Conformity Assessment Research Articles

CONDUCTING CONTROL (SUPERVISORY) ACTIVITIES IN RELATION TO LICENSEES

The article describes the conduct of control (supervisory) measures on the territory of the Kemerovo region – Kuzbass, as well as measures in relation to licensees (license applicants). A form of assessment of licensing requirements conformity is presented, which in turn is carried out in relation to the licensee to streamline the license register. The problems of regulating legal documents in the field of licensing due to the lack of a list of minimum equipment, tools, technical means, including measuring instruments, for carrying out work and providing services for extinguishing fires in settlements, industrial facilities and infrastructure facilities are disclosed. The problem of non-approved warning and inspection forms during preventive control (supervisory) measures, the lack of preventive conversation sheets and accounting logs during licensing is also considered.

Impact of metrological correlation on the total combined risk in pharmaceutical equivalence evaluations

Pharmaceutical equivalence evaluation requires a multiparametric conformity assessment for both generic and reference medicines. This paper investigates the impact of metrological correlations on the total combined risk in pharmaceutical equivalence evaluations. The study focused on the equivalence between ranitidine hydrochloride tablets, assessed by determining the average weight, the assay of the active pharmaceutical ingredient, and the uniformity of dosage units. The risks of false conformity decisions were evaluated using Monte Carlo method simulations across four scenarios, each reflecting different correlation conditions. The results of the study focus on evaluating pharmaceutical equivalence between ranitidine hydrochloride tablets from two manufacturers. The tablets were tested for three parameters: average weight, active pharmaceutical ingredient (API) assay, and uniformity of dosage units. The measured values were within the regulatory specifications for both medicines A and B. Four scenarios of metrological correlation were assessed: #1 – actual correlation from shared analytical steps, #2 – correlation between parameters within the same medicine, #3 – correlation between generic and reference medicines, and #4 – uncorrelated parameters. The study revealed that correlations significantly affect total and combined risk values. The correlations between different parameters of the same medicine affect the total risk values, while the correlations between generic and reference medicines for a given parameter influence the combined particular risk values. Correlations between parameters of the same medicine affect total risk values, while correlations between generic and reference medicines impact combined particular risk values. Both types of correlations significantly influence combined total risk values, making metrological correlations crucial in pharmaceutical equivalence evaluations. Proper consideration of these correlations ensures the quality, efficacy, and safety of generic and reference medicines.

Accessibility engineering in the mhealth industry - A multi-case study

Abstract Medical apps, i.e. apps that fall under the EU Medical Device Regulation (MDR), are increasingly becoming a relevant part of healthcare in European countries. This is particularly evident in the numerous partnerships between app vendors and insurers as well as in the launches of national reimbursement programs. However, when it comes to enabling as many patients as possible to benefit from the medical advantages associated with the use of these apps, funding is only one part of the equation. It is up to the app vendors to develop barrier-free user interfaces so that people - regardless of individual characteristics such as cognitive abilities, physical limitations or language skills - can interact successfully with the app. Little is known about how these companies approach the topic of accessibility, what challenges they face and how big the impact of medical device legislation and other regulations on accessibility is. Against this background, we are undertaking a case study in several companies offering apps on the German market that are certified as medical devices and targeted at patients. Through interviews with employees with various roles (e.g. business, engineering, design) we are aiming at reconstructing the development processes of the apps with a focus on accessibility. We plan to expand the results by interviews with experts, e.g., in the area of MDR conformity assessment. 20 interviews in four companies have revealed that accessibility only plays a minor role during development. As a result, the topic is not systematically addressed, but only a few features are implemented. The app’s compatibility with screen reader or voice control was not explicitly addressed in any of the companies. There was also no deliberate involvement of people with disabilities in user studies. The preliminary results also indicate that the influence of medical device legislation on the implementation of accessibility is negligible. Key messages • User interface accessibility has a very low priority in the mhealth companies we have examined so far. • The current regulations are not sufficient in enforcing the basic implementation of accessibility features requiring more guidance and detailed regulations, given our sample of companies.

