MSc (Med), Pharmaceutical Affairs, Faculty of Health Sciences, University of the Witwatersrand / Quality Assurance (QA) Audits are an essential component and an integral part of clinical trials. As a quality improvement tool, forming part of Good Clinical Practice (GCP) an audit can demonstrate that real efforts are being made to improve and enhance the quality of professional care to all trial subjects participating in clinical trials. Specifically, clinical research performed on the central nervous system (CNS) involves distinctive areas of concern to adherence to good clinical practice in this therapeutic area. For example an informed consent process not conducted appropriately for subjects with e.g. Schizophrenia or Alzheimer’s disease; or inter-individual rating differences in instances when different investigators (psychiatrist) assess a trial subject. A need was identified to analyze the association between the CNS indication audited and the audit findings and to perform a trend analysis that highlight re-occuring audit findings. A total of 123 CNS audit reports were obtained from the Quality Assurance Departments of Quintiles in South Africa and Europe. The audit reports were grouped into the 15 CNS indications that were audited. Five hundred and six (506) audit findings were derived from the 123 CNS audits reports. The audit findings were categorized according to GCP subject matter, regulatory requirements or Standard Operating Procedures (SOPs). The severity of audit findings was classified as critical or major. The results of this investigation suggested a need for substantial improvement in three important areas. Firstly; adherence to the study requirements inclusive of relevant Standard Operating Procedures (SOPs). Secondly the development of better defined protocols and thirdly training of monitors. Study planners and Clinical Trial Management should take a proactive role to minimize the audit findings by ensuring monitors with experience in the research field should be involved in the study. Procedures should be implemented to educate site staff. Focus should be placed on the importance of detailed source documentation, adherence to investigational product dosage requirements, the conduct of the informed consent process, and adequate study documentation maintenance.

The diploma thesis is being elaborated on the topic of “Marketing Audit”. The aim of this work is to implement marketing audit in the company XX. The subject of the audit is the oldest company’s product at the full- scale, i.e. general estimation of all marketing procedures. Marketing audit is a method of analysis in this diploma thesis. The results are summarized in the SWOT analysis, which was the resource for the list of recommendations for better marketing in the company. Consequently there is an estimation for a budget for further steps as well as estimated revenues. At the close I advise undergoing another audit to crosscheck accuracy of performed changes in the company.

The research question addressed in this research concerned the extent to which internally developed quality assurance processes are effective in the promotion and enhancement of quality in education and training programmes in business with special reference to adult literacy. The aim of the research was to explore the presence of and the need for a possible implementation of effective quality assurance processes in education and training in business. It also aimed at seeking for answers to the following questions: -- Do education and training programmes in business have effective quality assurance processes in place for the promotion and enhancement of quality? -- Do education and training programmes in business embrace best practice principles for continuous quality improvement? A literature review, interviews and questionnaires were the instruments employed for the collection of data. Through these research instruments, better insight into the concepts of ‘quality’ and ‘quality assurance’ was obtained. From the literature review, it emerged that the implementation of best practice principles borrowed from industry in education and training programmes can play a crucial role in continuous improvement. In contrast, it emerged from the empirical investigation