18 july 2016

Certification audit TÜV NORD

Representative from the international certification center TÜV NORD (Hamburg, Germany) has visited the production sight with an annual audit in the last days of June.

Manufacturer who received a TÜV certificate and a right to mark his products with a GS* sign must also pass mandatory annual audits. Such audit must verify that serial production still fulfills all the necessary standards and that the products manufactured still have the same quality characteristics with the sample given for certification.

Not only randomly selected serially produced item was tested but the whole manufacturing line – provisions and supplies, quality management system, stages of the production cycle, tools, personnel qualification.

Representative from the certification center was introduced with automated quality control system of the manufactured products – four consecutive steps of the Acceptance Tests (AT). All the acceptance steps have detailed description and are stored in the computer system’s memory. Inspector receives all the necessary information about each of four acceptance steps by scanning the bar-code located on the product itself. The system is made to prevent operator’s mistakes and not allow untrained personnel to do acceptance testing. It also excludes the possibility of using the tools with expired control certificate of metrological characteristics.Product’s access to the next step is blocked if some defects were found at some point of the acceptance tests until defect is eliminated and the product has passed the previous test.

First step of the acceptance tests is testing the leak-tightness of the cabinet construction.Second stage of the acceptance tests is performed on entirely assembled cabinet and checks the quality of assembly, completeness, configuration, integrity of the removable and movable parts, main functions.Third stage is tuning and verification of exploitation characteristics of the cabinets: electrical safety, airflow parameters balance (velocity, consumption, pressure), emergence alarm, HEPA filters integrity, air cleanliness class, visualization of the airflows, noise level and illumination of the work zone.Fourth step of the acceptance tests is final. It is performed on the product ready for shipment right before packing.

Test results of the each acceptance step are recorded in the special forms, which are further transferred into an acceptance tests protocol. Protocol is detailed document containing information on tests sequence, factual measurements and their comparison to the allowed criteria, factually used testing equipment.

Protocols are the documents of strict accounting and reporting. There is a special archive created and dedicated for storage and accounting of the acceptance protocols. Copy of the protocol can be sent to the user any time by request.

It is the second audit for the LAMSYSTEMS Company and it has proved that microbiological safety cabinets class II type A2 of the LAMSYSTEMS brand may be marked with a GS sign by the legal right of the manufacturer.* GS mark (Geprüfte Sicherheit, in translation from German means Guaranteed Safety) means that the product satisfies required quality and safety norms and is subject to the Equipment and Product Safety Act (GPSG).Among the LAMSYSTEMS products such mark is placed on the microbiological safety cabinets class II type A2 Neoteric. Certificate TÜV No. 44 330 13085601 was received by LAMSYSTEMS CC in 2014.