Form Deviation Uncertainty and Conformity Assessment on a Coordinate Measuring Machine

Coordinate measuring machines are widely used in the industrial field due to their ease of automation. However, estimating the measurement uncertainty is a delicate task, especially when controlling for deviation, given the large number of factors that influence the measurement. A precise estimate of the uncertainty is crucial to avoid incorrect conformity assessments. The purpose of this study is to control geometrical-form tolerance specifications, taking into consideration their associated uncertainty. A surface fitting model based on the least squares criterion is proposed, allowing one to obtain the variance–covariance matrix by iterative calculation according to the Levenberg–Marquard optimization method. The form deviation is then evaluated following the Geometrical Product Specifications (GPS) Standard, and its associated uncertainty is estimated using the guide to the expression of uncertainty in measurement (GUM) propagation of the uncertainty law. Finally, the conformity assessment is performed based on the measured deviation and its associated uncertainty. Different results for the measurement of straightness, flatness, circularity, roundness, and cylindricity are presented and detailed. This model is thereafter validated by a Monte Carlo simulation, and interlaboratory comparisons of the obtained results were performed, which showed satisfactory outcome. This contribution is of great use to manufacturing companies and metrology laboratories, allowing them to meet the normative guidelines, which stipulates that each measurement result must be accompanied by its associated uncertainty.

Indoor environmental quality assessment in passively ventilated classrooms in Germany and estimation of ventilation energy losses

In this field study we present an approach for the comprehensive and room-specific assessment of parameters with the overall aim to realize energy-efficient provision of hygienically harmless and thermally comfortable indoor environmental quality in naturally ventilated non-residential buildings. The approach is based on (i) conformity assessment of room design parameters, (ii) empirical determination of theoretically expected occupant-specific supply air flow rates and corresponding air exchange rates, (iii) experimental determination of real occupant-specific supply air flow rates and corresponding air exchange rates, (iv) measurement of indoor environmental exposure conditions of T, RH, cCO2, cPM2.5 and cTVOC, and (v) determination of real energy demands for the prevailing ventilation scheme. Underlying assessment criteria comprise the indoor environmental parameters of category II of EN 16798-1: Temperature T = 20 °C–24 °C, and relative humidity RH = 25 %–60 % as well as the guide values of the German Federal Environment Agency for cCO2cPM2.5 and cTVOC of 1000 ppm, 15 μg m−3, and 1 mg m−3, respectively.Investigation objects are six naturally ventilated classrooms of a German secondary school. Major factors influencing indoor environmental quality in these classrooms are the specific room volume per occupant and the window opening area. It is concluded that the rigorous implementation of ventilation recommendations laid down by the German Federal Environment Agency is ineffective with respect to anticipated indoor environmental parameters and inefficient with respect to ventilation energy losses on the order of about 10 kWh m−2 a−1 to 30 kWh m−2 a−1.

A Blueprint for Clinical-Driven Medical Device Development: The Feverkidstool Application to Identify Children With Serious Bacterial Infection

Clinical decision rules (CDRs) integrated into applications enhance diagnostic and treatment prediction support for clinicians, necessitating CE-mark certification to enter the European market. We describe the development of a CDR as a medical device, focusing on challenges from a physician's perspective exemplified by the Feverkidstool (FKT), a validated CDR for febrile children. We pursued a local process, aligned with the CE-marking process, to develop the FKT as in-house developed device. We aim to provide a blueprint for colleagues.Medical device development, conform the Medical Device Regulation and performed by a multidisciplinary team, encompassed five stages: market scan, design, production, verification and validation and conformity assessment. Regulatory processes were continuously updated. The market scan identified a need for the FKT compared to existing applications. A prototype was designed in stage 2, further adjusted and improved based on the qualitative and quantitative results of stage 2-4. Lastly, stage 5 confirmed FKT's performance and safety. Medical device development presents challenges for physicians, requiring collaboration for technical, regulatory, and financial expertise. Multidisciplinary teamwork also poses challenges, including uncertainties regarding responsibility and timelines. After CE-certification, adapting to evolving needs and ensuring data privacy highlights the ongoing nature of medical device development.

Upstream Review of intra-EU ICSID Arbitrations and Its Consequences: A Commentary on the Order of the Bundesgerichtshof (German Federal Court of Justice) in I ZB 43/22 MAINSTREAM Renewable Power et al. v. Germany

EU Member States may have recourse to ‘upstream’ national judicial protection under the German Civil Procedure Code to declare inadmissible and thereby preclude intra-EU investment arbitration proceedings brought under the auspices of the International Centre for Settlement of Investment Disputes (ICSID) Convention. That remarkable conclusion by the Bundesgerichtshof (German Federal Court of Justice) constitutes the first attempt of a higher court of an EU Member State to render compatible the seemingly contradictory obligations on national courts arising from EU law and the ICSID Convention. However, even more important than the court’s conformity assessment are the inherent consequences of its conclusion: the incompatibility of the ICSID Convention with EU law and the obligation, on all EU Member States and their institutions, to disapply that convention in intra-EU investment arbitration matters and ultimately to denounce it collectively.