results that no effective quality assurance processes are applied in education and training in business in South Africa. Business appeared not to be taking a holistic approach to quality assurance and management was found to be ignoring important aspects, such as human resources development, partnership and/or similar issues that need attention if quality is to be holistically promoted and enhanced. In conclusion, a few recommendations that could contribute to quality promotion and enhancement in education and training were made. These were the implementation of a market-related remuneration strategy or competency-based pay, a retention strategy, a quality assurance training programme, Total Quality Management, a Balanced Scorecard, recognition and incentive scheme, a performance appraisal system and the involvement of line managers and union representatives in the management of education and training programmes in business. / Thesis (PhD)--University of Pretoria, 2007. / Education Management and Policy Studies / unrestricted

In der heutigen Zeit ist der Wettbewerbsdruck in der Textilindustrie sehr präsent. Ein Qualitätsmanagementsystems nach DIN EN ISO 9000 ff. erhöht die interne Unternehmenstransparenz, vereinfacht Unternehmensstrukturen und verbessert interne Prozessabläufe. Eine permanente Analyse des Systems durch Audits, dient zur Fehlerprophylaxe und senkt letztendlich Kosten. Die Forschungsarbeit befasst sich mit der Frage, in welchem Umfang die DIN EN ISO 9000 ff. auf die Textilindustrie anwendbar sind. Qualitative Experteninterviews wurden im Rahmen der Untersuchung angewandt und das Ergebnis zeigt, dass die Normen auf die Textilindustrie anwendbar sind. Die Untersuchung zeigt ergänzend, dass Voraussetzungen zur Implementierung eines solchen Systems geschaffen werden müssen. Auf Grundlage der Erkenntnisse werden die erarbeiteten Voraussetzungen aufgegriffen und unter Berücksichtigung der Textilindustrie vertieft. Ein Kostenplan wurde bis zur Zertifizierung aufgestellt.:Abbildungsverzeichnis 5 Tabellenverzeichnis 6 Abkürzungsverzeichnis 7 1 Einleitung 8 1.1 Problemstellung 9 1.2 Zielsetzung der Arbeit 9 2 Theoretische Grundlagen 11 2.1 Textil- und Bekleidungsindustrie in Deutschland 11 2.2 Definition des Begriffs „Qualität“ 12 2.3 Branchenunabhängiges Qualitätsmanagementsystem 14 2.4 Qualitätsmanagement in der Textilindustrie 16 2.5 Entstehung der Normen 18 2.5.1 Entwicklungen der Normen 20 2.5.2 Entwicklung des Qualitätsaudits 23 2.6 Kernnormen der ISO-9000-Familie 24 2.6.1 ISO 9000 26 2.6.2 ISO 9001 27 2.6.3 ISO 9004 28 2.6.4 ISO 19011 29 2.6.5 Relevante Normen, Leitfäden und Best-Practice-Modelle fürs Qualitätsmanagement 31 2.7 Dokumente eines QS-Systems 34 2.8 Prinzipien des Audits 36 2.8.1 Qualitätsaudit 39 2.8.2 Systemaudit 41 2.8.3 Prozessaudit 41 2.8.4 Produktaudit 42 3 Untersuchungsmethodik 44 3.1 Experte I 45 3.1.1 DQS – Deutsche Gesellschaft zur Zertifizierung von Managementsystemen 46 3.2 Experte II 46 3.2.1 Intertek 47 4 Ergebnisse 48 4.1 Qualitätsmanagement-Handbuch 52 4.1.1 Qualitätshandbuch für den externen und internen Gebrauch 55 4.1.2 Enterprise Wiki als Dokumentationsverwaltungssystem 55 4.2 Auswahl geeigneter Auditoren 60 4.2.1 1. Persönliches Verhalten von Auditoren 61 4.2.2 2. Allgemeines Wissen und Fertigkeiten von Auditoren 62 4.2.3 3. Disziplin- und branchenspezifisches Wissen und Fertigkeiten von Auditoren 64 4.2.4 4. Allgemeines Wissen und Fertigkeiten eines Auditteamleiters 64 4.2.5 Auditorenauswahl in der Praxis 65 4.3 Kostenplan bis zur Zertifizierung 67 4.3.1 Unternehmen I 67 4.3.2 Unternehmen II 69 4.3.3 Kostenplan 70 4.3.4 Erläuterung des Kostenplans 74 4.3.5 Kosten und Nutzen 78 5 Nebenerkenntnis 80 5.1 Der Weg zur Zertifizierung 80 5.2 Ausblick auf die Norm 9001:2015 87 6 Fazit 90 7 Gender-Erklärung 92 8 Literaturverzeichnis 93 9 Anhang 98 9.1 Fragenkatalog – Interviewleitfaden 98 9.2 Aufwand und Kosten für eine Erst-Zertifizierung nach ISO 9001 100 / Nowadays, competitive constraints are very famous in the textile industry. A quality management system subject to DIN EN ISO 9000 et sqq. increases the intern transparency of companies, simplifies the structures of them and improves the intern processes. A permanent analysis of the system, undertaken by