Development of a Quality Management System (QMS) in Conformance with International Organization for Standardization (ISO) 13485:2016 Focusing on Sections 4 and 5 by Utilizing Technical Project Management Techniques for CDG Biotech Corporation
Master of Science
Department or Program
Clinical Laboratory Sciences
Department or Program Chair
Mary Sevigny, Ph.D.
Howard Koo, Ph.D.
Douglas C. Lane
CDG Biotech Corporation, a new biotechnology startup, plans to introduce medical devices for use in immunological diagnostics and therapies. CDG seeks to develop and implement a quality manual as part of their quality management system and to gain accreditation approval domestically and internationally. This project attempts to develop a customized quality manual based on International Organization for Standardization (ISO 13485:2016) standards utilizing quality management and technical project management concepts and tools. The main goal of the project is to provide a quality manual for medical devices with an emphasis on section 4: Quality Management System and section 5: Management Responsibility of the ISO standard. The quality manual and the quality management and project management tools/concepts provide a basic framework of the broader quality management system. The level of detail, depth, and outcome is limited by the time, cost, and external factors of business, regulatory, and international factors.
Mach, Martin, "Development of a Quality Management System (QMS) in Conformance with International Organization for Standardization (ISO) 13485:2016 Focusing on Sections 4 and 5 by Utilizing Technical Project Management Techniques for CDG Biotech Corporation" (2017). Master's Theses and Capstone Projects. 276.
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