Standard

SN EN ISO 15189:2022

Current

Existing or new amendments and versions must be purchased separately.

Language
Services

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.

Products specifications

  • Standard from INB
  • Published:
  • Effective:
  • Document type: EN
  • Pages
  • Publisher: SNV
  • Distributor: SNV
  • ICS: 03.120.10
  • ICS: 11.100.01
  • National Committee: INB/NK 157
  • Swiss Federal Authority: SECO
  • Designated under following Swiss law: 946.512
  • Designated under following EU law: EGV 765/2008

Product Relations