scholarly journals Documentation Required for Accreditation of Medical Testing Laboratories with Special Reference to National Accreditation Board for Testing and Calibration of Laboratories

Author(s):  
A.A. Kramarenko ◽  
V.V. Kirpichnik

The topical issues of participation of laboratories in interlaboratory comparison tests, the requirements of the international standards ISO, requirements of transnational and national standards ISO, the national accreditation body are considered. The progress on the revision of the international standard ISO/IEC 17025:2005 and the order of the transition to the updated version of 2017 are described. The information about changes in the approach of the national accreditation body to organizations of interlaboratory comparison tests (ICT) is given. The immediate prospects for the russian providers of interlaboratory comparison tests (ICT) and testing laboratories accredited in the national accreditation system are defined.


2021 ◽  
Author(s):  
Oleh Velychko ◽  
Tetyana Gordiyenko

National accreditation agencies in different countries have set quite strict requirements for accreditation of testing and calibration laboratories. Interlaboratory comparisons (ILCs) are a form of experimental verification of laboratory activities to determine technical competence in a particular activity. Successful results of conducting ILCs for the laboratory are a confirmation of competence in carrying out certain types of measurements by a specific specialist on specific equipment. To obtain reliable results of ILC accredited laboratories, it is necessary to improve the methods of processing these results. These methods are based on various data processing algorithms. Therefore, it is necessary to choose the most optimal method of processing the obtained data, which would allow to obtain reliable results. In addition, it is necessary to take into account the peculiarities of the calibration laboratories (CLs) when evaluating the results of ILС. Such features are related to the need to provide calibration of measuring instruments for testing laboratories. The evaluation results for ILCs for CLs are presented. The results for all participants of ILCs were evaluated using the En and z indexes. The obtained results showed that for the such ILCs it is also necessary to evaluate the data using the z index also.


Author(s):  
Dr Piyush Tailor ◽  
Dr. Niral Savaliya ◽  
Dr Chinka Patel

Background: For medical testing laboratories accreditation, laboratory has follow ISO: 15189:2012 and NABL-112. For this,quality manager of the laboratory must have to go under 4 days internal auditor training as per ISO 15189:2012 and NABL-112. Moodle is Learning Management System (LMS) which helps in systemic evaluation of trainee during internal auditor training. Objectives: The study was done to measure performance of trainee after completion of internal auditor training by comparing for each sub-clause of ISO 15189:2012 as well as for various categories of trainee. Materials and Methods: Online Moodle based - internal auditor training as per ISO 15189:2012 and NABL-112 was arranged in GMC, Surat, Gujarat for 4 days, with total 28 trainee. MCQ test was taken on-line with Moodle. Relationship of score with ISO 15189:2012 clauses and trainee category were analysed. Results: Participant’s average score in general, management and technical clause were 67% ,73.4% and 77.9% respectively. Teaching staff, Residents and Technicians scored 76.3 %, 77% and 70% respectively. Conclusion: Training emphasis and effectiveness in ISO 15189:2012 management clause was comparable with technical clauses. Moreover, the study found that, Training was effective across all categories of trainee. Keywords: ISO 15189:2012, NABL, Moodle


Author(s):  
Ila J. Elson

Radio Frequency Identification (RFID) is a technology that can be applied to the inventory management of reagents in medical testing laboratories throughout the world. This paper focuses on the case study methodology chosen to better understand the effectiveness and safety of prototype hardware and software and the usefulness of this new technology in laboratories. Study objectives and metrics are presented first. Then the case study approach is explained along with the logic for selecting a case, the generalization of the results and the benefits of the method. Human Factors practitioners and consultants in the healthcare information technology industry will find this information useful in designing case study research of new products for their clients.


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