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Defn Quality The degree to which a product or service meets requirements
Quality Control Provides a high degree of confidence that testing and examination
results are accurate for the batch of samples being tested or examined at
that time
It monitors the analytic method
Quality Assurance Set of planned actions to provide confidence that processes other than
testing that influence the quality of the laboratory's results and reports
are working as expected, individually and collectively.
Looks beyond the performance of just the test method or piece of
equipment to assess how well the laboratory's entire workflow is
functioning
Quality Management System Encompasses all the management activities needed to ensure that the
laboratory's workflow proceeds smoothly to provide laboratory services
to customers and patients
12 Quality Systems Essentials [QSEs] represents a way to organize all the
policies, processes, and procedures that any laboratory needs to meet
all requirements of U.S. laboratory regulatory and accreditation
organizations. This guideline has been published by the Clinical and
Laboratory Standards Institute [CLSI]
Quality Management in the Medical Laboratory.pdf Quality Management in the Medical Laboratory.pdf Quality Management in the Medical Laboratory.pdf