Организация системы менеджмента качества лабораторий с учетом требований ГОСТ ISO/IEC 17025-2019 с применением ЛИМС

2021 ◽  
pp. 569-575
Author(s):  
Konstantin S. Varaksin ◽  
Artem S. Makarov ◽  
Svetlana V. Gabova ◽  
Alexander Y. Alexander
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Information Management System ◽  
Risk Identification ◽  
Control Measures ◽  
Laboratory Activities ◽  
Process Implementation ◽  
Calibration Laboratories ◽  
Laboratory Information Management

The updated version of the ISO/IEC 17025 standard has introduced substantial changes to the structure, terminology, requirements to resources, processes, and quality management system of testing and calibration laboratories. New requirements were established for organization of laboratory activities – the process based approach and risk-targeted thinking, which provides for the cutting of some part of the prescriptive requirements and introduction of requirements based upon analysis of actions performed. In accordance with GOST ISO/IEC 17025-2019, the laboratory is required to provide risk identification and assessment processes, develop risk control measures and expand opportunities to achieve the established purposes and objectives. The standard requires the laboratory to plan and perform actions to manage risks and opportunities associated with laboratory activities. This article deals with organization of the quality management system of Transneft system organizations’ laboratories in the aspects of risk management, management of opportunities, corrective actions with the use of laboratory information management system (LIMS). The model of the process implementation is described, subject to requirements of GOST ISO/IEC 17025-2019. Обновленная редакция стандарта ISO/IEC 17025 внесла существенные изменения в структуру, терминологию, требования к ресурсам, процессам, системе менеджмента качества испытательных и калибровочных лабораторий. Были установлены новые требования к организации деятельности лабораторий – процессный подход и риск-ориентированное мышление, что предусматривает сокращение части предписывающих требований и введение требований, основанных на анализе выполнения действий. В соответствии с ГОСТ ISO/IEC 17025-2019 от лаборатории требуется обеспечить процессы идентификации и оценки рисков, разработку мер по контролю рисков и расширению возможностей для достижения поставленных целей и задач. Стандарт требует от лаборатории планирования и реализации действий по управлению рисками и возможностями, связанными с лабораторной деятельностью. В настоящей статье рассматривается организация системы менеджмента качества лабораторий организаций системы «Транснефть» в части управления рисками, возможностями, корректирующими действиями с применением лабораторной информационной менеджмент-системы (ЛИМС). Описана модель реализации процесса с учетом соблюдения требований ГОСТ ISO/IEC 17025-2019.

Competency management of laboratory personnel using LIMS

2020 ◽  
Vol 10 (6) ◽  
pp. 636-641
Author(s):  
Konstantin S. Varaksin ◽  
◽  
Artem S. Makarov ◽  
Alexander Y. Lyapin ◽  
◽  
...  
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Information Management System ◽  
Test System ◽  
Test Methods ◽  
Laboratory Activities ◽  
Resource Requirements ◽  
Laboratory Workers ◽  
Competence Test

The updated edition of the ISO/IEC 17025 standard introduced significant changes to the structure, terminology, resource requirements, processes, quality management system of testing and calibration laboratories. New requirements were established for the organization of laboratory activities – a process approach and risk-based thinking, which provides for a reduction in part of the prescriptive requirements and the introduction of requirements based on the analysis of the performance of actions. In accordance with GOST ISO IEC 17025-2019, the laboratory must authorize personnel to perform specific laboratory activities, as well as guarantee their competence. This article discusses the organization of the competence management system for the personnel of the laboratories of the organizations of Transneft system using the laboratory information management system (LIMS). The model of the process implementation has been described. It has been established that the competence test system allows you to regularly monitor the skills and knowledge of laboratory workers both in terms of the elements of the Quality Management System and in the applied measurement (test) methods. The personnel responsibility matrix implemented in LIMS regulates the powers and functionality of employees, ensuring that employees are allowed to perform work in accordance with their competence. The functions implemented in LIMS made it possible to automate the management of the competence of laboratory workers in accordance with the requirements of GOST ISO/IEC 17025-2019 and other regulatory documents.

