Infrastructure requirements in ISO 13485
By infrastructure in ISO 13485 is meant workspaces, process equipment, building, etc. Said in other words, to manufacture, design, or supply any medical device product or provide service needs an infrastructure. Clearly, without it, either company can’t carry out its activities.
However, all medical device companies, have to maintain such an infrastructure that will provide quality to the level required for customer satisfaction. They must maintain and pay attention to the infrastructures to remove the possibility of failure.
Identification of infrastructures
The focus is on the establishment and accessibility of infrastructures. It should be included all the requests, borders, and facilities needed for completion of the medical device from the design stages until its delivery. According to the iso standard, the infrastructures include software as well as hardware.
Infrastructure identification should be done first. Under the identification, it falls review of all processes that are associated with the QMS, relationship between the processes and infrastructure, identification of elements that might affect the quality of the product, etc. The focus should be on all the things that matter the realization of the medical device.
The next one is to list all the things that have been identified previously. Here are things like:
- Storage and production facilities with all the machinery including
- Design and development tools
- Buildings, structures, workspaces, halls
- Basic infrastructures like water supply, air systems, and electricity
- Security and safety means
- Computers information systems, record-keeping systems and servers, and process automation and management systems
- Means of transportation and distribution, etc.
Buildings and Structures
Buildings need to support processes and all that is required for the realization of the medical device.
These will enable:
- Provision of proper conditions for performing the working processes in an effective manner
- Planning of plant layouts and process flow, to eliminate the risk of mixing products with different status
- Optimization of plant layouts for the safety of personnel and devices, and agronomical parameters
- Consideration of interfacing with other infrastructures such as the supply of electricity, air or water, or transportation
Customer and regulatory requirements
Customer and regulatory requirements can establish requirements for infrastructures, their characteristics and they need maintenance. For example:
- Customers may deliver to the organization tools or machines necessary for the realization of the medical device, such equipment is to be considered as infrastructures
- Customer requirements may demand the storage of medical devices in certain conditions, such conditions require the manufacturer to install the appropriate control systems
- Several international standards or regulations relate to the maintenance of storage and production areas and require the specific measure to be implemented
The main goals of the evaluation are:
- Safe, sustainable and steady infrastructure
- Sustained medical device manufacturer with achieving quality targets and plans
- Verification of the infrastructure that it will not interfere with the objectives
- Areas identification and ranges for control
- Necessary control
- When needed, to implement improvements or to update the infrastructures
Integration of Risk Management Outputs and Safety Measures
Throughout the realization process, infrastructure still may pose risks to people working in it or to the products themselves. And such risks have to be identified:
- Process failures
- Risks to human resources
- Harm to the product
According to identified risks, appropriate controls and measures have to be applied. It will be made a documented plan with the described solution for all the potential problems regarding infrastructure.
The plan will refer to different aspects of the realization: production, quality, storage, and distribution, and will provide details and instructions according to the case. Such a plan will be available at the work stations to the appropriate employees.