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