ISO 13485:2016 Cl. 6.3 - Infrastructure - Almost Everything is Outsourced

[CTL_78]

Hi, I'm new to the forum, I found it in my search for help on our transition to 13485:2016. We outsource all manufacture, storage and distribution of our product range. Am I correct in thinking that section 6.3 can be excluded since we don't physically handle any product?

The only small sticking point to that is, from our sales office we hold a small stock of samples that our reps can supply to new customers FOC to 'try the product out'. By the time the product gets to the sales team it is already established as 'conforming to requirements' as it has been subject to market release.

 

[regork]

CTL_78,
Infrastructure includes all the means, applications, information technology, equipment, facilities, etc. necessary to support MD product realization from design to delivery. If you do design, you need to include the Infrastructure required for design. How do you track the ordering and delivery of your product? If a computer is used to track delivery it needs to be included in Infrastructure.

As the MD owner "manufacturer" you are responsible for demonstrating that the supplier meets your infrastructure requirements typically expressed in a supplier agreement and verified by supplier qualification and monitoring.

 

[Avraham Harris]

Regork,
It should just be clarified that Design is not included in maintenance of infrastructure requirements. However, you are presumably correct to include it in the requirement to define infrastructure requirements, specifically "requirements for the infrastructure needed to achieve
conformity to product requirements".

Avraham