Infrastructure and the Maintenance thereof – What is the requirement?

This blog post will describe the requirements within ISO 9001:2015 Clauses 7.1.3

Clause 7.1.3: Infrastructure.

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.

There are three aspects to these requirements: Determine, Provide, and Maintain.

In general, the requirements are to ensure the availability of appropriate infrastructures throughout the realization processes. However, besides the provision of the infrastructures, the company is required to maintain and take care of them in order to ensure appropriate operation of processes and to avoid the probability of non-conformities.

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/services 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.

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