"It is the people comprising
the workforce who have the ability to create a culture in which quality is promoted and value
is delivered to stakeholders. (Larry Kennedy)
Certifying the CRS Quality Management Culture
via the Quality Exploratory Program
The SASI Keeping-the-Promise Culture
Certifying the QM Culture is an essential educational first-step in creatiing the organizational unity to support the commitment to quality at every level of service. It is upon the strength of the QM work culture that a deliberately designed and implemented QM system can deliver on its promises.
The Quality Exploratory Program is built upon a specialized Clinical Research Quality Manager (CRQM) professional certification. The CRQM provides clinical research site leaders with the competencies required to develop a high-performing QM work culture. When these resources are properly implemented, clinical trial managers can improve the operations of a CRS and leverage their specialized subject matter expertise and clinical practice competencies to conform to the requirements of the SASI-QMS:2023-2.
This figure depicts how the curriculum builds a culture of competency and reliability into a workforce by teaching both values and skills. It shows the context within which the Clinical Research Quality Manager (CRQM) Certification becomes a viable resource for staff education and the necessary collaboration to implement the SASI-QMS:2023-2.
Read the Details of the Training Modules
Get a Quick Start Quietly and Confidentially
The Quality Exploratory Program (QAP) is the required starting point of accreditation. It can also be defined as the "pre-Accreditation" starting point because it allows an Accreditation Candidate to assesss and improve prior to and outside the Accrediation review process. It is designed to "certify" or "validate" the quality management bonafides of the Candidate work culture and "accelerate" the CRS's validation of its capacity to conform to and sustain its conformance to the Standard.
The SASI-QMS:2023-2 has adopted the constructs of the Quality Management
Institute’s Keeping-the-Promise Complete Quality Management curriculum. The online, self-paced, courses are supported by specialized
leadership discussions with QMI and SASI professionals. SASI recognizes the QMI currirulum as both a standard
for performance and a standard for training that creates a positive quality management work culture; one that supports
the production of accurate research data by a competent, high-performing, cohesive team.
Beyond Compliance to the "What," "Why," and "How" of Quality Management
Within a CRS, the strategic significance of developing a workforce that is reliable, competent and responsive is based upon the need to get beyond a work culture defined as compliant with regulations and requirements to create one based on systems thinking and continual improvement as part of a holistic approach. While processes and procedures that are built upon known requirements can substantially provide the "what" for a basis of quality management, the "why" and "how" are demonstrated by the skills and values of a workforce.
Knowing “why” it is necessary to do things – the consequences to people, processes and outcomes, with or without compliance – provides a sustainable motivation for continual improvement. Knowing “how” to properly implement SASI-QMS:2023-2 enables the framework for creating more reliable outcomes. These skills and values are covered either through the training requirements embedded within the main clauses or in the annexes of SASI-QMS:2023-2.