BIS IS/ISO 15189 : 2012
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
Published date
12-01-2013
Publisher
Superseded date
06-04-2023
Superseded by
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NATIONAL FOREWORD
1 Scope
2 Normative references
3 Terms and conditions
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 15189:2012
Bibliography
Describes requirements for quality and competence in medical laboratories.
| Committee |
MHD 14
|
| DocumentType |
Standard
|
| PublisherName |
Bureau of Indian Standards
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO 15189:2012 | 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 |
| BIS IS/ISO/IEC 17000 : 2004 | CONFORMITY ASSESSMENT - VOCABULARY AND GENERAL PRINCIPLES |
| 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 |
| BIS IS/ISO/IEC 17025 : 2005 AMD 1 | GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATION LABORATORIES |
| 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 |
Summarise
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