Hemodialysis water production : evaluation and assurance quality management

Hemodialysis water used to the treatment of patients with renal insufficiency is registered in a monography in the European Pharmacopea third edition. It’s under the pharmacyst responsability. ISO 9000 standards designate as special manufacturing process if it is not possible to prove the quality of the product before its use. Hemodialysis water is an example. In that case, it is important to validate the hemodialysis water production process before its first use, to supervise its routine functioning, and to maintain the equipment. Therefore, Orleans’ Regional Center Hospital’s director accepted to put in place a quality management with the collaboration of doctor, pharmacyst and engineer. Quality system’s procedures have been written in compliance with ISO 9002 standard.