Another specific requirement for ISO 13485 is that personnel be made aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives.

Written Procedures

This requirement is commonly interpreted as ensuring to include possible and common errors and their potential outcome in the written procedures. For example, let’s take a case of a ventilator which has a diaphragm that is supposed to be installed in a specific direction. A note in the installation procedure noting that if the component is installed in the reverse direction it may cause the device to fail prematurely is required, to ensure the person performing the process is aware of what could happen.

Personnel Record vs. Training File

One important item of note is not to confuse a personnel record with a person’s training file. Both records are kept for each employee, and both often contain a copy of the employee’s resume or CV. They also may both contain a copy of the person’s job description. However, it is strongly recommended that these be separate files. The personnel file will contain employee reviews and may contain other confidential and personal information which should not be included in the persons training record. Personnel files are often maintained with the human resources department and should be considered confidential, while training records need to be made available to auditors to provide evidence of compliance.