Quality management system’s (QMS) describes how organisations control their interconnected processes through four elements defined as quality planning, quality control, quality assurance and quality improvement to achieve quality through stakeholder satisfaction. The International Organization for Standardization (ISO) develops certifiable international standards for quality management. Through the development of ISO and other standardisers, many organisations require their partners and suppliers to hold a certified QMS. By holding an ISO 13485:2016 certificate an organisation reassure that they can deliver medical devices and related services that meets customers and regulatory requirements. Swedish Diagnostics AB (Swedia), a fictive company, is planning to develop “ViroDetect”, a device for detection and quantification of Human Immunodeficiency Virus (HIV) in blood plasma. For ViroDetect to be developed under ISO 13485:2016 Swedia will use Prevas AB as a development partner. During the project Prevas will put focus on improving their QMS, as continuous improvement of ones QMS is a requirement by ISO 13485:2016. Through a literature study combined with a document study of Prevas ́ QMS documents and direct observations with active participation of the development process of ViroDetect, this thesis aims to provide Prevas with improvement suggestions for their QMS certified according to ISO 13485:2016. Results showed that Prevas could improve regarding uniformity, traceability, and risk management to promote documentation and evidence-based decision making. Based on the limitations and observations done, the suggested improvements presented are considered reasonable for Prevas to implement. However, the general difficulties for organisations to achieve continuous improvement remains.

I en tid där en ny lågkonjunktur ökar pressen på företag att öka vinster och minska kostnader har engagerade medarbetares bidrag visat sig ha en avgörande roll. Trots detta utgör andelen engagerade medarbetare endast en femtedel av medarbetarna på Sveriges organisationer. De flesta medarbetare känner sig osäkra på sin uppgift eller om ledningen ens vill ha deras hjälp. Om engagerade medarbetare är nyckeln till organisationens överlevnad, varför nyttjas den inte i större utsträckning? Examensarbetets syfte har varit att undersöka hur delaktiga och engagerade medarbetare bidrar till förbättringsarbete utifrån frågeställningarna “Hur bidrar engagerade medarbetare till förbättringsarbetet?” och “Hur kan organisationer öka medarbetarnas delaktighet i förbättringsarbetet?”. Den teoretiska referensramen tar avstamp ur två av värderingarna som används inom offensiv kvalitetsutveckling: Skapa möjlighet för alla att vara delaktiga och arbeta ständigt med förbättringar. Studien utfördes utifrån en i huvudsak kvalitativ forskningsstrategi, genom utskickandet av en enkät. Enkätens utfall bekräftade tio identifierade faktorer från litteraturstudien som påverkar medarbetarengagemang. Studien visade vikten av bekräftelse och uppskattning, såsom belöning kopplat till engagemang och lyfte fram ytterligare en aspekt: Engagemang sprider engagemang. Forskningsfrågorna besvarades genom följande slutsatser: -        Engagerade medarbetare bidrar till förbättringsarbetet genom delaktighet, gott medarbetarskap, ett mer frekvent behovsinriktat idéflöde, självledarskap och genom att sprida engagemang i en lärande, idédriven organisationskultur. -        Organisationer kan öka medarbetarnas delaktighet i förbättringsarbetet genom att öka medarbetarengagemang, säkerställa progress och tillhandahålla tillfredsställande arbetsmiljö och arbetssätt. / At a time when a new recession is increasing the pressure on companies to increase profits and reduce costs, the contribution of engaged employees has proven to be crucial. Despite this, the percentage of engaged employees only makes up a fifth of the employees at the organizations in Sweden. Most employees feel uncertain about their role or whether management even wants their help. If engaged employees hold the key to the organization's survival, why is it not used to a greater extent? The purpose of this study has been to investigate how participating and engaged employees contribute to improvement work based on the following questions "How do engaged employees contribute to the improvement work?" and "How can organizations increase employee participation in improvement work?". The theoretical frame of reference is based on two of the values used in offensive quality development: Create the opportunity for everyone to participate and work continuously with improvements. The study was carried out based on an essentially qualitative research strategy, by sending out a questionnaire. The outcome of the survey confirmed ten identified factors from the literature study that affect employee engagement. The study showed the importance of affirmation and appreciation, such as rewards linked to engagement and highlighted another aspect: engagement spreads engagement. The research questions were answered through the following conclusions: -        Engaged employees contribute to the improvement work through participation, employeeship, a more frequent need-oriented flow of ideas, self-leadership and by spreading engagement in a learning, idea-driven organizational culture. -        Organizations can increase employee participation in improvement work by increasing employee engagement, ensuring progress and providing satisfactory work environment and working methods.

