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I.S. 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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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LABORATORY MEDICINE - REQUIREMENTS FOR REFERENCE MEASUREMENT LABORATORIES

Available format(s)

Hardcopy , PDF

Superseded date

21-02-2019

Language(s)

English

Published date

01-01-2003

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.


Dates of withdrawal of national standards are available from NSAI.

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

Covers the specific requirements for reference measurement laboratories in laboratory medicine.

DocumentType
Standard
Pages
25
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy

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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