Improvement of Prevas’ AB quality management system according to ISO 13485:2016 : As a parallel project with the fictive development of ViroDetect for Sweden Diagnostics AB

Abstract: 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.