# Emergence and evolution of standardization systems in medical biology laboratories

## TL;DR

This paper explores how standardization systems in medical biology laboratories have developed over time to ensure quality and international recognition.

## Contribution

The paper outlines key milestones in the evolution of quality system standards for medical laboratories, emphasizing the role of ISO 15189.

## Key findings

- Accreditation of medical laboratories has become mandatory in most countries based on national or international standards.
- ISO 15189 is highlighted as the most specific international standard for medical laboratories.
- More research is needed to assess if laboratory practices align with evolving standards.

## Abstract

The history of standardization relating to the activities of medical laboratories traces the development of quality system standards in the world, and their evolution.

In this study, we have included the key benchmarks that represent the stages of the quality system’s evolution in recent decades. Accreditation of medical laboratories has become compulsory in most countries, regarding national or international standards. International acknowledgment of the effectiveness of the results delivered to the many stakeholders, particularly patients and prescribers, is conferred through the use of standards.

The ISO 15189 standard represents the latest and most specific international standards for medical laboratories of all types.

More research is necessary to study if laboratory practices reflect the evolution of standards within the medical laboratory field.