135 results on '"ISO/IEC 17025"'
Search Results
2. Optimizing Customer Satisfaction Through Sustainable Service Quality in ISO 17025 Accredited Calibration Laboratories.
- Author
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Darwish, Marwan Walid Daoud, Doheir, Mohamed, Al-Kumaim, Nabil Hasan Saleh, Saleh, Hasan, and Yaacob, Noorayisahbe Mohd
- Subjects
CUSTOMER satisfaction ,CUSTOMER relationship management ,TESTING laboratories ,SAMPLE size (Statistics) ,RELIABILITY in engineering ,QUALITY of service - Abstract
This paper investigates how dimensions of sustainable service quality (SSQ) impact customer satisfaction, particularly in ISO 17025 accredited calibration laboratories in Saudi Arabia and Bahrain. The research addresses the challenge of maintaining customer satisfaction while enhancing competitive advantages through sustainable calibration services. Adopting the Stimulus-Organism-Response (S-O-R) theoretical model, this study employs a quantitative approach to test the proposed measurement model using Smart PLS 4. A pilot study with 35 respondents was conducted to validate the conceptual framework, which was based on the S-O-R theory. The pilot test confirmed the reliability of the constructs, though the sample size is limited. The findings provide preliminary support for the relationship between sustainable service quality and customer satisfaction. Future research will expand the dataset and conduct hypothesis testing to further inform practices in ISO 17025 laboratories. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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- View/download PDF
3. Toward ISO/IEC 17025 compliance: challenges and strategies for a university research laboratory
- Author
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Bennari, H., El Omari, S., Habsaoui, A., Chaair, H., and Belouafa, S.
- Published
- 2025
- Full Text
- View/download PDF
4. Quality approach towards ISO/IEC 17025 accreditation at the center of analysis and characterization of Marrakesh Cadi Ayyad University: metrology stakes.
- Author
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Outaki, Meriem, Benhaida, Sara, Belaqziz, Majdouline, Outzourhit, Abdelkader, Calchera, Gilles, Thévenon, Marie-France, Martin, Luc, Charki, Abdérafi, and Ajana, Hamid
- Abstract
In the context of the European Tempus project "Quality in Higher Agricultural Education in the Mediterranean (QESAMED)", Analysis and Characterization Center of Cadi Ayyad University has committed to implement a quality approach according to the ISO/IEC 17025 standard. The first objective was to accredit the testing carried out in the microbiology laboratory in response to strong demand from the food industry in the Marrakesh region. The process began with an initial assessment of the center activities to identify the main gaps from ISO/IEC 17025. The range of laboratory and standard testing to be accredited were determined and an appropriate action plan was established. After that, a staff training was programmed to improve their skills in relation to this standard and metrology concepts. Implementation of the metrology function is one of the key steps for the deployment of the continuous improvement process. This function guarantees the traceability of measurements and the reliability of microbiological testing results. Several actions have been carried out, including: (i) identification of critical quantities and associated metrological requirements, (ii) checking of the metrological consistency of equipment through the calculation of the capability coefficient. The management of equipment requires several steps, from receipt of the equipment to its decommissioning or reform: (i) identification of the equipment, (ii) creation of equipment files, (iii) performance of calibration, verification, and maintenance operations. Ultimately, the definition of a strategy ensuring metrological traceability will optimize management costs by taking into account the structural constraints linked to the organization of metrology on a national scale. [ABSTRACT FROM AUTHOR]
- Published
- 2024
- Full Text
- View/download PDF
5. QHFSS DNA laboratory – ISO/IEC 17025 conformance and accreditation
- Author
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Sean Doyle
- Subjects
Accreditation ,Conformance ,Non-conformity ,International standards ,ISO/IEC 17025 ,ISO 9001 ,Criminal law and procedure ,K5000-5582 - Abstract
This paper reviews evidence placed before a Commission of Inquiry (CoI) established by the State of Queensland, Australia, to consider the quality and reliability of DNA evidence. It also assesses whether the criticism levied in that report, of ISO/IEC 17025 being insufficient to assure the quality and reliability of DNA evidence, is warranted. The main conclusion drawn is that properly applied and embraced as a means of continuous improvement, conformance with ISO/IEC 17025:2017 alone is sufficient to assure the quality and reliability of the scientific outputs from a forensic science laboratory.Furthermore, it is clear from the observations and findings of the CoI and those recorded in this paper that the forensic science laboratory in question did not conform to ISO/IEC 17025:2017. Had it done so then the risk of the quality failures that led to the CoI would at least have been reduced and perhaps even avoided.
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- 2024
- Full Text
- View/download PDF
6. Uncertainty Assessment in Temperature Uniformity Survey of Thermal Processing Equipment According to AMS2750 Aerospace Specification.
- Author
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García-López, Carmen and Álvarez-Tey, Germán
- Subjects
UNIFORMITY ,AEROSPACE industry equipment ,TEMPERATURE ,INDUSTRIAL processing equipment ,PYROMETRY - Abstract
Thermal processing equipment used in the aerospace industry must meet the requirements of the processes for which they are intended. The periodic tests performed by calibration laboratories, according to the AMS2750 specification, are intended to ensure compliance with these equipment requirements. While this specification does not explicitly state the need for uncertainty calculation, it does specify that pyrometry laboratories must have an ISO/IEC 17025 Quality System accredited by a recognized regional body which is a member of the International Laboratory Accreditation Cooperation (ILAC). Therefore, the calculation of uncertainties is necessary. This work presents a methodology for conducting temperature uniformity surveys and uncertainty assessment in these tests. This methodology has been applied to four different types of equipment to analyse, in each case, the contributions of uncertainties and to assess their potential for improvement. The objectives that laboratories should aim for include improving measurement accuracy and reducing uncertainty components in order to meet the criteria of both AMS2750 and ISO/IEC 17025. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
7. Application of the FMEA Tool in an Accredited Testing Laboratory in the Context of the ISO/IEC 17025:2017 Standard
- Author
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Peter Blaško, Marek Šolc, Jozef Petrík, Lenka Girmanová, and Andrea Blašková
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failure mode and effect analysis (FMEA) ,risk assessment ,accredited laboratory ,ISO/IEC 17025 ,management system ,Mathematics ,QA1-939 ,Applied mathematics. Quantitative methods ,T57-57.97 - Abstract
Organizations and laboratories tend to integrate systems based on risk management. Risk management helps to optimize laboratory processes and information flow, increase valid and reliable results, and make better decisions. This paper describes the development and present trends in risk management related to standard ISO/IEC 17025. This paper focuses on risk assessment in the accredited testing laboratories using the FMEA tool. In the basic eight defined laboratory areas, risks were identified and evaluated, and methods were proposed to minimize them.
