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ISO 13485 의료기기 품질경영시스템 인증 및 교육 | LRQA
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href="/en-my/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="en-MY"> <span class="localLangTrans">Malaysia (English)</span> <span class="localLang" lang="en">Malaysia (English)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/en-gb/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="en-GB"> <span class="localLangTrans">United Kingdom (English)</span> <span class="localLang" lang="en">United Kingdom (English)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/en-us/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="en-US"> <span class="localLangTrans">United States (English)</span> <span class="localLang" lang="en">United States (English)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/es-cl/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="es-CL"> <span class="localLangTrans">South America (español)</span> <span class="localLang" lang="en">South America (Spanish)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/es-es/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="es-ES"> <span class="localLangTrans">España (español)</span> <span class="localLang" lang="en">Spain (Spanish)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/es-mx/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="es-MX"> <span class="localLangTrans">México (español)</span> <span class="localLang" lang="en">Mexico (Spanish)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/fr-be/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="fr-BE"> <span class="localLangTrans">Belgique (français)</span> <span class="localLang" lang="en">Belgium (French)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/fr-fr/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="fr-FR"> <span class="localLangTrans">France (français)</span> <span class="localLang" lang="en">France (French)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/id-id/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="id-ID"> <span class="localLangTrans">Indonesia (Indonesia)</span> <span class="localLang" lang="en">Indonesia (Indonesian)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/it-it/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="it-IT"> <span class="localLangTrans">Italia (italiano)</span> <span class="localLang" lang="en">Italy (Italian)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/en-ae/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="en-AE"> <span class="localLangTrans">Middle East (English)</span> <span class="localLang" lang="en">Middle East (English)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/nl-be/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="nl-BE"> <span class="localLangTrans">België (Nederlands)</span> <span class="localLang" lang="en">Belgium (Dutch)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/nl-nl/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="nl-NL"> <span class="localLangTrans">Nederland (Nederlands)</span> <span class="localLang" lang="en">Netherlands (Dutch)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/pl-pl/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="pl-PL"> <span class="localLangTrans">Polska (polski)</span> <span class="localLang" lang="en">Poland (Polish)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/pt-br/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="pt-BR"> <span class="localLangTrans">Brasil (Português)</span> <span class="localLang" lang="en">Brazil (Portuguese)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/pt-pt/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="pt-PT"> <span class="localLangTrans">Portugal (português)</span> <span class="localLang" lang="en">Portugal (Portuguese)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/ro-ro/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="ro-RO"> <span class="localLangTrans">România (română)</span> <span class="localLang" lang="en">Romania (Romanian)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/en-sg/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="en-SG"> <span class="localLangTrans">Southeast Asia (English)</span> <span class="localLang" lang="en">Southeast Asia (English)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/sv-se/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="sv-SE"> <span class="localLangTrans">Sverige (svenska)</span> <span class="localLang" lang="en">Sweden (Swedish)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/tr-tr/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="tr-TR"> <span class="localLangTrans">Türkiye (Türkçe)</span> <span class="localLang" lang="en">Turkey (Turkish)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/el-gr/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="el-GR"> <span class="localLangTrans">Ελλάδα (Ελληνικά)</span> <span class="localLang" lang="en">Greece (Greek)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/ar-ae/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="ar-AE"> <span class="localLangTrans">الشرق الأوسط(عربي)</span> <span class="localLang" lang="en">Middle East (Arabic)</span> </a> </li> <li class="pageHeaderLocalRegionSelItem"> <a href="/th-th/iso-13485/" class="pageHeaderLocalRegionSelItemLink" lang="th-TH"> <span class="localLangTrans">ประเทศไทย (ไทย)</span> <span class="localLang" lang="en">Thailand (Thai)</span> </a> </li> </ul> <p class="pageHeaderLocalRegionSelMenuText"></p> </div> </div> <ul class="pageHeaderButtonWrap pageHeaderEyebrow"> <li class="pageHeaderButton"> <a