Like we said before in our recent articles: the ISO organization doesn't like to leave anything open for any debate! Every aspect is taken care of. The ISO 13485 Standard requires that the organization shall manage its infrastructures, resources and the working environment which are directly related to the realization process and the medical device.

The organization is required to define, provide and maintain the infrastructure required to realize medical devices according to the requirements. In infrastructures are included:

The purpose of these requirements is to control any maintenance activities related to any infrastructures. Infrastructures are directly related to your product, therefore must be controlled.  The purpose is to define how one should handle the infrastructure, during the realization process.

What Are infrastructures

Within infrastructures we include all the equipment that the organization uses in order to realize the product – to get the product through, from the planning stage out into the world. Services that are related to the product count as well. All substructures must be under the Quality management system. Infrastructures include all the applications, interfaces and facilities used to develop, realize and maintain the medical device:

• Development tools
• Production means
• Information systems
• Working tools
• Accessories
• All kinds of equipment
• Control tools

Anything related to the product (or the service).

Identifying the infrastructures

First step is to identify all the processes that use the infrastructures. This way you would focus only on what is relevant to your product (this tip may save you a lot of time). Whether if it's a truck transport, customer's order or a development task - if it uses infrastructures (truck, CRM system or an application development tool) – it must be included on the list. After indentifying all the processes, you are required to maintain a list of equipment (supporting the processes) that requires control.
At the end of this step you are left with a list of equipment that requires control in your organization. The next step is to define for any component on the list, the control required. For example a forklift – must be checked at least twice a year by a safety supervisor in order to confirm that it is safe for working and once a year for intactness check to confirm that it doesn't go kaput.
 
Important notice: Any services which support the medical device (or the service) – transportation services, communication services, resources services (gas, oil, electricity) must be included under the control - any service supporting the infrastructures that participate within the product realization.

The infrastructures and the medical device

The infrastructures, working space, working means and any service means are required to compete to the type of the medical device and the process (regardless if the organization develop them himself or purchase them). This requirement will assure that products would not be damage during manufacturing.
Process equipment would compete to the product's needs and would be maintained properly.
Any support services such as transporting or communicating are available and maintained as well. All in order to assure that the medical device would receive the optimal conditions.
Let me review the next example. A chemical factory that produces several different products needs to clean and disinfect the machines after manufacturing each product before it can manufacture the next product: the tubes are required to be clean; the containers are required to be emptied and cleaned and so on. Clearly these actions determine the quality of the product. Therefore they are required to be documented with all parameters such as a description and frequencies of the activities, responsibilities and carrying out: who shall perform what, how and when.

Documentation Documentation Documentation
The 13485 requires documentation of any requirements regarding the infrastructures.  You are required to supply with clear definitions regarding the infrastructures. The documentation shall include the activities required (in order to preserve the infrastructure) and records. 
You may define it in a procedure (it is not required to maintain a procedure), a form, a table, an electronic chart – whatever suits your organization. But it must be defined and documented.
If we get back to the example above, the organization is required to supply with its employees with:

• Means to perform the activity of cleaning the manufacturing infrastructures
• Instructions to perform the activities
• A record of the process
• Verification of the process

I would suggest a form that specifies the stages of the process. The form would indicate what the employee must do (the instructions), and a field to sign (the record). I would also include within the internal audit plan a verification of the process (the verification). We are left only with the Means to clean the tubes. On that matter I would suggest nothing just because I am not experienced enough. The only tubes I clean are on my pipe.

Turn to our next thrilling article about the invigorating subject of the ISO 13485 work environment requirements. You would besusrprised...