Re‐engineering caused by ISO 9000 certification

Based on a project performed at a medium‐sized producer of medical utensils, reviews some of the problems which the company experienced in connection with the system built up during ISO 9001 certification, and the re‐engineering efforts which were performed in order to relieve these problems. Focuses in particular on a re‐structuring of the company’s system for production documentation and its relation to the traceability of their products. This system was radically altered during the project without the traceability requirements being violated or reduced. These changes resulted in a marked increase in productivity.