ISO certification

Definition of the term („What does ISO certification mean?“) 

The ISO cer­ti­fi­ca­ti­on is a pro­cess de­si­gned to pro­ve the com­pli­an­ce with cer­tain re­qui­re­ments. For ex­amp­le, ISO 9001 spe­ci­fies the re­qui­re­ments ap­p­ly­ing when im­ple­men­ting a glo­bal­ly ac­cep­ted qua­li­ty ma­nage­ment in a com­pa­ny. This ser­ves as a ge­ne­ral­ly ac­cep­ted pro­of for cus­to­mers and sup­pliers that the company’s exis­ting in­ter­nal qua­li­ty ma­nage­ment ba­sed on the ISO cer­ti­fi­ca­ti­on was suc­cess­ful­ly and ful­ly implemented.

How do you obtain an ISO certification? 

The ISO cer­ti­fi­ca­ti­on is per­for­med by an au­to­no­mous cer­ti­fi­ca­ti­on aut­ho­ri­ty to en­su­re an in­de­pen­dent pro­of of the com­pre­hen­si­ve exe­cu­ti­on of all re­qui­re­ments. Mo­reo­ver, the cer­ti­fi­ca­ti­on is per­for­med ba­sed on an au­dit spe­ci­fi­cal­ly ana­ly­zing all af­fec­ted departments.

The ty­pi­cal pro­ce­du­re of an ISO 9001 cer­ti­fi­ca­ti­on loo­ks like this:

  • In the first step of the cer­ti­fi­ca­ti­on au­dit, a com­pre­hen­si­ve do­cu­ment re­view and as­sess­ment of the com­pa­ny lo­ca­ti­on ta­kes place in or­der to de­ter­mi­ne the de­gree of com­pli­an­ce with the stan­dard and the po­ten­ti­al need for op­ti­miz­a­ti­on pri­or to the ac­tu­al audit.
  • In a se­cond step, it is che­cked if all do­cu­ments com­ply with ISO 9001… and the in­di­vi­du­al re­qui­re­ments. Fi­nal­ly, the re­sults of the cer­ti­fi­ca­ti­on au­dit are re­cor­ded in an au­dit re­port lis­ting pos­si­ble non­con­for­mi­ties and the au­dit procedure.

Once the ISO 9001 cer­ti­fi­ca­ti­on was suc­cess­ful­ly com­ple­ted, a cer­ti­fi­ca­te is is­sued, al­lowing to pro­ve the con­for­mi­ty of the QM sys­tem at any time.

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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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Which advantages does an ISO certification have? 

The ISO cer­ti­fi­ca­ti­on ser­ves as a pro­of that the qua­li­ty ma­nage­ment sys­tem is up-to-date and meets all re­qui­re­ments. Mo­reo­ver, it im­pro­ves the com­pe­ti­ti­ve­ness of a com­pa­ny and ad­di­tio­nal­ly sets a mi­ni­mum standard.

Ad­di­tio­nal ad­van­ta­ges include:

  • Crea­ting le­gal compliance
  • Im­ple­men­ting a qua­li­ty ma­nage­ment sys­tem crea­ting con­trol­led pro­ces­ses, de­fi­ning ro­les and re­spon­si­bi­li­ties and re­qui­ring the com­pa­ny to im­pro­ve the pro­ces­ses and in­cre­a­se the pro­cess performance
  • Pro­vi­des trans­pa­ren­cy for the customer
  • Au­dit re­sults may give you a ad­van­ta­ge over com­pe­ti­tors when cus­to­mers com­pa­re po­ten­ti­al suppliers
  • It is of­ten fi­nan­cial­ly sub­si­di­zed by the Fe­deral Of­fice of Eco­no­mics and Ex­port Con­trol (“Bun­des­amt für Wirt­schaft und Aus­fuhr­kon­trol­le”) in Germany

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Quality management handbook

De­fi­ni­ti­on of the term („What is a qua­li­ty ma­nage­ment hand­book?“)  The qua­li­ty ma­nage­ment ma­nu­al ser­ves as an in­ter­nal com­pi­la­ti­on and re­cord of the qua­li­ty management

Corrective Actions

De­fi­ni­ti­on of the term („What is a cor­rec­ti­ve ac­tion?“)  The ISO 9000 de­scri­bes a cor­rec­ti­ve ac­tion as a “mea­su­re to eli­mi­na­te the cau­se of a