Ubukhulu buqondwa kuzo zonke izinyathelo zokuzenza. Isikhulu sakithi esisindisiwe ngaphandle kwe-ISO 13485 sibuyisa ukuthi zonke izinkotho zokuphatha nokusebenza kwezinhlanzi zokuphatha kufanele kubhekise iziphumo zezinhlanzi zokuphatha ezizweni zonke.
Isigaba sakithi sokubona kwemithambo yezibonelo sisebenza ngokwanele kwezibonelo ezingaphezulu zezinhlanzi zokuphatha ezizweni zonke, sibonisa izinto ezintsha zethu zokuzenza, sibonana ngokwanele nabasendaweni bokuthenga, futhi sithuthukisa izihlalo zesikhathi esidingekayo ngokubonisa ngokwanele nokuqonda okuhambelana nomsebenzi wethu.
Isigaba sakithi sokuthenga sisebenza ngokwanele ukuze sithenge ngokuthekwanele nokulayisha ngokuthekwanele kwemifanekiso, sibuyisa ukuthi isikhundla sishoqolwa ngokuthekwanele futhi sibeka amandla okuthenga emfanekisweni. Konke okuthengwa kusakwa ngokuthekwanele futhi kuthumelwa ngexesha, ukusiza ukuthi ubonakale ukuthenga okunamandla okukhomba.
Sithandaza ubukhulu kwezilayishwa zokuthengisa ngokuphelele zokuthengisa.