href="/ko-kr/who-we-are/" class="pageHeaderEyebrowLink"> <span class="text"> LRQA 소개 </span> </a> </li> <li class="pageHeaderButton"> <a href="/ko-kr/client-portal/" class="pageHeaderEyebrowLink"> <span class="text"> 클라이언트 포털 </span> </a> </li> <li class="pageHeaderButton"> <a href="/ko-kr/contact-us/" class="pageHeaderEyebrowContact cta"> <span class="text"> 문의하기 </span> </a> </li> </ul> <div class="pageHeaderLogo"> <a href="/ko-kr/" class="pageHeaderLogoLink"> <svg focusable="false"> <title>로고</title> <use href="/static/images/svg.svg#svg-lrqaLogo"></use> </svg> </a> </div> <div class="pageHeaderButton nav"> <button type="button"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-menu"></use> </svg> </span> <span class="text"> 메뉴 </span> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-cross"></use> </svg> </span> <span class="text"> 닫기 </span> </button> </div> <div class="pageHeaderNav" inert=""> <nav class="navigation"> <ul class="navigationList level1"> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> 어슈어런스 4.0 </span> </button> <ul class="navigationList level2"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> 돌아가기 </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/ko-kr/who-we-are/assurance-4/" target="_self"> <span class="text">어슈어런스 4.0</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/assure-assets-and-management-systems/" target="_self"> <span 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class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> 인증 심사 서비스 </span> </button> <ul class="navigationList level3"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> 돌아가기 </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/ko-kr/assessment-certification/" target="_self"> <span class="text">인증 심사 서비스</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/transfer-certification-to-lrqa/" target="_self"> <span class="text">LRQA로 인증 전환하기</span> </a> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> 품질, 환경 및 안전&보건 </span> </button> <ul class="navigationList level4"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> 돌아가기 </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/ko-kr/quality-environment-health-and-safety/" target="_self"> <span class="text">품질, 환경 및 안전&보건</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/iso-9001/" target="_self"> <span class="text">ISO 9001 인증</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/iso-14001/" target="_self"> <span class="text">ISO 14001 인증</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/iso-45001/" target="_self"> <span class="text">ISO 45001 인증</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/safety-culture-ladder/" target="_self"> <span class="text">안전 문화 (Safety Culture Ladder)</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/iso-19443-certification/" target="_self"> <span class="text">ISO 19443 인증</span> </a> </li> </ul> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> 식품,음료 및 접객 </span> </button> <ul class="navigationList level4"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> 돌아가기 </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/ko-kr/food-beverage-hospitality/" target="_self"> <span class="text">식품,음료 및 접객</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/fssc-22000/" target="_self"> <span class="text">FSSC 22000 인증</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/brcgs-food-safety/" target="_self"> <span class="text">BRCGS 인증</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/2nd-party-audit-programmes/" target="_self"> <span class="text">2자 심사</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/iso-22000/" target="_self"> <span class="text">ISO 22000 인증</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/ifs/" target="_self"> <span class="text">IFS 인증</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/sqf-certification-safe-quality-food/" target="_self"> <span class="text">SQF 인증</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/haccp/" target="_self"> <span class="text">HACCP 인증</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/en/food-labelling-regulation-advisory-services/" target="_self"> <span class="text">Food 라벨링</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/gsa-bap/" target="_self"> <span class="text">GSA BAP 인증</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/msc/" target="_self"> <span class="text">MSC 인증</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/asc/" target="_self"> <span class="text">ASC 인증</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/fami-qs/" target="_self"> <span class="text">FAMI-QS</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/farm-first-assurance-scheme/" target="_self"> <span class="text">Farm First (팜 퍼스트) 인증</span> </a> </li> </ul> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> 지속가능성 & 책임있는 소싱 </span> </button> <ul class="navigationList level4"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> 돌아가기 </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/ko-kr/climate-change-sustainability/" target="_self"> <span class="text">지속가능성 & 책임있는 소싱</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/iso-14064/" target="_self"> <span class="text">ISO 14064 인증</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/iso-140672018-greenhouse-gases-carbon-footprint-of-products/" target="_self"> <span class="text">ISO 14067 인증</span> </a> </li> <li 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target="_self"> <span class="text">EU ETS</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/responsible-plastic-management/" target="_self"> <span class="text">책임있는 