Quality System ISO-GMP
The Skin Bank RER works according to International Standard ISO 9001: 2000 and the approval of Regional Council for authorization and accreditation of its activities (n. 327, 23/02/2004). The management of documents describes the responsibilities about procedure of preparation, review, approval, updating and distribution.
The internal and external documents of the Skin Bank are integral part of that of the Burn Center. The activity of production and the expected standards are showed in the the standard of service and product (SPS) document of the Emergency Department. Procedures and operating instructions describe all phases of the process, the activity of production, quarantine, storage, distribution and management of adverse events.
The Standard Operative Procedure (SOP) of Skin Bank ERR are aimed to give maximum evidence and traceability of its activity, in addition to record what is required by current regulation. To facilitate the collection, cataloging, archiving, storage, updating and elimination of these documents, the table “List of Quality recordings” was created. These documents provide the premise and the support to verify the effectiveness of the system and to carry out corrective and preventive actions.
The management of equipment is carried out according to procedure PA11 “Management of equipment” of “AUSL of Romagna” " through applicative portal.