- ISO 13485:2016 requires personnel performing work affecting product quality to be competent on the basis of appropriate education, training, skills and experience1. To meet the ISO 13485 requirements, you need to2:
- Define the knowledge and skill needed for each employee to conduct their job.
- Deliver training or other learning activities to develop the required knowledge and skill.
- Provide a way to prove whether the training was effective (test for understanding).
- Ensure employee awareness of how their activities contribute to the quality objectives.
Learn more:✕This summary was generated using AI based on multiple online sources. To view the original source information, use the "Learn more" links.ISO 13485:2016 addresses training and competency requirements in Section 6.2 Human resources of the standard: Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.www.greenlight.guru/blog/iso-13485-trainingKeeping Track of Training: How to meet the ISO 13485 Requirements
- Define the knowledge and skill needed for each employee to conduct their job.
- Deliver training or other learning activities to develop the required knowledge and skill.
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