As our company becomes compliant to ISO 13485:2003 through the help of a consultant will we need to establish procedures for IQ and OQ of our CNC lathes and mills? I ask this because some of our customers are requiring this for the equipment and I am try to decide if the IQ and OQ will be additional to 13485 certification or part being compliant.
Hi chasf,
If you refer ISO 13485:2003, section 7.5.2.1 clearly states -
The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.
Validation shall demonstrate the ability of these processes to achieve planned results.
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.
The organization shall establish documented procedures for the validation of the application of computer software (and changes to such software and/or its application) for production and service provision that affect the ability of the product to conform to specified requirements. Such software applications shall be validated prior to initial use.
Records of validation shall be maintained (see 4.2.4)
Therefore, validaion of any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement, is mandatory and prior to validation of the process, equipment qualification viz. IQ, OQ and PQ is a pre-requsite.
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