Training Procedure | ISO 13485 | FDA QMSR

The Training Procedure governs the methods used to ensure employees possess the necessary training and skills to adequately perform their particular job function.

• Includes Training Matrix and Training Records Forms

• MS Word Format

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ISO 13485:2016 Training Procedure

The Training Procedure governs the methods used to ensure employees possess the necessary education, training and skills to adequately perform their particular job function.

Training Procedure - Overview

The Training Procedure establishes training requirements for all employees, temporary, contractors, consultants, and outside parties involved in the sales and distribution of products.

The Training Procedure includes timelines for orientation and training for new hires, construction of a training plan for each individual, and re-training requirements for existing personnel.

The Training Procedure includes training effectiveness checks and includes a training matrix / training plan to establish the required training for each position within the company. The Training Procedure also includes training record forms to document individual and group training activities.

Regulatory framework

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.