ISO13485인증

ISO13485 획득의 이점

인증원 2017. 10. 24. 14:14

국제기준에 적합한 품질경영시스템의 정비와 경영기업의 확립

품질매뉴얼 및 기타 표준화문서에 의한 지속적 개선

기업내 불합리한 사항의 문서에 의한 지속적 개선

상거래(대출이자 감소) 및 각종 견적 입찰시 우대

제품의 품질향상과 불필요한 사항의 제거로 수익증대

고객에의한 품질검사의 간소화 

인증로고 명함 및 견적서 표기/P/L(제조물책임)법 시행에 대한 대응 

ISO13485인증서와 의료기기CE인증서 발행에 대한 궁금한 사항은 칼리테스트인증원(인증원식별넘버 NB2179)(TEL 02-581-2114)으로 문의하시기 바랍니다.

출처 : 칼리테스트인증원(
http://kalitest.co.kr)
 
 
 
 
 

iso13485,iso인증,EN,ISO13485,인증대행,인증대행업체,GMP,의료기기,CE인증,ISO,CE,MDD,해외인증,식약청,의료기기정보지원센터,규격,정부지원금,해외규격,구청,시청,도청,,,,인증원,인증기관,치과,외과,안과,재활,수출,수입,의료기기인증,의료기기규격,식품의약품안전처,레이저,iso컨설팅,컨설팅,초음파,기기,mark,marking,마크,마킹,유럽,영국,프랑스,독일,헝가리,kalitest,ceceiso,씨이써티소,이탈리아,이태리,그리스,정부지원자금,지방자치지원자금,인증지원금,ce지원금,iso지원금,지원자금,터키,폴란드,크로아티아,체코,영국,아일랜드,북아일랜드,체외진단,기기,위험관리,임상,화장품,메드트로닉코리아(),메디슨,FDA,CC,LVD,IVD,AIMDD,EMC,Machinery,PPE,PED,Toy,CPD,Lift,SPVD,ATEX,EEC,스페인,핀란드,노르웨이,벨기에,부품소재,유럽연합,컨설팅업체,iso인증의뢰,iso대행업체,13485대행업체,가정용의료기기,도소매,도매,소매,닥터메디,애니메디,고메드,의료소모품,건강마트,의료장비,이원케어,G마케,쇼핑몰,기구,재료,물질,보청기,메디스팜,유럽대리인,피부용레이져,CE인증서,시험검사,의료용전자부품,디에스,eniso13485,의료기기지침,의료기기제조업체,칼리테스트인증원,임상시험,의료용구,인증개요,카카오,kakao,CEmarking,CE마킹,멸균기기,측정기기,13485규칙,삽입의료용구,동물용의약품,무역,보건소장,수성구,ce인증의뢰,ce인증취득,기술문서,라벨링,요구사항,사후심사,ce마크,인증원식별넘버,nb2409,CE인증사후관리심사,의료기기ce인증서,멸균의료용구,cemarking필수국가,ce마킹적용국가,품질경영시스템,씨이,문서화요구사항,Technical Documentations,경영책임,의료기기법,자원관리,씨이써티소인증원,EN ISO13485,비상 및 집중치료의료기기,ISO13485인증준비,Medical Devices Directive,ISO인증업무,CE마킹부착,notified body,EC,OHSAS,NB0029,APRAGAZ A.S.B.L,Belgium,NB0029,TUV NORD CERT GmbH, Germany, NB0050, National standards authority of Ireland(NSAI), Ireland, NB0051, IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITA S.P.A, Italy, NB 0068, IRCM ISTITUTO DI RICERCHE E COLLAUDI MASINI S.R.L., Italy, NB 0086, BSI, United Kingdom, NB0088, Lloy’s register quality asurance LTD(0088), United Kingdom, NB 0120, SGS United Kingdom Limited, United Kingdom, NB 0123, Tuv sud product service gmbh zertifizierstellen, Germany, NB0124 DEKRA certifiation GmbH, Germany, NB 0197, Tuv rheinland LGA product gmbh, Germany, NB 0297, DQS medizinprodukte gmbh, Germany, NB 0318, AGENCIA Espanola de medicamentos y productos sanitarios, Spain, NB 0344, DEKRA certifiation B.V., Nertherlands, NB 0366, VDE-pruf-und zertifizierungsinstitut GmbH, Germany, NB 0373, Istituto superiore DI sanita’, Italy, NB 0398 APAVE italia cpm srl, Italy, NB 0402, SP sveriges tekniska forskningsinstitut ab/sp technical reserarch institute of sweden, Sweden, NB 0408 TUV austria services gmbh, Austria, NB 0413, Intertek semko AB, Sweden, NB 0425, ICIM S.P.A., Italy, NB 0426, Italcert srl, Italy, NB 0432 Materialprufungsamt nordrhein-westfalen(mpa nrw), Germany, NB 0434 det norske veritas certification as, Norway, NB 0459, laboratoire natonal d’essais/G-med, France, NB 0470, nemko as, Norway, NB 0473, Amtac certification serviceds ltd, United kingdom, NB Kiwa cermet italia s.p.a., Italy, NB 0477, Eurofins-modulo uno spa, Italy, NB 0481, ECM-zertifizierungsgesellschaft fur medizinprodukte ineuropa mbh, Germany, NB 0482, Medcert zertifizierungs-und prufungsgesellschaft fur die medizin gmbh, Germany, NB 0483 mdc medical device certification gmbh, Germany, NB 0494, SLG pruf und zertifizierungs gmbh, Germany, NB 0499, Societe nationale de certification et d’homologation s.a.r.l, Lexumbourg, NB 0503, Infarmed, I.P., Portugal, NB 0535, BSI Group deutschland gmbh, Germany, NB 0537, VTT expert services oy, Finland, NB 0543, Presafe denmark A/S, Denmark, NB 0546, Certiquality s.r.l.-instituto di certificazione della qualita’, Italy, NB 0598 SGS fimko oy, Finland, NB 0633, Berlin cert pruf-und zertifizierstelle fur medizinprodukte gmbh an der technischen universitat berlin, Germany, NB 0636, prufstelle fur medizinprodukte graz, Austria, NB 0653, Research center for biomaterials s.a., greece, NB 0805, Therapeutic goods amdinistration, Australia, NB 0843, UL international (uk) LTD, United kingdom, NB 1008, Tuv rheinland intercert kft., Hungary, NB 1011, National institute for quality and organizational development in healthcare and medicines, Hungary, NB 1014, NB 1015, NB 0121, NB 1023, NB 1250, NB 1251, NB1252, NB1253, NB1254, NB1275, NB1293, NB1297, NB1304, NB1434, NB1435, NB1451, NB1639, NB1783, NB1868, NB1979, NB1984, NB2195, NB2265, NB2274, NB2291, NB2292, NB2409, ITC인증원, SZUTEST인증원, TUV인증원, SGS인증원, DNV인증원, QA인증원, icr인증원, BSI인증원, 아이티씨인증원, 수주테스트인증원, 티유브이인증원, 에스지에스인증원, 디엔브이인증원, 한국표준인증원, 비에스아이인증원, 큐에이인증원, 아이씨알인증원

'ISO13485인증' 카테고리의 다른 글

ISO13485인증은  (0) 2017.11.01
ISO13485 획득시 기대효과  (0) 2017.10.26
ISO13485 획득의 필요성  (0) 2017.10.20
ISO 업무  (0) 2017.10.13
ISO13485 받는 업체의 준비 세부내역  (0) 2017.10.11