Description:
This Human Resources Procedure defines how we control hiring, onboarding, competence, and training to maintain an effective QMS and meet applicable requirements.

• Maintain a controlled Competence Matrix with qualification levels (Expert/Specialist/Junior).

• Apply a color-coded qualification status: Achieved / Under acquisition / Not achieved.

• Create roles using the Role and Responsibility Matrix (RRM) and align to the Job Description.

• Document onboarding and qualification in the Employee Qualification Record (EQR-XXXX).

• Plan and record trainings via Training Program, Training Plan, and Training Record Form.

• Use risk-based training effectiveness methods with defined acceptance criteria and results.

• Control training to QMS documents before each document’s effective date.

• Ensure resignation/termination includes resource revocation and controlled record archiving.

Your needs:

• Human resources procedure

• Human resources procedure for MDR decision-making

• Reduce rework, strengthen audit readiness, and keep competence evidence inspection-ready.

This procedure is used to ensure we have qualified personnel, controlled records, and an HR process that supports an ISO 13485-aligned quality system.

It covers core controls for competence. A Competence Matrix is the log that links roles to required education, experience, and skills—critical for consistent qualification decisions. Training effectiveness means verifying learning against acceptance criteria—critical to prevent recurring nonconformities.

• Define qualification levels and yearly reviews.

• Document onboarding and probation conclusions in EQR.

• Identify training needs during onboarding and performance review.

• Control training on revised QMS documents before effective date.

• Record trainer qualification and attendance evidence.

• Apply risk-based effectiveness methodology and results.

• Handle ineffective outcomes with re-training and status updates.

At Lexqara, we implement practical HR/QMS controls, training governance, and internal audit readiness (competence records, training effectiveness, and controlled templates). Explore our 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.