Training & Competence Kit (ISO 13485 Clause 6.2)

Teams often have training records but no controlled competence logic, no skills matrix, and no defensible evidence that staff were assessed against role requirements. This kit gives you the operational framework for clause 6.2 so you can define role competence, track training, evaluate effectiveness, and defend personnel records during audit. That means less time spent rebuilding documents from scratch and a stronger line of evidence when the process is sampled under audit.

What's included

• Competence and Training SOP.docx
• Training Attendance Register.docx
• Training Matrix Template.xlsx
• Training Effectiveness Log.xlsx
• Training Record Log.xlsx
• Training Request Log.xlsx
• Implementation Guide.pdf
• Audit Checklist.pdf

Best suited to: Quality manager, HR / admin, Department manager, and Regulatory consultant.

Useful in audit situations where you need to:

• Show a structured training and competence process during ISO 13485 certification, surveillance, supplier, or internal audits.
• Support FDA inspections with controlled records, traceability, and process evidence related to training and competence.
• Support EU MDR technical documentation or quality-system reviews where training and competence records need to be complete, controlled, and consistent.

Use this toolkit to move faster, create cleaner evidence, and reduce the time it takes to stand up or repair this part of your ISO 13485 system.