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This study assesses the compliance of a university research laboratory with the ISO/IEC 17025: 2017 standard, focusing on ensuring technical competence and the integrity of analytical results. An analytical approach was employed using a standard checklist to identify gaps and establish a corrective action plan. The evaluation revealed significant deficiencies in the laboratory's structural, resource, and process requirements, resulting in an overall satisfaction rate of only 15%. This percentage reflects the proportion of conformity criteria met by the laboratory in relation to the standard's requirements. These findings underscore the critical need for improvements in the laboratory's quality management system to enhance the reliability and credibility of its research outputs. The study also emphasizes the importance of implementing robust quality control measures and continuous staff training to meet international standards, thus positioning the laboratory to achieve full ISO/IEC 17025 compliance in the future. [ABSTRACT FROM AUTHOR]

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]

The challenges in estimating measurement uncertainty in the complex matrix of biological systems, while doing compliance testing by National Control Laboratories and its importance in meeting ISO/IEC 17025 requirements are emphasised. Two primary approaches for MU, the bottom-up and top-down approaches, are discussed. Highlighting the significance of accurate estimations in NCLs, it advocates the use of a top-down approach by leveraging available quality control data and control charts for precision and bias assessment and balancing regulatory compliance to ensure the product quality and its timely release into the market, while complying with accreditation standards. [ABSTRACT FROM AUTHOR]

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]

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.

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]

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.

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.

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.

This work presents research focused on obtaining and maintaining the ISO/IEC 17025 recognition in a Brazilian environmental analysis laboratory that acts as an environmental consultancy, providing services for the biological treatment of effluents. Three research cycles were conducted, covering the recognition preparation, surveillance period, and first reassessment preparation. The importance of considering both the technical and managerial aspects of this process is highlighted. In addition, it is fundamental to involve all employees in the process and reinforce the value of audits as an instrument for evaluating and improving the entire system. Despite the importance of the consultancy contracted to assist in the design of the management system, only with its effective use was it possible to improve the laboratory's needs. Thus, the contribution of all collaborators to this process is fundamental. Despite the importance of "metrological networks" for encouraging a quality culture and accreditation in Brazil, greater rigor may be needed regarding the demand for systematic evidence of sustainable compliance and maturity of the management system. The recognition and accreditation challenges are the first, as the need to review and improve the Quality Management System is recurrent, whether due to the greater maturity of the laboratory or the identification of new opportunities. [ABSTRACT FROM AUTHOR]

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.)

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]

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]

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]

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]

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]

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]

In the latest revision of the ISO/IEC 17025 standard, General requirements for the competence of testing and calibration laboratories, published in 2017, the concept of risk-based thinking was introduced in its requirements. Although the new version introduces the concept, procedures to be adopted for the implementation of risk management in testing and calibration laboratories are not addressed. The article is conceptual in nature and summarizes information from the literature to assess the application of reputable risk management models and implement them in laboratories. Furthermore, it includes discussions on the implementation of risk management in the daily laboratory operations in a practical and effective way as per the requirements of ISO/IEC 17025. [ABSTRACT FROM AUTHOR]

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.

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.)

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.)

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]

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.

Many higher education institutions in the world have testing laboratories linked, or not, to their teaching and/or research programs. However, only a small proportion of these laboratories have accreditation in accordance with the ISO/IEC 17025 standard. The ISO/IEC 17025 establishes the management and technical requirements necessary for the implementation and maintenance of a quality management system (QMS) in laboratories that perform testing, calibration and/or sampling activities, being used by them to demonstrate their competence in carrying out their activities. One of the requirements of the current version of the standard is the need to carry out risk management (RM), introduced with the demand for risk-based thinking. The objective of this research was to propose a system for the implementation of RM in laboratories, through mapping, identification, classification, critical analysis, and treatment of risks. The research considered the history of actions taken, the risks verified by the laboratory team, the evaluation of their impacts and the probabilities of their occurrence, their classification and the identification of actions necessary to accept, mitigate or eliminate these risks. The system proposed was applied in a testing laboratory at a university in southern Brazil, enabling the maintenance of its accreditation. [ABSTRACT FROM AUTHOR]

This report summarizes the authors' experience with the implementation of a quality management system according to the ISO/IEC 17025 standard for the purpose of accrediting the testing laboratories at the research centre of the University of Warsaw. Accreditation of these laboratories was an extremely complex process because of the specific conditions prevailing in university facilities. Nevertheless, the successfully completed process of accreditation has many benefits, which we would like to share. Beyond the initial motivation being one of the project indicators of the established research centre, important are improvement of laboratory organisation, implementation of quality concepts and culture over various activity of the university as well as the strengthening of credibility of the measurement service. Operating accredited laboratories within the university becomes also a great chance to strengthen students' competences by including the knowledge and experience on quality system within an academic curriculum, enriching the competence of students before they would enter the job market. [ABSTRACT FROM AUTHOR]

