11/30173018 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 15189 - MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
Hardcopy , PDF
English
30-11-2012
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Management requirements
5 Technical requirements
Annex A (informative) - Correlation with ISO 9001:2008
and ISO/IEC 17025:2005
Annex B (informative) - Comparison of ISO 15189:2007
to ISO 15189: 20XX
Annex C (informative) - Ethics in laboratory medicine
Bibliography
BS EN ISO 15189
| Committee |
CH/212
|
| DocumentType |
Draft
|
| Pages |
70
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| PREN ISO 15189 : DRAFT 2011 | 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 1087-1:2000 | Terminology work — Vocabulary — Part 1: Theory and application |
| 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 |
| EN 1614:2006 | Health informatics - Representation of dedicated kinds of property in laboratory medicine |
| ISO 15189:2012 | Medical laboratories — Requirements for quality and competence |
| ISO/IEC Guide 43-1:1997 | Proficiency testing by interlaboratory comparisons — Part 1: Development and operation of proficiency testing schemes |
| ISO/IEC 17011:2004 | Conformity assessment — General requirements for accreditation bodies accrediting conformity assessment bodies |
| ISO 15190:2003 | Medical laboratories — Requirements for safety |
| ISO/IEC 17043:2010 | Conformity assessment — General requirements for proficiency testing |
| ISO Guide 30:2015 | Reference materials — Selected terms and definitions |
| ISO/TS 22367:2008 | Medical laboratories — Reduction of error through risk management and continual improvement |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO/IEC Guide 43-2:1997 | Proficiency testing by interlaboratory comparisons — Part 2: Selection and use of proficiency testing schemes by laboratory accreditation bodies |
| EN 12435:2006 | Health informatics - Expression of results of measurements in health sciences |
| ISO/IEC Guide 98-3:2008 | Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) |
| ISO 3534-1:2006 | Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability |
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