ISO KAO POTVRDA KVALITETA PROIZVODNJE MEDICINSKOG SREDSTVA SA CE ZNAKOM

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1 ISO KAO POTVRDA KVALITETA PROIZVODNJE MEDICINSKOG SREDSTVA SA CE ZNAKOM Alenka TOPLAK / Vladimir BURGIĆ Seminar: 12. tradicionalni simpozijum ALIMS, Kroz saradnju u oblasti lekova i medicinskih sredstava do efikasnije zdravstvene zaštite stanovništva Hotel Šumarice, Kragujevac,

2 STANDARD ISO UVOD ISO je internacionalni standard (International Organization for Standardization) koji sistemski uređuje područje kvaliteta pri proizvodnji medicinskih sredstava. Namenjen je organizacijama koje su uključene u jednu ili više faza životnog veka medicinskih sredstva (proizvodnja medicinskih sredstava/ili s njima povezane usluge). Standard obuhvata osnove za projektovanje, razvoj, proizvodnju, nabavku, skladištenjemedicinskih sredstava, instalacijske i servisneaktivnosti, distribuciju i aktivnosti u postproizvodnoj fazi.

3 STANDARD ISO UVOD Standard ISO je oruđe za uspostavljanje sistema menadžmenta i održavanje efikasnosti procesa.sistem menadžmenta je niz pravila, procesa i postupaka, koji organizaciji pomažu u ispunjavanju zahteva zainteresovanih strana. ISO se temelji na ISO Omogućena je samostalna sertifikacija - dobijanje ISO sertifikata. Zasnovan je na Plan Do Check Act ciklusu, 4 stepena metode za kontrolu i neprestano poboljšavanje procesa i proizvoda. Standard (mogu) koristiti i druge zainteresovane strane uključujući i sertifikaciona tela za proveru regulatornih zahteva i zahteva kupaca.

4 ZAŠTO USPOSTAVITI ISO 13485? Implementacijom standarda ISO organizacija dokazuje da: ispunjava zakonske i regulatorne zahteve, efikasno upravlja rizicima, kroz uspostavljeni sistem menadžmenta obezbeđuje bezbedno i odgovarajuće stručno medicinsko sredstvo, stalno unapređuje i poboljšava sistem. konkurentsku prednost na tržištu. CILJ: bezbedno i pouzdano medicinsko sredstvo

5 SERTIFIKAT ISO Sertifikacija sistema menadžmenta kvalitetom ISO 13485: olakšava dobijanje CE znaka za medicinska sredstva po direktivi 93/42/EEC za medicinska sredstva(dobijanjem EC sertifikata), olakšan pristup drugim tržištima izvan EU, obezbeđuje veću bezbednost i adekvantnost medicinskog sredstva, obezbeđuje se sledljivostu celom lancu od proizvođača do kupca ili korisnika, vodi ka stalnom unapređenju i poboljšavanju.

6 STANDARD ISO 13485:2003 Medical devices Quality management systems Requirements for regulatory purposes (ISO 13485:2003) / Medicinski uređaji Sistemi menadžmenta kvalitetom Zahtevi za svrhe regulative (ISO 13485:2003)

7 STANDARD ISO Zahtevi standarda ISO opisuju sistemski pristup, gde proizvođači lako prepoznaju, proveravaju i odlučuju se na koji odgovarajući način da uključe regulatorne zahteve u svoj sistem menadžmenta. Pri tom moraju predvideti: - Potrebne resurse. -Sistem interne proverei preispitivanje od strane rukovodstva. - Infrastrukturu i kompetentno osoblje. - Dokumentaciju i zapisesistema menadžmenta kvalitetom. - Sistem za rešavanje neusaglašenosti, korektivne i preventivne mere.

8 STANDARD EN ISO 13485:2012 Od 2003.g. (EN ISO 13485:2003) je priznat u Evropi u industriji medicinskih sredstava. Standard ISO 13485:2003 je potvrdio CEN kao harmonizovanu verziju: EN ISO 13485:2012(bez posebnih promena). Standard ISO su harmonizovali i potvrdili takođe od strane EU komisije uz podršku bitnim zahtevima (Essential requirements) relevantne EU Medicinske direktive i CE označavanju medicinskih sredstava.

9 ZAHTEVI ZA MEDICINSKA SREDSTVA Medicinska sredstva na tržištu EU moraju ispunjavati bitne zahteve Direktive o medicinskim sredstvimai nacionalnog zakonodavstva/ regulative države (članice). Proizvođači medicinskih sredstava moraju pre puštanja proizvoda na tržište dokazati bezbednosti pouzdanostsvojih proizvoda. Pre izlaska medicinskog proizvoda na tržište, proizvođač mora na proizvod staviti CE znak. Time dokazuje, da je proizvod bezbedan i pouzdan.

