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This fourth edition cancels and replaces the third edition (ISO 15189:2012), which has been technically revised. It also replaces ISO 22870:2016.
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 Organisation for Standardization 's Technical Committee 212 (ISO/TC 212).
This corrected version of ISO 15189:2012 includes various editorial corrections. Introduction This International Standard, based upon ISO/IEC 17025 and ISO 9001, specifies requirements for competence and quality that are particular to medical laboratories 1 .
ISO 15189:2012 specifies requirements for quality and competence in medical laboratories. ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence.
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.
ISO 15189:2022(E) Introduction The objective of this document is to promote the welfare of patients and satisfaction of laboratory users through confidence in the quality and competence of medical laboratories. 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.
ISO 15189 accreditation underpins confidence in the quality of medical laboratories through a process that verifies their integrity, impartiality and competence.
Explain the purpose and intent of the international laboratory standard ISO 15189—Requirements for Quality and Competence. Describe the major changes from the third edition (2012) to the new fourth edition (2022).
ISO 15189 is a quality management system standard specific to laboratories. It includes all of the requirements of ISO 9001 but also has additional requirements related to the specific nature of laboratory work.