[ISO 13485 Cl 6.2] 

Clause 6 of ISO 13485:2016 refers to the Resource Management of the organization. This emphasizes having the necessary resources, including personnel, infrastructure, work environment, and contamination control, to effectively implement and maintain your quality management system.

Clause 6.2.2 emphasizes human resources and the competence, training, and awareness of personnel involved in the implementation of the QMS and continually improves its effectiveness. The organization must determine the knowledge necessary for its processes to achieve conformity of products and services.

Below are the key requirements.

1. Identify the Competence requirements.
2. Provide training to achieve necessary competence.
3. Evaluate the effectiveness of the training given.
4. Document the training activities conducted
5. Monitor the personnel performance and address any identified competence and awareness gaps.