[Evaluation of the quality control system in blood transfusion service].

INTRODUCTION

Implementation of quality system improvement at the Blood Transfusion Institute Novi Sad, included adjustments in practice to the request of ISO 9001 standard. Quality improvement must be a permanent activity of the Institute. The audit is a management tool for monitoring the quality assurance system and is either a quality audit or a medical audit. A well planned, comprehensive quality audit covers each activity of the Blood Transfusion Institute. The procedures may be internal or external.

INTERNAL AUDIT

Quality manager is responsible for annual internal quality audits. The purpose of internal audits is to check the efficiency of the quality system in terms of realization of quality policy, fulfullment of designed targets and implementation of quality system documents. An internal quality audit is performed in accordance with the procedure and audit findings are reported to the management in a form of internal quality report as a part of quality system review. The findings must be communicated to all persons responsible for the controlled area. Quality manager can initiate an internal quality audit whenever it is realized that problems about the quality system have occurred. Audits are conducted by the quality manager or an audit team. The accurate list of internal auditors is kept in the Institute archive.

MEDICAL AUDIT

Medical audit carried out by a transfusion committee, evaluates the quality of blood transfusion for determining the degree of compliance with established local or national guidelines, in order to promote optimal transfusion practice.

CONCLUSION

Audits are not only used for determining further quality management activities, but also make basis for creating and maintenance of excellent relations with product and service users. Considering all this, Blood Transfusion Institute exceeds the requirements of ISO 9000 standards series.