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ISO 9001:2008 Reference
7 Product realization
7.5 Production and service provision
7.5.2 Validation of processes for production and service provision
The organization shall establish arrangements for these processes including, as applicable
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The organization shall establish arrangements for these processes including, as applicable
a) defined criteria for review and approval of the processes,
b) approval of equipment and qualification of personnel,
c) use of specific methods and procedures,
d) requirements for records (see 4.2.4), and
e) revalidation.