audits, is used to avoid mistakes and to reduce costs in the end. This research deals with the question to what extend the DIN EN ISO 9000 et sqq. can be used for the textile industry. Qualitative interviews of experts were used in this study and the result is that the rules can be used for this branch of industry. The study shows also that preconditions must be created to implement such a system. On the basis of these findings the prepared preconditions are used and deepened under consideration of the textile industry. A financial plan (overview) has been established up to the certification.:Abbildungsverzeichnis 5 Tabellenverzeichnis 6 Abkürzungsverzeichnis 7 1 Einleitung 8 1.1 Problemstellung 9 1.2 Zielsetzung der Arbeit 9 2 Theoretische Grundlagen 11 2.1 Textil- und Bekleidungsindustrie in Deutschland 11 2.2 Definition des Begriffs „Qualität“ 12 2.3 Branchenunabhängiges Qualitätsmanagementsystem 14 2.4 Qualitätsmanagement in der Textilindustrie 16 2.5 Entstehung der Normen 18 2.5.1 Entwicklungen der Normen 20 2.5.2 Entwicklung des Qualitätsaudits 23 2.6 Kernnormen der ISO-9000-Familie 24 2.6.1 ISO 9000 26 2.6.2 ISO 9001 27 2.6.3 ISO 9004 28 2.6.4 ISO 19011 29 2.6.5 Relevante Normen, Leitfäden und Best-Practice-Modelle fürs Qualitätsmanagement 31 2.7 Dokumente eines QS-Systems 34 2.8 Prinzipien des Audits 36 2.8.1 Qualitätsaudit 39 2.8.2 Systemaudit 41 2.8.3 Prozessaudit 41 2.8.4 Produktaudit 42 3 Untersuchungsmethodik 44 3.1 Experte I 45 3.1.1 DQS – Deutsche Gesellschaft zur Zertifizierung von Managementsystemen 46 3.2 Experte II 46 3.2.1 Intertek 47 4 Ergebnisse 48 4.1 Qualitätsmanagement-Handbuch 52 4.1.1 Qualitätshandbuch für den externen und internen Gebrauch 55 4.1.2 Enterprise Wiki als Dokumentationsverwaltungssystem 55 4.2 Auswahl geeigneter Auditoren 60 4.2.1 1. Persönliches Verhalten von Auditoren 61 4.2.2 2. Allgemeines Wissen und Fertigkeiten von Auditoren 62 4.2.3 3. Disziplin- und branchenspezifisches Wissen und Fertigkeiten von Auditoren 64 4.2.4 4. Allgemeines Wissen und Fertigkeiten eines Auditteamleiters 64 4.2.5 Auditorenauswahl in der Praxis 65 4.3 Kostenplan bis zur Zertifizierung 67 4.3.1 Unternehmen I 67 4.3.2 Unternehmen II 69 4.3.3 Kostenplan 70 4.3.4 Erläuterung des Kostenplans 74 4.3.5 Kosten und Nutzen 78 5 Nebenerkenntnis 80 5.1 Der Weg zur Zertifizierung 80 5.2 Ausblick auf die Norm 9001:2015 87 6 Fazit 90 7 Gender-Erklärung 92 8 Literaturverzeichnis 93 9 Anhang 98 9.1 Fragenkatalog – Interviewleitfaden 98 9.2 Aufwand und Kosten für eine Erst-Zertifizierung nach ISO 9001 100

Date:                        2018-06-04 Level:                       Bachelor thesis in Business Administration, 15 cr Institution:              School of Business, Society and Engineering, Mälardalen University Authors:                   Blerta Balaj                                   Fariba Mohammedian                              Title:                        Digitization in the audit profession                                                                 – A qualitative study on how efficiency and quality have changed in                                                                       connection with digitization Tutor:                      Staffan Boström Keywords:              Digitization, audit, information technology, efficiency audit, quality audit Research questions:               What strengths and weaknesses result from the development of digitization within                                 the audit profession?                                 What possibilities does digitization bring within the audit profession? Purpose:                  The purpose of the study is to examine the impact of digitization on the audit                                 profession. Specifically, it is investigated how the efficiency and quality of audit                                 has changed in connection with digitization. Method:                  The study is based on a qualitative research method with an abductive approach.                                