ISO 13485 Standard - 6.3 Infrastructure E-mail

Infrastructures are the stock of the basic facilities and equipment needed for the operation of a process or the maintenance, storage, or distribution of a product. It provides the suitable conditions and accessories to perform the appropriate business tasks and functions and assist in achieving the desired conformity of product and service requirements. Thus, it is strongly related to the product and has a direct effect on the quality of the medical devices.

The requirements of the ISO 13485 Standard are to ensure the availability of appropriate infrastructures throughout the realization processes. But beside the provision of the infrastructures, the manufacturer is required to maintain and take care of them in order to eliminate the probability of failure. The maintenance of the infrastructures is a necessary precondition for the preservation of processes’ long-term capability, ensures reproducibility of processes, and guarantees the achievement of the product requirements. And what is a better way to reach such quality management goals than to identify, plan, document, control, and record. The control over the infrastructures shall reach all levels of process support. According to this basic rule, even equipment whose failure might not harm and affect the medical device, but will affect the organization’ ability to supply the medical device on schedule must be controlled and maintained.

Identification of Infrastructures as Process Equipment

The basic goal of the organization is to ensure the provision and availability of infrastructures. Within infrastructures we include all the means, applications, interfaces, and facilities necessary for the realization of the medical device from the design stages until its delivery. According to the ISO standard the 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 needed to make it clear that both areas are included under the definition of infrastructures, the spiritual as well as the material. The definition includes services that support software and hardware and assist them in meeting the specifications. The first step in initiating the control will be to identify the infrastructures. The objective is to focus only on what is relevant to the realization of the medical device. The most effective way to do this is to:

  • Review all the processes that are related to the realization and are included under the QMS: capture of customer requirements, operation of raw materials and parts, transportation through various phases of the material flow, production, assembly, and delivery activities
  • To map and list all the infrastructures that are being used
  • To analyze the relation between the processes and the infrastructures
  • To indicate which parameters may affect the processes and quality of the product

Buildings and Structures

Buildings and structures are regarded as infrastructures; these are facilities that support processes and are necessary for the realization of a product. Characters of buildings and structures, and layouts of work spaces will be planned and implemented according to the needs of the processes that they are supporting: realization processes and activities, and conditions of storage. These will facilitate:

  • Provision of proper conditions for performing the working processes in an effective manner
  • Planning of plant layouts and process flow, in order to eliminate the risk of mixing products with different status
  • Optimization of plant layouts for 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

Thus, a multidisciplinary approach involving different roles and different aspects of the realization is recommended for the evaluation of whether work spaces and structures indeed support the processes. The output of the review will determine and define which controls are required for the maintenance of these structures and buildings and for the prevention of failures. The control will include aspects such as installation, periodical controls, cleaning, maintenance and services, repairs, licenses, and other necessary operations.

Integration of Risk Management Outputs and Safety Measures

The use of the infrastructures throughout the realization processes may pose risks to the users as well as to the products themselves. Such risks will be identified and discussed. Risks may appear as

  • Process failures
  • Risks to human resources
  • Harm to the product

When such risks are identified, the proper controls and prevention measures will be applied. For example, the use of materials and pressurizing activities during the sterilization processes may generate corrosion in the chamber. Risks like this must be identified and the appropriate controls are to be implemented at the appropriate process stages. Risks to human resources are to be referred to as well. A classic example which almost cost me a rejection of external audit is the common ladder; during one of my external audits, the auditor demanded to see records indicating that a ladder was safe for use (!?!). To tell the truth it never crossed my mind to examine the ladder. But in fact this ladder was used daily and required semiyearly maintenance according to the manufacturer’s specifications. Imagine that. But a ladder is a simple system. What about machines, electro systems, cranes, conveyor belts, forklifts, etc.? Each type of infrastructure shall be reviewed for the risks related to it and the necessary control and preventions will be integrated into the maintenance activities. A risk management output may serve as a reference to the review.

A documented plan for a solution of a problem related to the infrastructures will be implemented in the organization. The purpose of the plan is to define for the relevant parties or employees in different areas or departments what is to be done in case of a quality problem or failure concerning the infrastructures. 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.

This webpage contains only a fragment of the chapter 6 Resource Management  from the book: ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry published by:

CRC Press

 You may purchase the book through:



Complete Guide to Quality Management in the Medical Device Industry

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