Training & Competence Kit

Who This Kit Is For

QA, HR and functional managers responsible for planning, delivering and documenting competence and awareness across the QMS.

The Compliance Problem It Solves

• Audits identifying incomplete or informal training records and unclear competence criteria.
• Roles not clearly mapped to required training, leading to ad hoc or inconsistent programmes.
• No standard approach to training effectiveness and re-training triggers.

What You Get In This Kit

• Training slide deck on ISO 13485 competence and awareness requirements and role-based training planning.
• Trainer guide to implementing a competency framework and training matrix.
• Learner workbook to help managers define role profiles, competence criteria and training plans.
• Assessment pack for evaluating understanding of competence, awareness and training documentation.

How This Kit Reduces Your Audit Risk

• Aligns your training and competence approach to ISO 13485:2016 clauses 6.2 and 6.3.
• Supports creation of a documented, auditable training matrix linked to QMS processes and SOPs.
• Improves the quality and consistency of training records across functions and sites.

How To Implement It (Step-by-Step)

1. Download the kit and review against your HR/training procedures and QMS structure.
2. Train managers and supervisors responsible for competence management.
3. Use workbook tasks to build or refine your competency matrix and training plan.
4. Capture training records and update your training SOP and matrices to reflect the new structure.

Technical & Regulatory Alignment

• Built for: ISO 13485:2016 clauses 6.2, 6.3 and 5.6 (via management review input).
• Typical use: organisation-wide competence framework and training documentation.
• Document type: training and competence system training kit.