Essential buildings, pieces of plant and equipment which are necessary to achieve product conformance must be maintained, specifically:
• Buildings and workspaces
• Process equipment, both hardware and software
• Support services, such as transport and communication
It is not a mandatory requirement to implement a procedure to control how you manage your infrastructure. However, you should always look to adequately define and control any operational process that directly impacts product quality.
NB this procedure is often called the 'Facilities Management Procedure' by quality professionals.
Develop and implement a 'Facilities Management' procedure that defines:
We provide a template for the operational procedure '6.3 Facilities Management' to help you document this process in many of our ISO Templates.
The effectiveness of infrastructure management might be determined by reviewing how it affects product conformity, e.g. ‘do our buildings, services and equipment add to the overall quality of our products? What could be changed to enhance product conformity?’