The purpose of the measuring processes is to collect, analyze and report data relevant to the medical devices and the realization processes. The analysis shall strive to support the processes, maintain the effectiveness of your quality management system, the quality of the medical devices. The Measurement, analysis and shall promote the organization on a effectively course towards improvement. Pay attention, I use the word "effective" all the time. If I t was a web site that deals with the ISO 9001 Standard, I would have written "continually". But the ISO 13485 Standard demands an effective quality management system. This is one of the, main differences throughput the standard. In order to improve effectively the organization must prepare an improvement plan with objectives, control the execution of the plan, and the results regarding the objectives.

The organization is required to plan implement and monitor the processes for measurements, monitoring and improvements. The purposes are:

The next requirement of the ISO 13485 Standard refers to (once again) the regulatory requirements. If by any regulatory requirement, it is required to maintain any kind of improvement; statistical analysis, documented method, periodical trainings etc. the organization must follow and carry out.