Critical factors and performance indicators: accreditation of testing- and calibration-laboratories

2017 ◽  
Vol 24 (7) ◽  
pp. 1814-1833 ◽  
Author(s):  
Nagarajan Karthiyayini ◽  
Chandrasekharan Rajendran
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Laboratory Accreditation ◽  
Extensive Literature ◽  
Critical Factors ◽  
Content Type ◽  
And Performance ◽  
The Impact ◽  
Calibration Laboratories

Purpose The purpose of this paper is to determine the critical factors (CRFs) of IS/ISO/IEC 17025:2005 laboratory accreditation and indicators of the performance (IOPs) in the testing/calibration laboratories. The impact of accreditation on the performance is analyzed using the level of presence of critical factors that can be used to benchmark the best practices in the accredited testing and calibration laboratories. Design/methodology/approach A questionnaire is designed on the basis of an extensive literature review on laboratory accreditation and performance. Based on the responses from pilot study, the developed instrument is tested for its unidimensionality, reliability and validity. Multiple regression analysis is carried out to analyze the impact of critical factors on the IOPs. Findings The findings reveal that the six distinct critical dimensions of laboratory accreditation (which are the independent variables) have a significant impact on the performance of the accredited testing/calibration laboratories. The performance is measured by the dependent variables which are the IOPs. The customer satisfaction, employee satisfaction, laboratory performance, image of the laboratory, the number of increased customers and loyalty of the existing customers are highly influenced by the accreditation which in turn improves the performance to gain the competitive advantage. Research limitations/implications Contribution to research is in the area of laboratory accreditation and the performance measurement by the development of a comprehensive instrument to analyze the Laboratory Quality Management System. The results are dependent on the number of respondents who are the quality/technical managers. Practical implications This instrument would enable the accredited laboratories to analyze their performance through the feedback from the quality/technical managers to gain credibility and to continually improve and benchmark the quality management system in alignment with the quality policies. Originality/value This paper proposes an instrument to measure and benchmark the performance of the accredited testing and calibration laboratories.

scholarly journals CHARACTERISTICS OF INTERNAL AUDITS IN IMPROVEMENT OF QUALITY GOALS IN CALIBRATION LABORATORIES

2018 ◽  
Vol 18 (2) ◽  
pp. 91
Author(s):  
Jimmy Pusaka ◽  
Budhy Basuki
Keyword(s):  
Quality Management ◽  
Strong Correlation ◽  
Management System ◽  
Quality Management System ◽  
Internal Audit ◽  
Calibration Laboratories

The Quality Goals and Internal Audits are two important links in the quality management system. These two interrelated points are in many cases surprisingly not considered as they should be. Quality goals aren’t often subject to internal audits. Similarly with quality goals scarcely describe the improvement of internal audits as a tool to strengthen the quality management system. The fact, recent audit findings found no more than 11 out of 165 findings in 18 accredited calibration laboratories operated on the basis of ISO/IEC 17025 that relates to quality goals. This paper proves no strong correlation between quality goals and internal audit statistically. The importan thing for the improvement of quality goals – internal audits relationship is giving more clarification to clause 4.10 Improvements and add internal audit-based items on the quality goals.

scholarly journals Experiences with the accreditation of the Institute for Medical Research and Occupational Health, Zagreb, Croatia

2020 ◽  
Vol 71 (4) ◽  
pp. 312-319
Author(s):  
Zdenko Franić ◽  
Tomislav Bituh ◽  
Ranka Godec ◽  
Mirjana Čačković ◽  
Tomislav Meštrović ◽  
...  
Keyword(s):  
Quality Management ◽  
Occupational Health ◽  
Medical Research ◽  
Radiation Protection ◽  
Management System ◽  
Quality Management System ◽  
Ambient Air ◽  
Objective Evidence ◽  
Accreditation Agency ◽  
Calibration Laboratories

AbstractAccreditation in accordance with the international General Requirements for the Competence of Testing and Calibration Laboratories (HRN EN ISO/IEC 17025 standard) has become a widely accepted method of quality management and objective evidence of technical competence, knowledge, and skills of testing and calibration laboratories. In 2010, the Institute for Medical Research and Occupational Health (IMROH) had its management system accredited against the HRN EN ISO/IEC 17025 standard for the following scopes: determination of radioactivity, testing of ambient air quality, and testing in the scope of ionising radiation protection. This accreditation encompassed three laboratories: Radiation Protection Unit, Environmental Hygiene Unit, and the Radiation Dosimetry and Radiobiology Unit. In accordance with the rules of the Croatian Accreditation Agency, the second re-accreditation is due in 2020. This paper describes and discusses the quality management system at IMROH over the ten years of its implementation. We share our experiences about non-conformities discovered during regular work, internal audits, and external audits performed by the Croatian Accreditation Agency. The accredited management system significantly improved the performance of the accredited units, and the Institute increased its visibility and marketing advantage, consequently improving its market position.

