ISO 13485: transition period expires in the end of July 2006
From 1th August 2006 solely the DIN ISO 13485:2003 will be applicable for manufacturers of medical products as verification for a quality management system.
A certified quality management is an important element of conformity evaluation for all manufacturers of class IIa, IIb and III medical products; no medical products may be introduced without this evaluation. The standards SO 13485:2001 and 13488:2001 will no longer be valid after 31th July. Enterprises in which no reorganisation has taken place yet run the risk of losing the certificate in the extreme case.
ISO 13485:2003 for the first time introduces a quality management standard that specifically comprises all regulatory requirements for organisations that intend to produce or put in circulation medical products, including In-vitro-diagnostica. It is structured in the same way and process-oriented in the style of ISO 9001.
Several additional requirements regarding quality targets, resource planning and risk management in the context of product development, data analysis, customer feedback as well as internal and external communication belong to the most important innovations compared to former standards.