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CEN - EN ISO 15189

Medical laboratories - Particular requirements for quality and competence

inactive
Organization: CEN
Publication Date: 1 April 2007
Status: inactive
Page Count: 52
ICS Code (Quality management and quality assurance): 03.120.10
ICS Code (Laboratory medicine in general): 11.100.01

Document History

EN ISO 15189
December 1, 2022
Medical laboratories - Requirements for quality and competence
This document specifies requirements for quality and competence in medical laboratories. This document is applicable to medical laboratories in developing their management systems and assessing...
EN ISO 15189
December 1, 2022
Medical laboratories - Requirements for quality and competence
This document specifies requirements for quality and competence in medical laboratories. This document is applicable to medical laboratories in developing their management systems and assessing...
EN ISO 15189
November 1, 2012
Medical laboratories - Requirements for quality and competence
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...
EN ISO 15189
April 1, 2007
Medical laboratories - Particular requirements for quality and competence
A description is not available for this item.
EN ISO 15189
February 1, 2003
Medical laboratories - Particular requirements for quality and competence
A description is not available for this item.

References

This document references:
ISO 80000-1 - Quantities and units — Part 1: General TECHNICAL CORRIGENDUM 1
Published by ISO on October 1, 2011
ISO 80000-1 gives general information and definitions concerning quantities, systems of quantities, units, quantity and unit symbols, and coherent unit systems, especially the International System of...
This document references:
ISO 9001 - Quality management systems — Requirements
Published by ISO on September 15, 2015
This International Standard specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet...
This document is referenced by:
CLSI HS1 - A Quality Management System Model for Health Care; Approved Guideline
Published by CLSI on November 1, 2004
The quality management system model described in this guideline can be developed for any healthcare organization or individual service unit (e.g., laboratory, pharmacy, respiratory, imaging). The...
This document is referenced by:
CLSI GP31 - Laboratory Instrument Implementation, Verification, and Maintenance; Approved Guideline
Published by CLSI on April 1, 2009
This guideline provides a basic understanding of the considerations for the implementation, verification, and maintenance of laboratory equipment. Recommendations are generic and not substitutes for...
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