Training in the company

According to requirement 6.2 Human resources, the following documents are required: documented requirements for establishing competencies, providing the needed training, and ensuring awareness of personnel.

This means that you need to documents what are competencies needed for each job position (this is usually called Job systematization), what kind of training do you have (for example internal training, external training, self-education), how the training will be conducted (how the person can ask to go to certain training, how the management will define the budget for the education, what kind of records there will be); and how the effectiveness of the education will be conducted (will it be for each education or just for the educations that have the most impact on the business of product quality, how the effectiveness will be checked: by oral or written exam, monitoring the everyday work, or something else). 

Usually, the responsible person is the head of the human resource department. However, very often the head of each department is responsible to decide to which training it is necessary for the employee to go and to define the method of the effectiveness check.

On the following links, you can see with which documents we cover this topic in our ISO 13485:2016 Documentation toolkit:

• Procedure for Human Resources https://advisera.com/13485academy/documentation/procedure-for-human-resources-iso-13485-2016/
• Training Program https://advisera.com/13485academy/documentation/training-program-iso-13485-2016/
• Training Record https://advisera.com/13485academy/documentation/training-record-iso-13485-2016/
• Record of Attendance https://advisera.com/13485academy/documentation/record-of-attendance-iso-13485-2016/