SCHU­MA­CHER Elek­tro­me­cha­nik GmbH has been cer­ti­fied accor­ding to the EN ISO 13485: 2016 stan­dard sin­ce 2017. This deter­mi­nes the requi­re­ments for a cle­ar­ly defi­ned qua­li­ty manage­ment sys­tem for the sup­p­ly of medi­cal pro­ducts and cor­re­spon­ding ser­vices that con­stant­ly meet cus­to­mer requi­re­ments and appli­ca­ble legal requirements.

Com­pli­ant with the ISO stan­dard, SCHU­MA­CHER Elek­tro­me­cha­nik GmbH has com­mit­ted to a clear and always trans­pa­rent defi­ni­ti­on and descrip­ti­on of plan­ning, deve­lo­p­ment, pro­cu­re­ment and pro­duc­tion, all the way to final testing.

The high medi­cal stan­dards con­nec­ted to ISO are found throug­hout the who­le Schu­ma­cher Elek­tro­me­cha­nik Eco-Sys­tem. This includes our own sup­pli­ers, who pro­vi­de com­pon­ents that are obli­ga­ted to com­ply with the requi­red qua­li­ty standards.

We are also com­mit­ted to kee­ping to the orga­niza­tio­nal struc­tures spe­ci­fied in the stan­dard so that poten­ti­al errors can be assi­gned to the respec­ti­ve pro­cess steps at any time and can be opti­mi­zed or adjus­ted if necessary.

The SCHU­MA­CHER Elek­tro­me­cha­nik Com­pe­ten­cy Plus

• Trans­pa­rent and safe manu­fac­tu­ring engineering
• Defi­ned mea­su­ring equip­ment management
• Employee qua­li­fi­ca­ti­on
• Tracea­bi­li­ty
• More fle­xi­bi­li­ty and adhe­rence to schedule
• ESD-com­pli­ant pro­duc­tion to pro­tect against elec­tro­sta­tic discharges