ISO 13485 Training & Competence Kit (8 Training Modules)

Show auditors that everyone in a quality-affecting role is competent: the procedure, the training matrix and records, and eight ready-to-run training modules, each with slides, a trainer guide, a learner workbook and an assessment.

What's inside (39 files)

• Procedure and Records: Competence and Training SOP; Training Attendance Register; Training Effectiveness Log; Training Matrix; Training Record Log; Training Request Log.
• Training Modules (each with slides, trainer guide, learner workbook and assessment): CAPA; Complaint Handling; Design Control; Document Control; Internal Auditing; PMS and Vigilance; Records Management; Risk Management.

How to use it

1. Adapt the competence and training SOP, including how effectiveness is evaluated.
2. Set required training for each role in the training matrix.
3. Deliver the modules: each has a slide deck, trainer guide, learner workbook and assessment.
4. Record attendance, results and effectiveness checks.
5. Review the matrix whenever roles, procedures or regulations change.

Who it's for

Quality and HR teams that need to show competence under clause 6.2 and train staff without building courses from scratch.

Good to know

• Instant download. Editable Microsoft Office files, no macros.
• Includes a Start Here guide with the contents and how to use them.
• Licensed for one organization, including its sites.
• Templates don't reproduce ISO standards. You need your own licensed copies.
• Also in the ISO 13485 Starter Kit and the Complete QMS Kit, which cost less than buying kits separately.