Conformity Assessment of a Modernised Locomotive Bogie and Body Connection – Type Tests and Results

Referring to the lecture held on 16th Mini-Conference on Vehicle System Dynamics, Identification and Anomalies, Budapest, 5-7 November 2018, the accredited Notified Body started the conformity assessment process of the modernized bogie-locomotive body connection of MÁV-START Class V63 electric locomotives running with Ganz-MÁVAG UFC-type bogies, in 2017. Since the planned modification of the locomotives was delayed, the Conformity Assessment Body could perform the necessary riding quality and noise test in the summer of 2020 instead of September 2018. The study presents the modification carried out on the locomotives, the test procedures, and the test results. The aim and the novelty of the research was to apply the latest developments of the test procedures on a modified, existing rolling stock. The conformity for the new requirement makes challenges for the development of testing even if theoretically a well-known test method is applied. The article gives an example for the application of a classic test method combined with of the new possibilities, that makes unnecessary the use of additional railway test cars.

Challenges and improvements in HER2 scoring and histologic evaluation: insights from a national proficiency testing scheme for breast cancer diagnosis in China

BackgroundIn 2022, our team launched the pioneering national proficiency testing (PT) scheme for the pathological diagnosis of breast cancer, rapidly establishing its credibility throughout China. Aiming to continuously monitor and improve the proficiency of Chinese pathologists in breast pathology, the second round of the PT scheme was initiated in 2023, which will expand the number of participating institutions, and will conduct a nationwide investigation into the interpretation of HER2 0, 1+, and 2+/FISH- categories in China.MethodsThe methodology employed in the current round of PT scheme closely mirrors that of the preceding cycle in 2022, which is designed and implemented according to the “Conformity assessment—General requirements for proficiency testing”(GB/T27043—2012/ISO/IEC 17043:2010). More importantly, we utilized a statistics-based method to generate assigned values to enhance their robustness and credibility.ResultsThe final PT results, published on the website of the National Quality Control Center for Cancer (http://117.133.40.88:3927), showed that all participants passed the testing. However, a few institutions demonstrated systemic biases in scoring HER2 0, 1+, and 2+/FISH- with accuracy levels below 59%, considered unsatisfactory. Especially, the concordance rate for HER2 0 cases was only 78.1%, indicating challenges in distinguishing HER2 0 from low HER2 expression. Meanwhile, areas for histologic type and grade interpretation improvement were also noted.ConclusionsOur PT scheme demonstrated high proficiency in diagnosing breast cancer in China. But it also identified systemic biases in scoring HER2 0, 1+, and 2+/FISH- at some institutions. More importantly, our study highlighted challenges in the evaluation at the extreme lower end of the HER2 staining spectrum, a crucial area for further research. Meanwhile, it also revealed the need for improvements in interpreting histologic types and grades. These findings strengthened the importance of robust quality assurance mechanisms, like the nationwide PT scheme conducted in this study, to maintain high diagnostic standards and identify areas requiring further training and enhancement.

Lessons learned: drive-through COVID-19 clinic testing during an adaptive epidemic response and a point-of-care test assessment of a computer-read rapid lateral flow immunoassay with fluorescence-based detection.

