ISO 13485:2016 Standard – 6.3 Infrastructure

Infrastructures are the stock of the basic facilities and equipment needed for realizing the medical device or providing a related service. Infrastructures should provide the suitable conditions and accessories to perform the appropriate business asks and activities and assist in achieving the desired conformity of the medical device specifications and requirements: product, safety, and regulatory. Thus, they are strongly related to the medical device and have a direct effect on its quality. The basic goal of the organization is to ensure the provision, availability, and sustainability of infrastructures. Infrastructures include all the means, applications, interfaces, and facilities necessary for the realization of the medical device throughout its life-cycle phases, from the design stages through its delivery, post-delivery activities, and disposal. In general, the requirements of the ISO 13485 Standard are to ensure the availability of appropriate infrastructures throughout the realization processes. However, besides the provision of the infrastructures, the manufacturer is required to maintain and take care of them in order to ensure appropriate operation of processes and to avoid the probability of nonconformities. Maintenance of the infrastructures is a necessary precondition for the preservation of processes’ long-term capability, to ensure reproducibility of processes, and to guarantee the achievement of the product requirements. And what better way to reach such quality management goals than to identify, plan, and control? Control over the infrastructures shall reach all levels of process support. According to this basic rule, even equipment whose failure might not harm or affect the product directly, but will affect, for example, the organization’s ability to supply the product on schedule, a customer requirement, must be controlled and maintained. The standard ensures the scope of the controls by including

•  Equipment used in production
• Equipment used to control the work environment
• Equipment used for performing, monitoring, and measurement activities

Objectives of controlling and maintaining infrastructures

The standard specifies four distinctive objectives for the controls that will be implemented over infrastructures. The controls and techniques for managing infrastructures in the QMS shall achieve these objectives:

• Realization of the product
• Maintain conformity to product requirements
• Prevention of product mix-up
• Orderly handling of product

Identification of infrastructures as process equipment

What is infrastructure? Infrastructure is a structure that provides a framework that supports the operation of a system. In our case, they are structures that enable and support the progress of realization of the medical device or its related services. According to the ISO 13485 Standard, infrastructures include software (the collection of functions and programs that provide instructions for a unit for the operation of activities) as well as hardware (the physical layout of components or parts of a system). In other words, the standard makes it clear that both areas are included under the definition of infrastructures, the virtual as well as the material. The definition includes services that support software and hardware and assist them in meeting the specifications. The first stage in initiating control will be the identification of infrastructures relevant to the realization of the medical device or its relevant service activities. The objective is focusing on infrastructures that directly and indirectly support the realization processes. In my book I suggest an effective way to identify the relevant infrastructures:

• In the first step, you are to review the main process and its subprocesses that are related to the realization
• The next step will be to map and list all the infrastructures that are being used for these operations and activities listed above.
• Next, you will analyze the relations between the processes and the infrastructures and indicate which parameters may affect the processes and quality of the product.

Integration of risk analysis outputs and safety measures

The use of infrastructures during the realization processes may end up in a failure of the infrastructure and thus impact the medical device, affect the safety of the medical device, and create risks to the users and may generate hazardous situations that must be addressed and controlled. For example, when sealing machine is not maintained, the sealer might not produce enough pressure to seal a pouch containing the medical device. Such risks shall be identified (or should have already been) analyzed and evaluated for their impact on the safety of the medical device. These are the outputs of the risk management file (I dedicate a whole chapter in my book to the issue of the risk management and refer to the risk management file). The principle is to identify which characteristics of the infrastructure may affect the medical device and identify the risks associated with these characteristics. In practice, you are to refer to the risk management file and identify, implement, and integrate the necessary controls and preventions into the maintenance activities and the activities of operating the infrastructures (as part of their preservation).

Installation qualification, operational qualification, and performance qualification

IQ, OQ, and PQ are set of activities that will qualify infrastructure and equipment and validate and ensure they are suitable and adequate for use in the realization of the medical device.

• Installation qualification—Establishing by objective evidence that all key aspects of the infrastructure, equipment, and ancillary system installation comply with the manufacturer’s approved specification and that the recommendations of the supplier of the equipment are suitably considered
• Operational qualification—Establishing by objective evidence control limits and action levels of the infrastructure and equipment, which results in delivering all predetermined requirements
• Performance qualification—Establishing by objective evidence that the infrastructure, under specified conditions, consistently delivers a product that meets all predetermined requirements

I am dedicating in my book a paragraph to each type of qualification. But first, which infrastructures or equipment are required with IQ, OQ, and PQ? Generally, all infrastructures or equipment that are used or influenced by many parameters:

• That may change over time
• Over which you do not have 100% control
• Where risks to the characteristics, performance, or safety of the medical device are identified

This webpage contains only a fragment of the chapter 4 – Quality management system from the book:ISO 13485:2016: A Complete Guide to Quality Management in the Medical Device Industry, Second Edition published by:

Why choose this book???