This fourth edition cancels and replaces the third edition (ISO 15189:2012), which has been technically revised. It also replaces ISO 22870:2016. The main changes are as follows: — Increased emphasis on risk management. Any feedback or questions on this document should be directed to the user’s national standards body.

ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organization for Standardization 's Technical Committee 212 (ISO/TC 212).

ISO 15189 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems. This third edition cancels and replaces the second edition (ISO 15189:2007), which has been technically revised. A correlation between the second and third editions of this International Standard is provided as Annex B.

ISO 15189 accreditation underpins confidence in the quality of medical laboratories through a process that verifies their integrity, impartiality and competence.

objective document is to promote the welfare of patients and satisfaction of laboratory users document confidence the quality requirements and competence of medical laboratories.

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.

Aug 8, 2024 · ISO 15189 is the international standard that specifies the requirements for quality and competence of medical laboratories. As with ISO/IEC 17025, it covers both technical and management criteria which must be considered. Key current information: ISO 15189:2022.

ISO 15189 is a comprehensive standard, offering an overarching structure to laboratory operations.

Understand and interpret the requirements of ISO 15189, including its QMS. Identify required documents and understand a risk management plan. Receive a complete overview of ISO 15189 with valuable insights and tools to help you implement the requirements of the standard. See the detailed Course Outline/Syllabus here. Who Should Attend?

Feb 7, 2023 · The ISO 15189:2022 is an international standard that specifies the requirements for quality and competence in medical laboratories. The medical laboratory is essential to patient care since decisions on patient treatment are made based on laboratory results.