[Certification of quality in catheterization laboratories: from the requirements of GISE to ISO 9002].

National and regional health plans are being issued, where the implementation of quality assurance programs is fostered. The ISO 9002 certification has been chosen in several units and hospitals as a guarantee of the processes being followed in patient care. One major limitation, however, of the ISO 9002 certification is that--despite accurate control of all procedures--it does not imply control of the output, i.e. patient outcomes. Insofar as Cardiac Catheterization Laboratories are concerned, a Quality Certification Program has been issued by the Italian Society for Invasive Cardiology (GISE) in 1998. This program was based on the general structure of the ISO Norms, and requires consideration of a number of indicators pertaining to both the process of health care delivery, and the outcomes of patients. Careful application of such indicators and reference standards to specific items of the ISO 9002 Norms (namely, items 10 and 18) may improve the applicability of the latter to the process of patient care, with greater attention to the satisfaction of both "customers" and "operators".