ISO 13485

Employee Training Record

Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements.

Fully Customizable Audit Ready Instant Download
Standard
ISO 13485
Document Type
Records
Format
DOCX
Language
English
Tags
ISO 13485, Medical Devices, Records

This record is the individual training file for one employee. It brings together, in one place, the evidence of the person’s education, training, skills and experience required by ISO 13485:2016 clause 6.2 (e), together with their induction, awareness (6.2 d), training history, the effectiveness of that training (6.2 c), competency assessments and current authorisations.

What's Inside

  • Part A — Employee Details
  • Part B — Education, Qualifications and Experience
  • Part C — Induction
  • Part D — Training History
  • Part E — Competency Assessments and Authorisations
  • Part F — Current Competency Status
  • Part G — Awareness Declaration
  • Part H — Open Training and Development Plan

ISO 13485 Alignment

Supports ISO 13485:2016 requirements, including Clause 6.2. It fits with the rest of the QEHS Vault ISO 13485 document set.

Format

Supplied as a fully editable Microsoft Word (.docx) file. Add your organisation’s name, logo and details, then use it straight away. Instant download after purchase.

Key Benefits

  • Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements