ISO 15189:2012 Medical laboratories — Particular requirements for quality and competence

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ISO 15189:2012 Medical laboratories — Particular requirements for quality and competence


ISO 15189:2012 Medical laboratories — Particular requirements for quality and competence: This International Standard is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognising the competence of medical laboratories. While this International Standard is intended for use throughout the currently recognised disciplines of medical laboratory services, those working in other services and disciplines could also find it useful and appropriate.

Abbreviation: ISO 15189:2012


MitoPedia concepts: MitoFit Quality Control System 

Publicly available informative sections of standards

Biological reference interval: reference interval; central 95% interval of the distribution of reference values.
Examination: set of operations having the object of determining the value or characteristics of a property. In some disciplines (e.g. microbiology) an examination is the total activity of a number of tests, observations or measurements.
Laboratory capability: physical, environmental and information resources, personnel, skills and expertise available for the examinations in question. A review of laboratory capability could include results of earlier participation in interlaboratory comparisons or external quality assessment schemes or the running of trial examination programmes, or all these, in order to demonstrate uncertainties of measurement, limits of detection, etc.
Laboratory management: person(s) who manage the activities of a laboratory headed by a laboratory director.
Measurement: set of operations having the object of determining a value of a quantity.
Medical laboratory: clinical laboratory; laboratory for the biological, microbiological, immunological, chemical, immunohaematological, haematological, biophysical, cytological, pathological or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention and treatment of disease in, or assessment of the health of, human beings, and which may provide a consultant advisory service covering all aspects of laboratory investigation including the interpretation of results and advice on further appropriate investigation. These examinations also include procedures for determining, measuring or otherwise describing the presence or absence of various substances or micro-organisms. Facilities which only collect or prepare specimens, or act as a mailing or distribution centre, are not considered to be medical or clinical laboratories, although they may be part of a larger laboratory network or system.
Post-examination procedures: postanalytical phase; processes following the examination including systematic review, formatting and interpretation, authorization for release, reporting and transmission of the results, and storage of samples of the examinations.
Pre-examination procedures: preanalytical phase; steps starting, in chronological order, from the clinician’s request and including the examination requisition, preparation of the patient, collection of the primary sample, and transportation to and within the laboratory, and ending when the analytical examination procedure begins.
Primary sample: specimen; set of one or more parts initially taken from a system. In some countries, the term “specimen” is used instead of primary sample (or a subsample of it), which is the sample prepared for sending to, or as received by, the laboratory and which is intended for examination.
Quality management system: management system to direct and control an organization with regard to quality [SOURCE: ISO 9000:2005, definition 3.2.3]. For the purposes of this International standard, the "quality" referred to in this definition relates to matters of both management and technical competence.
Quantity: attribute of a phenomenon, body or substance that may be distinguished qualitatively and determined quantitatively.
Referral laboratory: external laboratory to which a sample is submitted for a supplementary or confirmatory examination procedure and report.
Sample: one or more parts taken from a system and intended to provide information on the system, often to serve as a basis for decision on the system or its production. EXAMPLE: A volume of serum taken from a larger volume of serum.
Traceability: property of the result of a measurement or the value of a standard whereby it can be related to stated references, usually national or international standards, through an unbroken chain of comparisons all having stated uncertainties [SOURCE: VIM:1993, definition 6.10].
Trueness of measurement: closeness of agreement between the average value obtained from a large series of results of measurements and a true value (adapted from ISO 3534-1:1993, definition 3.12).
Uncertainty of measurement: parameter, associated with the result of a measurement, that characterizes the dispersion of the values that could reasonably be attributed to the measurand.