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ISO 9001:2008 Reference
7 Product realization
7.1 Planning of product realization. The organization shall plan and develop the processes needed for product realization.
In planning product realization, the organization shall determine the following, as appropriate:
b) the need to establish processes and documents, and to provide resources specific to the product;
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b) the need to establish processes and documents, and to provide resources specific to the product;