10 VEZA MEDICINSKIH DIREKTIVA Proizvođač medicinskih sredstava dokazuje usaglašenost svog sistema menadžmenta relevantne medicinske direktivekroz zahteve standarda ISO Direktiva 90/385/EEC AIMDD (aktivna implantabilna medicinska sredstva); Direktiva 93/42/EEC MDD(opšta medicinska sredstva); Direktiva 98/79/EC IVD (in vitrodijagnostička medicinska sredstva.

11 VEZA MEDCINSKIH DIREKTIVA Annex 2, Annex 5 AIMD Annex II, V i VI MDD Annex III, IV i VII IVD sadrži regulatorne zahtevei zahteve za prijavljene organe, koji nisu u obimu EN ISO (Annex ZA, Annex ZB i Annex ZC) ispunjavaju zahteve medicinske direktive: Direktiva 90/385/EEC AIMDD (aktivna implantabilna medicinska sredstva); Direktiva 93/42/EEC (opšta medicinska sredstva) MDD; Direktiva 98/79/EC (in vitro dijagnostička medicinska sredstva) IVD u slučaju sa odgovarajućom tč. standarda ISO

12 VEZA MEDICINSKIH DIREKTIVA

13 VEZA MEDICINSKIH DIREKTIVA

14 STANDARD ISO 13485:2016 NOVO - Medical devices Quality management systems Requirements for regulatory purposes (ISO 13485:2016) - Standard ISO 13485:2016 Medicinski uređaji Sistemi menadžmenta kvalitetom Zahtevi za svrhe regulative(iso 13485:2016) Nova verzija standarda izdata je Prelazni period za prelazak na novu reviziju standarda je 3 godine(do )

15 STANDARD ISO 13485: Namena standarda nije promenjena (usklađenost regulatornim i zakonskim zahtevima, efikasno upravljanje rizicima, sistem za proizvodnju bezbednih i efikasnih medicinskih sredstava,...) - Bazira na standardu ISO 9001: Dodatak A poređenje ISO 13485:2003 sa ISO 13485: Dodatak B poređenje ISO 13485:2016 sa ISO 9001: Dodatak ZB veza između zahteva MDD 93/42/EEC i standarda

16

17 STRUKTURA STANDARDA ISO Sistem menadžmenta kvalitetom 5. Odgovornost rukovodstva 6. Upravljanje resursima 7. Realizacija proizvoda 8. Praćenje, merenje i poboljšavanje

18 ISO 13485: BITNE PROMENE Tokom celog sadržaja naglašava se poštovanje svih važećih propisa(ciljevi za ispunjavanje zakonskih zahteva, pored zahteva za proizvod). Pristup kojise temelji na rizicima( risk based approach ) za sve procesesistema menadžmenta kvalitetom (stari standard usmeren samo u 7.1), upotrebiti za sve postupke i procese, uključujći outsource procese date dobavljačima.

19 ISO 13485: Sistem menadžmenta kvalitetom - dokumentovanje uloge organizacije (proizvođač, distirbuter) -poštovanje svih važećih propisai pristup koji se temelji na rizicima - kontrola predatih procesa (outsource) - validacija softvera pre prve upotrebe -izostavljanje moguće u tačkama 6, 7. i 8. -zahtevi za tehnički fajl minimalni sadržaj(dodato kao nova tačka 4.2.3)

20 ISO 13485: Odgovornost rukovodstva -proširivanje zahteva za preispitivanje od strane rukovodstva (input, output) 6. Upravljanje resursima - efikasnost osposobljavanja, koje se temelji na principu rizika - zahtevi, koji sprečavaju da se proizvodi pomešaju međusobno - nadzor opreme i proizvodnje u određenim intervalima -dodata je tačka Nadzor kontaminacijeza sterilna medicinska sredstva

21 ISO 13485: Realizacija proizvoda - Upravljanje rizicima u realizaciji proizvoda (dokumentovanje procesa, zapisi) - Zakonski zahtevikoji se odnose na proizvod moraju biti ispunjeni

22 ISO 13485: Dizajn i razvoj - proširenje zahteva pri definisanju ulaznih podataka u razvoj - proširenje zahteva za verifikaciju i validaciju; organizacija dokumentuje svoje planove, verifikuje ih i validira - dodata dokumentovana procedura za prenos dizajna i razvoja -uvođenje datoteka/ dosijeaza svaku kategoriju medicinskih sredstava