- Published
- 2023
- Full Text
- View/download PDF
8. Verification and validation of analytical methods in accordance with the ISO/IEC 17025 standard
- Author
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Đukić Miloš, Vasiljević Sanela, Sovrlić Zorica, and Adamović Dragana
- Subjects
validation ,verification ,iso/iec 17025 ,Mining engineering. Metallurgy ,TN1-997 ,Mineral industries. Metal trade ,HD9506-9624 - Abstract
Validation of analytical methods ensures reliability and accuracy of analytical data. Accredited laboratories in accordance with the international standard ISO/IEC 17025, that is the Serbian standard SRPS ISO/IEC 17025, must fulfill and document the selection, validation, or verification of the analytical method. In the validation and verification process, it is mandatory to assess: limit of detection (LoD), limit of quantification (LoQ), linearity and measurement uncertainty.
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- 2023
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9. Uncertainty Calculation for the Determination of Chromium Oxide in Leather
- Author
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Tahira Ayaz, Muhammad Kashif Pervez, Rajkumar Dewanı, and Sarwat Mahboob
- Subjects
deri ,krom oksit ,belirsizlik ,kalite güvencesi ,iso/iec 17025 ,leather ,chromium oxide ,uncertainty ,quality assurance ,Architecture ,NA1-9428 ,Architectural drawing and design ,NA2695-2793 - Abstract
This work describes the uncertainty calculation for the determination of chromium oxide in leather. Following the various steps for the calculation of uncertainty which includes assembling a list of sources of uncertainty, with the help of basic formula used to calculate the measure and as all parameters cause an influence on the result because of the uncertainty value associated with it then the basic cause and effect diagram is made which shows the correlation between these and indicates their effect on the uncertainty of the result.All individual sources of uncertainty are evaluated by quantification. Mass, purity, and molecular mass of potassium dichromate are calculated against the volume of sodium thiosulphate following the first step in the test method is the standardization of sodium thiosulphate with the primary standard, potassium dichromate. So the overall uncertainty value depends on the uncertainties associated with the mass, purity, and molecular mass of potassium dichromate.
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- 2022
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10. 检测实验室与检验机构认可标准要求异同分析 --基于ISO/IEC 17025 与ISO/IEC 17020 标准比较.
- Author
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郭冉冉, 柳俏凡, 白庆华, 周永运, and 席 静
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TESTING laboratories ,INTERNATIONAL trade ,FAIRNESS ,ACCREDITATION ,AMBIGUITY - Abstract
Copyright of Experimental Technology & Management is the property of Experimental Technology & Management Editorial Office and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2023
- Full Text
- View/download PDF
11. Application of the FMEA Tool in an Accredited Testing Laboratory in the Context of the ISO/IEC 17025:2017 Standard.
- Author
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Blaško, Peter, Šolc, Marek, Petrík, Jozef, Girmanová, Lenka, and Blašková, Andrea
- Subjects
FAILURE mode & effects analysis ,ORGANIZATION management ,RISK management in business ,DECISION making ,INFORMATION retrieval - Abstract
Organizations and laboratories tend to integrate systems based on risk management. Risk management helps to optimize laboratory processes and information flow, increase valid and reliable results, and make better decisions. This paper describes the development and present trends in risk management related to standard ISO/IEC 17025. This paper focuses on risk assessment in the accredited testing laboratories using the FMEA tool. In the basic eight defined laboratory areas, risks were identified and evaluated, and methods were proposed to minimize them. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
12. Maturity Models for Testing and Calibration Laboratories: A Systematic Literature Review.
- Author
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Gerônimo, Bruna Maria and Lenzi, Giane Gonçalves
- Abstract
Currently, testing and calibration laboratories are undergoing organizational restructuring in view of technical and regulatory requirements. To assist these laboratories, maturity models (MMs) can be used for the implementation and maintenance of management systems. The use of fuzzy logic is often found in association with the construction of MMs. Fuzzy logic helps in the construction of these models, removing subjective elements from the maturity assessment. Therefore, the objective of this study was to perform a systematic literature review (SLR) using the Methodi Ordinatio focused on MMs built with fuzzy logic that aim to evaluate the degree of maturity of testing and calibration laboratories that have implemented ISO/IEC 17025 for their quality management systems (QMSs). This analysis was performed with articles published between 2012 and 2022 in several databases using keywords such as "maturity model", "fuzzy" and "ISO 17025" and resulted in 18 articles, which made up the bibliographic portfolio. After analyzing the content of these studies, it was possible to conclude that, although no study specifically discussed this MM, the discovered articles were important for presenting ideas and suggestions for future research. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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- View/download PDF
13. Assessment of uncertainty estimation for measurement of ethanol concentration in COVID-19 hand sanitizer using FTIR spectroscopy.
- Author
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Panya Khaenamkaew, Chailoek Tanghengjaroen, Dhonluck Manop, Worasit Palkawong Na Ayuthaya, Krirk Wongsorntam, and Narudom Noulkhow
- Subjects
- *
FOURIER transform infrared spectroscopy , *HAND sanitizers , *QUALITY control standards , *COVID-19 , *ABSORPTION spectra , *ETHANOL - Abstract
Analysis of uncertainty estimation for measurement of type and concentration of alcohol in hand sanitisers is a matter of urgency in the COVID-19 situation. FTIR spectroscopy was used to investigate hand sanitisers made in our laboratory and commercial products. An internal standard addition method was used to control the measurement quality. The absorption spectra of ethanol were found to be at 1086 and 1044 cm-1, corresponding to C-O stretching. The area under the C-O adsorptions is used to create a calibration curve, which is then used to calculate the ethanol percentage. Additional standard sample and quality control sample showed calibration curves with slopes of 0.1267 and 0.1285, respectively. The regression coefficients and residual variance of 0.0057 showed a 'best fit' with the predicted value. These parameters were used to estimate the uncertainty of six commercial products. The ethanol concentration of commercial products is measured between 71.38 and 81.54% v/v, with an estimated uncertainty of 1.14% v/v. The results showed that the ethanol content of all products differed from the label but could be used to kill bacteria and viruses. This entire process was established as a SOP for measuring alcohol concentration in hand sanitizer. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
14. Práticas de modelos de gestão de pessoas em laboratórios acreditados e sua influência sobre o número de não-conformidades na norma ABNT NBR ISO/IEC 17025.
- Author
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de Almeida Maia, Andreia Queiroz, Santos Fermam, Ricardo Kropf, and Barretto da Costa Felix, Rodrigo Pereira
- Subjects
- *
PERSONNEL management , *INSTITUTIONAL environment , *LABORATORY management , *SOCIAL impact , *TESTING laboratories , *TECHNOLOGICAL innovations - Abstract
The current scenario is of a permanent change in the organizational environment of companies due to increasingly fierce competition and technological innovation. The purpose of this research paper is to analyze the influence of selecting the people management model on the competence of accredited testing and calibration laboratories. Theoretical framework. People management is a topic of relevance for companies due to the changes in business and the intense technological development, which has given rise to a significant finding in organizations: people become the main competitive advantage in the organizational world. Design/methodology/approach. A questionnaire was developed to identify the adherence of laboratories to the People Management Models and their relationship with the number of non-conformities in item 6.2 (Personnel) according to the international standard ISO/IEC 17025(2017). The questionnaire was applied to the laboratory manager. Findings. The laboratories are at different levels of maturity for human behavior and personnel management. It is necessary to look beyond the requirements of the standard to remain in the market and to go toward new business challenges. Research, Practical & Social implications. The results are valid for laboratories attending to the requirements of ISO/IEC 17025(2017). Originality/value. Accredited laboratories need to look at their staff beyond the standard requirements. It is worth noting that skilled laboratory professionals foster new markets. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
15. ESTRATEGIA DEL GRUPO DE GESTION DE SERVICIOS CIENTIFICO- TECNICOS DEL CNIC PARA DAR CONFORMIDAD A LA NC- ISO/IEC 17025:2017.
