<p>In past decades information technology has changed the conditions of organizations, not at least within the industry. Advanced IT systems have become a fact in order to cope with rapid changes in the market and to effectively manage an organization’s knowledge. When organizations became more flexible and customized expectations from customers and stakeholders also become higher. These expectations and guidelines are documented in a company’s management system, which can be designed differently depending on what standards the company chooses to implement. ISO standards consist of requirements and guidance in relation to quality, environment, energy, etc. In order to manage and work in line with these standards they are often integrated into a single management system.</p><p>This thesis discusses and analyzes how an integrated management system can be an active part of a company’s efforts to control and manage business. One problem in today’s industry is that management systems are not always a priority in relation to other information systems such as production, economics and intranet. For the management system to be successful it must have</p><p>priority, especially when its intention is to get the company’s employees to work in a uniform manner following the goals and visions that the management has established. To examine how a company’s management system can be more effective, a situation analysis was conducted at a middle-</p><p>sized industrial enterprise. The main focus was to examine the advantages and disadvantages of the management system based on the employees’ wishes and point of view.</p>

In past decades information technology has changed the conditions of organizations, not at least within the industry. Advanced IT systems have become a fact in order to cope with rapid changes in the market and to effectively manage an organization’s knowledge. When organizations became more flexible and customized expectations from customers and stakeholders also become higher. These expectations and guidelines are documented in a company’s management system, which can be designed differently depending on what standards the company chooses to implement. ISO standards consist of requirements and guidance in relation to quality, environment, energy, etc. In order to manage and work in line with these standards they are often integrated into a single management system. This thesis discusses and analyzes how an integrated management system can be an active part of a company’s efforts to control and manage business. One problem in today’s industry is that management systems are not always a priority in relation to other information systems such as production, economics and intranet. For the management system to be successful it must have priority, especially when its intention is to get the company’s employees to work in a uniform manner following the goals and visions that the management has established. To examine how a company’s management system can be more effective, a situation analysis was conducted at a middle- sized industrial enterprise. The main focus was to examine the advantages and disadvantages of the management system based on the employees’ wishes and point of view.

It is estimated that approximately 360 Million people have a permanent disabling hearing loss (WHO, 2015). The majority of these people live in lower to middle income countries, where screening and follow-up treatment is not always accessible (WHO, 2015). School based hearing screening is one of the procedures that are not always available due to a number of challenges one of which include the high cost of audiometrical headphones. School based hearing screening is performed with an audiometrical headphones and audiometer, it usually can be used to test all school-aged children and adults. In an attempt to reduce the cost of school based hearing screening, this study evaluated the Sennheiser HD 202 II headphone to establish it as a widely available and cost-effective alternative for audiometrical headphones currently used. The headphones were compared to ISO standards (ISO 389-1, ISO 389-5 and ISO 389-9) and IEC standards (IEC 60318-1 and IEC 60645-1). The following characteristics of the headphone were compared: equivalent threshold sound pressure levels, attenuation, maximum permissible ambient noise levels, force of the headband, total harmonic distortion and frequency response. After evaluation the Sennheiser HD 202 II does not show the same standard as audiometrical headphones for diagnostic testing. The headphone can however be used for screening purposes if a few measures are taken into account. The correct ETSPL values should be used, disruptive background noise should be avoided and only the frequencies from the research (250- 1600 Hz) can be tested. once these measures are taken into account the Sennheiser HD 202 II proves to be a cost-effective alternative headphone for screening purposes. / Dissertation (M Communication Pathology)--University of Pretoria, 2017. / Speech-Language Pathology and Audiology / M Communication Pathology / Unrestricted

