Total quality management in blood transfusion

Area of Science:

• Transfusion Medicine
• Quality Management Systems
• Public Health

Background:

• Quality management in transfusion medicine gained prominence following the AIDS epidemic.
• Early quality control focused on product orientation, evolving to process orientation with Good Manufacturing Practice (GMP).
• The introduction of ISO9001 further emphasized people and system orientation globally.

Purpose of the Study:

• To discuss the evolution of quality management in transfusion medicine.
• To highlight the need for harmonized quality systems and management.
• To review current initiatives for developing universal quality standards.

Main Methods:

• Review of quality management principles and their application in transfusion medicine.
• Analysis of the impact of Good Manufacturing Practice (GMP) and ISO9001.
• Examination of initiatives by organizations like AABB, EU, Council of Europe, and IFRC.

Main Results:

• Quality management has shifted from product to process orientation.
• Global standards like GMP and ISO9001 are influencing transfusion quality systems.
• Various international bodies are developing harmonized quality systems, with differing approaches.

Conclusions:

• Harmonization and uniformity are essential for a universally applicable Quality System in transfusion medicine.
• A common denominator approach is recommended to integrate various quality system designs.
• Continued collaboration is needed to establish a unified global standard for transfusion quality management.