Description:
This Employee Qualification Record documents employee details, competence evidence, QMS document qualification, and follow-up actions to maintain controlled staffing decisions.

• Capture Employee detail including Hiring date, Contract number, and signed agreements.

• Link the approved Job description with Document, Revision, and approval status.

• Confirm essential Resources (equipment, software, access) as Applicable and Available.

• Record Competence and education requirements from the Competence Matrix with Evidence of conformity.

• Assess qualification for QMS documents using the Master Document List and record Qualifications.

• Define Training need and planning with timelines and Evidence of implementation.

• Document Annual performance review with Acceptance Criteria, results, and conclusions.

• Track Follow-up actions and finalize Approval with names, dates, and Signature.

Your needs:

• Employee qualification record

• Employee qualification record for ISO 13485 and MDR compliance

• Reduce rework, strengthen onboarding consistency, and improve audit readiness.

Use this form when onboarding, changing responsibilities, or reviewing annual competence to ensure every role has documented evidence and controlled approvals.

It covers qualification requirements end-to-end. A Competence Matrix defines the minimum skills and evidence expected; it matters because it makes qualification decisions consistent. The Master Document List identifies controlled QMS documents; it matters because people must be qualified to the right revisions.

• Record employee identity and employment status data.

• Reference an approved job description tied to current responsibilities.

• Provide required resources and access needed to perform duties.

• Collect objective evidence for education/experience requirements.

• Confirm qualification to required QMS documents and current revisions.

• Define training actions when gaps are identified, with evidence.

• Record objectives, acceptance criteria, and results for reviews.

• Close actions and approvals with signatures and dates.

At Lexqara, we help implement controlled qualification workflows, align competence evidence to roles, and prepare you for internal audits and inspection readiness. Resource Center [https://lexqara.com/resource-center] and QMS Implementation [https://lexqara.com/services/qms-implementation]. See ISO 13485 [https://www.iso.org/standard/59752.html]. Request a short gap assessment.