Standard

NS-EN ISO 15189:2022

Dec 2022 Published

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Abstract

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 information

Standard from SN
Published: 20 December 2022
Edition: 2022-12
Version: 1
Document type: NAT
Pages
ISBN:

ICS 03.120.10
ICS 11.100.01
National Committee SN/K 116

Legal references

EU law:

Law reference	Restrictions
765/2008

Product Relations

Adopted from: EN ISO 15189:2022, 0

NS-EN ISO 15189:2022

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