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EN ISO 15195:2003

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003)
Superseded date

11-07-2019

Published date

01-10-2003

Publisher

Comite Europeen de Normalisation

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Management system requirements
  4.1 Organization and management
  4.2 Quality management system
  4.3 Personnel
  4.4 Measurement documentation and records
  4.5 Contracting
5 Technical requirements
  5.1 Premises and environmental conditions
  5.2 Handling of samples
  5.3 Equipment
  5.4 Reference materials
  5.5 Reference measurement procedures
  5.6 Metrological traceability - Uncertainty of measurement
  5.7 Quality assurance
  5.8 Reporting results
Annex A (informative) Cross-references to ISO/IEC 17025:1999
Annex ZA (normative) Normative references to international
         publications with their relevant European publications
Bibliography

ISO 15195:2003 gives the specific requirements for reference measurement laboratories in laboratory medicine. Examinations of properties with results reported on a nominal or ordinal scale are not included.ISO 15195:2003 is not applicable to routine medical laboratories.The general requirements for the competence of calibration laboratories are laid down in ISO/IEC 17025 for testing and calibration laboratories. ISO 15195:2003 refers to the specific aspects of calibration laboratories in the field of laboratory medicine where such "calibration laboratories" are usually denoted as "reference measurement laboratories".ISO 15195:2003 may form a basis for the accreditation of a reference measurement laboratory that applies for official recognition of the performance of a reference measurement procedure. Reference measurement laboratories are usually accredited by national metrology institutes or national accrediting bodies.

Committee
CEN/TC 140
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
BS EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
DIN EN 14136:2004-08 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
ISO/IEC Guide 58:1993 Calibration and testing laboratory accreditation systems General requirements for operation and recognition
ISO 15194:2009 In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content of supporting documentation
ISO 15193:2009 In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for content and presentation of reference measurement procedures
EN ISO 18153:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)
ISO 15189:2012 Medical laboratories — Requirements for quality and competence
ISO 18153:2003 In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
ISO 17511:2003 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
ISO Guide 30:2015 Reference materials Selected terms and definitions
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
EN ISO 17511:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)
ISO 3534-1:2006 Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability

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