logo
nav-bg
Home>Events

English

Events

On June 28, 2019, the China National Clinical Research Center for Neurological Diseases obtained the ISO 9001:2015 International Certification

Date: 2019-07-01 09:35
 
On June 28, 2019, the China National Clinical Research Center for Neurological Diseases (hereinafter referred to as the “Center”) of Beijing Tiantan Hospital affiliated to Capital Medical University officially obtained ISO 9001:2015 Quality Management System Certification from the internationally recognized inspection, verification, testing and certification company SGS. The successful acquisition of the certificate marks the international certification of the construction and management level of the quality control system of the Center's clinical research, which provides a guarantee for the standardized operation of the Center and the results of high-quality research. Professor Wang Yongjun, Executive Vice President of Beijing Tiantan Hospital and Deputy Director of the Center, and Xin Bin, Director of SGS Certification and Enterprise Optimization Department in China, attended the certificate issuing ceremony.
Xin Bin (left), Director of SGS Certification and Enterprise Optimization Department in China, issued ISO 9001:2015 Quality Management System Certificate to Professor Wang Yongjun (right), Executive Vice President of Beijing Tiantan Hospital and Deputy Director of the Center.
Photo of representatives of the Center and the SGS
In the medical field, clinical research institutions are in the central position of the chain of medical science and technology innovation. The Center is the core force to undertake basic disease researches, transform cutting-edge technological achievements, apply and evaluate innovative products, formulate guidelines and promote research results on the network. However, for a long time, clinical research has been a weak point in the chain of medical science and technology innovation in China. The progressed made in frontier research fields of life science can not be timely and effectively transformed into clinical application. Clinical resources are highly scattered and clinical research innovation is insufficient. It’s been a prominent  problem that the overall development are lagging behind. Strengthening the construction of the Center is effective way to promoting China's medical innovation capacity, and an effective way to accelerating the transformation of health science and technology achievements in China.
 
The National Clinical Medical Research Center's Five-Year (2017-2021) Development Plan mentioned "focusing on large-scale, multi-Center clinical effect evaluation and medical quality improvement research". Clinical Centers are encouraged to establish a clinical evaluation platform for drugs and medical devices in accordance with the requirements of the Drug Clinical trial quality Management Standard and the Medical device Clinical trial quality Management Standard. There are many particularity in hospital management, such as diversity of laws and regulations, complexity of management, severity of risk, rigor of implementation and so on. This requirement is highly consistent with the quality management principles of ISO 9001, and the implementation of ISO 9001 is fully in line with and even exceeds the requirements of the Ministry of Science and Technology of the PRC and the National Health Commission of the PRC. It can make the implementation of these requirements more secure with the introduction of ISO 9001 systematic management, the development and implementation of the three-level monitoring mechanism included in ISO 9001, combined with the supervision of regular external audits. ISO 9001 has undergone revisions in five editions, of which the 2015 edition has stricter and more refined requirements for “risk” and “quality control” in the 2008 edition of the standard.
 
Professor Wang Yongjun, Executive Vice President of Beijing Tiantan Hospital and Deputy Director of the Center, said at the certification ceremony, "it’s a great pleasure to witness the Center obtain the ISO9001:2015 quality management system certification in 5th Annual Scientific Session of Chinese Stroke Association & TISC 2019. Since its establishment in August 2013, through the unremitting efforts of all colleagues, the quality of clinical research has improved year by year. By February this year, the Center had ranked first in the world in the field of ischemic stroke and TIA. I believe that there are two core parts of clinical research, one of which is the quality of research, and the other is research data. There will be no good research data if there is no good quality of research; there will be no fine output if there is no fine research data. On behalf of the Center, I would like to express my sincere gratitude to the more than 100 colleagues who have participated in the preparation for the certification of the quality management system in the past year. I would also like to thank SGS for its work in improving the work flow, optimizing the management ideas and continuously improving the level of scientific research management for the Center. This certification will lay a solid foundation for the quality management of the Center in recent years. "
On behalf of SGS, Xin Bin, Director of SGS Certification and Enterprise Optimization Department in China, warmly congratulated the Center on its acquisition ISO 9001:2015 certification, and said at the ceremony, " The smooth passage of certification indicates that the Center has put forward very stringent and refined requirements for the quality of scientific research in accordance with the requirements of ISO 9001, combined with the relevant regulations of the National Clinical Research Center, optimizing internal processes, controlling external risks. A set of safety and risk management system has been established to improve the scientific research management consciousness of the whole staff, strengthen the quality management of clinical research Center in an all-round way, and continuously improve the research. Through the three-level monitoring mechanism of daily supervision and inspection, internal regular audit and management review, combined with regular external audit, the quality and risk management of scientific research management can be implemented and achieved results, which meet and exceed the requirements of the Ministry of Science and Technology of PRC. I would like to express my heartfelt congratulations on this great achievement made by the China National Clinical Research Center for Neurological Diseases!"
Founded on August 23, 1956, Beijing Tiantan Hospital is a comprehensive teaching hospital of Grade 3A, which is led by neurosurgery and characterized by neuroscience cluster and which integrates curing, teaching, researching and preventing. It is one of the three major neurosurgery research Centers in the world and a clinical, scientific research and teaching base for neurosurgery in Asia.
Adhering to the quality policy of "rigorous, realistic, exploring, innovating and sharing", with a rigorous scientific attitude, Centering on the clinical problems of nervous system diseases, combined with innovative thinking and advanced technology, the Center explores and validates new diagnosis and treatment technologies and programs, so as to realize the transformation and sharing of achievements and improve the level of diagnosis and treatment of patients with nervous system diseases all over the world. According to ISO 9001:2015 standard and its best practice management requirements, the Center trains the heads and backbone of each department of the Center in the quality management system, determines the quality policy and objectives of the Center, the responsibilities of each department and position, combs the work flow of the team, establishes the efficiency and benefit-oriented process and system requirements, and controls the risks in the operation of clinical medical projects. A total of 521 quality system documents were written, including 1 first-level document, 38 second-level documents, 128 third-level documents and 354 fourth-level documents, totaling more than 5.2 million words.
The Center welcomed the on-site audit of SGS expert audit team from April to May 2019, and successfully passed the ISO 9001:2015 quality management system certification. Clinical data and biological sample database, basic and transformational medical research Center, neural system monogenic disease diagnosis Center / nervous system precision medical research Center, after expert review, obtained the sub-certificates of the ISO 9001:2015 quality management system.
SGS issues ISO 9001:2015 certification sub-certificates for clinical data and biological sample database, basic and transformational medical research Center, neural system monogenic disease diagnosis Center / nervous system precision medical research Center.
 
