ISO 15189:2007
Medical laboratories - Particular requirements for quality and competence

Standard No.

ISO 15189:2007

Release Date

2007

Published By

International Organization for Standardization (ISO)

Status

Withdraw

Replace By

ISO 15189:2012

Latest

ISO 15189:2022

Scope

1.1 This International Standard specifies requirements for quality and competence particular to medical laboratories. 1.2 This International Standard 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.

ISO 15189:2007 Referenced Document

• ISO 9000:2005 Quality management systems - Fundamentals and vocabulary
• ISO 9001:2000 Quality management systems - Requirements
• ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
• ISO/IEC Guide 43-1 Proficiency testing by interlaboratory comparisons - Part 1: Development and operation of proficiency testing schemes

ISO 15189:2007 history

• 2022 ISO 15189:2022 Medical laboratories — Particular requirements for quality and competence
• 2012 ISO 15189:2012 Medical laboratories - Requirements for quality and competence
• 2007 ISO 15189:2007 Medical laboratories - Particular requirements for quality and competence
• 2003 ISO 15189:2003 Medical laboratories - Particular requirements for quality and competence