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:

  • quality objectives and requirements for the product
  • the need to establish processes and documents, and to provide resources specific to the product
  • required verification, validation, monitoring, measurement, inspection and test activities specific to the
    proddct and the criteria for product acceptance
  • records needed to provide evidence that the realization process and resulting product meet requirements (see 2.4.2)

    The output of this planning shall be in a form suitable for the organizations method of operations,

    NOTE 1 A document specifying the processes of the quality management system (including the product realization
    processes)and tbe resources to be applied to a specific product, project or contract can be referred to as a quality plan.

    NOTE 2 The organization may also apply the requirements given In 7.3 to the development of product realization

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