Biomaterial Database

Practical aspects of internal quality assurance. 1991

A Uldall

Department of Clinical Chemistry, University of Copenhagen, Herlev Hospital, Denmark.

The final analytical quality of a result is influenced by external and internal factors. The quality of external elements is influenced by the individual laboratory through its choice of method and supply; such elements are, e.g. reference materials, calibrators, control materials, reagents, reagent kits, instruments and disposables. The internal elements can be described through rules for good laboratory practice (GLP), and include all aspects of internal quality assurance. In this paper, GLP is used to describe the proper milieau in which the optimally selected method is working. The control system for acceptance or rejection of any particular batch of analysis, as well as the long-term control, are also described separately.

UI	MeSH Term	Description	Entries
D007753	Laboratories	Facilities equipped to carry out investigative procedures.	Laboratory
D009626	Terminology as Topic	Works about the terms, expressions, designations, or symbols used in a particular science, discipline, or specialized subject area.	Etymology,Nomenclature as Topic,Etymologies
D011786	Quality Control	A system for verifying and maintaining a desired level of quality in a product or process by careful planning, use of proper equipment, continued inspection, and corrective action as required. (Random House Unabridged Dictionary, 2d ed)	Control, Quality,Controls, Quality,Quality Controls
D012015	Reference Standards	A basis of value established for the measure of quantity, weight, extent or quality, e.g. weight standards, standard solutions, methods, techniques, and procedures used in diagnosis and therapy.	Standard Preparations,Standards, Reference,Preparations, Standard,Standardization,Standards,Preparation, Standard,Reference Standard,Standard Preparation,Standard, Reference
D012016	Reference Values	The range or frequency distribution of a measurement in a population (of organisms, organs or things) that has not been selected for the presence of disease or abnormality.	Normal Range,Normal Values,Reference Ranges,Normal Ranges,Normal Value,Range, Normal,Range, Reference,Ranges, Normal,Ranges, Reference,Reference Range,Reference Value,Value, Normal,Value, Reference,Values, Normal,Values, Reference
D002138	Calibration	Determination, by measurement or comparison with a standard, of the correct value of each scale reading on a meter or other measuring instrument; or determination of the settings of a control device that correspond to particular values of voltage, current, frequency or other output.	Calibrations
D002624	Chemistry, Clinical	The specialty of ANALYTIC CHEMISTRY applied to assays of physiologically important substances found in blood, urine, tissues, and other biological fluids for the purpose of aiding the physician in making a diagnosis or following therapy.	Clinical Chemistry
D005568	Forms and Records Control	A management function in which standards and guidelines are developed for the development, maintenance, and handling of forms and records.	Records Control,Forms Control,Records Management,Controls, Records,Management, Records,Records Controls
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D015203	Reproducibility of Results	The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results.	Reliability and Validity,Reliability of Result,Reproducibility Of Result,Reproducibility of Finding,Validity of Result,Validity of Results,Face Validity,Reliability (Epidemiology),Reliability of Results,Reproducibility of Findings,Test-Retest Reliability,Validity (Epidemiology),Finding Reproducibilities,Finding Reproducibility,Of Result, Reproducibility,Of Results, Reproducibility,Reliabilities, Test-Retest,Reliability, Test-Retest,Result Reliabilities,Result Reliability,Result Validities,Result Validity,Result, Reproducibility Of,Results, Reproducibility Of,Test Retest Reliability,Validity and Reliability,Validity, Face