7 Product realization
7.1 Planning of product realization
The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality
management system (see 4.1).
In planning product realization, the organization shall determine the following, as appropriate:
(a)Quality objectives and requirements for the product
(b) The need to establish processes and documents, and to provide resources specific to the product
(c)Required verification, validation, monitoring, measurement, inspection, and test activities specific to the product and the criteria for product acceptance
(d)Records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4)