KPI and Data Analysis — Process Package (ISO 13485)
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
Process Package
Complete KPI and Quality Objectives system covering ISO 13485 §8.4 + EU MDR Art. 84 + FDA QMSR §820.250. Risk-based KPI catalog mapped to all SOPs in the kit.
What’s included:
- SOP-ISO-05 KPI and Data Analysis — 4-level KPI hierarchy (Strategic / Process / Operational / Tactical), trigger thresholds, escalation.
- F-ISO-05.1 KPI Catalog and Dashboard (Excel — 4 tabs) — 23 pre-populated KPIs covering all SOPs, 90 formulas auto-calc Q1/Q2/Q3/Q4/YTD averages, conditional formatting GREEN/YELLOW/RED on YTD Status.
- F-ISO-05.2 Quality Objectives Tracker (Excel) — 8 sample strategic objectives with ACHIEVED/PARTIAL/NOT ACHIEVED conditional formatting.
Why this package: Auditors look for data-driven evidence of QMS effectiveness. This package gives you a ready-to-use KPI infrastructure with industry-typical metrics already populated.
Format: Microsoft Excel (fully editable)
Updated: May 2026 — reflects EU MDR + FDA QMSR (Feb 2026) + latest MDCG guidance
Delivery: Instant download after purchase
€69.00
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Alessandro Stella
Alessandro Stella is a freelance Medical Device Regulatory Consultant and ISO 13485 / ISO 9001 Lead Auditor based in Italy. With over 13 years of experience spanning R&D, Quality, and Regulatory Affairs, he has supported companies across Europe and beyond in EU MDR technical documentation, QMS implementation, ISO 13485 compliance, and FDA submissions. His device expertise covers cardiovascular devices, AI-based standalone software, robotic surgery systems, active wearables, and more. Alessandro is the founder of MD Regulatory.