Managing radical change is a critical undertaking for young companies aiming to achieve growth and adapt to evolving market dynamics. This research explores the strategies, models and challenges involved in navigating and implementing significant organizational changes. The research examines the root causes of radical change failures and investigates the impact this might have on employees and organizations. The identified key factors for failure in radical change management are among others: lack of communication and information, lack of training and support, lack of proper documentation, and lack of skilled leadership and proper performance management. The research also found that poorly managed change implicates employees' well-being and grows issues of personal matter, such as performance, competence and trust-related problems. Identified implications for organizations are among others; lack of controls, damaged public relations, inefficient processes and decreased performance. Finally, the research identified the potential need for creating a new management theory that would support young companies in managing radical change specifically.

With the introduction of RIS and PACS technologies in clinical radiology, the field has become increasingly technology dependent. The quality assurance in radiology have however yet to catch on. With many quality assurance programs mainly focusing on the clinical side of radiology whilst little attention is paid to the technical aspects. This thesis serves to change that, by investigating quality assurance of radiology equipment in the workflow of hospital physicists and biomedical engineers at Södersjukhuset emergency hospital. To improve said workflows, process modelling and multi-actor system analysis was utilized in combination with the on-site inventory system Medusa. In order to model the workflows, the process modelling technique flowchart was used. To add additional information into the flowcharts, multi-actor system analysis was employed. This was done for the workflow of both scheduled and unscheduled maintenance of radiology equipment. Initially resulting in a pair of pre-study models which modelled the after the existing workflows. From said pair of pre-study models, both redundancies and main objectives for improvement were deduced. This in combination with an extensive semistructured literature review, led to a list of requirements. Two pairs of improved models were then created with the list of requirements in mind. All the models were then evaluated, including the pair of pre-study models, in workshops held with hospital physicists, biomedical engineers and respective leadership staff. These workshops contained both an open discussion and a questionnaire, asking the participants to rate the alignment of the models with the different requirements in the list. Based on the results from the workshops, one of the proposed pairs of improved models were then chosen as the final solution of an improved workflow. A workflow in which redundancies were reduced, traceability capabilities added in form of digital storage, and alignment with legislative demands from SSM assured. A step in the digitalization of Södersjukhuset. Utilizing digital technology to improve quality assurance in the workflow of radiology equipment. / I samband med introduktionen av RIS och PACS teknologi i klinisk radiologi, så har fältet blivit mer teknikdrivet. Kvalitetledning av radiologisk utrustning har däremot inte förändrats. Då de flesta kvalitetslednings program har primärt fokus på den kliniska sidan av radiologi och förbiser de tekniska aspekterna. Detta examensarbete försöker bemöta detta, genom att utreda kvalitetsledningen av radiologisk utrustning hos arbetsflödena av sjukhusfysiker och medicintekniska ingenjörer på Södersjukhuset. För att förbättra arbetsflödena, så användes processmodellering och analys av multi-aktörsystem i kombination med det lokala inventariesystemet Medusa. För att skapa en modell av arbetsflödet så användes processmodelleringstekniken flowchart. För att lägga till ytterligare information i flödena så utfördes en multi-aktörsystem analys. Detta utfördes för både förebyggande- och avhjälpande underhåll av radiologisk utrustning. Vilket resulterade i ett par av förstudiemodeller som modellerade det nuvarande arbetsflödet. Baserat på detta par av förstudiemodeller, så kunde både överflödigheter och huvudsakliga förbättringsmål härledas. Detta i kombination med en semistrukturerad litteraturundersökning, ledde till en lista med krav på modellerna. Sedan så skapades två par av modeller som förslag till förbättrat arbetsflöde, baserat på listan med krav. För att utvärdera alla modeller, inklusive förstudiemodellerna, så hölls workshops med sjukhusfysiker, medicintekniska ingenjörer och respektive chefspersonal. Dessa workshops innehöll både en öppen diskussion och ett formulär, som bad deltagarna att utvärdera de olika paren av modeller gentemot de olika kraven som hade formulerats i listan. Baserat på resultaten från dessa workshops, så valdes en av de två förslagna paren av modeller för förbättrat arbetsflöde, som en slutgiltig lösning. Ett arbetsflöde där överflödigheter har motarbetats, spårbarhet förbättrats med hjälp av digital lagring, och sammanstämning med regulatoriska krav från SSM har säkerställts. Ett steg i digitaliseringen av Södersjukhuset, genom att utnyttja digital teknik för att förbättra kvalitetledningen av radiologisk utrustning.