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CEN - EN ISO 15189

Medical laboratories - Requirements for quality and competence

active, Most Current
Organization: CEN
Publication Date: 1 December 2022
Status: active
Page Count: 78
ICS Code (Quality management and quality assurance): 03.120.10
ICS Code (Laboratory medicine in general): 11.100.01
scope:

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 their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.

This document is also applicable to point-of-care testing (POCT).

NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

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...
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...
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...
April 1, 2007
Medical laboratories - Particular requirements for quality and competence
A description is not available for this item.
February 1, 2003
Medical laboratories - Particular requirements for quality and competence
A description is not available for this item.

References

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