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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EU GMP Guidelines Chapter 4

The chap­ter 4 re­la­tes to the do­cu­men­ta­ti­on. A good do­cu­men­ta­ti­on is an es­sen­ti­al part of the qua­li­ty ma­nage­ment. Mo­reo­ver, it con­sti­tu­tes a key func­tion for

Standard Operating Procedure (SOP)

De­fi­ni­ti­on of the term (“What is an SOP?”)  SOP (Stan­dard Ope­ra­ting Pro­ce­du­re) is the Eng­lish term for the Ger­man term “Stan­dard­ar­beits­an­wei­sung”. This is to be understood