- Author
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Luna Saucedo, Bárbara, Espinoza Llorens, Ma Carmen, López Torres, Matilde, Bataller Venta, Mayra, and León Hernández, Yadiana
- Subjects
- *
SOLID waste , *INFORMATION policy , *COMMUNICATION policy , *PRIVATE security services , *LABORATORY management - Abstract
The third edition of the ISO/IEC 17025 standard had significant changes with respect to its predecessor version, such as the approach and structure based on the process, the thought and action based on risk and the new requirement of impartiality and confidentiality, among others, no less important. The problem was how to deal with the transition to this third version of the standard and meet all its requirements. The mission of the DECA Scientific-Technical Services Management Group (GG SCTDECA), of the CNIC, is to provide specialized Scientific-Technical Services (SCT) for the characterization of water, wastewater and solid waste, the design and technical task of technological treatment solutions, as well as material protection services. All of them are covered by a management system in accordance with NC-ISO / IEC 17025 and accredited by the National Accreditation Body of the Republic of Cuba (ONARC). The objective of the work was the strategy to be followed in the Group to comply with the new requirements of ISO/IEC 17025. The procedure, descriptive and qualitative, took into account the main changes, taking as a guide a correlation between the second and third edition of the standard, which allowed, together with a documentary review, to define what needed to be done or improved. The necessary actions were defined to comply with the new requirements of the third edition and a plan was drawn up, establishing the deadlines for compliance and those responsible for executing them. Among other actions, an Impartiality Policy was developed and records of Confidentiality Commitments were established for internal and external personnel who can influence the Laboratory's activities. A procedure was implemented to address the Risks and Opportunities, the risks to impartiality were identified, a Policy for information and communication with the interested parties was defined, the Process Map and the Process Files were improved, the Profiles were adapted staff competence and training seminars were held. [ABSTRACT FROM AUTHOR]
- Published
- 2023
16. Technical and health governance aspects of the External Quality Assessment Scheme for the SARS-CoV-2 molecular tests: institutional experience performed in all clinical laboratories of a Regional Health Service.
- Author
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Di Gaudio, Francesca, Brunacci, Giuseppina, Contino, Flavia, Gallo, Alessia, and Centineo, Fabio
- Subjects
- *
SARS-CoV-2 , *TESTING laboratories , *REVERSE transcriptase polymerase chain reaction , *PATHOLOGICAL laboratories , *MEDICAL care , *COVID-19 testing - Abstract
Since December 2019, the worldwide public health has been threatened by a severe acute respiratory syndrome caused by Coronavirus-2. From the beginning, a turning point has been the identification of new cases of infection, in order to minimize the virus spreading among the population. For this reason, it was necessary introducing a panel of tests able to identify positive cases, which became crucial for all countries. As a Regional Reference Centre, the CRQ Laboratory (Regional Laboratory for the Quality Control) developed and conducted an External Quality Assessment (EQA) panel of assay, so as to evaluate the quality of real-time reverse transcription polymerase chain reaction (PCR), which were used by 62 Sicilian laboratories, previously authorized to issue certificates for the COVID-19 diagnosis, on behalf of the Public Health Service. The qualitative performance test was based on pooled samples with different viral loads of SARS-CoV-2 or human Coronavirus OC43. 75% of the participating laboratories tested all core samples correctly, while the remaining 25% interpreted incorrectly the EQA exercise samples matching negatively the standards required. Subsequent inspection visits confirmed the issue of incorrect positive and negative certifications for COVID-19 by private and public laboratories, despite the possession of the authorization requirements currently provided for by current regulations, with a significant impact on the SSR. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
17. Uncertainty Assessment in Temperature Uniformity Survey of Thermal Processing Equipment According to AMS2750 Aerospace Specification
- Author
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Carmen García-López and Germán Álvarez-Tey
- Subjects
uncertainty assessment ,temperature uniformity survey ,industrial thermal processing equipment ,AMS2750 ,ISO/IEC 17025 ,Motor vehicles. Aeronautics. Astronautics ,TL1-4050 - Abstract
Thermal processing equipment used in the aerospace industry must meet the requirements of the processes for which they are intended. The periodic tests performed by calibration laboratories, according to the AMS2750 specification, are intended to ensure compliance with these equipment requirements. While this specification does not explicitly state the need for uncertainty calculation, it does specify that pyrometry laboratories must have an ISO/IEC 17025 Quality System accredited by a recognized regional body which is a member of the International Laboratory Accreditation Cooperation (ILAC). Therefore, the calculation of uncertainties is necessary. This work presents a methodology for conducting temperature uniformity surveys and uncertainty assessment in these tests. This methodology has been applied to four different types of equipment to analyse, in each case, the contributions of uncertainties and to assess their potential for improvement. The objectives that laboratories should aim for include improving measurement accuracy and reducing uncertainty components in order to meet the criteria of both AMS2750 and ISO/IEC 17025.
- Published
- 2023
- Full Text
- View/download PDF
18. IMPLANTAÇÃO DA ABNT NBR ISO/IEC 17025: UMA ABORDAGEM POR GERENCIAMENTO DE PROJETOS.
- Author
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Tascheto Santos, Pedro Henrique, Pizzolato, Morgana, and Soliman, Marlon
- Subjects
CONSTRUCTION projects ,UNIVERSITIES & colleges ,PROJECT management ,TOTAL quality management ,TESTING laboratories ,COMPUTER software management - Abstract
Copyright of Exacta is the property of Exacta - Engenharia de Producao and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2022
- Full Text
- View/download PDF
19. Uncertainty Calculation for the Determination of Chromium Oxide in Leather.
- Author
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MAHBOOB, Sarwat Jahan, DEWANI, Rajkumar, PERVEZ, Muhammad Kashif, and AYAZ, Tahira
- Subjects
LEATHER ,CHROMIUM oxide ,MOLECULAR weights ,POTASSIUM dichromate ,QUALITY assurance ,UNCERTAINTY - Abstract
Copyright of Journal of Architectural Sciences & Applications (JASA) is the property of Journal of Architectural Sciences & Applications and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2022
