Quality Management System Implementation Case Study

This case study outlines the implementation of Scilife’s Document Control and Change Control Management modules by QuaDigi, a company in the medical devices industry. The objective was to enhance quality management efficiency and prepare for ISO certification. The onboarding process was described as smooth, with effective support from Scilife, allowing QuaDigi to manage document access and organization efficiently. The modules automated the approval process, reducing manual follow-ups and saving time. The system ensures that the right team members have access to relevant documents, preventing misplacement or unauthorized access. Although QuaDigi has not yet achieved ISO 9001 and ISO 13485 certifications, the implementation of Scilife's eQMS is positioning them to meet these compliance goals by 2025. The case study emphasizes the importance of having a scalable eQMS that supports long-term quality management needs.