SOP Human Resources and Training
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Use this SOP Human Resources and Training template to systematically document and manage employee competence, training, and qualification requirements in your medical device company, ensuring compliance with ISO 13485, FDA 21 CFR 820, and EU MDR/IVDR regulations. Complete this template when onboarding new staff, updating roles, or implementing new or revised processes to maintain thorough training records, verify employee readiness, and support effective performance reviews. This is essential for demonstrating regulatory compliance and maintaining high product quality standards.