Background. The COVID-19 pandemic demonstrated a need for robust SARS-CoV-2 test evaluation infrastructure to underpin biosecurity and protect the population during a pandemic health emergency.Gap statement. The first generation of rapid antigen tests was less accurate than molecular methods due to their inherent sensitivity and specificity shortfalls, compounded by the consequences of self-testing. This created a need for more accurate point-of-care SARS-CoV-2 detection methods.Aim. Here we present the lessons-learned during the COVID-19 emergency response in Western Australia including the detailed set-up, evaluation and operation of rapid antigen test in a state-run drive-through sample collection service during the COVID-19 pandemic after the strict border shutdown ended.Methods. We report a conformity assessment of a novel, second-generation rapid antigen test (Virulizer) comprising a technician-operated rapid lateral flow immunoassay with fluorescence-based detection.Results. The Virulizer rapid antigen test demonstrated up to 100% sensitivity (95% CI: 61.0-100%), 91.94% specificity (95% CI: 82.5-96.5%) and 92.65% accuracy when compared to a commercial PCR assay method. Wide confidence intervals in our series reflect the limits of small sample size. Nevertheless, the Virulizer assay performance was well-suited to point-of-care screening for SARS-CoV-2 in a drive-through clinic setting.Conclusion. The adaptive evaluation process necessary under changing pandemic conditions enabled assessment of a simple sample collection and point-of-care testing process, and showed how this system could be rapidly deployed for SARS-CoV-2 testing, including to regional and remote settings.

Strong reasons make strong actions: What Shakespeare’s ‘King John’ can teach us about the Internet of Things

The rapid proliferation of Internet of Things (IoT) devices in modern societies brings forth unprecedented opportunities for convenience and connectivity but also poses significant cyber security challenges. This paper examines the risks associated with these devices and the regulatory frameworks governing them in key regions including the US, the EU, China and India. Through a comprehensive analysis, it becomes evident that while efforts are being made to address IoT cyber security concerns, discrepancies in approaches and regulations hinder global harmonisation and create obstacles for industry compliance. Drawing from insights into existing cyber security frameworks and industry practices, the paper proposes actionable recommendations to enhance consumer IoT cyber security. These recommendations include defining baseline security requirements, promoting expertise within IoT workforces, advocating for the independent involvement of conformity assessment bodies (CABs), leveraging the quality infrastructure ecosystem, and launching an international awareness campaign. By implementing these measures, stakeholders can foster a safer and more secure IoT environment, mitigating the risks posed by cyber threats and ensuring the trust and resilience of connected devices. As society continues to navigate the complexities of IoT adoption, it is imperative to recognise the urgency of addressing cyber security challenges. By heeding the lessons from Shakespeare’s ‘King John’ — ‘Strong reasons make strong actions’ — and taking decisive steps to fortify IoT cyber security, we can safeguard individuals, businesses and critical infrastructure from the evolving threat landscape.

Regarding the establishment of the anti-burn «Fenix-MS» bed conformity with the requirements of quality and safety standards

The standards that anti-burn beds must meet are given. The design of the domestically produced anti-burn «Phoenix-MS» bed, which has improved design and technological indicators, is briefly described. The main test results of this bed, obtained in the process of independent conformity assessment, are presented. Their analysis showed that the product meets quality standards and ensures the safety of patients and medical personnel during its operation in medical institutions. It is noted that the manufacturer needs to carry out a more complete clinical evaluation of the product, taking into account the strengthening of this requirement in the new EU Regulation 2017/745 on medical devices.

Assuring fire safety in nuclear plants with international standards

This paper presents the evolution and benefits of international standards for fire safety engineering11Fire safety engineering and performance-based fire safety are both widely used, and both represent an engineering process to determine performance of a fire protection plan based on the results of fire calculations. developed at the International Organization of Standardization (ISO). The history of fire safety in nuclear power plants along with the need for fire safety regulation is discussed to lay the foundation for the standards development work. The evolution of fire safety regulation from prescriptive to performance-based is also presented as the background for the research.Extensive research of the issues that arise for performance-based fire safety regulation, specifically for computer models for fire safety calculations, which included international benchmark exercises formed the basis to identify the need for developing international standards for fire safety engineering. The research focused both on the verification and validation (V&V) of computer fire models and determining their predictive capability. The paper for the first time takes new scientific and engineering data from benchmark exercises to assess the suitability and applicability of computer fire models for application in nuclear power plants. The paper reports on the findings of the benchmark exercises and their use in formulating new requirements in ISO international standards on verification and validation of fire calculation methods and the fire safety engineering process through a consensus process of international experts.Discussion of the foundational research at the ISO fire safety engineering committee (ISO TC 92 SC 4) led to a consensus to revise two international standards. One specifying the principles and general requirements for fire safety engineering, and another on the verification and validation procedures for fire calculation methods. The development and content of these two international standards are discussed in this paper. An international technical report was subsequently developed at the ISO committee for conformity assessment (CASCO) to provide guidance for the certification of the fire safety engineering process, and specific parts of it, namely the V&V of fire calculation methods.It is concluded that the fire safety engineering international standards presented in this paper can support rigorous performance-based fire safety regulation for nuclear power plants. These ISO international standards will be particularly useful to nations that have not yet developed the regulatory infrastructure for nuclear power regulation. The international standards are also available to those that would like to transition to the use of international standards and an ISO standards-based certification scheme. Regulations based on these international standards will provide citizens with confidence in nuclear power as a viable option to address climate change.

