The ISO 9001 Standard requires that the organization will manage its infrastructures, resources and the working environment which are related to the realization process and the product. Like we said before in our recent articles: the ISO organization doesn't like to leave anything open for any debate!

What are the infrastructures? The basic framework or features of a system that supports the organization. The stock of basic facilities, equipment, services, and installations needed for the functioning the organization.  The infrastructures are needed for the operation of an organization. Viewed functionally, infrastructure facilitates the production of goods and services.

Infrastructures include all the facilities and the equipment that are needed to realize and provide the product (or the service):

• Trucks
• Forklifts
• Computer networks
• Working tools
• Uniforms
• Software
• Press machines
• Etc.

• Logistic centers
• Manufacture halls
• Stores
• Meeting rooms
• Dressing rooms
• Offices
• Service centers
• Information systems
• And more…

• A description of all spaces and halls required to realize the product (or the service).
• Definitions related to the working environment. The purpose of the definitions is to clarify crucial topics for behavior, conducting and utilization around the working environment in order to ensure the appropriate conditions for realization. For example in a chemical factory, you should define exactly what must be done after any process in order not to mix chemicals and to prevent disasters. Pay attention! We didn't say procedures or working instruction - the requirement is for definitions. How may you define, it's up to you!
• Within any working environment, you must define who is authorized and who is restricted to use it. The ISO 9001 Standard requirements apply for external visitors as well as internal. External visitors may be customers, suppliers, auditors etc. For example, in a food factory, you should define who is authorized in the manufacturing halls and who is not! Otherwise you might find there some unwelcomed guests tasting the food direct from the oven...
• Reference is required to physical factors that may affect the product – storage requirements, dust, ESD (for electronics components), light, dress requirements (at labs or sterilized halls) etc. You are not required here for the employees' security. This topic is covered within the human resources management (chapter 6.2.2) and the OHSAS 18001 Standard with more details.
• Reference is required to any regulatory requirements regarding the working environment – allowed opening hours, environmental requirements or any other regional requirements.

DEFINITIONS FOR INFRASTRUCTURES

Like we said before, within infrastructures we include all the equipment that the organization uses in order to realize the product – to get the product through, from the planning stage out into the world. Services that are related to the product count as well. All substructures must be under the Quality management system. How to achieve?!? It's not complicated.
First step is to identify all the processes that use the infrastructures. The processes are related to the product realization. This way you would focus only on what is relevant to your product (this tip may save you a lot of time). Whether if it's a truck transport, customer's order or a development task - if it uses infrastructures (a truck, a CRM system or a computer network) – it must be included on the list. After indentifying all the processes, you are required to maintain a list of equipment (supporting the processes) that requires control. At the end of this step you are left with a list of equipment that requires control in your organization. The next step is to define for any component on the list, the control required. For example a forklift – must be checked at least twice a year by a safety supervisor to confirm that it is safe for working and once a year and intactness check to confirm that it doesn't go kaput. You must define and document it. You may define it in a procedure, a form, a table,
an electronic chart – whatever suits your organization. But it must be defined and documented. The definition must refer to the documentation (What?!?). Here is the thing. The last thing we would advise it to become the ISO 9001 Standard secretary. You are not required for a procedure that describes the control process but you are required to prove implementation and performance of a control process.

Characteristic of infrastructures (in other words – what you may document):
Note – the next outlines are solely recommendations. It may differ from organization to organization.

• List of infrastructures that require control. The list must be confirmed by the responsible party. We will get there soon…
• Identifying details - each infrastructure has its own indentifying details: model, location, department, activity, working hours, serial number, manufacturer etc. These details helps you recognize the infrastructure in the organization's environment.
• Responsibility – each infrastructure is under someone's responsibility (or at least it is supposed to be in a healthy organization). You may document who must perform the control and if something goes wrong, you have someone to turn to…
• The control itself – each infrastructure bears it own control. Some requires observation only, while others require a complicated maintenance. But both must be documented. You are required to define the action needed to maintain the control. For example you should define a list of periodical examination that should be carried out. You may document it as a procedure (highly recommended but not required). If you do choose to document it within a procedure make sure you define, for any infrastructure how should it be controlled, who is the responsible and how to verify it. Another way are forms, special maintenance software etc.

SUMMARY

• The ISO 9001 Standard requires that the organization will manage its infrastructures, resources and the working environment which are related to the realization process and the product.
• The infrastructures and the working environment are supposed to supply you with the optimal conditions for the realization processes.
• Infrastructures include all the facilities and the equipment that are needed to realize and provide the product (or the service).
• Infrastructures must be included under your Quality management system.
• Any services which support the product (or the service) must be included under the control as well.
• Working environment includes all the spaces and halls that serve the organization for operation and product realization.

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