Validation of processes for production and service provision of ISO 13485
Validation of processes for production and service provision of ISO 13485
Clause 7.5.2
7.5.2.1 General requirements
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)
7.5.2.2 Particular requirements for sterile medical devices
The organization shall establish documented procedures for the validation of sterilization processes.
Sterilization processes shall be validated prior to initial use.
Records of validation of each sterilization process shall be maintained (see 4.2.4).
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