TINJAUAN YURIDIS TERHADAP STANDARDISASI PRODUK HELM IMPOR

Business entities that carry out trade activities by importing helmets into the country without adhering to the Indonesian National Standard (SNI) is a form of violation related to Standardization and Conformity Assessment. The main issue is whether imported helmets entering the Indonesian market comply with the standardization requirements set forth in Law Nomor 20 of 2014 on Standardization and Conformity Assessment, and what sanctions are imposed on importers who violate these provisions. The study uses a normative type of research and descriptive research methods, which is then analyzed qualitatively, and conclusions are drawn using deductive reasoning. The findings indicate that business entities without an Indonesian National Standard (SNI) certificate who distribute and trade imported helmet products without being accompanied by Indonesian National Standard (SNI) standardization violate the provisions of Article 25 paragraph (4) of Law Nomor 20 of 2014. Such violations can result in criminal sanctions in accordance with Articles 65 and 67 of Law Number 20 of 2014, which include a maximum prison sentence of 5 (five) years and/or can be subject to a maximum fine of IDR 35,000,000,000.

Calibration methods for high frequencies: Development and validation

The paper presents an introduction of an advanced method for calibration of high-frequency instruments, such as oscilloscopes, frequency counters and function generators that operate at the frequencies between 1 MHz and GHz range. Based on conducted thorough survey of the needs for calibration of high-frequency measurement devices in the region of Southeast Europe, and the identified calibration and measurement capability gap in comparison to the international metrology offer, the Laboratory for Electrical Measurements at Ss. Cyril and Methodius University in Skopje developed new methods, following the general recommendations of the EURAMET cg-7 Calibration Guide. An original approach in the design of the experimental procedure, and a novel data fusion concept for the evaluation of the measurement uncertainty is deployed. The paper also investigates and resolves some challenges of setting up an unbroken measurement traceability chain, and uncertainty estimation for calibration in the domain of high frequencies. The established and accredited calibration capabilities are essential for the region of Southeast Europe, where the metrology facilities for the calibration/testing of high frequency electronic devices are inadequate to meet the conformity assessment needs of the quickly growing automotive supply chain sector, and the needs of other electrical and electronic industries.

Measurement uncertainty evaluation of equivalent roughness in hydraulic pipes

This paper addresses the quantification of the dispersion of equivalent roughness values obtained from the experimental study of hydraulic pipes used, for example, in water supply networks. This quantity is mainly used in the determination of the friction factor related to pipe fluid flow. In this context, non-linear and complex mathematical models, such as the Colebrook-White equation, are applied to characterize the equivalent roughness of hydraulic pipes composed of different types of materials. However, knowledge about the measurement uncertainty of the obtained estimates is still reduced, having a direct impact in the conformity assessment of this type of hydraulic component and in the technical comparison between different types of pipes (materials and manufacturers). The paper describes the application of a Monte Carlo method (MCM) in the measurement uncertainty evaluation of equivalent roughness. In addition to presenting the theoretical and experimental background, the paper describes the measurement uncertainty propagation, from the probabilistic formulation of the input quantities up to the output quantity. A numerical example, based on experimental data retrieved from field testing of hydraulic pipes integrated in a large-scale agricultural irrigation network, is shown in the paper, illustrating the suitability, advantages, and limitations of the proposed approach.

