The certification company BSI Group Deutschland spent almost a month auditing and confirming the successful recertification of the quality management system (DIN EN ISO 9001:2015) and the Good Distribution Practice for pharmaceuticals (GDP 2013/C343/01) for all German trans-o-flex companies (Express, ThermoMed and Logistik-Service). The GDP conformity was certified independently of this and, additionally, also by TÜV Süd. trans-oflex first had its quality management system certified in 1995. GDP conformity was first certified in 2010 and then raised to a new level in 2013 with the publication of the new EU-GDP. “GDP certification is so important to us that this year we purposely used two different expert organisations to have our system audited by independent experts,” says Wolfgang P. Albeck, CEO of trans-o-flex. “The GDP certification reflects the quality of trans-oflex, which of course also benefits customers outside the healthcare industry.” Among other things, quality control, training, safety, cleanliness, active temperature control at 15 to 25 degrees Celsius and 2 to 8 degrees Celsius and internal monitoring procedures were audited. The new certification is valid for three years.
As regards ISO standards, the companies trans-oflex ThermoMed and trans-o-flex Logistik-Service were also certified according to the environmental management system DIN EN ISO 14001 for the first time this year. trans-o-flex Express was recertified according to this standard.