Följande examensarbete är skrivet på Kungliga Tekniska Högskolan inom maskinteknik med inriktningen industriell ekonomi och produktion och utförd i ett ingenjörsföretag. ISO standarden 11608–1:2014 listar olika tester som måste genomföras för att få en autoinjektor godkänd för användning. Ett utav testerna är att man släpper autoinjektorn från en bestämd höjd och riktning i fritt fall. Det testet kallas för droptest. Minimikraven för ISO 11608–1 för droptest kan potentiellt ha begränsningar då de inte representerar verkligheten, som exempelvis att en autoinjektor kan falla från höjder och riktningar som inte tillhör minimikraven. Detta kan skapa osäkerheter hur en autoinjektor kan prestera under nödsituationer. Syftet med arbetet är att undersöka ifall man kan öka säkerheten vid användning av autoinjektorer vid nödsituationer, och då har man satt som mål att undersöka ifall det krävs att droptesta mer än minimikravet i ISO-standarden. Detta utförs genom att genomföra olika experiment för att avgöra om ISO-standarden räcker till. Där man experimenterar med att släppa autoinjektorer från högre höjder och fler riktningar samt utför hur detta har påverkat funktionen på apparaterna. Metoden genomförs i företaget, kommer ge data hur funktionen har påverkats. Mer specifikt data på om det krävs mer eller mindre kraft för att dra bort locket. Och data på hur aktiveringen av sprutan har påverkats. Med hjälp av lådagram så analyseras värdena då man skapar grafer för att hitta olika trender som kan uppstå. Resultatet efter genomföranden och analysen blev det att inga tydliga trender uppstod och inga tydliga indikationer att det krävs att drop testa över minimikravet. Däremot kan analysen från detta examensarbete användas som underlag vid diskussioner och planering av droptest på företaget / The following thesis will give the reader a better understanding about autoinjectors and drop tests. ISO standard 11608-1:2014 lists various tests that must be carried out to get an autoinjector approved for use. One of the tests is to drop the autoinjector from a certain height and direction in free fall. That test is called a drop test. The minimum requirements of ISO 11608-1 for drop testing can potentially have limitations as they do not represent reality, such as an autoinjector falling from heights and directions outside the minimum requirements. This can create uncertainties in how an autoinjector can perform during emergency situations. The purpose of this thesis is to investigate whether it is possible to increase safety when using autoinjectors in emergency situations, where the goal is to investigate whether droptests from higher heights and different directions are required. This is done by conducting various experiments to determine if the ISO standard is sufficient. Where one first performs dropstests from higher heights and more directions and secondly performs functional testing on the devices to see how they have been affected. The method is carried out in the company and will provide data on how the function has been affected. More specifically, data on whether force is required to pull the lid off. And data on how the activation of the syringe has been affected. Through using boxplots, the values are analysed when creating graphs to find different trends that may occur. The result after implementation and analysis was that no clear trends emerged and there were no clear indications that it is required to drop test above the minimum requirement. However, the analysis from this thesis can be used as a basis for discussions and planning of drop tests for others.

Denna avhandling analyserar värdet av planhet hos stålindustrins kunder utifrån ett tid- och kostnadsbaserat perspektiv. Med hjälp av värdekedjor och processanalyser kvantifieras värdet på planhet beroende av bearbetningsprocess liksom ståltyp. Utifrån informationen i denna rapport kan kvaliteten på olika stålprodukter bättre marknadsanpassas till dess användningsområde med en lägre bearbetningskostnad för stålanvändaren. Rapporten visar att kostnader för oplanhet förekommer i grovplåtsbearbetning liksom tunnplåtsbearbetning där materialets form från stålverket behålls intakt till de första bearbetningsprocesserna. De stora kostnaderna för oplanhet uppkommer då bearbetningshastigheten sänks i förebyggande syfte under längre tid, på grund av ojämn kvalitet i den behandlade plåten. Likaså involverar stillestånd i maskiner på grund av oplanhet i vissa fall mycket höga kostnader.

Legionella pneumophila is a human pathogen commonly found in natural and artificial aquatic environments and can cause a condition called legionellosis. Monitoring for legionellae is therefore important for protecting public health and identifying its environmental sources is a way to prevent illness. This has resulted in development of several control strategies to identify these sources. One of these strategies is to construct a valid method to detect Legionella pneumophila and monitoring these methods is a way to ensure the method remain effective at tracing infection.  The current version of standardized method is called ISO 11731:2017 and supersedes its former version called ISO 11731:1998. The former version uses a combination of heat and acid solution treatment to reduce interfering microorganisms in water with high background, whereas the current version separates the treatment by subdividing the sample in three parts. One part is subjected to heat treatment, one with acid solution treatment and one remains untreated. Therefore, the aim of this study is to analyse how this difference in method strategy will affect detection of Legionella pneumophila between the current and its former version of ISO 11731. To do this, this study divided the experiment into two parts: experiment A was aimed at evaluating the validity of the method and experiment B was designed to study repeatability in terms of dispersion and performance data range. For experiment A: 14 samples were tested using both ISO 11731:2017 and 11731:1998 to see how the results differentiated. Six are natural samples and was appointed based on their previous results that showed positive for Legionella. Four samples were spiked with different serotypes of Legionella and the remaining four were spiked with both Legionella and Legionella-inhibited bacteria. For experiment B, three certified reference material with different concentration of Legionella pneumophila serotype 1 was tested in repeatability conditions with each sample producing ten replicates.  In conclusion, based on results assessed in this study ISO 11731:1998 was more suitable to analyse water with higher concentration of interfering microorganisms. By a combination of heat and acid solution treatment: it maximizes the reduction of interfering microorganisms which facilitates Legionella to cultivate on agar. ISO 11731:2017 was more efficient in recovering different serotypes of Legionella. Although, there were a significant increase in dispersion and performance data range results in ISO 11731:2017. This indicates that since there is an additional dilution step added in acid solution treatment: it increases the risk of human error and therefore a greater vulnerability to the method.

