Chapter 3 · Training records

A training record must be maintained for every staff member, covering: initial orientation, method-specific training, equipment training, safety training, and any external CPD. Records must show the date, content, trainer, and outcome. The quality manager is responsible for ensuring the training matrix is current. Missing training records are one of the most common findings at ISO 15189 assessment.

Practical example

During an ISO 15189 assessment, the assessor asks to see the training records for the blood gas analyser. Good practice: The QM produces the training matrix showing each staff member’s training date, the trainer’s name, and the competency sign-off. Poor practice: The QM says ‘everyone has been trained’ but cannot produce any records — this is a finding regardless of whether the training actually happened.

What this means for your practice: Training records are the proof. No record means no proof. Keep the training matrix current — update it on the same day the training occurs.