Quality Assurance (QA) is a framework aimed at ensuring the quality of products or services through planned and systematic approaches. Laboratory Quality Assurance (QA) includes the implementation of procedures within a laboratory to ensure the accuracy, reliability,...
A Laboratory Quality Management System (LQMS) refers to a set of policies, procedures, and practices implemented in a laboratory to ensure consistent quality and accuracy in its operations. Various standards and regulations outline specific requirements for...
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. The...
An efficient laboratory document control system is essential for the lab manager to keep records of all processes in place and documents always up-to-date. Medical laboratories and testing companies must have complete control over their documents and protocols to...
Regulatory bodies such as the ISO and the FDA frequently evaluate laboratory operations to check compliance. Because laboratories guarantee quality in medical device and pharmaceutical companies’ operations, any non-conformance in the laboratory can mean...