- Full Text
- View/download PDF
20. Shewhart, CUSUM and EWMA Control Charts: A Comparative Study on Intermediate Check of Balances.
- Author
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Rosa Lakus, Diego, Pizzolato, Morgana, de Medeiros Albano, Filipe, and Langer Menin, Pâmela
- Abstract
The quality assurance of the measurement results generated by ISO/IEC 17025 testing and calibration laboratories is directly associated with monitoring the processes performed by their measuring instruments. This monitoring can be performed through the application of control charts, and, for this study, four electronic balances belonging to two different laboratories were chosen as the measuring instruments analyzed. The main goal of this research is to identify, among the cumulative summation (CUSUM) control charts, exponentially weighted moving average (EWMA) and Shewhart control charts, the most adequate to monitor the trends of these balances. It was necessary to define the periods of analysis of the data collected by the laboratories, to calculate the control limits of each chart (phase I), to carry out the monitoring of the process (phase II), followed by the comparison between the three types of control charts. The Minitab Statistical 17 software was used for the construction of these control charts. This study identified that the EWMA control chart is the best alternative to monitor trends at all points of the mid-check since it is the only one that can be used with both normal and non-normal data. However, it was not possible to identify which control chart detects the special causes earlier. [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
- View/download PDF
21. The conception and initial years of a quality management system based on ISO/IEC 17025: an action research
- Author
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de Jesus, Laura Neves, Penteado, Ricardo Batista, Malheiros, Fernando Costa, Medrano Castillo, Lucio Abimael, and de Almeida, Luís Fernando Magnanini
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- 2023
- Full Text
- View/download PDF
22. Improving Exposure Assessment Using Non-Targeted and Suspect Screening: The ISO/IEC 17025: 2017 Quality Standard as a Guideline
- Author
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Juliana Monteiro Bastos da Silva, Jade Chaker, Audrey Martail, Josino Costa Moreira, Arthur David, and Barbara Le Bot
- Subjects
non-targeted ,suspect screening ,quality management ,environmental health ,ISO/IEC 17025 ,high-resolution mass spectrometry ,Therapeutics. Pharmacology ,RM1-950 ,Toxicology. Poisons ,RA1190-1270 - Abstract
The recent advances of novel methodologies such as non-targeted and suspect screening based on high-resolution mass spectrometry (HRMS) have paved the way to a new paradigm for exposure assessment. These methodologies allow to profile simultaneously thousands of small unknown molecules present in environmental and biological samples, and therefore hold great promises in order to identify more efficiently hazardous contaminants potentially associated with increased risks of developing adverse health outcomes. In order to further explore the potential of these methodologies and push the transition from research applications towards regulatory purposes, robust harmonized quality standards have to be implemented. Here, we discuss the feasibility of using ISO/IEC 17025: 2017 as a guideline to implement non-targeted and suspect screening methodologies in laboratories, whether it is for accreditation purposes or not. More specifically, we identified and then discussed how specificities of non-targeted HRMS methodology can be accounted for in order to comply with the specific items of ISO/IEC 17025: 2017. We also discussed other specificities of HRMS methodologies (e.g., need for digital storage capacity) that are so far not included in the ISO/IEC 17025 requirements but should be considered. This works aims to fuel and expand the discussion in order to subsidize new opportunities of harmonization for non-targeted and suspect screening.
- Published
- 2021
- Full Text
- View/download PDF
23. Customer requirement or appropriate calibration method? Which is more important?
- Author
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Suelí Fischer Beckert
- Subjects
CMC ,Calibration ,ISO/IEC 17025 ,Accreditation ,Electric apparatus and materials. Electric circuits. Electric networks ,TK452-454.4 - Abstract
For accreditation of calibration laboratories, the standard reference is ISO/IEC 17025, which specifies the general requirements for competence, impartiality and consistent operation of laboratories. When analyzing various scopes of accreditation in different accreditation bodies, there was a significant variation in the Calibration and Measurement Capabilities (CMC) declaration for the same type of equipment. This article presents a critical analysis of factors that may have generated this variation. And consider the need to prioritize the adequacy of calibration methods to metrological characteristics of the equipment, in order to have less variation in the presentation of accreditation scopes.
- Published
- 2021
- Full Text
- View/download PDF
24. Technical and health governance aspects of the external quality assessment system for classical and new psychoactive substances analysis testing in blood.
- Author
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Di Gaudio, Francesca, Giaccone, Vita, Cucina, Annamaria, Indelicato, Sergio, Raso, Maria, Brunacci, Giuseppina, Lundari, Anna, Rotolo, Maria Concetta, Busardò, Francesco, and La Rocca, Mario
- Subjects
- *
BLOOD testing , *SYNTHETIC marijuana , *DRUG control , *PHARMACEUTICAL policy , *DRUG abuse , *BIOMOLECULES - Abstract
New psychoactive substances (NPS) are uncontrolled analogues of existing drugs or newly synthesized chemicals that exhibit psychopharmacological effects. Due to their diverse nature, composition, and increasing prevalence, they present significant challenges to the healthcare system and drug control policies. In response, healthcare system laboratories have developed analytical methods to detect NPS in biological samples. As a Regional Reference Centre, the Sicilian CRQ Laboratory (Regional Laboratory for Quality Control) developed and conducted an External Quality Assessment (EQA) study to assess, in collaboration with the Istituto Superiore di Sanità (ISS), the ability of different Italian laboratories to identify NPS and traditional drugs of abuse (DOA) in biological matrices. Two blood samples were spiked with substances from various drug classes, including synthetic cannabinoids, cathinones, synthetic opiates, and benzodiazepines, at concentrations ranging from 2 to 10 ng/mL. The blood samples were freeze-dried to ensure the stability of DOA and NPS. Twenty-two laboratories from the Italian healthcare system participated in this assessment. The information provided by the laboratories during the registration in an in-house platform included a general description of the laboratory, analytical technique, and the chosen panels of analytes. The same platform was employed to collect and statistically analyze the data and record laboratory feedback and comments. The evaluation of the results revealed that the participating laboratories employed three different techniques for analyzing the samples: GC-MS, LC-MS, and immunoenzymatic methods. Approximately 90 % of the laboratories utilized LC-MS techniques. Around 40 % of false negative results were obtained, with the worst results in the identification of 5-chloro AB PINACA. The results showed that laboratories that used LC-MS methods obtained better specificity and sensitivity compared to the laboratories using other techniques. The results obtained from this first assessment underscore the importance of external quality control schemes in identifying the most effective analytical techniques for detecting trace molecules in biological matrices. Since the judicial authorities have not yet established cut-off values for NPS, this EQA will enable participating laboratories to share their analytical methods and expertise, aiming to establish common criteria for NPS identification. • NPS pose challengesto healthcare and drug control policies due to their diverse nature and increasing prevalence. • EQA study to evaluate the identification NPS and traditional drugs of abuse in biological matrices in Italian laboratories. • GC-MS, LC-MS, and immunoenzymatic methodswere reported, with LC-MS showing higher specificity and sensitivity. • The absence of cut-off values for NPS emphasizes the need to establish common criteria for their identification. [ABSTRACT FROM AUTHOR]
- Published
- 2024
- Full Text
- View/download PDF
25. Obtaining laboratory accreditation – required activities
- Author
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Macchi Silva, Vítor Vasata and Ribeiro, José Luis Duarte
- Published
- 2019
- Full Text
- View/download PDF
26. Significance of Accreditation of Forensic Science Laboratories in India
- Author
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Jog, Madhavi and Pandey, Astha
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- 2019
- Full Text
- View/download PDF
27. Improving Exposure Assessment Using Non-Targeted and Suspect Screening: The ISO/IEC 17025: 2017 Quality Standard as a Guideline.
