ISO 15189:2022

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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Main informations

Collections

International ISO standards

Thematics

Management et performance

Publication date

December 2022

Number of pages

62 p.

Reference

ISO 15189:2022

ICS Codes

11.100.01   Laboratory medicine in general
03.120.10   Quality management and quality assurance

Print number

1
Sumary
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.

Replaced standards (2)
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.

ISO 22870:2016
November 2016
International standard Cancelled
Point-of-care testing (POCT) - Requirements for quality and competence

ISO 22870:2016 gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of this document apply when POCT is carried out in a hospital, clinic and by a healthcare organization providing ambulatory care. This document can be applied to transcutaneous measurements, the analysis of expired air, and in vivo monitoring of physiological parameters. Patient self-testing in a home or community setting is excluded, but elements of this document can be applicable.

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