ISO 9001:2015

ISO 9001:2015 de­fi­nes ge­ne­ral princi­ples and terms re­la­ting to qua­li­ty ma­nage­ment. It also de­fi­nes the mi­ni­mum qua­li­ty ma­nage­ment re­qui­re­ments that an or­ga­ni­sa­ti­on must meet in or­der to ma­nu­fac­tu­re pro­ducts that are re­co­gnis­ed by the authorities.

The la­test re­vi­si­on of the norm took place in the year 2015. Among other things, this sta­tes that pro­ces­ses must be va­li­da­ted which can­not be mo­ni­to­red du­ring their crea­ti­on and whe­re the re­sult only be­co­mes evi­dent in the end. Ac­cord­in­gly, the com­pon­ents sup­por­ting this pro­cess, in­clu­ding the soft­ware, must also be va­li­da­ted. It is sta­ted here that do­cu­men­ted in­for­ma­ti­on in­clu­ding tho­se using soft­ware must be iden­ti­fia­ble and as­si­gnab­le, have an ade­qua­te for­mat and must be sub­ject to a re­spec­ti­ve va­li­da­ti­on and ap­pro­val. The sub­ject of re­gu­lar con­trol of all data and do­cu­ments and their ma­nage­ment is also gi­ven ap­pro­pria­te con­si­de­ra­ti­on in this standard.

The cer­ti­fi­ca­ti­on of the norms is con­duc­ted by es­tab­lis­hed aut­ho­ri­ties such as the TÜV (Tech­ni­scher Über­wa­chungs­ver­ein). The norms ISO 9001 as well as ISO 13485 pro­vi­de a le­gal ba­sis of spe­cial si­gni­fi­can­ce for or­ga­niz­a­ti­ons ope­ra­ting internationally.

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Preventive Actions

De­fi­ni­ti­on of the term („What are pre­ven­ti­ve ac­tions?“) The ISO 9000 de­scri­bes a pre­ven­ti­ve ac­tion as a “mea­su­re to eli­mi­na­te the cau­se of a detected