There is a broad consensus on the importance and advisability of testing laboratories adopting a Quality Management System (QMS) to support their work, no matter they are industrial or research oriented. However, laboratories involved in R&D have specific difficulties to implement a QMS due to the peculiar nature of their activity. This paper analyzes the main challenges and difficulties found by professionals when implementing a QMS in a research testing laboratory, based on the literature review and a questionnaire with 86 laboratories participating performed in collaboration with RedLab (Red de Laboratorios de la Comunidad de Madrid). After this analysis, a set of requirements for the competence of research testing laboratories based on ISO/IEC 17025 and UNE 166002 is defined, and an agile methodology for the fulfilment of these requirements is proposed. [ABSTRACT FROM AUTHOR]

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.

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]

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]

The number of accredited laboratories in the world shown considerable growth in the last 2 decades. These laboratories are from different institutions, such as national or multinational organizations, Higher Education Institutions (HEI) and Research Institutes (RI). This paper presents and comments on the current landscape of accreditation, from the point of view of testing and calibration laboratories under the ISO/IEC 17025 standard, in Europe. Laboratories accredited by signatory bodies of the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement (ILAC MRA) were identified and classified by institution type. The results were compared with those obtained in a previous research on the American Continent. An upward trend in the number of accredited laboratories with the increase in the population and/or GDP was observed in EU countries. Several similar characteristics were found in both regions, America and Europe. Nevertheless, a strong regulation in specifics areas seems to be higher in Europe and a smaller disparity was observed between European countries. Besides, as accreditation of laboratories in HEI and RI presents additional difficulties, the identification of these laboratories will be used as a basis for future work. [ABSTRACT FROM AUTHOR]

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]

With the worldwide increasing number of testing and calibration laboratories accredited according to the ISO/IEC 17025 standard to satisfy requirements of customers, the arising question is how much laboratories in the science and higher education system in Croatia use their potentials to respond to these requirements. All accreditations granted in Croatia were reviewed, and special attention was given to accreditations granted to testing and calibration laboratories in the science and higher education system. Accreditations granted to testing laboratories alone comprise almost 50 % of all granted accreditations in Croatia, making the ISO/IEC 17025 standard the most used standard for accreditation in Croatia. This is additionally supported by accreditations granted to calibration laboratories, the third accreditation scheme in frequency. However, only a smaller portion (approx. 20 %) of these accreditations is granted to laboratories in the science and higher education system. Low portions of scientific and higher education institutions involved in accreditation lead to a conclusion that the main driving force for accreditation of laboratories in Croatia are laboratories associated with industry rather than scientific laboratories, despite their enormous potential in a form or highly skilled personnel and sophisticated equipment. [ABSTRACT FROM AUTHOR]

There is an increasing demand for laboratories to have a quality management system (QMS) to ensure internationally accepted standards of quality are met, thereby providing assurance to their clients of the performance, competency and quality of the test results produced. This paper presents the steps involved in the establishment and implementation of a QMS in the Biosecurity Authority of Fiji plant health laboratories, with the support from New Zealand Ministry for Primary Industries Plant Health and Environment Laboratory. The paper describes the manner in which an organisation can receive external support through subject matter experts, whom are operating in a relevant technical field, utilising their skills and experience to create a QMS framework. Our experience of implementing QMS for a plant health laboratory in Fiji may help other laboratories in developing countries to pursue a QMS for their laboratories. This paper provides guidance on how to start a QMS from a minimalistic plan and incrementally build towards accreditation, and potentially ISO/IEC 17025:2017. [ABSTRACT FROM AUTHOR]

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]

Certified reference materials (CRMs) are the backbone for qualitative and quantitative determination of pesticides in technical materials, formulations, and food matrices. However, their stringent expiry date, limited shelf life, and diminishing purity with time, limits their use beyond expiry. Stability study of 89 CRMs of multiclass pesticides, stored at − 25 °C, has been conducted to assess the purity of CRMs beyond their expiry date. It was evident that > 96 % of the CRMs remained optimally stable with respect to their observed purity even after their expiry date as per certificate of analysis. Percentage deviations in purity of expired and valid CRMs posited well below 7 % and are within ± 10 % acceptable range as recommended by the SANTE. During 2013–2017, performance of the valid and expired CRMs was evaluated through 44 z-scores obtained in 14 international and national proficiency testing programmes. All the z-scores received for 15 expired and 29 valid CRMs were found satisfactory. Inter-laboratory comparison of 6 randomly selected expired and valid CRMs was tested at three different ISO/IEC 17025 accredited laboratories and their % difference between purities ranged from − 2.35 % to + 0.95 %. It was inferred that by maintaining proper storage conditions and continuous monitoring of purity, the expired CRMs can give comparable results as valid CRMs. [ABSTRACT FROM AUTHOR]

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

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.

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.