- Author
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Monteiro Bastos da Silva, Juliana, Chaker, Jade, Martail, Audrey, Costa Moreira, Josino, David, Arthur, and Le Bot, Barbara
- Subjects
QUALITY standards ,MASS spectrometry ,ENVIRONMENTAL sampling ,SMALL molecules ,ENVIRONMENTAL risk ,ENVIRONMENTAL health - Abstract
The recent advances of novel methodologies such as non-targeted and suspect screening based on high-resolution mass spectrometry (HRMS) have paved the way to a new paradigm for exposure assessment. These methodologies allow to profile simultaneously thousands of small unknown molecules present in environmental and biological samples, and therefore hold great promises in order to identify more efficiently hazardous contaminants potentially associated with increased risks of developing adverse health outcomes. In order to further explore the potential of these methodologies and push the transition from research applications towards regulatory purposes, robust harmonized quality standards have to be implemented. Here, we discuss the feasibility of using ISO/IEC 17025: 2017 as a guideline to implement non-targeted and suspect screening methodologies in laboratories, whether it is for accreditation purposes or not. More specifically, we identified and then discussed how specificities of non-targeted HRMS methodology can be accounted for in order to comply with the specific items of ISO/IEC 17025: 2017. We also discussed other specificities of HRMS methodologies (e.g., need for digital storage capacity) that are so far not included in the ISO/IEC 17025 requirements but should be considered. This works aims to fuel and expand the discussion in order to subsidize new opportunities of harmonization for non-targeted and suspect screening. [ABSTRACT FROM AUTHOR]
- Published
- 2021
- Full Text
- View/download PDF
28. COMPETENCIA TÉCNICA EN LABORATORIOS DE ENSAYOS ANALÍTICOS. EXPERIENCIAS DE LA UNIDAD DE GESTIÓN DE LOS SERVICIOS CIENTÍFICOTÉCNICOS DECA.
- Author
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Espinosa Lloréns, Ma. del Carmen, López Torres, Matilde, Luna Saucedo, Bárbara, and León Hernández, Yadiana
- Subjects
- *
TESTING laboratories , *TESTING laboratory accreditation , *QUALITY control , *CUSTOMER satisfaction , *RESEARCH - Abstract
A laboratory must produce analytical data of sufficient precision and reliability within an acceptable time frame and at an allowable cost. For laboratories accredited by the 17025 standard, this objective becomes even more important, being the participation in Proficiency Testing (PT), as external quality control, the superior way of demonstrating their technical competence. DECA (formerly the Department of Studies on Environmental Pollution, today the Scientific-Technical Services Management Unit DECA), belonging to the National Center for Scientific Research in Cuba, with a long tradition of work in the field of the environment (including the characterization of water, wastewater and solid waste), achieved its first accreditation by the National Accreditation Body of the Republic of Cuba (ONARC, acronym in Spanish) in 2001 and has maintained a regular participation in PT. The objective of this work is to demonstrate the technical competence of the Unit of Management of Scientific-Technical Services (UG SCT-DECA, acronym in Spanish) in the analytical services it provides, through the results it has obtained from its continued participation in PT. Taking into account the PTs (national and international) in the period 2008-2019, different indicators were used to measure their performance, as well as graphic tools that allowed to visualize the behavior over time. The evidence demonstrates the technical competence maintained by DECA's analytical services, strengthening the quality and reliability of the results it brings to its clients, which has allowed the faithfulness of a considerable number of them. [ABSTRACT FROM AUTHOR]
- Published
- 2020
29. Integrating quality function deployment and failure mode and effect analysis in subcontractor selection.
- Author
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Putra, Novreza Utama and Wang, Fu-Kwun
- Subjects
FAILURE mode & effects analysis ,QUALITY function deployment - Abstract
Evaluating subcontractor competence in ISO/IEC 17025 standard is usually based on the readiness of equipment and manpower (RoEM) of laboratory involved in production activities. However, the risk of failure factors including the process of receiving samples, testing process and reporting test results to the customer have to be included. In this study, we present an integrating quality function deployment and failure mode and effect analysis in subcontractor selection for ISO/IEC 17025 standard. The ranking of all subcontractors is based on the different weights of the RoEM and the risk priority number. A case study with three scenarios is used to illustrate the applicability of the proposed method. [ABSTRACT FROM AUTHOR]
- Published
- 2020
- Full Text
- View/download PDF
30. ISO 9001 and ISO/IEC 17025 : Which is the best option for a laboratory of metrology? The Portuguese experience
- Author
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Barradas, José and Sampaio, Paulo
- Published
- 2017
- Full Text
- View/download PDF
31. Lower frequency of certain nonconformities against ISO/IEC 17025 after many year accreditation
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Suthon Vongsheree, Soavanee Aromsuk, Piyawan Chainarongkuekul, and Awiruth Kejonnit
- Subjects
Nonconformities ,ISO/IEC 17025 ,accreditation cycles ,difference in nonconformities ,Medicine - Abstract
Background: It is predictable that the laboratories with many years of accreditation should get lower amount of nonconformities than those of the new ones. The objectives of the study are to find the differences in characteristics and nonconformities among ISO/IEC 17025 accredited laboratories undergoing on-site assessment in 2015 and verify the above prediction. Materials and methods: A cross-sectional study of the characteristics and the nonconformities from 2015 assessment of 134 laboratories were compared between the laboratories with 6 or more years or at least 3 cycles of accreditation and the ones with shorter accreditation year. Statistical analyses were done by using Stata-intercooled version 6. Results: There were 1,459 total nonconformities, 572 (39%) were those against management requirements and 887 (61%) were those from technical ones. Longer and new accredited laboratories shared similar basic characteristics. Longer accredited laboratories got lower total nonconformities (mean±SD; 9.1±4.8 vs 12.7±9.0: t-test=2.89, p=0.003), and lower technical nonconformities (mean±SD; 5.0±3.1 vs 8.3±6.9: t-test=3.57, p
- Published
- 2018
32. Perancangan Sistem Manajemen Mutu Terintegrasi di Baristand Industri Padang
- Author
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Yudo Purnomo, Nilda Tri Putri, and Elita Amrina
- Subjects
Sistem Manajemen Mutu ,ISO 9001 ,ISO/IEC 17025 ,ISO/IEC 17065 ,KNAPPP 02 ,Industry ,HD2321-4730.9 - Abstract
Baristand Industri Padang is an agency under control Ministry of Industry of Indonesia which it has a duty to serve the industries involving research activities, standardization and certification. To realize the programs, Baristand Industri Padang implemented a quality management system including ISO 9001, ISO/IEC 17025, ISO/IEC 17065, and KNAPPP 02. Nevertheless, it has been running separately. Therefore, quality of products not only proven by testing the final product, but also needed other evidence as a certificate that ensuring the quality of products. This research aims to design the Quality Management System for Baristand Industri Padang which it was implemented using life cycle methodology. Finding of this study revealed there was integration of ISO 9001, ISO/IEC 17025, ISO/IEC 17065, and KNAPPP 02 in the context of the structure of the process, documents, and organization. In the context of the structure of processes, it obtained four groups of primary process involving management, research and standardization, support, and improvement. Moreover, In terms of documentation, there was three levels of the document such as the document of strategic policy, quality guideline and procedures. While aspects of the organizational structure, the integration of quality management system required to develop the organizational structure that consist of Top Management, Technical Manager, Quality/Management Representative, Researcher and Administrative/Technical Staff. In addition, this study provided an integrated quality management information system including management of quality documents and quality records. Finally, the integrated quality management system and quality management information system has been designed to meet the expectations of the organization.