23 ISO 13485: Proces nabavke - dodati su zahtevi za ocenu i izbor dobavljača(kriterijumi za izbor) -kriterijumi moraju proporcionalno poštovati rizikepovezane sa finalnim proizvodom -gde je potrebno organizacija mora u pismenom ugovoru sa dobavljačem da dogovri uslove obaveštavanja o promenama - verifikacija dobavljača na osnovu rizika nabavke

24 ISO 13485: Proizvodnja i usluge servisa - kvalifikacija infrastrukture - analiziranje zapisa o izvršenom servisiranju -dokumentovana procedura za validaciju(uključujući i statističke tehnike i uzorkovanje) - validacija softvera, koji se koristi u proizvodnji ili servisnim aktivnostima -dokumetovan postupak za validaciju sterilizacije i sterilnih setova/bariernih sistema

25 ISO 13485: Praćenje i merenje - povratne informacije iz proizvodne i postproizvodne faze -povratne informacije moraju biti uključene u proces upravljanja rizicima -formirana je nova tačka standardaza pritužbe i reklamacije (tč ) -formirana je nova tačka komunikacija sa trećom stranom (regulatorni organi) - proces za identifikaciju merne opreme (8.2.6)

26 ISO 13485: Kontrola neusaglašenih proizvoda - Zahtevi za kontrolu su prošireni(aktivnosti na neusaglašene proizvode pre isporuke, aktivnosti na neusaglašene proizvode posle isporuke) - Veza popravka i regulatorni zahtevi 8.5 Poboljšanje - Kada se uvode poboljšanja za održavanje bezbednosti i efikasnosti medicinskog sredstva - Kada se sprovode korektivne ili preventivne mere i kada je potrebno proveriti da li su rezultati u skladu sa važećim zakonskim zahtevima

27 PRILOG - ISO 13485:2016 1) Da li nam je potreban standard ISO 13485, iako nismo proizvođači medicinskih sredstava? Organizacije, koje su uključene u jednu ili više faza životnog vekamedicinskog sredstva (dizajn, razvoj, proizvodnja, skladištenje i distribucija, instalacijske, servisne aktivnosti, konačnog odlaganja medicinskog uređaja ili s medicinskim sredstvom povezanih radnji (tehnička podrška) uspostavljaju sistem menadžmenta po standardu ISO 13485). Standard se može primentiti prema dobavljačima ilidrugim zainteresovanim stranama.

28 2) Kakva je sada važnost sertifikata izdatih po ISO 13485:2003 (EN ISO 13485:2012)? U prelaznom periodu do važeći su sertifikati izdati po oba standarda. Organizacije se u prelaznom periodu mogu sertifkovati obe verzije standarda. Sertifikacija po prethodnoj verziji standarda neće biti moguća u poslednjoj godini primene i važenja. 3) Kako proizvođači koji već imaju ISO 1348:2003 sertifikat mogu dobiti ISO 13485:2016 sertifikat? Proizvođači mogu po želji uraditi prelaz na redovnoj ili resertifkacijskoj proveri. O tome moraju blagovremeno obvestiti sertifkaciono telo pre sprovođenja redovnog termina provere.

29 4) Da li su sertifikaciona tela već obavestila nosioce sertifkata ISO o rokovima za prelaz - tranziciju? Sertifikaciona tela će blagovremeno obaveštavati proizvođače medicinskih sredstava i nuditi im pravovremene informacije za prelaz tranziciju na novu verziju/ reviziju) standarda. 5) Kako će nove medicinske regulative uticati na standard ISO 13485? Potrebna je promena standarda (nova verzija?), ta struktura će se uklopiti u novu regulativu (promena Annexa Z).

30 SLOVENSKI INSTITUT ZA KVALITET I METROLOGIJU (SIQ) - OBIM DELATNOSTI Ocenjivanje i sertifikovanje sistema menadžmenta Merenje Bezbednost i elektromagnetika Obrazovanje Tehnologije igra na sreću

31 ISO KAO POTVRDA KVALITETA PROIZVODNJE MEDICINSKOG SREDSTVA SA CE ZNAKOM SIQ, Ljubljana Tržaška cesta 2 SI Ljubljana/ Slovenija t e l. : f a x: http : / / w w w. s i q. s i alenka.toplak@siq.si SIQ d.o.o. Beograd Cara Dušana Beograd Zemun, Srbija Kontakt: Zoran Vuković t e l. : f a x :

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