Semi-structured interviews with four authorized auditors have been conducted for                                 the collection of information. Information gathering has also been done through                                scientific articles, literature and electronic sources. Conclusion:            More assignments per auditor can be performed but there is currently insufficient                                knowledge within information technology. The evolution of digitization enables                                increased efficiency and quality within the audit profession. In the future,                                increased knowledge within IT will be crucial to the profession. / Datum:                    2018-06-04 Nivå:                        Kandidatuppsats Företagsekonomi, 15 hp Akademi:                Akademin för Ekonomi, Samhälle och Teknik, Mälardalens Högskola Författare:              Blerta Balaj                                   Fariba Mohammedian                                                    Titel:                        Digitalisering inom revisionsyrket                                                               – En kvalitativ studie om hur effektivitet och kvalitet har förändrats i                                                                     samband med digitaliseringen Handledare:            Staffan Boström Nyckelord:              Digitalisering, revision, informationsteknologi, effektivitetsrevision,                                                                 revisionskvalitet Forsknings- frågor:                     Vilka styrkor och svagheter medför utvecklingen av digitalisering inom                                                                    revisionsyrket?                                                              Vilka möjligheter öppnar digitaliseringen upp för inom revisionsyrket? Syfte:                       Syftet med arbetet är att studera vilken påverkan digitaliseringen har medfört                                 inom revisionsyrket. Specifikt undersöks hur effektivitet och kvalitet av revision                                 har förändrats i samband med digitaliseringen. Metod:                     Studien utgår från en kvalitativ forskningsmetod med en abduktiv ansats.                                Semistrukturerade intervjuer med fyra auktoriserade revisorer har utförts för                                insamling av information. Informationsinsamling har även skett genom                                vetenskapliga artiklar, litteratur samt elektroniska källor. Slutsats:                  Fler revideringar per revisor kan utföras men det finns i nuläget bristande kunskap                                 inom informationsteknik. Digitaliseringens utveckling möjliggör för ökad                                 effektivitet och kvalitet inom revisionsyrket. I framtiden kommer ökad kunskap                                 inom IT vara avgörande för yrket.

This diploma thesis called Quality Management In The Selected Company is focused on quality management system, its oganisation, management and development. The aim of this diploma thesis is to analyse chosen areas of implemented quality management system in the selected company, to identify bottlenecks and to suggest changes and to propose recommendations for achieving better results in this area. The analysed company is called EBAS spol. s r.o. which focuses on metal and wood production. The theoretical review is dedicated to the issue of quality management, starting with term and concept of quality and quality management, followed by identification of advantages and importance of quality management system. Certain attention is paid to quality management processes, and last but not least, costs of quality and documentation in quality management system. The practical part of the diploma thesis begins with the company in general, especially with company history, its activities, portfolio and organization structure, followed by the analysis of selected areas of current quality mangement system applied in the company. The analysis includes the analysis of processes of the quality management system, documentation of QMS, quality goals and politics, supplier rating system and at last but not least, customer satisfaction monitoring system. Based on this analysis there are several reccomendations proposed, which should lead not only to increased quality management system efficiency, but also to increased efficiency of company in general.