- Published
- 2017
- Full Text
- View/download PDF
33. A proposal of model for a quality management system in research testing laboratories
- Author
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Martínez-Perales, Silvia, Ortiz-Marcos, Isabel, and Ruiz, Jesús Juan
- Published
- 2021
- Full Text
- View/download PDF
34. System proposal for implementation of risk management in the context of ISO/IEC 17025
- Author
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da Silva, Fabiane Rodrigues, Grochau, Inês Hexsel, and Veit, Hugo Marcelo
- Published
- 2021
- Full Text
- View/download PDF
35. Analysis Implementation Effectiveness of ISO/IEC 17025 on Testing Laboratory.
- Author
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Sari, Irma Permata and Nurcahyo, Rahmat
- Subjects
TOTAL quality management ,LABORATORIES ,CUSTOMER satisfaction ,ACCREDITATION ,JOB satisfaction - Abstract
In improving the quality management system, the testing laboratory uses the ISO / IEC 17025 standard as a benchmark for the general requirements of testing / calibration competence, including sampling. This standard is also used for quality, administrative and technical activities. Customer laboratories, regulators and accreditation bodies may also use them to confirm or acknowledge the competence of the laboratory. The application of standards in laboratory testing is closely related to achieving the quality objectives contained in the laboratory. By using the standard ISO / IEC 17025 then the resulting product is guaranteed security, reliable and certainly has a quality that no doubt. Testing laboratory can be said to run effectively when it can manage or manage flexibility, customer, production, value-oriented, and the main job of its employees. Therefore, the analysis of the effectiveness of ISO / IEC 17025 implementation takes an important role for the testing laboratory. The Focus Group Discussion (FGD) method consisting of several competent assessors is instrumental in assessing any clauses related to the effectiveness of ISO implementation. [ABSTRACT FROM AUTHOR]
- Published
- 2018
36. Analytical method validation of GC-FID for the simultaneous measurement of hydrocarbons (C2-C4) in their gas mixture
- Author
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Oman Zuas, Harry budiman, and Muhammad Rizky Mulyana
- Subjects
method validation ,hydrocarbons ,GC-FID ,ISO/IEC 17025 ,Chemistry ,QD1-999 - Abstract
An accurate gas chromatography coupled to a flame ionization detector (GC-FID) method was validated for the simultaneous analysis of light hydrocarbons (C2-C4) in their gas mixture. The validation parameters were evaluated based on the ISO/IEC 17025 definition including method selectivity, repeatability, accuracy, linearity, limit of detection (LOD), limit of quantitation (LOQ), and ruggedness. Under the optimum analytical conditions, the analysis of gas mixture revealed that each target component was well-separated with high selectivity property. The method was also found to be precise and accurate. The method linearity was found to be high with good correlation coefficient values (R2 ≥ 0.999) for all target components. It can be concluded that the GC-FID developed method is reliable and suitable for determination of light C2-C4 hydrocarbons (including ethylene, propane, propylene, isobutane, and n-butane) in their gas mixture. The validated method has successfully been applied to the estimation of hydrocarbons light C2-C4 hydrocarbons in natural gas samples, showing high performance repeatability with relative standard deviation (RSD) less than 1.0% and good selectivity with no interference from other possible components could be observed.
- Published
- 2016
- Full Text
- View/download PDF
37. Trends in developments of certified reference materials for chemical analysis - Focus on food, water, soil, and sediment matrices.
- Author
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Olivares, I.R.B., Souza, G.B., Nogueira, A.R.A., Toledo, G.T.K., and Marcki, D.C.
- Subjects
- *
ANALYTICAL chemistry , *FOOD chemistry , *WATER analysis , *SOIL sampling , *SEDIMENTS , *QUALITY control - Abstract
The growing demand for traceable and reliable results in analytical chemistry can be illustrated with the growth in ISO/IEC 17025 accreditation. Among different technical requirements in this quality system, the use of CRMs is highlighted because of its applications in many operations, such as method validation, proficiency tests, estimation of the uncertainties and quality control. Over the past several years, there has been an increased need to use different types of CRMs in chemical analysis, new CRM publications about its developments and certification. This paper proposes to show a detailed review considering the development of certified reference materials (CRM) for chemical analysis, focusing on food, water, soil and sediment matrices. An evaluation of the trends and best-applied practices in its development in the last 2 years was performed, to guide new developments for this material that is increasingly necessary to laboratories. [ABSTRACT FROM AUTHOR]
- Published
- 2018
- Full Text
- View/download PDF
38. Cross-validation of standardisation techniques at ANSTO using cobalt-60 and learnings from the presence and identification of non-gamma-ray emitting impurities.
- Author
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van Wyngaardt, W.M., Bowan, A.H.H., Clark, E.L., Keevers, C.M.B., Smith, M.L., Zarifi, M., and Stopic, A.
