Dokumenthantering inom den medicintekniska branschen : En fallstudie

The aim of this thesis is to examine the records management in an enterprise in the private sector. The thesis dis-cuss the process construction within the core business and how the employee interpreters its construction. Also the goals in the processes are discussed by their Quality Management System and what the employees sees as their goals in the processes. To understand how people manage their records the information culture is studied in different variations, for example in observations and in records management systems.The case study which has been examined is a multinational enterprise in the medical technology industry. The industry is characterized by regulations, such as Food and Drug Administration (FDA) and International Organi-zation of Standardization (ISO). To put the findings in the thesis in a perspective the Swedish process oriented archival description is used as a counterpoint, to highlight similarities and contradictions with the aim of develop-ing the different perspective in both private and public sector from an archival science point of view. The position-ing is organization theory with the aim of process orientation and different ways to perform a process description. As a method to understand the organization and how the core business is assembled, a process description was created based on both the enterprise's Quality Management System and the interviews performed. To overview the general records management in the enterprise, the employees were asked to perform a survey about their hab-its and point of views about records management.The result of the analysis shows that the enterprise's Quality Management System mainly describes their pro-cesses in a way to achieve quality, requirements and efficiency. And not in a way that helps the employee to pre-form records management in a sustainable and long-term way. A long-term storage is in this case study about 10 years after the product has been out of production and in some few cases more. The thesis has shown that in many cases, only adequate solutions occur in records management in the enterprise, and this attitude is part of the in-formation culture. Adequate solutions means that the enterprise still fulfills the regulations that FDA and ISO require. But the records management that's part of their daily work routines can improve to prevent human errors and to ensure the quality of long-term storage. This is a two years master's thesis in Archive studies