Confirmation through the provision of objective evidence , that the requirements for a specific intended use or application have been fulfilled
Confirmation , through provision of objective evidence , that specified requirements have been fulfilled
4.14.7 Quality Indicators
The laboratory shall establish quality indicators to monitor and evaluate performance throughout critical aspects of pre – examination , examination and post examination processes
5.5.2 Biological Reference Intervals Or Clinical Decision Values
The laboratory shell define the biological reference intervals or clinical decision valuer , document the basis for the reference intervals or decision values and communicate this information to users.
When a particular biological reference interval or decision value is no longer relevant for the population served , appropriate changes shall be made and communicated to the users .
When the laboratory changer an examination procedure or pre examination procedure , the laboratory shall review associated reference intervals and clinical decision values , as applicable .