- Subjects
- *
LIQUID scintillation counting , *EXTRAPOLATION , *COINCIDENCE - Abstract
To fulfil the technical requirements for accreditation to ISO/IEC 17025, the end-to-end validation of all processes associated with standardising 60Co, including gravimetric source dispensing, primary standardisation by the 4π(LS)β-γ coincidence and live-timed anti-coincidence extrapolation techniques, and impurity determination were performed and documented. Pure-beta-emitting impurities in a 60Co stock solution were identified. The impact of such impurities on measurement by liquid scintillation counting and comparison in the ESIR are discussed. A fresh 60Co source was produced, standardised, and compared using the SIR. • Progress towards ISO/IEC 17025 accreditation. • Cobalt-60 produced by neutron activation of pure cobalt metal in OPAL reactor. • 4π(LS)β-γ live-timed anti-coincidence extrapolation technique validated. • Pure-beta impurities (14C and 99Tc) in 60Co solution identified and quantified. • Impact of pure beta impurities on ESIR demonstrated and discussed. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
39. Quality Management System at NPLI: Transition of ISO/IEC 17025 From 2005 to 2017 and Implementation of ISO 17034: 2016
- Author
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Goutam Mandal, Muhammad Afnan Ansari, and Dinesh K. Aswal
- Subjects
Review Paper ,ISO/IEC 17025: 2017 ,Physics and Astronomy (miscellaneous) ,Computer science ,NMI ,media_common.quotation_subject ,International standard ,Quality system ,ISO/IEC 17025 ,Manufacturing engineering ,Metrology ,Units of measurement ,Quality management system ,ISO 17034: 2016 ,Physical laboratory ,Metre convention ,Calibration ,Quality (business) ,CIPM MRA ,media_common - Abstract
ISO/IEC 17025 is the single most popular and well adopted international standard which is applicable for any testing and calibration laboratories irrespective of size of the laboratories. Similarly, ISO 17034 is also very important international standard for development/production of reference materials (RMs) by competent producers. CSIR-National Physical Laboratory of India (NPLI) was one of the 38 National Metrology Institutes (NMIs) those who signed International Committee for Weights and Measures Mutual Recognition Arrangement (CIPM MRA) during 21st General Conference on Weights and Measures (CGPM) meeting in Paris, France on 14th October, 1999. NPLI has been maintaining quality system based on ISO/IEC 17025 for more than two decades to fulfil the requirements of CIPM MRA. NPLI has participated in 130 international inter-comparisons so far; some of them were also piloted by NPLI. NPLI has also undergone International Peer Reviews through Asia Pacific Metrology Programme (APMP) to register 236 Calibration and Measurement Capabilities (CMCs) on various parameters in International Bureau of Weights and Measures Key Comparison Database (BIPM KCDB). However, NPLI for the first time implemented uniform quality system based on ISO 17034 in 2020. In this direction, NPLI for the first time prepared integrated Quality Manual to make policies, objectives and procedures addressing all the requirements of both the standards. Presently, 28 Sub-Divisions of NPLI follow quality system. Some of the Sub-Divisions are involved only in calibration/testing activities maintain only ISO/IEC 17025: 2017. Similarly, some of the Sub-Divisions are involved only in development/production of RMs/certified reference materials (CRMs) (Bharatiya Nirdeshak Dravya, BND®–Indian Reference Material) maintain only ISO 17034. On the other hand, few Sub-Divisions are involved both in calibration/testing as well as BND activities and accordingly follow both the standards. It is an extraordinary challenge for implementation and monitoring of quality system in such a big organization like NPLI. In this article, authors have highlighted preparation process of integrated quality manual based on ISO/IEC 17025: 2017 and ISO 17034: 2016 including policies, objectives & procedures adopted and its implementation process at NPLI. In November, 2020, NPLI has undergone on-site peer review of quality system of 23 Sub-Divisions through APMP.
- Published
- 2021
- Full Text
- View/download PDF
40. Quality Assurance for In Situ Uranium Concentration Measurements of Aqueous Samples from Mineral Processing Studies Using a Portable XRF Analyser in Compliance with ISO/IEC 17025 Requirements
- Author
-
Ahmad Abukashabeh and Rachael Abu-Halimeh
- Subjects
Aqueous solution ,business.industry ,Metallurgy ,Analyser ,chemistry.chemical_element ,Geology ,Uranium ,ISO/IEC 17025 ,chemistry ,Geochemistry and Petrology ,Inductively coupled plasma atomic emission spectroscopy ,Environmental science ,business ,Quality assurance ,Inductively coupled plasma mass spectrometry ,Mineral processing - Published
- 2021
- Full Text
- View/download PDF
41. Experience in establishing a quality management system at a plant diagnostic laboratory in Fiji
- Author
-
Murugan, S., Anderson, D., Gunawardana, D., Gosai, R., Kumarasinghe, L., and Kumwenda, H.
- Published
- 2020
- Full Text
- View/download PDF
42. Monitoring of purity and stability of CRMs of multiclass pesticides during prolonged storage before and after expiration
- Author
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Sharma, Krishan Kumar, Tripathy, Vandana, Gautam, Rahul, Gupta, Ruchi, Tayade, Amol, Sharma, Khushbu, Yadav, Rajbir, Shukla, Poonam, Devi, Suneeta, Pandey, Priya, Singh, Gitansh, Kalra, Shobhita, and Walia, Suresh
- Published
- 2020
- Full Text
- View/download PDF
43. Kalibrierung in der Werkstofftechnik als Mittel zur Qualitätssicherung.
- Author
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Gerber, S. and Ellermeier, J.
- Abstract
Translation abstract: In order to achieve trusted results calibration of material testing machines is the required. The results have to be traceable to national standards. According to the state of technology this is mostly done by accredited labs. The uncertainty of measurements is calculated and taken into consideration. The corresponding procedure is demonstrated on the basis of the calibration of material testing machines ‐ taking the uncertainty into account without worsening of the class of the machine – and in consideration of ISO/IEC 17025. This can be verified on closer examination of the results of calibration for one machine over the last 60 years. [ABSTRACT FROM AUTHOR]
- Published
- 2018
- Full Text
- View/download PDF
44. Effectiveness of the Management System in Accredited Laboratory as a Tool to Enhance Competitiveness
- Author
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Wierzowiecka Joanna
- Subjects
accredited laboratory ,iso/iec 17025 ,quality management system ,effectiveness of the management system ,Management. Industrial management ,HD28-70 ,Business ,HF5001-6182 - Abstract
The situation on the market of laboratory services in Poland is growing rapidly. In order to stay in this difficult market, one shall convince potential customers to his/her competences and quality of services. Testing or calibration laboratories, wishing to assert its position in the market, introduce the management system based on the PN-EN ISO/IEC 17025:2005 standard, the so-called ‘General requirements for the competence of testing and calibration laboratories’, and then apply for the certificate of accreditation in the Polish Centre for Accreditation (PCA) [14].
