ISO 9001 certification of a hospital cornea bank

The Tissue and Cell Bank of the HCL (Hospices Civils de Lyon) has, since 10 June 1999, consisted of the Skin Substitutes Laboratory (Laboratoire des Substituts Cutanés (LSC)) and the Cornea Bank. As the LSC had been ISO 9001‐certified since March 1997, our aim was to raise the Cornea Bank to the same level of quality, so as to coincide with the renewal of the LSC certificate. On 7 March 2000, the bank obtained an ISO 9001 certificate for its combined functions, only nine months after the merger of the Cornea Bank. The decree 99‐741 of 30 August 1999 demanded quality control. Our application for certification had anticipated this regulation. This helped us enormously when compiling the dossier accompanying the official request and was an essential element in obtaining the favourable response of the Agence Française de Sécurité Sanitaire des Produits de Santé on 21 June 2000.