ISO 9001 clause 7.1.3 is focused on "Infrastructure" as one of the key resources required for an effective Quality Management System (QMS). This clause requires organizations to:
- Determine, provide, and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services.
- Infrastructure includes buildings and associated utilities, equipment (including hardware and software), transportation resources, and information and communication technology.
- Ensure that the infrastructure is suitable for its intended purpose and can sustain the delivery of conforming products and services.
- Maintain the infrastructure to ensure its continued availability and suitability for operations.
- Consider aspects such as maintenance, contingency plans, backup systems, security, and environmental protection when managing infrastructure.
- Consider how transportation resources are affected
- Determine what affects will be on the information and communication technology
The intent of this clause is to ensure that organizations have the necessary facilities, equipment, systems, and support services to consistently meet product and service requirements. It emphasizes the importance of identifying, establishing, and maintaining an appropriate infrastructure that enables effective process operation and delivery of conforming outputs.
By addressing infrastructure needs, this clause aims to minimize risks associated with inadequate or failing infrastructure, which could potentially lead to nonconformities, disruptions, or an inability to meet customer or regulatory requirements.