Premarket and postmarket regulatory challenges for mechanical ventilators: scenario in Brazil and comparison with other countries

BackgroundThis study critically assesses the regulatory challenges faced in Brazil for mechanical ventilators amid the COVID-19 pandemic. It evaluates the effectiveness of expedited regulatory actions, compares strategies with other countries, and proposes future optimization in emergency conditions. Methods: Premarket submissions of mechanical ventilators were surveyed, involving accompanying certification documentation, rejections, approvals, and cancellations. Postmarket occurrences were surveyed until June 2023, evaluating their incidence and presence of certifications. Regulatory pathways in other countries were reviewed for comparison. Results: Brazil’s regulatory strategy increased its ventilator supply capacity 17 times in 10 months. However, the absence of essential certifications in 95.52% of the premarket submissions, such as the Certificate of Conformity issued by the Brazilian Conformity Assessment System (CC-SBAC), raised safety and performance concerns. Among temporarily approved ventilators, the main cause of cancellation (76.92%) was the absence of certifications after the temporal approval, notwithstanding the already installed devices maintaining authorization for use in health services. Postmarket alerts lacked CC-SBAC issuance in 75% of the cases when sponsors reported the occurrences. It highlighted the importance of ongoing technical assistance and monitoring, particularly for devices lacking proper certifications. Conclusions: The extraordinary regulatory conditions in Brazil significantly impacted ventilator premarket evaluation. However, lacking essential certifications led to post-approval cancellations. Postmarket occurrences emphasized necessary vigilance, with most alerts involving uncertified devices. Improved premarket evaluation, considering component shortages and real-world usage scenarios, as collaborative efforts from other countries and international bodies, is crucial for ensuring the safety and effectiveness of ventilators in public health emergencies.

Overview of proficiency testing results for the invivo determination of sun protection factor.

A sunscreen product is allowed to be marketed if a protection is provided against ultraviolets (UV) including UVA rays and UVB rays expressed by the sun protection factor (SPF). UVB is radiation that is in the region of the ultraviolet spectrum which extends from about 290 to 320 nm in wavelength and that is primarily responsible for sunburn, ageing of the skin, and the development of skin cancer. Thus, since April 2009, the Bureau Interprofessionnel d'Etudes Analytiques (BIPEA) set up a proficiency testing scheme (PTS) for the determination of SPF invivo of sunscreen products according to ISO 24444 standard [Cosmetics - Sun protection test methods - in vivo determination of the sun protection factor (SPF)] to evaluate the analytical performances of laboratories on these analyses. This PTS gathers twenty-six laboratories around the world with one trial a year. For each test, the statistical treatment of the data is performed according to ISO 13528 standard [Statistical methods for use in proficiency testing by interlaboratory comparison]. The assigned and tolerance values are calculated from the participants' data and the performances of the laboratories are evaluated individually and collectively according to ISO 17043 standard [Conformity assessment - General requirements for proficiency testing]. This paper presents the design of the PT program, its development, and an attentive analysis of laboratories results, which highlight the global performances obtained by laboratories on this type of analysis. The evaluation of the results shows, in fact, a relatively constant dispersion of data since the implementation of the PT program (variability between 10% and 50%).

Strategy and Metrological Support for Indoor Radon Measurements Using Popular Low-Cost Active Monitors with High and Low Sensitivity.

Traditionally, for indoor radon testing, predominantly passive measurements have been used, typically applying the solid-state alpha track-etch method for long-term and the charcoal method for short-term measurements. However, increasingly, affordable consumer-grade active monitors have become available in the last few years, which can generate a concentration time series of an almost arbitrary duration. Firstly, we argue that consumer-grade monitors can well be used for quality-assured indoor radon assessment and consequent reliable decisions. Secondly, we discuss the requirements of quality assurance, which actually allow for reliable decision-making. In particular, as part of a rational strategy, we discuss how to interpret measurement results from low-cost active monitors with high and low sensitivity with respect to deciding on conformity with reference levels that are the annual average concentration of indoor radon. Rigorous analysis shows that temporal variations in radon are a major component of the uncertainty in decision-making, the reliability of which is practically independent of monitor sensitivity. Manufacturers of low-cost radon monitors already provide sufficient reliability and quality of calibration for their devices, which can be used by both professional inspectors and the general public. Therefore, within the suggested measurement strategy and metrologically assured criteria, we only propose to clarify the set and values of the key metrological characteristics of radon monitors as well as to upgrade user-friendly online tools. By implementing clear metrological requirements as well as the rational measurement strategy for the reliable conformity assessment of a room (building) with radon safety requirements, we anticipate significant reductions in testing costs, increased accessibility, and enhanced quality assurance and control (QA/QC) in indoor radon measurements.

Certification of food products

The article discusses the goals and objectives of food product certifi cation, types of conformity assessment (mandatory declaration, state registration, voluntary certifi cation), as well as the procedure for carrying out the procedure and other information.