EN ISO 15195:2003

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.