دانلود مقاله انگلیسی رایگان:سیستم جامع عملکرد سیستم یکپارچه (TIPES): یک جهت شمال واقعی برای مرکز پشتیبانی کارآزمایی بالینی - 2018
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  • Total integrated performance excellence system (TIPES): A true north direction for a clinical trial support center Total integrated performance excellence system (TIPES): A true north direction for a clinical trial support center
    Total integrated performance excellence system (TIPES): A true north direction for a clinical trial support center

    سال انتشار:

    2018


    عنوان انگلیسی مقاله:

    Total integrated performance excellence system (TIPES): A true north direction for a clinical trial support center


    ترجمه فارسی عنوان مقاله:

    سیستم جامع عملکرد سیستم یکپارچه (TIPES): یک جهت شمال واقعی برای مرکز پشتیبانی کارآزمایی بالینی


    منبع:

    Sciencedirect - Elsevier - Contemporary Clinical Trials Communications, 9 (2018) 81-92. doi:10.1016/j.conctc.2017.12.005


    نویسنده:

    Mike R. Sathera,∗, Sherry Parsonsa, Kathy D. Boardmana, Stuart R. Warrena, Anne Davis-Karima, Kevin Griffina, Jane A. Bettertona, Mark S. Jonesa, Stanley H. Johnsona, Julia E. Vertreesa, Jan H. Hickeya, Thelma P. Salazara, Grant D. Huangb


    چکیده انگلیسی:

    This paper presents the quality journey taken by a Federal organization over more than 20 years. These efforts have resulted in the implementation of a Total Integrated Performance Excellence System (TIPES) that combines key principles and practices of established quality systems. The Center has progressively integrated quality system frameworks including the Malcom Baldrige National Quality Award (MBNQA) Framework and Criteria for Performance Excellence, ISO 9001, and the Organizational Project Management Maturity Model (OPM3), as well as supplemental quality systems of ISO 15378 (packaging for medicinal products) and ISO 21500 (guide to project management) to systematically improve all areas of operations. These frameworks were selected for applicability to Center processes and systems, consistency and reinforcement of complimentary approaches, and international acceptance. External validations include the MBNQA, the highest quality award in the US, con tinued registration and conformance to ISO standards and guidelines, and multiple VA and state awards. With a focus on a holistic approach to quality involving processes, systems and personnel, this paper presents activities and lessons that were critical to building TIPES and establishing the quality environment for conducting clinical research in support of Veterans and national health care.
    Keywords: Integration of quality systems ، Quality hierarchy ، Baldrige criteria ، ISO 9001 and 15378 standards ، ISO 21500 guideline standards ، Organizational project management maturity ، model


    سطح: متوسط
    تعداد صفحات فایل pdf انگلیسی: 12
    حجم فایل: 658 کیلوبایت

    قیمت: رایگان


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