Standards exist to unify requirements and to make it possible to make sure that equipment is tested in the same way, even when several different test labs perform the test. But as new technology comes to market, and old technology evolves, so must the standards. The International Organization for Standardization are continuously developing new standards and updating existing standards, and sometimes the specified tests changes, rendering old test equipment obsolete. In this thesis, we will look at the differences between the old and the current versions of the ISO 7637 standards as well as how we can verify if older test equipment lives up to the new requirements. A verification method will be designed, partly implemented and evaluated. Several of the aspects for automating the verification will be considered. The results will show that older equipment most likely will be usable with the newer version of the standard, as well as point out some of the difficulties of verifying that this is the case.

Biomedical devices that function in-vivo offer a tremendous promise to improve the quality of life for many who suffer from disease and trauma. The most important consideration for these devices is that they interact with the physiological environment as designed without initiating a deleterious inflammatory response. ISO 10993 outlines the current international guideline for investigating the biocompatibility of such devices. Numerous groups report the use of ISO 10993 as the basis for their experimental evaluation of candidate materials for neuroprosthetics, as well as other biomedical devices, however most of these reports fail to completely comply with the standard. This leads to a lack of consistent results between R&D groups, which hinders progress in the implantable biomedical device field. For the first time, and to the best of our knowledge, we present a methodology that is in strict adherence to the methodologies presented in ISO 10993, namely direct contact and extract testing. In addition we show that the MTT assay, which has been used in multiple reports, suffers from a major flaw that can create false results especially for conductive materials. We also report on our application of ISO 10993-12 with respect to control materials and preparation methods. These materials are gold and polyethylene as negative reaction controls, and copper and polyvinyl chloride organotin (PVC-org. Sn) as positive reaction controls. The results of our tests are consistent to what has been previously reported, albeit in separate reports. We used silicon carbide, which is a very promising candidate material for neuroprosthetics, as our test materials. Not only have we confirmed the outstanding in-vitro response of 3C-SiC and amorphous SiC, we do this in strict compliance to ISO 10993 thus showing that it is indeed possible to quantitatively assess the performed of materials in a statistically significant and highly repeatable fashion.

The analysis of the quality management system and the implementation of the quality management system in the realm of the school system. To propose the methodology of the procedure and practical verification of individual steps of the methodology, including the analysis, if the matter of the quality management is meaningful also in this realm.

Denna studie är en slutlig undersökning av ett examensarbete som skrevs under hösten 2017 på Mälardalens högskola av två ingenjörsstudenter. Studien berör hur ett fallföretag i framtiden ska kunna genomföra en ISO-certifiering, vilket kommer att ge byggstenar till företaget för hur en implementering skulle kunna genomföras. Med hjälp av ISO-standardens sju grundprinciper – kundfokus, ledarskap, medarbetarnas engagemang, processinriktning, förbättring, faktabaserade beslut och relationshantering – ger det företaget en stabil grund att stå på, samt förutsättningar för att kunna införa ett kvalitetsledningssystem. Studien kommer att besvara problemformuleringen ”Att definiera glappet mellan ISO-standarden och fallföretaget.” Problemformulering är alldeles för övergripande för studiens tidsram och innefattar för stort arbete och har därför delats in i två mindre frågeställningar: 1. Vilka utmaningar ställs små och medelstora företag, såsom Husmuttern, inför vid en implementering av ISO 9001? 2. Hur kan små och medelstora företag hantera utmaningarna att bli ISO-certifierade? Informationen till studien har funnits med hjälp av en litteraturstudie och intervjuer för att få fram de byggstenar fallföretaget behöver inför deras framtida implementering. Litteraturstudien har bland annat bestått av artiklar, böcker och den internationella, officiella standarden ISO 9001:2015 för en ISO-certifiering. Intervjuerna har kvalitativt genomförts med semistrukturerade frågor tillsammans med fallföretagets VD, samt med VD:n på Mektig Technology Group. För att kunna genomföra studien användes en rekommenderad arbetsprocess på fyra steg från handboken ISO 9001 för små och medelstora företag (Bowin, 2002). Studiens teori har tillsammans med fallföretagets nulägesanalys sammanfattats i bland annat den fortsatta rekommendationen att fallföretaget ska påbörja en dokumentation av alla deras arbetsprocesser och policys inom företaget. Ytterligare rekommendationer består av att fallföretaget tar hjälp av extern hjälp, såsom utbildningar och kurser. Extra viktigt, som studien kommit fram till är att en implementering av en ISO-certifiering bör vara väl genomtänkt och planerat då det är både tidskrävande och kostsamt för ett företag att genomföra. En ISO-certifiering är väldigt tidskrävande och därför har endast denna studie kommit med underlag för hur fallföretaget skulle kunna genomföra en ISO-certifiering. Eftersom detta endast är ett underlag behöver fortsatta studier och rekommendationer, som nämnts ovan, genomföras.