of non-conforming consignments or those with incomplete Not met test results, to ensure no risk of cross contamination. Partially met Almost met Fully met or exceeded GQ1i There are procedures to ensure tissues and /or cells are not Not applicable released from quarantine until verification has been Not met completed and recorded. Partially met Almost met Fully met or exceeded GQ1j There are procedures detailing the critical materials and Not applicable reagents used and where applicable, materials and Not met reagents meet the standards laid down by the European Partially met directives on medical devices and in vitro diagnostic Almost met medical devices. Fully met or exceeded GQ1k There is a procedure for handling returned products. Not applicable Not met Partially met Almost met Fully met or exceeded GQ1l There are procedures to ensure that in the event of Not applicable termination of activities for whatever reason, stored tissues Not met and /or cells are transferred to another licensed Partially met establishment or establishments. Almost met Fully met or exceeded GQ1m The criteria for allocating tissues and/or cells to patients Not applicable and health care institutions are documented and made Not met available to these parties on request. Partially met Almost met Fully met or exceeded
of non-conforming consignments or those with incomplete test results, to ensure no risk of cross contamination. Not met Partially met Almost met Fully met or exceeded GQ1i There are procedures to ensure tissues and /or cells are not released from quarantine until verification has been completed and recorded. Not applicable Not met Partially met Almost met Fully met or exceeded GQ1j There are procedures detailing the critical materials and reagents used and where applicable, materials and reagents meet the standards laid down by the European directives on medical devices and in vitro diagnostic medical devices. Not applicable Not met Partially met Almost met Fully met or exceeded GQ1k There is a procedure for handling returned products. Not applicable Not met Partially met Almost met Fully met or exceeded GQ1l There are procedures to ensure that in the event of termination of activities for whatever reason, stored tissues and /or cells are transferred to another licensed establishment or establishments. Not applicable Not met Partially met Almost met Fully met or exceeded GQ1m The criteria for allocating tissues and/or cells to patients and health care institutions are documented and made available to these parties on request. Not applicable Not met Partially met Almost met Fully met or exceeded