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Effects of the "new" ATEX Directive 2014/34/EU - consequences for manufacturers - claims by users
(2016)
Directive 94/9/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres has been substantially amended. The new ATEX Di-rective 2014/34/EU on equipment and protective systems intended for use in potentially explosive atmospheres replaces Directive 94/9/EC. The new Directive was published on March 29, 2014, became enacted on April 19, 2014 and will become effective starting April 20, 2016. It was the aim of the revision to harmonize the requirements with the New Legal Framework (New Legislative Framework - NLF). The NLF consists of the following two documents: the Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008, which sets out the re-quirements for accreditation and market surveillance relating to the marketing of products, and the Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008, which sets on a common framework for the marketing of products.
The harmonization with the NLF especially results in a lot of new definitions and a new structure compared with the “old” ATEX. Some content which was in the annexes of the “old” ATEX is now turned into distinct chapters or articles in the main part. New content was included which comprises things like presumption of conformity, principles of CE marking, notification of conformity as-sessment bodies, Union market surveillance, and Union safeguard procedure. What is more, the definitions of the economic operators like manufacturer, distributor and importer and the description of their duties are now in separate chapters. Thus, the “new” ATEX is much bigger than the “old” one. With the publication of the Directive 2014/34/EU a lot of questions were raised especially from manufacturers.
These questions include:
- Did everything change now?
- Does the new Directive affect essential safety and health requirements (ESHR) for equipment and protective systems intended for use in hazardous areas?
- Is the module system for conformity assessment changed?
- What happens with existing certificates?
- What happens with products which were already produced before April 20, 2016 but will be placed on the market later?
The presentation will deal with some of these questions. But it has to be stated that the essential health and safety requirements for equipment and protective systems intended for use in potentially explosive atmospheres have not changed. That means: A product which was safe under the Directive 94/9/EC is still a safe product in the sense of the Directive 2014/34/EU.
The evaluation of measurement uncertainty is essential for testing and calibration laboratories. This paper provides a general process description for the determination of the measurement uncertainty of quantitative data and its application to the conformity assessment with examples, and how to deal with the uncertainty of qualitative (Boolean) results, e. g. when "Alarm" or "No alarm" occours in an instrument display.
The determination of the measurement uncertainty of quantitative and qualitative results is an important quality management tool, for example to describe measuring equipment, procedures, measurement results and the quality of products. The lecture presents the process description for the determination of the measurement uncertainty according to GUM, the determination of uncertainties in qualitative measurement results and the application of the measurement uncertainty for conformity assessment.
Impact of the COVID-19 Pandemic on Conformity Assessment: Insights from a Multinational Study
(2021)
The COVID-19 pandemic has posed new and manifold challenges to organizations and their operations worldwide. Conformity assessment bodies (CABs), such as testing or medical laboratories, certification, and inspection bodies, are also affected by the associated disruptions. Their situation in this crisis is highly relevant, as CABs are essential pillars of the quality infrastructure: Their activities ensure that products and services meet requirements as defined in standards and regulations, thereby contributing to their safety and reliability. Considering the roles and functions of CABs in economy, health, and innovation, the question arises how CABs and their operations were affected by the pandemic and how they responded. To this end, we present the results of an international survey of 986 CABs of all types in Germany, the UK, Italy, and New Zealand. Overall, CABs reported on average a negative development of demand during the pandemic, facing restrictions in all countries. In addition, the pandemic had overall negative impact on the CABs’ investment and innovation activities. However, investments in digital infrastructure were increased as countermeasure, with CABs reporting an increased need for digitalization. Resources relevant to organizational resilience were available to different extents, affecting the speed of response to the challenges of the pandemic. The paper highlights and discusses results from in-depth analyses, which are relevant for policy makers and industry alike.
Global Status and Trends in Digital Transformation and Conformity Assessment – The Case of Germany
(2022)
This presentation summarizes findings from the first comprehensive study on digitalization in conformity assessment worldwide. The reults are based on data from a survey among conformity assessment bodies (CABs) in Germany conducted in 2022, as well as some first insights from Latin American countries. It highlights the digital maturity of the organizations, the motives, benefits and obstacles of digital transformation as well as the actual technology trends.
The study on CABs is part of a global project that covers various countries (see www.qi-fokus.de).
This presentation summarizes major findings from an international study in 16 countries and regions on digital transformation in conformity assessment bodies such as testing and calibration laboratories or certification and inspection bodies. It draws from survey data of 1.476 participants and specifically highlights findings on the digital maturity of the organizations, providing an international comparison.