QUALITY MANAGEMENT IN BIOBANK. WORLD TENDENCIES AND EXPERIENCE OF BIOBANK OF FSI «NMRC FOR PREVENTIVE MEDICINE» OF THE MINISTRY OF HEALTHCARE OF RUSSIA

2019 ◽  
Vol 64 (6) ◽  
pp. 380-384
Author(s):  
M. S. Pokrovskaya ◽  
A. L. Borisova ◽  
O. V. Sivakova ◽  
V. A. Metelskaya ◽  
A. N. Meshkov ◽  
...  

This paper provides several definitions of the term “biobank”; a list of standards developed by the International Organization for Standardization (ISO) applicable to the activities of biobanks; analyzes the legal and ethical requirements; the Russian legal framework in the field of biobanking, the best international practices and recommendations; describes the experience of the development and implementation of quality management systems according to ISO 9001 in Biobanks established in different countries, and the experience of the Bank of Biological Material of the National Medical Research Center for Preventive Medicine of the Ministry of Healthcare of Russia. The ISO 20387 Biobanking Standard, released in August 2018, combined the knowledge and experience of specialists from around the world and defined the general requirements that must be fulfilled by biobanks and repositories wishing to guarantee their customers the high quality of the preanalytical stage of scientific research, biological samples and associated data. In 2019, the Russian version of this standard is expected. Documents of the quality management system provide the reproducibility of activities on the main storage processes and facilitates the process of incorporating a new employee; conducting internal and external audits; Biobank knowledge management - continuous staff education. The introduction of an effective quality management system into biobank activity warrants the high quality of biological samples, the standardized pre-analytical stage, reliable, regulated long-term storage of biomaterial and related information for use in research purposes today and in future.

F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 660
Author(s):  
Michael Hewera ◽  
Ann-Christin Nickel ◽  
Nina Knipprath ◽  
Sajjad Muhammad ◽  
Xiaolong Fan ◽  
...  

Background: Increasing concerns emerge regarding the limited success in reproducing research results. This is a major problem for science, society and economy. Driven by industry or scientific networks, several attempts to combat this crisis are initiated. However, only few measures address the applicability and feasibility of implementation of actions into an academic research environment with limited resources. Methods: Here we propose a strategy catalogue aiming for a quality management system suitable for many research labs. Our proposal is guided by its inexpensiveness and possibility of rapid installation. Moreover, we restrict presentations of our actions on those for what we received a positive feedback by the users regarding its applicability.  For this we used eLabFTW, an electronic lab book, as hub for all other components of our quality management system (QMS). Storage of lab journals and project management will be done there as well. Standard operation procedures have been introduced. Those will be stored in eLabFTW too. Furthermore, we implemented a bio bank for safer long term storage of bio samples and cryo-cultures of cell lines. Next we set up a lab meeting as feedback mechanism for the QMS. In a final step we implemented an automated pipeline to be used for example for drug screens. Results: With this effort we want to reduce individual differences in work techniques, to further improve the quality of our results. Although, just recently established, we can already observe positive outcomes in quality of experimental results, improvements in sample and data storage, stakeholder engagement and even promotion of new scientific discoveries. Conclusions: We believe that our experiences can help to establish a road map to increase value and output of preclinical research in academic labs with limited budget and personnel.


Author(s):  
Н.М. ПРИВАЛОВА ◽  
М.В. ДВАДНЕНКО ◽  
Л.Ю. КИСЕЛЕВА

Проведен анализ построения системы управления качеством на ОАО Ставропольский пивоваренный завод . Отмечено, что гарантией стабильно высокого качества продукции является внедрение на предприятии СМК на базе международных стандартов ISO серии 14000 согласно национальным стандартам ГОСТ Р ИСО 9001 и ГОСТ Р ИСО 14000. The analysis of the construction of the quality management system at OJSC Stavropol brewery is carried out. It is noted that the guarantee of consistently high quality of products of this enterprise is the introduction of QMS at the enterprise on the basis of international standards ISO 14000 series in accordance with national standards GOST R ISO 9001 and GOST R ISO 14000.


2020 ◽  
Vol 8 (2) ◽  
pp. 45-49 ◽  
Author(s):  
E. Rogozina ◽  
T. Filimonikhina ◽  
N. Dmitriev

This article discusses the processes of building a quality management system that takes into account the need for innovative updating. The needs of mankind are increasing every year, and to achieve competitive advantages it is necessary to ensure high quality of products. The implementation of a quality management system is a complex and time-consuming process, which includes a set of works and affects almost all aspects of the business entity. A model of an innovative quality management system was proposed.


F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 660 ◽  
Author(s):  
Michael Hewera ◽  
Ann-Christin Nickel ◽  
Nina Knipprath ◽  
Sajjad Muhammad ◽  
Xiaolong Fan ◽  
...  

Background: Increasing concerns emerge regarding the limited success in reproducing data and translating research results into applications. This is a major problem for science, society and economy. Driven by industry or scientific networks, several attempts to combat this crisis are initiated. However, only few measures address the applicability and feasibility of implementation of actions into an academic research environment with limited resources. Methods: Here we propose a strategy catalogue aiming for a quality management system suitable for many research labs, on the example of a cell culture focused laboratory. Our proposal is guided by its inexpensiveness and possibility of rapid installation.  For this we used eLabFTW, an electronic lab book, as hub for all other components of our Quality Management System (QMS) and digital storage of lab journals. We introduced Standard Operation Procedures (SOPs) as well as a managed bio bank for safer long-term storage of bio samples. Next, we set up a lab meeting as feedback mechanism for the QMS. Finally, we implemented an automated pipeline to be used for example for drug screens. Results: With this effort we want to reduce individual differences in work techniques, to further improve the quality of our results. Although, just recently established, we can already observe positive outcomes in quality of experimental results, improvements in sample and data storage, stakeholder engagement and even promotion of new scientific discoveries. Conclusions: We believe that our experiences can help to establish a road map to increase value and output of preclinical research in academic labs with limited budget and personnel.