The purpose of the study is to explore the current policy and practice of the national and institutional QA system in public HEIs in Ethiopia in order to determine how the quality of teaching and learning might have been enhanced through the QA system. Two organisational theories – contingency and neo-institutional theory – provide a theoretical lens to explain how internal and external organisational environments affect the implementation of QA in the HEIs. The mixed-methods research approach was used in the study, including document analysis, semi-structured interviews and questionnaires. Three public universities were chosen as data source. At macro level, the HERQA was also included to examine the effect of the institutional environments on internal quality assurance practices. The findings revealed that there is little evidence of self-initiated quality enhancement activities in the public HEIs. They do not have adequate structures, systems, and written policies to assure quality. The quality assurance efforts were implemented without a clear sense of direction and purposes and therefore lacked effective coordination. The self-evaluations were symbolically took place at the higher levels of the universities and that the results of the evaluations were rarely used in a structured way in improvement of teaching-learning, faculty decision-making and planning processes. It is far from clear that whether the internal quality assurance contributed to the teaching and learning or transformed the student learning experience. It can be concluded that the HERQA’s quality assurance policy and practices seems to be de-coupled from internal initiatives to improve quality in the higher education institutions. It is recommended that HEIs should develop QA policy, mobilise resources for institutional quality improvement, establish full-fledged QA structures at all levels, and furnish the structures with necessary human resources. The HEIs should initiate and undertake effective self-assessment of their activities, own it and work towards achieving their own stated objectives. It is important that the HERQA should develop accreditation procedures, particularly at programme level, for the public HEIs. The HERQA should consider playing more active roles in communicating with HEIs regularly about QA; pay more attention to a follow-up of the audits, the punctual development and delivery of the SEDs. The HERQA should be more independent, have more autonomy and sufficient resources to become a viable professional agency informing the HE sector on the quality of its performance. / Educational Management and Leadership / D. Ed. (Education Management)

The purpose of the study is to explore the current policy and practice of the national and institutional QA system in public HEIs in Ethiopia in order to determine how the quality of teaching and learning might have been enhanced through the QA system. Two organisational theories – contingency and neo-institutional theory – provide a theoretical lens to explain how internal and external organisational environments affect the implementation of QA in the HEIs. The mixed-methods research approach was used in the study, including document analysis, semi-structured interviews and questionnaires. Three public universities were chosen as data source. At macro level, the HERQA was also included to examine the effect of the institutional environments on internal quality assurance practices. The findings revealed that there is little evidence of self-initiated quality enhancement activities in the public HEIs. They do not have adequate structures, systems, and written policies to assure quality. The quality assurance efforts were implemented without a clear sense of direction and purposes and therefore lacked effective coordination. The self-evaluations were symbolically took place at the higher levels of the universities and that the results of the evaluations were rarely used in a structured way in improvement of teaching-learning, faculty decision-making and planning processes. It is far from clear that whether the internal quality assurance contributed to the teaching and learning or transformed the student learning experience. It can be concluded that the HERQA’s quality assurance policy and practices seems to be de-coupled from internal initiatives to improve quality in the higher education institutions. It is recommended that HEIs should develop QA policy, mobilise resources for institutional quality improvement, establish full-fledged QA structures at all levels, and furnish the structures with necessary human resources. The HEIs should initiate and undertake effective self-assessment of their activities, own it and work towards achieving their own stated objectives. It is important that the HERQA should develop accreditation procedures, particularly at programme level, for the public HEIs. The HERQA should consider playing more active roles in communicating with HEIs regularly about QA; pay more attention to a follow-up of the audits, the punctual development and delivery of the SEDs. The HERQA should be more independent, have more autonomy and sufficient resources to become a viable professional agency informing the HE sector on the quality of its performance. / Educational Leadership and Management / D. Ed. (Education Management)