systematic instrument useful for auto industry, transportation and policy on environment is provided by timely supply of various statistics to the industry.

• Smart Structures and Systems
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• v.25 no.5
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• pp.631-641
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• 2020

To meet the urgent requirements of safety surveillance from civil engineering management authorities, this study proposes a refined and efficient approach to generate full-field high-resolution panorama of construction sites using camera-amounted UAV (Unmanned Aerial Vehicle). GPS (Global Position System) information extraction for pre-registration, feature points filtering for efficient registration and optimal seaming line seeking for fusion are performed in sequence to form the full-field panorama generation framework. Advantages of the proposed method are as follows. First, GPS information can sort images for pre-registration, avoiding inefficient repeated pairwise calculations and matching. Second, the feature points are filtered according to the characteristics of the construction site images to reduce the amount of calculation. The proposed framework is validated on a road construction site and results demonstrate that it can generate an accurate and high-quality full-site panorama for the safety supervision in a much efficient manner.