ISO 15189:2012

ISO 15189:2012

November 2012
International standard Cancelled

Medical laboratories - Requirements for quality and competence

ISO 15189:2012 specifies requirements for quality and competence in medical laboratories.ISO 15189:2012 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.

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Main informations

Collections

International ISO standards

Thematics

Management et performance

Publication date

November 2012

Number of pages

50 p.

Reference

ISO 15189:2012

ICS Codes

03.120.10   Quality management and quality assurance
11.100.01   Laboratory medicine in general

Print number

3 - 15/08/2014
Sumary
Medical laboratories - Requirements for quality and competence

ISO 15189:2012 specifies requirements for quality and competence in medical laboratories.

ISO 15189:2012 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.

Replaced standards (1)
ISO 15189:2007
April 2007
International standard Cancelled
Medical laboratories - Particular requirements for quality and competence

ISO 15189:2007 specifies requirements for quality and competence particular to medical laboratories. ISO 15189:2007 is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognising the competence of medical laboratories.

Standard replaced by (1)
ISO 15189:2022
December 2022
International standard Current
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 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.

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