Data Analysis & Management Review Dashboard Kit (ISO 13485 Clause 8)

Teams collect quality data but still struggle to turn it into meaningful trend analysis, management review evidence, and executive decisions that auditors can follow. This kit gives you the dashboards, action trackers, and presentation structure needed to turn raw QMS data into management-review output. That means less time spent rebuilding documents from scratch and a stronger line of evidence when the process is sampled under audit.

What's included

• Data Analysis SOP.docx
• KPI Dashboard.xlsx
• Basic Dashboard.xlsx
• Data Analysis Plan.xlsx
• Management Review Action Plan.xlsx
• Presentation Template.pptx
• Executive Summary Guide.pdf

Best suited to: Founder / CEO, Quality manager, Regulatory consultant, and Startup manufacturer.

Useful in audit situations where you need to:

• Show a structured data analysis and management review process during ISO 13485 certification, surveillance, supplier, or internal audits.
• Support FDA inspections with controlled records, traceability, and process evidence related to data analysis and management review.
• Support EU MDR technical documentation or quality-system reviews where data analysis and management review records need to be complete, controlled, and consistent.

Use this toolkit to move faster, create cleaner evidence, and reduce the time it takes to stand up or repair this part of your ISO 13485 system.