Author(s):  
C. X. Chen ◽  
J. X. Zhang ◽  
H. T. Zhao ◽  
Y. M. Xu ◽  
S. Yin

Abstract. Today's society has entered the era of big data, and the quality of surveying and mapping results has become the focus of government departments. As the statistical results of other industries, surveying and mapping results as one of the basic data sources provide data support for government decision-making, The status of surveying and mapping projects is constantly improving. This article introduces the ISO9001 quality management system implemented by the surveying and mapping production unit, the CMA quality management system implemented by the surveying and mapping quality inspection unit, and the first-level acceptance system for the two-level inspection of surveying and mapping products. Through the cause and effect diagram, taking the quality control of the fundamental geographical conditions monitoring of the national major surveying and mapping project as an example, the use method of the core tool 5M1E (Man, Machine, Material, Methods, Measurement, Environment) in the quality management system is demonstrated to prove that the quality management system plays an important role in the project. Provide reference experience for peers.


2019 ◽  
Vol 1 (15) ◽  
pp. 53-56
Author(s):  
D. V. Melik-Guseinov ◽  
V. Emanuel ◽  
L. A. Khodyreva ◽  
P. S. Turzin ◽  
A. Emanuel

The problem of assessing and improving the quality of medical care in a medical organization is considered. Analyzed the management of medical organization processes. A scheme for managing these processes, a list of regulatory documents, types and methods for monitoring the effectiveness of their implementation are presented. Formed groups of criteria used to assess the quality of the medical organization. It is argued that the introduction of a quality management system for the provision of medical care in a medical organization increases the efficiency of its activities.


2016 ◽  
Vol 4 (3) ◽  
pp. 37
Author(s):  
Dewi Setiawati

This research mainly aims to explore competencies of training graduated which focuses on factors that influence competencies of training graduates, such as the implementation of quality management system ISO 9001:2008 and teaching quality of Widyaiswara. The main research problem addressed in this study is how the implementation of quality management system ISO 9001:2008 and teaching quality of Widyaiswara contribute to competencies of training graduates, both partially and altogether. I conducting this research, explanatory survey method is used with questionairres using likert and interval scales as the data collection techniques, that are distributed to 51 graduates of training at PPPPTK Penjas dan BK. To analyse the data, the study employs PPM (Pearson Product Moment), to investigate the direct and non-direct correlations of dependent and independent variables. Significance tests are administered using F-test and t-test. The results show that (1) the impelementation of quality management system ISO 9001:2008 significantly influences competencies of training graduates; (2) teaching quality of Widyaiswara significantly influences competencies of training graduates; and (3) both the implementation of quality management system ISO 9001:2008 and teaching quality of Widyaiswara significantly influence competencies of training graduates.


Author(s):  
Amitava Mitra

As the competition for products and services continues to grow, with customer satisfaction playing an integral part in this process, organizations are faced with the task of ensuring quality in all of their activities. Since many organizations do not necessarily produce the entire product or deliver the service by themselves, they are dependent on other vital sources, for example, suppliers, that impact quality of the finished product/service. This necessitates development and implementation of a quality management system which can integrate information from the various entities to facilitate decision making in a timely manner. Additionally, it is desirable for such a quality management system to be responsive to the existing quality environment at the various sources that contribute to the manufacture of the product or delivery of the service. This chapter provides a foundation for accomplishing such quality management objectives.


2018 ◽  
Vol 183 ◽  
pp. 01009
Author(s):  
Artur Gawlik ◽  
Piotr Kucybała ◽  
Danuta Owczarek ◽  
Janusz Pobędza

One of the important aspects in the implementation of new products for production in the open field is the assessment of the impact of environmental conditions on their operation. Typically thermo-climatic research is carried out for such project. The laboratory of Techno-climatic Research and Heavy Duty Machines of Cracow University of Technology, equipped with a large-sized thermo-climatic chamber conducts this type of research. Bearing in mind the assurance of high quality of the conducted research, the quality management system (QMS) was developed and implemented. The article describes the requirements, scope and process of obtaining a Polish Centre for Accreditation (PCA) certificate.


2019 ◽  
Vol 297 ◽  
pp. 06010
Author(s):  
Albert Simkin ◽  
Tatyana Mozhaeva ◽  
Alexander Proskurin

The strategic goal of the state policy of the Russian Federation concerning education is to ensure the quality of functioning of additional professional education (APE) as means of social development, and in this regard, the creation of a modern system of continuous education, i.e. the implementation of the concept of lifelong learning. The solution of this problem is possible on the basis of the development and integration into the overall management system of the educational organization of the quality management system (QMS) of additional professional education, taking into account the specifics of this type of activity. The paper is proposed to develop the QMS of APE of higher education on the basis of a standard model of quality system proposed in 2006 by a consortium of representatives of educational institutions of secondary vocational and higher education of the Russian Federation. The creation of quality systems of educational organizations on the basis of the model of QMS of OO considered in the article, adapted to the specifics of APE will contribute to the creation of conditions for ensuring the quality of training of students of professional educational programs.


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