Quality Management Representative (QMR)

Definition of the term („What is a Quality Management Representative?“) 

A qua­li­ty ma­nage­ment re­pre­sen­ta­ti­ve (QMR) ser­ves as a qua­li­ty ma­nage­ment con­sul­tant in a com­pa­ny. As the key per­son, he was ex­pli­ci­tly re­qui­red ac­cord­ing to ISO 9001 un­til the re­vi­si­on ISO 9001:2015. Sin­ce the en­act­ment of the la­test re­vi­si­on, howe­ver, a QMR is no lon­ger ex­pli­ci­tly re­qui­red. Sin­ce ISO 9001:2015, the role of the qua­li­ty ma­nage­ment re­pre­sen­ta­ti­ve is no lon­ger re­gar­ded as a stan­dard re­qui­re­ment so that the ma­nage­ment le­vel no lon­ger de­le­ga­tes its re­spon­si­bi­li­ty as the pro­mo­ter of qua­li­ty ma­nage­ment and the as­so­cia­ted hig­her re­qui­re­ments to the QMR. Howe­ver, the tasks of the QMR re­main and will still have to be per­for­med in the future.

Which tasks does a quality management representative have?

The QMR or the per­sons de­di­ca­ted sin­ce the re­vi­si­on of ISO 9001:2015 are re­spon­si­ble for im­ple­men­ting the re­qui­re­ments spe­ci­fied in ISO 9001 with re­fe­rence to the qua­li­ty ma­nage­ment sys­tem. Mo­reo­ver, their tasks in­clu­de en­su­ring the pro­cess im­ple­men­ta­ti­on, the rea­liz­a­ti­on and main­ten­an­ce of the qua­li­ty ma­nage­ment sys­tem ac­cord­ing to ISO 9001.

Ad­di­tio­nal tasks are:

  • Ob­li­ga­ti­on to coope­ra­te in the plan­ning and im­ple­men­ta­ti­on of com­pa­ny-spe­ci­fic qua­li­ty po­li­ci­es and targets
  • Com­mu­ni­ca­ti­on of qua­li­ty princi­ples to im­pro­ve qua­li­ty awa­reness in the company
  • Con­ti­nuous checks and eva­lua­ti­on of the fur­ther de­ve­lo­p­ment of the qua­li­ty ma­nage­ment system
  • Coor­di­na­ti­on, sup­port and trai­ning of ma­nage­ment staff and the ope­ra­ti­ve em­ployees with re­gard to qua­li­ty management
  • Coor­di­na­ti­on of the de­ve­lo­p­ment, up­date and fur­ther de­ve­lo­p­ment of stan­dard QM do­cu­ments: work in­st­ruc­tions, pro­cess in­st­ruc­tions and other ope­ra­ti­ve documents

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Our di­gi­ta­liz­a­ti­on so­lu­ti­ons pri­ma­ri­ly ad­dress do­cu­ment-ba­sed pro­ces­ses in ma­nu­fac­tu­ring, pro­duc­tion and qua­li­ty ma­nage­ment. The ba­sis of the d.3 life sci­en­ces sys­tem is a ho­listic ECM/DMS sys­tem. The ECM/DMS sys­tem can be lin­ked to your exis­ting ERP sys­tem (e.g. SAP), thus en­ab­ling you to im­ple­ment al­most all do­cu­ment-ba­sed pro­ces­ses in your company. 
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GMP stands for “Good Ma­nu­fac­tu­ring Prac­ti­ce” or Ger­man “Gute Her­stell­pra­xis”. Thus, GMP con­tains po­li­ci­es and re­gu­la­ti­ons that al­ways have to be ob­ser­ved, if or­ga­niz­a­ti­ons deal

Enterprise Content Management System (ECM)

De­fi­ni­ti­on of the term (“What is ECM?”)  ECM is the ab­bre­via­ti­on of En­ter­pri­se Con­tent Ma­nage­ment. This is the ma­nage­ment of all data and in­for­ma­ti­on ge­ne­ra­ted in