Glossary

ISO 15189

What is ISO 15189?

ISO 15189 is an international standard that specifies the requirements for quality and competence in medical laboratories. It is designed to ensure that medical laboratories meet both the technical and management requirements necessary to deliver reliable and accurate test results, thereby promoting confidence in their services.

What are the benefits of ISO 15189 in pharma?

The benefits of ISO 15189 accreditation for medical laboratories include:

Risk Reduction: Implementing ISO 15189 helps identify and mitigate potential risks, enhancing the reliability of laboratory operations and patient safety.

Improved Quality Management: The standard establishes a robust quality management system (QMS), enabling laboratories to quickly identify and correct errors, thereby enhancing overall quality.

Increased Efficiency: Laboratories can streamline processes and procedures, leading to greater operational efficiency and productivity.

Enhanced Customer Satisfaction: By providing accurate and reliable test results, ISO 15189 accreditation improves service quality, resulting in higher customer satisfaction among healthcare providers and patients.