BS EN ISO 15189:2012
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Medical laboratories. Requirements for quality and competence
Hardcopy , PDF
English
30-11-2012
01-06-2023
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 15189:2012
Bibliography
Describes requirements for quality and competence in medical laboratories.
| Committee |
CH/212
|
| DevelopmentNote |
Supersedes 99/562552 DC (03/2003) Supersedes 11/30173018 DC. (11/2012)
|
| DocumentType |
Standard
|
| Pages |
64
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
This International Standard specifies requirements for quality and competence in medical laboratories.
This International Standard can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.
NOTE International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.
| Standards | Relationship |
| EN ISO 15189:2012 | Identical |
| NF EN ISO 15189 : 2012 | Identical |
| DIN EN ISO 15189:2014-11 | Identical |
| I.S. EN ISO 15189:2012 | Identical |
| NEN EN ISO 15189 : 2015 | Identical |
| NS EN ISO 15189 : 2012 | Identical |
| ISO 15189:2012 | Identical |
| NBN EN ISO 15189 : 2013 | Identical |
| UNE-EN ISO 15189:2013 | Identical |
| BS 70000:2017 | Medical physics, clinical engineering and associated scientific services in healthcare. Requirements for quality, safety and competence |
| 15/30323396 DC : 0 | BS 70000 - MEDICAL PHYSICS, CLINICAL ENGINEERING AND PHYSIOLOGICAL SCIENCE SERVICES IN HEALTHCARE - REQUIREMENTS FOR QUALITY, SAFETY AND COMPETENCE |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO/IEC 17000:2004 | Conformity assessment — Vocabulary and general principles |
| ISO 5725-1:1994 | Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions |
| ISO 19011:2011 | Guidelines for auditing management systems |
| 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 |
| ISO/IEC 27001:2013 | Information technology — Security techniques — Information security management systems — Requirements |
| ISO 22870:2016 | Point-of-care testing (POCT) — Requirements for quality and competence |
| EN 1614:2006 | Health informatics - Representation of dedicated kinds of property in laboratory medicine |
| ISO/IEC 17011:2004 | Conformity assessment — General requirements for accreditation bodies accrediting conformity assessment bodies |
| ISO/IEC Guide 99:2007 | International vocabulary of metrology — Basic and general concepts and associated terms (VIM) |
| 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 2:2004 | Standardization and related activities — General vocabulary |
| EN 12435:2006 | Health informatics - Expression of results of measurements in health sciences |
| ISO 27799:2016 | Health informatics — Information security management in health using ISO/IEC 27002 |
| ISO 3534-1:2006 | Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability |
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