Requirement for ISO 13485 of procedure of Human resources and another procedure of Infrastructure and working environment

1. Hi, if we have few employees (8) with many outsourced freelancers, and we don't own the working place, is it required for ISO13485 a procedure of Human resources and another procedure of Infrastructure and working environment?

According to the ISO 13485:2016 requirement 6.2 Human resources, for all personnel that performs work that affects product quality you need to document competencies, training needed, and description of how you will ensure the awareness of the employees. Therefore, you need a Human resource procedure for your 8 employees, but also for all freelancers because you need to state the criteria how will you choose your freelancers and which competencies freelancers need to have.

You can see on the following link how our Procedure for Human resource in our ISO 13485:2016 documentation toolkit looks like: https://advisera.com/13485academy/documentation/procedure-for-human-resources-iso-13485-2016/

2. If it is, why?

Considering the procedure for infrastructure and working environment, if you do not have a working place, then you can exclude the working environment part. However, if you have computers, mobile phones, and/or cars for your employees, then those elements are your infrastructure. Therefore, you need to make a documented procedure for maintaining this electronic equipment. Your infrastructure is also some server where you make your back-up or cloud service so be sure that it is included as well.

For more details on managing medical device infrastructure requirements, please read the following article:

• Managing medical device infrastructure requirements according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/06/28/managing-medical-device-infrastructure-requirements-according-to-iso-13485/

You can see on the following link how the Procedure for Infrastructure and work environment in our ISO 13485:2016 documentation toolkit looks like: https://advisera.com/13485academy/documentation/procedure-for-infrastructure-and-work-environment-iso-13485-2016/