Difference between ISO 13485 and ISO 9001

Standard ISO 13485 is based on the ISO 9001 quality management standard, however both standards are not completely congruent.
In addition to the requirements that are specifically related to the medical devices, the both standards primaly differ in two points: ISO 13485 (Art. 8.2, 8.5) excludes ISO 9001 requirements related to continual improvement and customer satisfaction.

Both these ISO 9001 requirements can not be objective verified in the legal controlled sector. Therefore is in ISO 13485 the term “customer satisfaction” replaced by the term “customer fulfillment” and the term “continual improvement” by the term “maintenance of efficiency”.

The legal regulations require the monitoring of marketet devices, analysis of observations and, if necessary, appropriate corrective actions.