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Any company cannot operate its operations without an infrastructure, which is required for the production, design, or supply of any good or service. Buildings, offices, utilities, machinery, tools, computer systems, and transportation systems are all examples of infrastructure. Similarly, all businesses engaged in the production or distribution of medical devices are obligated to keep an effective framework in place that guarantees product quality at the level necessary for client satisfaction.
Organizations have to maintain an infrastructure that guarantees product conformance and quality according to ISO 13485:2016. Preventing product mix-ups and maintaining efficient order management of products are two crucial goals of ISO 13485:2016 infrastructure requirements. According to ISO 13485:2016 standard, infrastructure is used "to achieve conformity to product requirements." According to the standard, infrastructure entails:
- Buildings, workspaces, and associated utilities – The structure that offers space for product manufacturing and, ultimately, storage is included in this. Workspaces are designated places within a building where various operations can be carried out in isolation, and utilities such as electricity, gas, water, sewage, and internet connections are included as accompanying services. Consequently, a medical device company must maintain an infrastructure that includes all utilities, structures (necessary for efficient operations), and workspaces (examples of workspaces in such industries include raw material stores, heat treatment areas, assembly areas, finished goods stores, etc.).
- Process equipment (both hardware and software) – The following comprises the machinery that makes up the process equipment as well as the software that powers it—the programs that control those components. Therefore, medical device manufacturers must keep up with the necessary hardware (for machining the forged component) and G-codes (software saved for all item codes) to satisfy production plans.
- Supporting services (such as transport, communication, or information systems) – The term "supporting services" refers to all of the equipment required for communication, transportation, or information systems. Conveyor belts, forklifts, cargo lifts, and other forms of transportation that are used to move raw materials, finished goods, or in-process goods are referred to as transport services, and they must be kept in working order by medical device makers. Similar to this, they must keep up with services like maintaining ISO 13485 documents, email systems, and message-delivery ERP systems that are necessary for interdepartmental communication.
The most recent standard includes a further requirement that businesses maintain the infrastructure to avoid product mix-ups and guarantee the processing of items in an orderly way. Information systems have also been introduced to the infrastructure's supporting services division. The requirements can be totalled up as follows:
- Document infrastructure requirements – To assure product quality, prevent mixing between various lots, batches, and other products, and ensure the efficient handling of customer orders, the organization is necessary to document all infrastructure needs. An efficient ERP system that manages product stocks, client orders, product labelling, and inspection and manufacturing status can help with this. Physically, the production lots are accompanied by an ERP-generated production card. The production operator updates the physical production card at each manufacturing stage, along with the status update in the ERP system, and then the manufacturing lot moves on to the following manufacturing activity.
- Identify maintenance activities that could affect quality, and maintain records – Any maintenance conducted on processing equipment, whether it be hardware or software, must be identified, documented, and managed at specific intervals.
- Provide the infrastructure needed to control the work environment – A controlled work environment is necessary to guarantee the quality of the finished product. Therefore, it is necessary to identify and provide the equipment that will be utilized to monitor and maintain the environment.
- Provide the infrastructure for monitoring & measurement – At the time of inspection, all equipment utilized to monitor and gauge the quality of the product should be noted and available. These devices must be calibrated both within and externally to ensure their effectiveness.
Source: https://13485certificationprocedures.wordpress.com/2023/09/16/most-efficient-way-to-comply-with-iso-13485s-requirements-for-medical-device-infrastructure/
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