logo

Standards Manage Your Business

We Manage Your Standards

ISO

ISO 15189:2022

Medical laboratories — Requirements for quality and competence

Standard Details

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.

General Information

Status : Published
Standard Type: Main
Document No: ISO 15189:2022
Document Year: 2022
Pages: 62
Edition: 4
  • Section Volume:
  • ISO/TC 212. Clinical laboratory testing and in vitro diagnostic test systems
  • ICS:
  • 03.120.10 Quality management and quality assurance
  • 11.100.01 Laboratory medicine in general

Life Cycle

Currently Viewing

Published
ISO 15189:2022
Knowledge Corner

Expand Your Knowledge and Unlock Your Learning Potential - Your One-Stop Source for Information!

© Copyright 2024 BSB Edge Private Limited.

Enquire now +