Infrastructures are the stock of the basic facilities and equipment needed for realizing a product or providing a service. Infrastructures should provide the suitable conditions and accessories to perform the appropriate business tasks and activities and assist in achieving the desired conformity of product and service requirements. Thus, it is strongly related to the product or service and has a direct effect on their 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 products or services from the design stages through its delivery and post-delivery activities. Let us take a look at the ISO 9001 requirements regarding infrastructures:
- The organization shall identify, determine, and define infrastructures necessary for
- Effective operation of the QMS
- The realization of products or services
- Meeting customer requirements
- Enhancing customer satisfaction
- Infrastructures include all applicable facilities that participate in the realization of the product: buildings, work spaces, tools, equipment, machinery, and associated utilities necessary for the realization of the processes.
- The provision of infrastructures shall include the resources and the necessary services needed to support and operate them: transport, maintenance, communication, and information systems.
In general, the requirements of the ISO 9001 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. The 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.
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, structures that enable the realization of products or services. For example, a production hall enables the manufacturing of a product, a communication system at a call center enables the provision of services, a warehouse enables the storage of goods, and a CRM system enables data management of customers. According to the ISO 9001 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). Internet is a good example; the Internet infrastructure includes the telephone lines, the television cables, the routers, aggregators, and repeaters that channel the information that goes through the net, but also all software used to operate and manage the different Internet subsystems. 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 the control will be the identification of infrastructures relevant to the realization of the product or service. The objective is focusing only on infrastructures that support directly or indirectly the realization processes. I suggest here an effective way for identifying the relevant infrastructures:
- In the first step, you are to review the main process and its subprocesses that are related to the realization and are included under the QMS: capture of customer requirements, planning of products and operations, purchase of goods or services, acceptance of goods and services, storage, transportation through various phases of the material flow, and manufacturing and delivery activities to the end customer. The review is part of the application of the process approach and should provide you with a long list of processes and activities that use infrastructures.
- The next step will be to map and list all the infrastructures that are being used for these operations and activities. Customers, as well as national or regional regulations, may set requirements for infrastructures. This listing is very important to the later planning of the maintenance activities and prevention measures.
- 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. Significance will be given to the effect of an infrastructure on a given process, and this is measured on various levels: process parameters, elements of infrastructure, operators and responsibilities, and stage of process. This is the time to ask yourself the next question: How can infrastructures adversely affect process parameters, goods or service characteristics, and expected outcomes?
Evaluation of Infrastructures
After determining the required infrastructures, we need to evaluate their suitability to the QMS. The evaluation shall be conducted with respect to quality objectives and quality planning. The goals of the evaluation are
- To ensure that the infrastructures are intact, sustainable, and stable
- To ensure that the infrastructures will support the organization in achieving quality targets and plans
- To verify that the infrastructures will not disturb the achievement of objectives or reduce the capability of processes
- To identify areas and ranges for control
- To determine which controls are needed
- When needed, to implement improvements or to update the infrastructures
The evaluation shall be conducted with six parameters:
- Suitability: The quality of having the properties that are right for a specific purpose. zhis parameter evaluates how appropriate an infrastructure is to its final purpose and how much it can support this purpose.
- Security: This parameter evaluates the ability of an infrastructure to guarantee that an expected outcome will be met.
- Reliability: The quality of being worthy of reliance or trust. This parameter evaluates whether an infrastructure is reliable while playing its role in the realization process.
- Maintainability: The capability of being kept in good condition. This parameter evaluates how well can an infrastructure be maintained.
- Efficiency: The capability of the output to the input of any system. This parameter evaluates the results of an infrastructure with comparison to its objective.
- Safety: The state of being certain that adverse effects will not be caused by using the infrastructures under defined conditions and controls the impact of the infrastructure on the work environment.
This webpage contains only a fragment of the chapter 7.1 Resources from the book: ISO 9001: 2015 – A Complete Guide to Quality Management Systems published by:
Why choose the book ISO 9001: 2015?
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