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Obtaining an ISO certification is an important achievement for any organization, but maintaining that certification requires continuous commitment. An organization cannot simply obtain an ISO certificate and consider the process complete. Regular assessments are conducted to verify that the management system continues to meet the applicable ISO standard. An ISO Surveillance Audit is one of these important assessments. It helps determine whether an organization is consistently maintaining and implementing its management system after certification. Understanding the surveillance audit process can help businesses prepare properly and avoid unnecessary nonconformities. What Is an ISO Surveillance Audit? An ISO Surveillance Audit is a periodic audit conducted by an independent certification body after an organization has received ISO certification. The purpose is to check whether the organization's management system continues to comply with the requirements of the relevant ISO sta...

The healthcare industry operates under rigorous standards to ensure the accuracy, reliability, and timeliness of medical diagnoses and treatment. Among these, ISO 15189 has emerged as a cornerstone in the domain of medical laboratories. This international standard specifies the quality and competence requirements particular to medical laboratories, playing a pivotal role in ensuring consistent and reliable patient care. Understanding ISO 15189 ISO 15189, titled "Medical laboratories — Requirements for quality and competence," was first published by the International Organization for Standardization (ISO) in 2003. This standard is specifically tailored to medical laboratories, drawing from the general requirements of ISO/IEC 17025 (testing and calibration laboratories) and ISO 9001 (quality management systems). It serves as a framework for laboratories to develop robust management systems, ensure technical competence, and consistently generate valid results. The standard cov...