Human Resources and Training — 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 HR + competence management system covering ISO 13485 §6.2 and EU MDR Art. 15 PRRC requirements. Includes role-based competence framework, training effectiveness verification.
What’s included:
- SOP-ISO-04 Human Resources and Training — competence determination, training cycle, effectiveness verification.
- F-ISO-04.1 Job Description (Word) — with dedicated section 5 for PRRC qualification per EU MDR Art. 15.
- F-ISO-04.2 Training Plan and Record (Excel — 4 tabs) — conditional formatting PASS/PENDING/FAIL.
- F-ISO-04.3 Competence Matrix (Excel) — 16 pre-populated competences with EXP/INT/BAS/R/NA levels and conditional formatting.
Why this package: Auditor expectation: every QMS function has a competent owner. This package operationalizes that expectation with measurable evidence.
Format: Microsoft Word | 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.