{"product_id":"qms-data-analysis-procedure-template-iso-13485-fda-qmsr","title":"Medical Device Analysis of Data Procedure Template – QMSR Compatible","description":"\u003ch2\u003eQuality Data Analysis Procedure Template\u003c\/h2\u003e\u003cp\u003eTake the guesswork out of regulatory compliance with this structured, risk-based procedure template for collecting, trending, and analyzing quality and product data — purpose-built for medical device organizations.\u003c\/p\u003e\u003cp\u003eImagine having a single, audit-ready document that keeps your QMS performing at its best, flags adverse trends before they become nonconformances, and gives your management team the objective evidence they need to make confident decisions. That's exactly what this template delivers.\u003c\/p\u003e\u003ch3\u003eKey Objectives This Template Addresses\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eDemonstrate and maintain the effectiveness of your Quality Management System (QMS)\u003c\/li\u003e\n\u003cli\u003eDetect adverse trends and identify opportunities for continual improvement\u003c\/li\u003e\n\u003cli\u003eProvide objective evidence for management review, corrective action (CAPA), and regulatory submissions\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eRegulatory Compliance Coverage\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eISO 13485:2016 Clause 8.4\u003c\/strong\u003e – Analysis of Data, including measurement, monitoring, and improvement requirements\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFDA QMSR (21 CFR Part 820)\u003c\/strong\u003e – Effective February 2, 2026, incorporating ISO 13485:2016 by reference\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho This Template Is For\u003c\/h3\u003e\u003cp\u003eQuality managers, regulatory affairs specialists, and compliance teams at medical device manufacturers and suppliers who need a controlled, risk-based framework for data analysis that satisfies both FDA and ISO requirements.\u003c\/p\u003e\u003ch3\u003eStop Reinventing the Wheel\u003c\/h3\u003e\u003cp\u003eThis template gives your team a proven, structured starting point — reducing documentation burden, minimizing audit risk, and keeping your QMS continuously improving.\u003c\/p\u003e","brand":"Sonic Quality Templates","offers":[{"title":"Default Title","offer_id":51206095208681,"sku":null,"price":197.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0813\/9243\/5433\/files\/AnalysisofData.png?v=1781108718","url":"https:\/\/sonicqualitytemplates.com\/products\/qms-data-analysis-procedure-template-iso-13485-fda-qmsr","provider":"Sonic Quality Templates","version":"1.0","type":"link"}