{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Fbd2d1d2b-d767-4e03-83aa-239c39a85ac1","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Quality Systems Management (QSM) vs. Quality Management System (QMS) - What's The Difference?","description":"Do you know the difference between quality management system (QMS) and quality systems management (QSM)? \n\nToday\u2019s guest is Larry Mager of Mgmt-Ctrl. He describes the difference between QMS and QSM, as well as offers tips on concepts that make medical device businesses more efficient and effective to benefit patients. \n\nSome of the highlights of the show include:\n \n\u25cf\tChallenges with management control include the different definitions of quality management. Most organizations define it too narrowly and passively.\n\u25cf\tQMS documents processes, procedures, and responsibilities to achieve quality policies/objectives. \n\u25cf\tFor Mgmt-Ctrl, QMS includes quality operations and QSM. The QSM solution is designed to measure, manage, and improve the quality of products/processes.\n\u25cf\tCompanies focus more on compliance than quality due to costs. Predictive analytics extract info from data to find patterns that may predict outcomes.\n\u25cf\tCompany\u2019s executive team and person responsible for regulatory compliance (PRRC) are responsible for measuring and confirming process/product quality.\n\u25cf\tMedical device companies need to be proactive, not reactive. And, they need to understand management control terminology, such as product and process. \n\u25cf\tDesign and development process has not focused on critical quality controls or reviewed released products against those controls to make adjustments.\n\u25cf\tA medical device that\u2019s a software component must be controlled and managed appropriately within a quality system.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/71f07152-dfb0-4e00-943b-3b266df698d9/37b2c902-6ca8-4672-b7b9-16f2f3a7ad31.jpg"}