Competence, Training and Awareness Procedure

This procedure defines how your organisation ensures that personnel performing work affecting product quality are competent on the basis of appropriate education, training, skills and experience, as required by ISO 13485:2016 clause 6.2. It documents your organisation’s process for establishing competence, providing needed training and ensuring the awareness of personnel.

What's Inside

• Determining Competence Requirements
• Recruitment and Selection
• Induction
• Identifying Training Needs
• Planning Training
• Delivering Training
• Evaluating Training Effectiveness
• Qualification, Authorization and Requalification

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.