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.
","abstract_html":"<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>","abstract_has_math":false,"creators":["Mach, Martin"],"institution":null,"degree_name":"Master of Science","degree_level":"Master's Thesis","degree_discipline":"Clinical Laboratory Sciences","degree_department":null,"school":null,"contributors":["Howard Koo, PhD","Douglas C. Lane"],"advisors":[],"committee_chairs":[],"committee_members":[],"year":2017,"date_issued":"2017-05-01T07:00:00Z","date_published":"2017-05-01T07:00:00Z","updated_at":"2026-07-24T02:04:44Z","subjects":["technical project management","quality management systems","ISO","Analytical, Diagnostic and Therapeutic Techniques and Equipment","Equipment and Supplies","Management Sciences and Quantitative Methods"],"languages":[],"rights":[],"rights_urls":[],"identifier_entries":[]},"links":{"outbound_url":"https://scholar.dominican.edu/masters-theses/276","outbound_label":"Repository record","outbound_source":"dc:identifier"},"metadata_groups":[{"id":"people","label":"People","entries":[{"key":"dc:contributor","label":"Contributor","values":["Howard Koo, PhD","Douglas C. Lane"]},{"key":"dc:creator","label":"Author","values":["Mach, Martin"]}]},{"id":"academic_context","label":"Academic Context","entries":[{"key":"dc:date.available","label":"Dc Date Available","values":["2017-05-31T07:00:00Z"]},{"key":"thesis:degree_discipline","label":"Discipline","values":["Clinical Laboratory Sciences"]},{"key":"thesis:degree_level","label":"Degree Level","values":["Master's Thesis"]},{"key":"thesis:degree_name","label":"Degree Name","values":["Master of Science"]}]},{"id":"subjects_keywords","label":"Subjects and Keywords","entries":[{"key":"dc:subject","label":"Dc Subject","values":["technical project management","quality management systems","ISO","Analytical, Diagnostic and Therapeutic Techniques and Equipment","Equipment and Supplies","Management Sciences and Quantitative Methods"]}]},{"id":"identifiers","label":"Identifiers","entries":[{"key":"dc:identifier","label":"Identifier","values":["https://scholar.dominican.edu/masters-theses/276"]}]},{"id":"additional","label":"Additional Metadata","entries":[{"key":"dc:description.abstract","label":"Abstract","values":["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.
"]},{"key":"dc:title","label":"Title","values":["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"]}]}],"canonical_facts":{"dc:contributor":["Howard Koo, PhD","Douglas C. Lane"],"dc:creator":["Mach, Martin"],"dc:date.available":["2017-05-31T07:00:00Z"],"dc:description.abstract":["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.
"],"dc:identifier":["https://scholar.dominican.edu/masters-theses/276"],"dc:subject":["technical project management","quality management systems","ISO","Analytical, Diagnostic and Therapeutic Techniques and Equipment","Equipment and Supplies","Management Sciences and Quantitative Methods"],"dc:title":["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"],"thesis:degree_discipline":["Clinical Laboratory Sciences"],"thesis:degree_level":["Master's Thesis"],"thesis:degree_name":["Master of Science"]},"updated_at":"2026-07-24T02:04:44Z"}