Standardization Institute of the Republic of North Macedonia
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MKC EN ISO 15189:2022

The purpose of this standard is to ensure reliability, satisfaction and trust of patients and users of medical laboratories, with the aim of achieving greater quality and competence of medical laboratories. This fourth edition cancels and replaces the third edition (ISO 15189:2012), which has been technically revised.

The main changes are:

— Compliance with ISO/IEC 17025:2017 with management requirements now appearing at the end of the document;

— Incorporated point-of-care testing (POCT) requirements, previously in ISO 22870;

— Increased emphasis on risk management, security and sample collection and transport.

Benefits include: increasing the effectiveness of the management system, reducing the likelihood of invalid results and reducing potential harm to patients, laboratory staff, the public and the environment