Description:
Use this Competence Matrix to assess and maintain role-based qualification levels for QMS and regulatory activities across departments.

• Apply the qualification colour code: Achieved, Under acquisition, Not achieved

• Identify each Department and Individuals (Name, Surname) covered

• Record Education / Overall Experience (degree level and years in MD industry)

• Define Activity and Sub-Activities to be evaluated

• Capture required Competence / Experience per activity (e.g., ISO 19011, ISO 13485, (EU) 2017/745, QSR/QMSR)

• Maintain the matrix Date for controlled review and updates

Your needs:

• Competence matrix

• Competence matrix for MDR decision-making

• Identify training gaps, reduce audit findings, and accelerate onboarding

This document is used to demonstrate competency management and training planning for regulated roles, including internal audit competence, ISO 13485 competence, and MDR awareness.

It ensures competency is defined, assessed, and kept current. Under acquisition means the skill is being built with planned training and supervised practice; it matters because gaps must be controlled. Competence / Experience means the evidence-based ability to perform tasks; it matters because it drives qualification status.

• Define a consistent rating scale for all roles

• Map QMS/regulatory tasks to roles and departments

• Document education/experience prerequisites

• Plan role-based training actions and timelines

• Review and update the matrix with a controlled date

At Lexqara, we help you structure the matrix, define meaningful criteria, and align it with your training records and audit readiness activities. Use our Resource Center [https://lexqara.com/resource-center/] and Trainings support [https://lexqara.com/service/trainings/]. For the legal baseline, use EU MDR (Regulation (EU) 2017/745) [https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng]. Download the template or request a short gap assessment.

A robust matrix also supports annual competency reviews, onboarding checklists, and objective evidence during internal and notified body audits.