Quality - SOP - Data Analysis and Reporting

Quality - SOP - Data Analysis and Reporting

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The process outlined in this document will ensure that your company complies with the relevant clauses of ISO 13485 (8.4), 21 CFR (820.100), and EU MDR/IVDR.


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Purpose of Document

The measurement and analysis of quality data is essential to determine the suitability, conformity, and effectiveness of the quality management system, and to evaluate what improvements can be made. The purpose of this procedure is to suggest which data analyses and key performance indicators may be generated in preparation for various review processes, and the corresponding reporting methods.

This process ensures that Company consistently meets customer expectations, delivers high quality products, achieves continual improvement of its quality management system, and complies with 21 CFR 820.100, ISO 13485 (8.4) and EU MDR (2017/745)/IVDR (2017/746).

Scope of Document/s

This procedure applies to the measurement, analysis and reporting of all quality data generated by your company through its monitoring and measuring activities. It also applies to quality data generated by suppliers which your company has requested via a Quality Agreement.

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