A Quality System for Placental Blood Banking aimed at the transplantat
ion of haematopoietic stem cells to related and unrelated allogeneic r
ecipients is described. It includes the organizational structure, proc
edures, processes and resources needed to implement quality management
. The Quality System described in this article is based on ISO 9002, a
model for quality assurance in production, installation and servicing
developed in 1987 and revised in 1994 by the International Organizati
on for Standardization. ISO 9002 includes 20 clauses that provide guid
ance for the implementation of the Quality System, The development of
the Quality System is started by the Placental Blood Bank Medical Dire
ctor with the definition of a General Quality Plan including: (1) the
written description of the Mission, Objectives, Technical and Organiza
tional Policies, and Staff Organization Chart; (2) the definition and
aquisition of adequate financial, human and structural resources; (3)
the appointment of a Quality System Head, who must identify the Placen
tal Blood Banking process together with the Placental Blood Bank perso
nnel; implement a documentation plan; identify quality indicators; sta
rt regular internal audit; report audit results to the Medical Directo
r for review. Following staff training and qualification, the Quality
System is launched, The Placental Blood Bank can then undergo audit by
an external inspector and be finally certified for compliance to ISO
9002, The Quality System must be maintained and subjected to external
audit at regular intervals so that certification is confirmed.