In addition to the QMS structure and QSEs, there has to be a structured laboratory operations workflow that is applied to the QMS structure. The actual pattern of workflow is specific to each laboratory. The workflow pattern for any laboratory includes all phases of testing: pre-examination (preanalytical), examination (analytical), and post-examination (postanalytical). The 12 QSEs serve as structural components that can be applied to the three phases of laboratory testing and apply to all laboratory disciplines. See the sample workflow diagram for an overview of how workflow and the QSEs are incorporated into the laboratory operation.