- Published
- 2013
- Full Text
- View/download PDF
45. Improving Exposure Assessment Using Non-Targeted and Suspect Screening: The ISO/IEC 17025: 2017 Quality Standard as a Guideline
- Author
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Audrey Martail, Barbara Le Bot, Arthur David, Jade Chaker, Josino Costa Moreira, Juliana Monteiro Bastos da Silva, Chard-Hutchinson, Xavier, Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Fundação Oswaldo Cruz (FIOCRUZ), Réseau International des Instituts Pasteur (RIIP), École des Hautes Études en Santé Publique [EHESP] (EHESP), Laboratoire d'étude et de recherche en environnement et santé (LERES), Département Santé Environnement Travail et Génie Sanitaire (DSETGS), Université d'Angers (UA)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), and Fundação Oswaldo Cruz / Oswaldo Cruz Foundation (FIOCRUZ)
- Subjects
Hgh-resolution mass spectrometry ,Quality management ,Computer science ,media_common.quotation_subject ,[SDV]Life Sciences [q-bio] ,environmental health ,Harmonization ,RM1-950 ,Toxicology ,01 natural sciences ,suspect screening ,03 medical and health sciences ,RA1190-1270 ,quality standard ,Quality (business) ,high-resolution mass spectrometry ,030304 developmental biology ,Accreditation ,media_common ,Exposure assessment ,Pharmacology ,0303 health sciences ,ISO/IEC 17025 ,010401 analytical chemistry ,Guideline ,Pollution ,0104 chemical sciences ,[SDV] Life Sciences [q-bio] ,Exposome ,Risk analysis (engineering) ,Toxicology. Poisons ,Perspective ,non-targeted ,Therapeutics. Pharmacology ,Suspect ,quality management - Abstract
International audience; The recent advances of novel methodologies such as non-targeted and suspect screening based on high-resolution mass spectrometry (HRMS) have paved the way to a new paradigm for exposure assessment. These methodologies allow to profile simultaneously thousands of small unknown molecules present in environmental and biological samples, and therefore hold great promises in order to identify more efficiently hazardous contaminants potentially associated with increased risks of developing adverse health outcomes. In order to further explore the potential of these methodologies and push the transition from research applications towards regulatory purposes, robust harmonized quality standards have to be implemented. Here, we discuss the feasibility of using ISO/IEC 17025: 2017 as a guideline to implement non-targeted and suspect screening methodologies in laboratories, whether it is for accreditation purposes or not. More specifically, we identified and then discussed how specificities of non-targeted HRMS methodology can be accounted for in order to comply with the specific items of ISO/IEC 17025: 2017. We also discussed other specificities of HRMS methodologies (e.g., need for digital storage capacity) that are so far not included in the ISO/IEC 17025 requirements but should be considered. This works aims to fuel and expand the discussion in order to subsidize new opportunities of harmonization for non-targeted and suspect screening.
- Published
- 2021
- Full Text
- View/download PDF
46. Inadequacy of Mathematical Models of Measurement Objects and Calculations of Risk Based On the Use of Gost ISO/IEC 17025–2019
- Author
-
S. F. Levin
- Subjects
Mathematical model ,Computer science ,Applied Mathematics ,Probabilistic logic ,Measurement uncertainty ,Audit risk ,Risk assessment ,Instrumentation ,Competence (human resources) ,ISO/IEC 17025 ,Metrology ,Reliability engineering - Abstract
The problem of inadequacy of mathematical models of measurement objects in connection with the problem of “definitional uncertainty of measurements” and with the need to control risks in accordance with GOST ISO/IEC 17025–2019, General Requirements for the Competence of Testing and Calibration Laboratories, is considered. The history of the problem from the development of the moment approach and the compositional approach through assessment of precision to the introduction of the specialized term, error of inadequacy of a mathematical model of a measurement object, is described. The negative influence of the hopelessness of conceptual and terminological transformations in metrology and the critical contradiction of assessments of the applicability of the statistical methods presented in GOST R ISO/IEC 31010–2011, Management of Risk. Methods of Risk Assessment, and in the Guide to the Expression of Measurement Uncertainty are noted. It is shown that taking into account the inadequacy of probabilistic models in calculations of risk is a necessary condition for assuring the reliability of the results of measurements.
- Published
- 2020
- Full Text
- View/download PDF
47. Model to Measure the Readiness of University Testing Laboratories to Fulfill ISO/IEC 17025 Requirements (A Case Study)
- Author
-
Era Febriana Aqidawati, Wahyudi Sutopo, and Roni Zakaria
- Subjects
assessment framework ,innovation ,ISO/IEC 17025 ,readiness level ,university testing laboratories ,Management. Industrial management ,HD28-70 ,Business ,HF5001-6182 - Abstract
Universities are considered as a source of open innovations by producing new technology. The innovations need to be tested in licensed laboratories in order to create certified products if they are to be commercialized to the market. Many universities have established laboratories that provide testing services to society and act as a revenue-generating source. Universitas Sebelas Maret (UNS) owns an accredited center laboratory that provides testing services to external parties. In addition, the university owns other laboratories in several faculties to conduct academic activities and research and yet provide testing services, but have not been accredited. Therefore, the laboratories have the potential to be developed as part of the testing service business to support the incubation process of new technology and provide testing services. In this article, we chose UNS, one of the universities in Indonesia, to develop a framework of readiness level measurement instrument, to evaluate the readiness and to suggest improvements for laboratories to achieve accreditation. A framework of laboratory readiness measurement was developed using integration of management approach and laboratory approach. Descriptive statistics were used to create a radar chart to determine the readiness level. Based on findings and evidence analysis, we proposed improvement planning using ISO 17025 and management concept.
- Published
- 2019
- Full Text
- View/download PDF
48. Indoor noise measurements evaluations for HVAC-Unit using inter-laboratory comparisons
- Author
-
Seddeq H. S. and Medhat A. Fahim A.A.
- Subjects
indoor sound measurements ,noise level in dba ,air-conditioning unitary unit ,proficiency testing ,uncertainty ,iso/iec 17025 ,astm 1574 ,Technology - Abstract
The international standard, ISO/IEC 17025 was developed to determine technical competence and to evaluate laboratories throughout the world. Accreditation bodies playing a vital role are increasingly using proficiency testing methodology as a tool to ensure the credibility of their accreditation programs. The successful completion of a well-designed proficiency test can validate the measurement method and uncertainty budgets of a testing laboratory. Additionally, proficiency tests can provide a good indication about the quality of the test results. An important part of inter-laboratory comparisons and proficiency testing is the determination of the associated error analyses which are focused on uncertainty values. This paper presents the implementation of proficiency tests using inter-laboratory methodology among five different acoustic laboratories. These tests were carried out on 5.27 KWCooling standard unitary air conditioner, A/C, such as through-wall or split room standard A/C units, for the assessment of Housing & Building National Centre acoustic laboratory. Analyses of results show a good agreement for En-Value among the selected laboratories when compared with the lowest uncertainty as stated by proficiency tests standards.
- Published
- 2011
- Full Text
- View/download PDF
49. Generic System for Remote Testing and Calibration of Measuring Instruments: Security Architecture
- Author
-
Jurčević M., Hegeduš H., and Golub M.
- Subjects
internet-enabled testing and calibration ,travelling standard ,hardware security module (hsm) ,iso/iec 17025 ,Mathematics ,QA1-939 - Published
- 2010
- Full Text
- View/download PDF
50. ISO/IEC 17025: custos de acreditação em uma universidade pública brasileira.
- Author
-
Bender, Rodrigo S., Pizzolato, Morgana, and Albano, Filipe
- Abstract
Copyright of Exacta is the property of Exacta - Engenharia de Producao and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2017
- Full Text
- View/download PDF
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