What document set provides guidance for quality in laboratory diagnostics?

The document set that provides guidance for quality in laboratory diagnostics is ISO 15189:2007. This standard specifically addresses the quality management systems and the competence of medical laboratories. It outlines the requirements for quality and competence in laboratory medicine, ensuring that laboratories operate effectively and deliver reliable and accurate results in diagnostics.

ISO 15189 includes criteria for management and technical aspects of laboratory processes, emphasizing the importance of ongoing quality assurance, staff qualifications, and the use of appropriate equipment and techniques. By adhering to this standard, laboratories can demonstrate their capability to deliver high-quality diagnostic results while maintaining compliance with regulatory requirements and ensuring patient safety.

The other options refer to different aspects of quality standards; for instance, ISO 3001:2021 pertains to supply chain management systems, ISO 14001:2016 focuses on environmental management systems, and ISO/IEC 17020:2012 is related to the requirements for the operation of various types of bodies performing inspection. Therefore, these do not specifically cater to the quality of laboratory diagnostics like ISO 15189:2007 does.