How to determine and provide the infrastructure needed?(2001,April-2w)
ISO9001: 2000 requires the infrastructure needed to achieve conformitytoproduct requirements from customers, but there is no requirement for documentation for the procedures. And there is also no clear requirement for Quality Manual to include the procedures how to determine and provide the infrastructure.
In order to understand the way to determine and provide theinfrastructure,it is useful to take an example in the case of building anew factory.
Basic procedures are as follow.
1. Determine products family and their quantity to make (forecastingmarketdemand)
2. Determine processes to produce the products
3. Determine necessary machines and equipment to do those processes
4. Determine utilities necessary for operating these machines andequipment
5. Determine size of land (location), buildings to accommodate thesemachines, equipment and utilities
6. Procurement and install the determined the infrastructure (purchasing)
7. Opereting of the factory( production)
Item 1.is customer-related and a kind of product design process. From item 2 to item 5 are processes design works with large scale, done by a production-engineering department. Therefore you can easily understand the processes from item 1.to item 7. are similar to production realization processes referred to 7clause of ISO9001:2000.
The inherited obscurity of process design or production engineering in ISO9001: 2000 may generate the complicated structure and placement of the requirement of the infrastructure.