Photos of the on-site audit
About the Center:
Relying on Beijing Tiantan Hospital, the China National Clinical Research Center for Neurological Diseases was formally approved by the Ministry of Science and Technology of PRC, the National Health Commission of the PRC, the Logistics Support Department of the Central Military Commission, and the former General Administration of Food and Drug Administration and established in August 2013. It is also the first batch of recognized clinical medical research Centers for neurological diseases, and the director of the Center is Academician Zhao Jizong. The establishment of the Center is a major measure for the state to deepen the reform of the medical system and implement the 12th five-year Plan for the Development of Medical Science and Technology. It bears the task of strengthening the construction of medical scientific innovation system and enhancing the ability of clinical research in the field of clinical medicine and transformation of nervous system diseases. The Center is oriented to the needs of disease prevention and control in China, guided by clinical application, with medical institutions as the main body, and supported by collaborative network. It is a national science and technology construction base to carry out clinical research, technological innovation, academic exchanges, personnel training, international cooperation.
Research orientation of the Center: carrying out high-quality evidence-based medicine research; verifying new technologies and methods; implementing interdisciplinary transformation research; developing and popularizing appropriate technologies at the grass-roots level; exploring clinical research methods and management models; building a national platform for public technical support for clinical research.
The China National Clinical Research Center for Neurological Diseases, The China National Medical quality Control Center for Neurological Diseases, National Cerebrovascular Disease Prevention and Control Office, WHO Neuroscience Training Cooperation Center, Beijing Institute of Neurosurgery, Fifth Clinical Medical College of Capital Medical University, Brain tumor Research Institute of Beijing Institute of Major Brain Diseases, Stroke Research Institute of Beijing Institute of Major Brain Diseases, Beijing Clinical Research Center for Cerebrovascular Diseases, Beijing Office of Guidance for Prevention and Treatment of Cerebrovascular Diseases, the Beijing Cerebrovascular Disease Rescue and Treatment Center, the Chinese Journal of Neurosurgery, and the Chinese Journal of Stroke, are located in Beijing Tiantan Hospital.
The quality management work is overall planned and managed by the office of the Center, and 12 subordinate organizations participating in. They include the Department of Epidemiology, Department of Big Data and AI , the Statistics Department, the Clinical Department, the Project Management Department, the Clinical Trial Center, the Imaging Research Center, the Supercomputing Center, the Beijing Cerebrovascular Disease Prevention and Treatment Office, the Clinical Data and Biological sample Database, the Basic and Transformational Medical Research Center, and the Nervous System Monogene Disease Diagnosis Center / Nervous System Precision Medical Research Center.
 
About SGS:
SGS is an internationally recognized inspection, verification, testing and certification company, with more than 97,000 employees worldwide, distributed in more than 2,600 branches and laboratories, forming a global service network. In the field of hospital quality management, SGS has a global network of commissioned analytical laboratories and cutting-edge clinical trial facilities. It is the first third party organization commissioned by the National Health and Family Planning Commission to supervise and audit hospitals. So far, it has provided services to more than 200 hospitals at home and abroad. Based on industry-leading professional quality management knowledge and experience, combined with rich hospital quality control management and quality improvement practices, SGS is committed to providing one-stop quality management solutions for the hospital field. In addition to providing ISO 9001 quality management system certification, it can also provide comprehensive risk identification and control for all types of organizations in the field of big health (including quality risk, environmental risk, occupational safety and health risk, organizational and personal information security risk, etc.). It also provides ISO 13485, ISO 14001, ISO 45001, IECQ QC 080000, ISO/IEC 27001, ISO 28001, ISO 50001 and other management system training and certification for the whole medical supply chain, including medical devices, drugs, hospitals/medical institutions/medical examination Centers/nursing homes, etc., so as to help the organization to establish a management system suitable for organizational development strategy, build a continuous improvement mechanism and core team, and improve the level of organizational management.