Infrastructure requirements according to ISO 13485:2016

Updated: October 9, 2023.

The manufacturing, design, or supply of any product or service needs an infrastructure – without infrastructure, no firm can carry out its activities. Infrastructure includes buildings, workspaces, utilities, process equipment, instruments, information technology systems, and transportation mechanisms. Similarly, all companies involved in medical device manufacturing or distribution shall maintain a robust infrastructure that assures product quality to the level required for customer satisfaction. ISO 13485:2016 requires organizations to manage an infrastructure that ensures product conformity and quality.

The new revision of ISO 13485 offers more clarity than the prior version. The important objectives of ISO 13485:2016 infrastructure requirements include prevention of product mix-up and ensuring effective order handling of product.

Requirements for infrastructure according to ISO 13485
  1. Document infrastructure requirements
  2. Identify maintenance activities that could affect quality, and maintain records
  3. Provide the infrastructure needed to control the work environment
  4. Provide the infrastructure for monitoring & measurement

How does ISO 13485 define infrastructure, and in which clause?

ISO 13485:2016 identifies the purpose of infrastructure as being “to achieve conformity to product requirements.” The standard specifies infrastructure in requirement 6.3 as:

  1. Buildings, workspaces, and associated utilities – This includes the building that provides the area for manufacturing of products and, ultimately, storage. Workspaces are separate areas for different processes within the building, whereas associated utilities include power supplies, gas supplies, water supplies, sewage systems, and internet connections. Therefore, a medical device company has to maintain an infrastructure that covers all utilities, buildings (necessary for effective operations), workspaces necessary for different processes (example of workspaces in such industries are raw material stores, milling halls, heat treatment areas, assembly areas, finished goods store, etc.).
  2. Process equipment (both hardware and software) – This includes process equipment hardware, i.e.  machinery, and process equipment software, i.e., applications to run those machines. For example, a CNC milling machine is hardware, and CNC G-code programming is software to run the machine. So, medical device manufacturers have to maintain sufficient CNC milling machines to meet production plans (hardware for machining the forged component), and the programs in G-codes (software saved for all item codes).
  3. Supporting services (such as transport, communication, or information systems) – All of those mechanisms used for transportation, communication, or information systems are referred to as supporting services. Medical device manufacturers have to maintain a conveyor belt, forklift, cargo lift, or any other transportation mechanism used to transport in-process, raw material or finished goods, which are referred to as transport services. Similarly, they have to maintain services needed for interdepartmental communication, like internal documents, e-mail systems, or ERP systems used to convey messages. Information systems include ERP systems that manage information about inventories and the production processes.

Requirements for infrastructure according to ISO 13485

There is a new requirement in the latest standard, unlike in ISO 13485:2003, that requires organizations to maintain the infrastructure to prevent product mix-up and ensure the handling of product in an ordered manner. Moreover, information systems have also been added under the supporting services branch of infrastructure.

The requirements can be summarized as:

  1. Document infrastructure requirements – The organization is required to document all infrastructure requirements to ensure product quality; to avoid mixing within different lots, batches, and other product (e.g., from different types or lots); and to ensure the effective handling of customer orders. This can be met with an effective ERP system that handles product inventories, customer orders, product labeling (with traceability numbers, lot numbers, and item codes), and inspection and production status. An ERP-generated production card goes physically with the manufacturing lots. At each manufacturing step, the physical production card is updated, along with the status update in the ERP system by the production operator, and then the manufacturing lot goes to the next manufacturing operation.
  2. Identify maintenance activities that could affect quality, and maintain records – All the maintenance activities within planned intervals for processing equipment, whether hardware or software, that affect product quality should be identified, recorded, and managed. For example, an organization analyzes poor quality records, reworks, and rejections. Analysis results show that the CNC milling machine has an 80% defect rate. It is because of improper seating of a forged work piece on the CNC milling machine, which is because of cutting chips entrapped between the work piece and stopper surface of the machine. So, you make a visual autonomous maintenance plan for every CNC machine that requires the operator to clean the work piece stopper surface and other parts of the CNC machine on a daily basis.
  3. Provide the infrastructure needed to control the work environment – Ensuring the quality of the end product requires a controlled work environment. For that reason, the equipment that will be used to monitor and maintain the environment shall be identified and provided (air conditioners, heaters, temperature and humidity meters, or any other device).
  4. Provide the infrastructure for monitoring & measurement – All those devices that are used to monitor and measure product quality should be identified and provided (Vernier calipers, micrometers, gauges) and provided at the point of inspection (for example, set up inspection of a machined part at the CNC milling machine). The effectiveness of these devices has to be ensured through external and internal calibration.

The benefits and objectives of ISO 13485 infrastructure requirements

The benefits of ISO 13485 infrastructure requirements include:

  1. Enhanced quality management: Implementing ISO 13485 infrastructure requirements helps organizations establish a robust Quality Management System. This enables them to consistently provide safe and effective medical devices and meet regulatory requirements.
  2. Improved efficiency: By having well-defined infrastructure requirements, organizations can streamline their processes, reduce errors, and improve efficiency in their operations. This leads to cost savings and increased productivity.
  3. Risk management: ISO 13485 infrastructure requirements emphasize the importance of risk management in the medical device industry. By implementing these requirements, organizations can identify and mitigate risks associated with infrastructure, ensuring the safety and reliability of their products.

Benefits of ISO 13485 infrastructure requirements

The objectives of ISO 13485 infrastructure requirements are:

  1. Establishing adequate facilities: The infrastructure requirements aim to ensure that organizations have suitable facilities to support the design, development, production, and distribution of medical devices. This includes appropriate workspace, utilities, and environmental conditions.
  2. Ensuring proper equipment: ISO 13485 requires organizations to have the necessary equipment, both hardware and software, to support their operations. This ensures the accuracy, reliability, and consistency of processes and product outcomes.
  3. Competent personnel: The infrastructure requirements emphasize the need for competent personnel who can perform their assigned tasks effectively. This includes having qualified staff with appropriate training, skills, and knowledge to ensure the quality and safety of medical devices.

Implementing ISO 13485 infrastructure requirements helps organizations establish a solid foundation for their Quality Management System, enhance product quality, and meet regulatory requirements in the medical device industry.

Helping organizations to understand the need for infrastructure

It is possible that without the ISO 13485 standard, an organization could not comprehensively meet infrastructure requirements. This means the organization might compromise on an essential part of the infrastructure, causing many kinds of problems, which have to be handled after a problem has occurred. For example, if maintenance activities for process equipment (e.g., furnace, belt-grinding machines, CNC machines) whose absence affects product quality is not properly identified and is not carried out at defined intervals – what will happen? The process equipment starts malfunctioning and producing defective products. The reactive approach will be reworks, followed by breakdown maintenance. This approach wastes time, money, utilities, labor hours, and more.

The ISO 13485 standard, with its effective organizational infrastructure, has made it easier for organizations to deal proactively with potential non-conforming products and defective lots. With the help of a robust infrastructure, an organization can effectively manage its operations, ensure product quality, avoid process losses, and gain customer satisfaction. ISO 13485:2016 helps organizations to build such a system with robust infrastructure where business excellence is ensured.

Click here to download a free white paper: Clause-by-clause explanation of ISO 13485:2016, to see the requirements of the whole standard.