SYS-017 Data Analysis Procedure Webinar

This procedure meets the requirements for clause 8.4 of ISO 13485:2016, but this procedure also addresses the requirements of clauses 8.2.5 and clause 5.4.1. The title of this procedure is actually, “Monitoring, Measurement and Data Analysis Procedure.” The procedure is in its third draft. There are no specific forms or lists associated with this procedure. The procedure is 5 pages in length.

The purpose of this procedure is to define the process for monitoring, measuring, and analysis of processes within your company’s quality management system. The procedure was updated to include references to the applicable ISO 13485:2016 clauses, and Matthew Walker added color coding (i.e., blue font) and symbols (i.e., #) to facilitate auditors identifying where the requirements for each sub-clause are found. The procedure also explains where the requirements for monitoring and measurement of processes can be found for each process.