I.S. EN ISO 15195:2003
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
21-02-2019
English
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.
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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Superseded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 |
| Standards | Relationship |
| ISO 15195:2003 | Identical |
| BS EN ISO 15195:2003 | Identical |
| NF EN ISO 15195 : 2004 | Identical |
| SN EN ISO 15195 : 2003 | Identical |
| NS EN ISO 15195 : 1ED 2003 | Identical |
| EN ISO 15195:2003 | Identical |
| UNI EN ISO 15195 : 2004 | Identical |
| NEN EN ISO 15195 : 2003 | Identical |
| ONORM EN ISO 15195 : 2004 | Identical |
| UNE-EN ISO 15195:2004 | Identical |
| DIN EN ISO 15195:2004-01 | Identical |
| 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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