Yiziphi izidingo eziqondile ze-FDA zohlelo lwekhwalithi yama-mobility Scooters?

Yiziphi izidingo eziqondile ze-FDA zohlelo lwekhwalithi yama-mobility Scooters?

I-US Food and Drug Administration (i-FDA) inochungechunge lwezidingo ezithile zesistimu yekhwalithi yezikuta ezihambayo, eziboniswa kakhulu ku-Quality System Regulation (QSR), okungukuthi 21 CFR Ingxenye 820. Nazi ezinye izimfuneko ezibalulekile ze-FDA ngesistimu yekhwalithi yama-mobility Scooters:

1. Inqubomgomo yekhwalithi kanye nesakhiwo senhlangano
Inqubomgomo yekhwalithi: Abaphathi badinga ukusungula izinqubomgomo nezinjongo zekhwalithi futhi bazibophezele ekuqinisekiseni ukuthi inqubomgomo yekhwalithi iyaqondwa, isetshenziswa futhi igcinwe kuwo wonke amazinga enhlangano.
Isakhiwo senhlangano: Abakhiqizi badinga ukusungula futhi bagcine isakhiwo senhlangano esifanele ukuze baqinisekise ukuthi ukuklanywa nokukhiqizwa kwedivayisi kuhlangabezana nezidingo zokulawula.

2. Izibopho zokuphatha
Izibopho neziphathimandla: Abakhiqizi badinga ukucacisa izibopho, iziphathimandla kanye nobudlelwano babo bonke abaphathi, abaphathi kanye nomsebenzi wokuhlola ikhwalithi, futhi banikeze ukuzimela okudingekayo kanye negunya lokwenza le misebenzi.
Izinsiza: Abakhiqizi badinga ukuhlinzeka ngezinsiza ezanele, okuhlanganisa ukwabiwa kwabasebenzi abaqeqeshiwe, ukuphatha, ukwenza umsebenzi nokuhlola imisebenzi, okuhlanganisa nokuhlolwa kwekhwalithi kwangaphakathi, ukuhlangabezana nezimfuneko zokulawula.
Omele abaphathi: Abaphathi kudingeka baqoke omele abaphathi onomthwalo wemfanelo wokuqinisekisa ukuthi izidingo zesistimu yekhwalithi zisungulwa ngempumelelo futhi zigcinwa, futhi abike ukusebenza kwesistimu yekhwalithi ezingeni labaphathi kanye nezibopho eziphezulu.

3. Ukubuyekezwa kwabaphathi
Ukubuyekezwa kwesistimu yekhwalithi: Abaphathi badinga ukubuyekeza njalo ukufaneleka nokusebenza kahle kwesistimu yekhwalithi ukuze baqinisekise ukuthi uhlelo lwekhwalithi luhlangabezana nezidingo zokulawula kanye nezinqubomgomo zekhwalithi nezinjongo ezisungulwe umenzi.

4. Ukuhlelwa Kwekhwalithi Nezinqubo
Ukuhlela Ikhwalithi: Abakhiqizi badinga ukusungula uhlelo lwekhwalithi ukuze bachaze izinqubo zekhwalithi, izinsiza kanye nemisebenzi ehlobene nokuklama nokukhiqizwa kwemishini.
Izinqubo Zesistimu Yekhwalithi: Abakhiqizi badinga ukusungula izinqubo nemiyalelo yesistimu yekhwalithi, futhi basungule uhlaka lwesakhiwo sedokhumenti lapho kufanele.

5. Quality Audit
Izinqubo Zokucwaninga Ngekhwalithi: Abakhiqizi badinga ukusungula izinqubo zokucwaninga ezisezingeni eliphezulu futhi benze ukucwaninga kwamabhuku ukuze baqinisekise ukuthi uhlelo lwekhwalithi luhlangabezana nezidingo zesistimu yekhwalithi emisiwe futhi banqume ukusebenza kahle kohlelo lwekhwalithi.

6. Abasebenzi
Ukuqeqeshwa Kwabasebenzi: Abakhiqizi kudingeka baqinisekise ukuthi abasebenzi baqeqeshwe ngokwanele ukuze benze imisebenzi abayabelwe ngendlela efanele.

7. Ezinye izidingo eziqondile
Ukulawulwa Kwedizayini: Abakhiqizi badinga ukusungula nokugcina izinqubo zokulawula ukwakheka ukuze baqinisekise ukuthi ukwakheka kwesisetshenziswa sihlangabezana nezidingo zabasebenzisi kanye nezidingo zohlelo lokusebenza.
Ukulawulwa Kwamadokhumenti: Izinqubo zokulawula amadokhumenti zidinga ukusungulwa ukuze kulawulwe imibhalo edingwa uhlelo lwekhwalithi
Ukulawula Ukuthenga: Izinqubo zokulawula ukuthenga zidinga ukusungulwa ukuze kuqinisekiswe ukuthi imikhiqizo ethengiwe kanye nezinsizakalo zobuchwepheshe zihlangabezana nezidingo ezithile
Ukukhiqizwa Nokulawulwa Kwenqubo: Izinqubo zokulawula ukukhiqiza kanye nenqubo zidinga ukusungulwa ukuze kuqashwe futhi kulawule inqubo yokukhiqiza
Imikhiqizo engahambisani: Izinqubo zokulawula umkhiqizo ezingavumelani nazo zidinga ukusungulwa ukuze kuhlonzwe futhi kulawulwe imikhiqizo engahlangabezani nezidingo.
Izinyathelo zokulungisa nezokuvikela: Izinqubo zezinyathelo zokulungisa nezokuvikela zidinga ukusungulwa ukuze kuhlonzwe futhi kuxazululwe izinkinga zekhwalithi.

Lezi zidingo ezingenhla ziqinisekisa ukuthi ama-Mobility Scooters aklanywa, akhiqizwa, ayahlolwa, futhi ayanakekelwa ukuze kuqinisekiswe ukuphepha komsebenzisi nokusebenza komkhiqizo. Le mithetho ye-FDA yakhelwe ukunciphisa ubungozi, ithuthukise ikhwalithi yomkhiqizo iyonke, futhi iqinisekise ukuthi ama-mobility Scooters ahlangabezana nezidingo zemakethe nezabathengi.