scholarly journals CORRIGENDUM: Computer system validation

2021 ◽  
Vol 26 (1) ◽  
pp. 1-1
Author(s):  
Tomaž Sallubier ◽  
Borut Rusjan
Keyword(s):  
Quality Management ◽  
System Design ◽  
Computer System ◽  
Management System ◽  
Quality Management System ◽  
System Validation ◽  
Process Implementation

The authors regret that in „Computer system validation: Example of quality management system design and process implementation“ the following co-author was mistakenly missed from the authorship: Tomaž Sallubier, TS4U d.o.o, Kamnik, Slovenia.

scholarly journals ISO/IEC 17025: HISTORY AND INTRODUCTION OF CONCEPTS

Química Nova ◽  
2021 ◽  
Author(s):  
Anna Miguel ◽  
Renata Moreira ◽  
André Oliveira
Keyword(s):  
Quality Assurance ◽  
International Trade ◽  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Normative Document ◽  
Present Concept ◽  
The Face ◽  
Technical Capacity ◽  
Calibration Laboratories

Quality is an increasingly present concept nowadays, so meeting the customers’ needs, who buy and use products and hire services, becomes essential. For laboratories, the concept is applied to the reliability and traceability of the results produced and presents itself not only to meet the customer’s needs, but also to allow the signing of agreements in the international trade. The concept of Quality in a laboratory can be carried out from the elaboration of a Quality Management System (QMS). To this end, the normative document ISO/IEC 17025, internationally accepted, has been changing over the years aimed at instructing the elaboration of a management system which proves the technical capacity of testing and calibration laboratories and guides the generation of reliable results. The document is in its third version as a standard, the most current one published in 2017, and it presents requirements to achieve the proposed objective and the quality assurance. In the face of the importance of these concepts and the unquestionable need of laboratories to provide reliable and traceable results, this article presents the norm history and its most recent changes. Its intent is support laboratories whose objective is to implement a QMS according to this normative reference

ANALYSIS THE IMPACT OF THE IMPLEMENTATION OF QUALITY MANAGEMENT SYSTEM (QMS) AND SAFETY AND HEALTHY AT WORK MANAGEMENT SYSTEM (SHWMS / SMK3) ON THE JOB PERFORMANCE OF EMPLOYEES

2018 ◽  
Vol 3 (01) ◽  
pp. 45
Author(s):  
Nur Hidayat ◽  
Indah Kusuma Hayati
Keyword(s):  
Quality Management ◽  
Job Performance ◽  
Latent Variables ◽  
Management System ◽  
Quality Management System ◽  
Partial Least Square ◽  
Least Square ◽  
Global Challenges ◽  
The Impact ◽  
Work Management

Recently, the evolvement of globalization era has been the global challenges that cannot be avoided either by private or government sectors, and they are requested to be survived encountering such the condition. The implementation of Quality Management System (QMS) in the operational company is the way how to guarantee the quality of products or services offered to the people. One of the purposes of QMS implementation is to provide a prime satisfaction to the customers. The impact of QMS implementation is expected to increase job performance of the employees. Besides the implementation of Quality Management System (QMS), the impact of global challenges has been increasing the competitive efforts to execute more effective production process. However, it has required manpower protection accordingly. This research aims to find out whether the implementation of quality management system and safety and healthy at work management system have impacted on the job performance of employees. Objects of this research are the employees in the production department at PT Guna Senaputra Sejahtera Plant 1 Bogor. Data analysis technique of this research has applied software Smart PLS (Partial Least Square). PLS has estimated a model of correlation among the latent variables and correlation between latent variables and its indicators. Result of data processing has indicated that the implementation of Quality Management System (QMS) and system of safety and healthy at work have positively and significantly impacted job performance of employees.Keywords : Quality Management System (QMS), Safety and Healthy at Work System ( SHWS / SMK3), and Job Performance of Employees

Development of a Quality Management System for Electric Power applied to Small Wind Turbines

2012 ◽  
pp. 1083-1088
Author(s):  
O.H. Ando Junior ◽  
M.O. Oliveira ◽  
J.M. Neto ◽  
A.D. Spacek ◽  
R.C.B. Leborgne ◽  
...  
Keyword(s):  
Quality Management ◽  
Electric Power ◽  
Wind Turbines ◽  
Management System ◽  
Quality Management System ◽  
Small Wind Turbines
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