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This document specifies requirements for medical laboratories to plan and implement actions to address risks and opportunities for improvement. It also covers point-of-care testing, risk management, laboratory safety, sample collection and transport, and alignment with ISO/IEC 17025.
- Iso/Dis 15189
This document is applicable to medical laboratories in...
- Medical Laboratories
ISO 15189:2012 specifies requirements for quality and...
- Iso/Dis 15189
Learn how to achieve ISO 15189 certification for medical laboratories in Malaysia with IAS, a leading certification body. ISO 15189 certification demonstrates quality and accuracy of test results and enhances customer satisfaction and reputation.
This document specifies requirements for quality and competence in medical laboratories and point-of-care testing. It is applicable to medical laboratories in developing their management systems and assessing their competence.
ISO 15189:2012 specifies requirements for quality and competence in medical laboratories. It was withdrawn in 2012 and replaced by ISO 15189:2022, which can be used for quality management and competence assessment.
ISO 15189 is an international standard that specifies the quality management system requirements for medical laboratories. It is based on ISO/IEC 17025 and ISO 9001, but takes into account the specific needs of the medical environment and patient care.
Jun 20, 2017 · ISO 15189 standard, Medical laboratories - Requirements for quality and competence, hereafter referred to as ISO 15189, was first published in 2003 and revised in 2007 and again in 2012. ISO 15189 is not a tool merely to meet accreditation requirements or provide quick fixes for individual mistakes.
Aug 8, 2024 · NATA provides accreditation for medical laboratories that perform pathology testing in accordance with ISO 15189 and NPAAC standards. Learn about the benefits, process, criteria and resources for ISO 15189 accreditation.
