ISO 13485 Training Requirements

Keeping Track of Training: How to meet the ISO 13485 Requirements

As with many parts of the ISO 13485 quality standard, the training requirements were designed to help improve the organization’s quality. The standard required employees to be trained with the knowledge and skill necessary to do their jobs with quality. But the added requirement is to verify that the training provided was effective (see #3 below).

Here is a summary of the training requirements from section 6.2.2 Competence, awareness and training.

  1. Define the knowledge and skill needed for each employee to conduct their job.
  2. Deliver training or other learning activities to develop the required knowledge and skill.
  3. Provide a way to prove whether the training was effective (test for understanding)
  4. Ensure employee awareness of how their activities contribute to the quality objectives. They should understand the relevance and importance of their role.
  5. Keep training records and records of employee education, skills and experience.

Once an organization determines how to organize a training program to meet these requirements, they must find a way to keep track of the training schedules, evaluation activities and training records for every employee. Regardless of the size of the organization, most find these administrative demands very time consuming and difficult to maintain so the information is easily available during audits.

We have a solution: ISO 13485 Employee Training


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