The use of statistical tools applied for Quality System became an essential requirements for any Quality System and the Data Analysis Procedure is highly linked to this specific requirement.
The Data Analysis Process is important to keep the QMS under control. This process is highly connected with the Management Review process and the tools used to measure the efficiency of any Quality System.
Here at QualityMedDev we show an example of data analysis procedure, fully compliant with ISO 13485, with specific examples of items which can be measured for the evaluation of the efficiency of the QMS.
This procedure defines the requirements for collection and analysis of data and for the follow-up process, where the data analysis is linked to the CAPA process. The type of data collected are the one defined within ISO 13485:2016 and the procedure provides examples of type of data that can be taken in consideration as per the requirements defined in the ISO standard.
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