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

<p>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. <strong></strong></p>

Name thesis:degree_name

Master of Science

Level thesis:degree_level

Master's Thesis

Discipline thesis:degree_discipline

Clinical Laboratory Sciences

Year dc:date.available

2017

Author dc:creator

• Mach, Martin

Contributors dc:contributor

• Howard Koo, PhD
• Douglas C. Lane

• technical project management
• quality management systems
• ISO
• Analytical, Diagnostic and Therapeutic Techniques and Equipment
• Equipment and Supplies
• Management Sciences and Quantitative Methods

Repository record dc:identifier

https://scholar.dominican.edu/masters-theses/276

OAI identifier oai:identifier

oai:scholar.dominican.edu:masters-theses-1286