IQ/OQ

Equipment qualification in the context of quality management or validation is an essential pre-requirement for a large number of companies in deciding on a specific supplier. Apart from the calibration certificate, which is included by default for the Excellent and Perfect classes, Memmert also issues IQ/OQ certificates on request. To support the customers' own IQ/OQ certification, we can offer IQ/OQ documentation. 

The Installation Qualification IQ is the documented proof that facilities and equipment have been delivered and installed in accordance with the requirements and statutory safety regulations stipulated in the design qualification. The documentation for an Installation Qualification normally consists of: 

IQ test plan:Contains detailed information of the tests to be performed on the respective equipment in the context of the Installation Qualification.

IQ report: After completion of the Installation Qualification IQ, the results are summarised, evaluated and compiled in an IQ report. All deviations, as well as measures taken to eliminate these, are documented. After the deviations have been eliminated, these must be tested again, documented and evaluated in a new IQ report.

• Stocktaking of the components delivered, together with a check of the order documents
• Testing of manufacturer documentation for conformity (rating plate, delivery note)
• Testing of operator documentation for conformity (operating instructions)
• Testing of assembly and ensuring installation was performed correctly, based on various plans (insofar as is necessary)
• Documented evidence of operating personnel being instructed on operating equipment
• Documentation of test data for the initial inspection in accordance with DIN VDE 0700 Part 1 and EN 60335-3

After a successfully completed Installation Qualification IQ, this is released by the signatures in the qualification report of the persons responsible in the qualification team, countersigned by the user of the equipment, thus completing the process, or releasing the equipment for the next stage of qualification. 

The Operation Qualification OQ is a test process that evaluates the correct functioning of a facility or an appliance. During the Operation Qualification OQ, all items specified in the test plan are processed and documented in writing, to ensure that the system functions in accordance with specifications. Tests in accordance with the OQ can under some circumstances (otherwise only normal for the Performance Qualification PQ) only be performed with a loaded chamber. The (successfully) performed Operation Qualification OQ is a prerequisite for the technical acceptance of a facility or appliance. The Operation Qualification OQ may only be performed after a successfully completed Installation Qualification IQ. The documentation for an Operation Qualification normally consists of: 

OQ test plan: Contains detailed information of the tests to be performed on the respective equipment in the context of the Operation Qualification OQ This test plan contains detailed specifications on the course of the test itself.

OQ report: After completion of the Operation Qualification OQ, the results are summarised, evaluated and compiled in an OQ report. All deviations, as well as measures taken to eliminate these, are documented. After the deviations have been eliminated, these must be tested again, documented and evaluated in a new OQ report.