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

Graduation Date


Document Type

Master's Thesis

Degree Name

Master of Science

Department or Program

Clinical Laboratory Sciences

Department or Program Chair

Mary Sevigny, PhD

First Reader

Howard Koo, PhD

Second Reader

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.

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