I.S. EN ISO 15189:2012
Current
The latest, up-to-date edition.
MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE (ISO 15189:2012, CORRECTED VERSION 2014-08-15)
Hardcopy , PDF
English
01-01-2012
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 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.
| DocumentType |
Standard
|
| Pages |
70
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 15189:2012 | Identical |
| BS EN ISO 15189:2012 | Identical |
| NF EN ISO 15189 : 2012 | Identical |
| DIN EN ISO 15189:2014-11 | 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 |
| 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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