Role and Responsibilities Matrix

Lexqara helps medical device organisations define clear responsibilities that keep the QMS running and auditable. Explore the Resource Center or review our Regulatory Strategy Services.

Description:
This Role and Responsibilities Matrix defines who does what across key QMS processes and ensures clear governance for reviews, approvals, and execution.

• List each Department and Position involved in the QMS

• Define responsibility codes for Reviewer (R), Approver (A), and Qualified (Q)

• Map each QMS Activity to defined Sub-Activities

• Assign process ownership across functions (QA, RA, R&D, Production, Validation, Purchasing)

• Ensure documented Approval with Name, Position, Date, and Signature

• Maintain consistent role allocation to support training needs and handovers

Your needs:

• Role and Responsibilities Matrix

• Role and Responsibilities Matrix for MDR decision-making

• Reduce ambiguity, improve audit readiness, and speed up cross-functional decisions

Use this matrix when setting up or updating your QMS, onboarding teams, or clarifying RACI-style responsibility assignment during changes and deviations.

It defines who is accountable for each activity and how decisions are validated. Reviewer means the role that checks content for adequacy; it matters because gaps are caught before approval. Approver means the role that authorises release; it matters because approval is the formal decision point.

• Clear role definition per Department/Position

• Consistent use of R/A/Q responsibility codes

• Coverage of each Activity and Sub-Activities

• Documented approval trail (Name/Date/Signature)

• Alignment of responsibilities across functions

At Lexqara, we help you tailor the matrix to your organisation, align it with your procedures, and deploy it through practical QMS implementation and training. Access templates in our Resource Center [https://lexqara.com/resource-center/] and see our Quality Management System Creation and Implementation support [https://lexqara.com/service/quality-management-system-creation-and-implementation/]. For institutional context, use the European Commission medical devices sector [https://health.ec.europa.eu/medical-devices-sector_en]. Download the template or request a short gap assessment.