ISO 13485:2016 IMPLEMENTATION AND INTERNAL AUDIT READINESS IN A UKRAINIAN MEDICAL DEVICE MANUFACTURER
| dc.contributor.author | Zabroda, Daryna | |
| dc.date.accessioned | 2026-06-04T10:04:57Z | |
| dc.date.available | 2026-06-04T10:04:57Z | |
| dc.date.issued | 2026-05 | |
| dc.description.abstract | This capstone examines the implementation of ISO 13485:2016 quality management systems and internal audit readiness within a Ukrainian medical device manufacturer. The research addresses the problem of the gap between formal certification and actual operational effectiveness of quality management systems in emerging regulatory environments. This research is guided by the following research questions: how the level of ISO 13485 implementation affects regulatory readiness and compliance performance; how internal audit practices influence the recurrence of nonconformities; and how management involvement impacts CAPA effectiveness. The aim of the research is to evaluate the relationship between implementation depth, audit performance, and the effectiveness of corrective action. A mixed-methods single-case study design was applied. Quantitative data were collected through a clause-based gap analysis and internal audit metrics, while qualitative data were obtained through structured document analysis of QMS documentation. The sample consists of one Ukrainian medical device manufacturing organization in the pre-certification stage. The results indicate a moderate level of ISO 13485 implementation (70.5%), with stronger performance in documentation and weaker integration in monitoring and improvement processes. Internal audits effectively identify nonconformities but have a limited impact on preventing recurrence (32% repeat rate). CAPA processes demonstrate moderate effectiveness, with delays and incomplete closure. The findings suggest that implementation depth, rather than certification status, determines regulatory readiness and quality performance. Management involvement is critical for improving CAPA effectiveness and reducing recurring issues. The research contributes to theory by emphasizing implementation maturity and provides practical recommendations for improving QMS effectiveness in Ukrainian medical device organizations. | en |
| dc.identifier.citation | Zabroda, Daryna. (2026). ISO 13485:2016 IMPLEMENTATION AND INTERNAL AUDIT READINESS IN A UKRAINIAN MEDICAL DEVICE MANUFACTURER. Kyiv: American University Kyiv. URI: https://er.auk.edu.ua/handle/234907866/184 | en |
| dc.identifier.uri | https://er.auk.edu.ua/handle/234907866/184 | |
| dc.language.iso | en_US | |
| dc.publisher | Manuscript | |
| dc.subject | ISO 13485 | |
| dc.subject | quality management system | |
| dc.subject | internal audit | |
| dc.subject | medical devices | |
| dc.subject | CAPA | |
| dc.subject | Ukrainian medical device organizations | |
| dc.title | ISO 13485:2016 IMPLEMENTATION AND INTERNAL AUDIT READINESS IN A UKRAINIAN MEDICAL DEVICE MANUFACTURER | |
| dc.title.alternative | ВПРОВАДЖЕННЯ СТАНДАРТУ ISO 13485:2016 ТА ГОТОВНІСТЬ ДО ВНУТРІШНЬОГО АУДИТУ НА УКРАЇНСЬКОМУ ПІДПРИЄМСТВІ З ВИРОБНИЦТВА МЕДИЧНИХ ВИРОБІВ | |
| dc.type | Thesis |