플라스틱 관리(RPM)</span> </a> </li> </ul> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> 정보보안 경영시스템 </span> </button> <ul class="navigationList level4"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> 돌아가기 </span> </button> </li> <li class="navigationListItem parentLink"> <a 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href="/ko-kr/containers/" target="_self"> <span class="text">컨테이너 인증</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/product-certification/type-approval/" target="_self"> <span class="text">타입 승인</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/utilities/" target="_self"> <span class="text">유틸리티 부문 스킴</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/construction-industry/" target="_self"> <span class="text">건설부문 스킴</span> </a> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> 에너지 전환 서비스 </span> </button> <ul 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class="text"> 교육 서비스 </span> </button> <ul class="navigationList level3"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> 돌아가기 </span> </button> </li> <li class="navigationListItem parentLink"> <p class="navigationListItemLink"> <span class="text">교육 서비스</span> </p> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> LRQA 교육 과정 모두 보기 </span> </button> <ul class="navigationList level4"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> 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<span class="text">넷 제로</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/double-materiality/" target="_self"> <span class="text">이중 중대성</span> </a> </li> </ul> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> 전략 및 설계 </span> </button> <ul class="navigationList level4"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> 돌아가기 </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/ko-kr/strategy-and-design/" target="_self"> <span class="text">전략 및 설계</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/supply-chain-risk-assessment-and-segmentation/" target="_self"> <span class="text">공급망 리스크 평가 및 세분화</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/carbon-footprint-and-decarbonisation-strategy/" target="_self"> <span class="text">탄소 발자국 및 탈탄소화 전략</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/safety-culture-ladder/" target="_self"> <span class="text">안전 문화(Safety Culture Ladder)</span> </a> </li> </ul> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> 이행 </span> </button> <ul class="navigationList level4"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> 돌아가기 </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/ko-kr/implementation/" target="_self"> <span class="text">이행</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/grievance-mechanism/" target="_self"> <span class="text">고충 처리 메커니즘</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/ghg-inventory/" target="_self"> <span class="text">온실가스(GHG) 인벤토리</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/ko-kr/waste-and-emissions-supply-chain-engagement/" target="_self"> <span class="text">폐기물 및 배출량 공급망 참여</span> </a> </li> </ul> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="icon"> <svg focusable="false" class="arrow-desktop"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> <span class="text"> 보고 및 정보 공개 </span> </button> <ul class="navigationList level4"> <li class="navigationListItem back"> <button type="button" class="navigationListItemLink"> <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-arrow"></use> </svg> </span> <span class="text"> 돌아가기 </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/ko-kr/reporting-and-disclosure/" target="_self"> <span class="text">보고 및 정보 공개</span> </a> 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</button> </form> </div> <figure class="quickLinks"> <figcaption class="quickLinksTitle">자주 찾는 링크</figcaption> <div class="swipeNav col-12"> <div class="swipeNavWrap"> <ul class="swipeNavList"> <li class="swipeNavListItem"> <a href="/ko-kr/events/" class="swipeNavLink cta ctaTertiary"> <span class="text"> 세미나/행사 </span> </a> </li> <li class="swipeNavListItem"> <a href="/ko-kr/insights/articles/" class="swipeNavLink cta ctaTertiary"> <span class="text"> 전문가 의견 </span> </a> </li> <li class="swipeNavListItem"> <a href="/ko-kr/resources/" class="swipeNavLink cta ctaTertiary"> <span class="text"> 참고 자료 </span> </a> </li> <li class="swipeNavListItem"> <a href="/ko-kr/client-portal/" class="swipeNavLink cta ctaTertiary"> <span class="text"> 클라이언트 포털 </span> </a> </li> <li class="swipeNavListItem"> <a href="/ko-kr/case-studies/" class="swipeNavLink cta ctaTertiary"> <span class="text"> 케이스스터디 </span> </a> </li> </ul> </div> </div> </figure> </div> </div> </header> <nav class="breadcrumbs"> <p class="offscreen" id="breadcrumblabel">You are here:</p> <ol class="breadcrumbsList" aria-labelledby="breadcrumblabel"> <li class="breadcrumbsItem"> <a class="breadcrumbsLink" href="/ko-kr/"> <span class="breadcrumbsLinkText"> Home </span> <span class="breadcrumbsLinkText breadcrumbsLinkTextPrevious"> 이전 페이지로 돌아가기 </span> <span class="icon breadcrumbsIconSvg"> <svg focusable="false" class=" breadcrumbsIconSvg"> <use href="/static/images/svg.svg#svg-chevron"></use> </svg> </span> </a> </li> <li class="breadcrumbsItem"> <strong class="breadcrumbsLinkText breadcrumbsCurrent"> ISO 13485 </strong> </li> </ol> </nav> <img src="/static/assets/search-grey.svg" loading="eager" style="display:none;" /> <main id="content" tabindex="-1"> <section class="grid headerContentArea" > <div class="hero heroVariant2 heroAlignCentre canvas canvasNavy col-12" id="H1+-+ISO+13485+Medical+Quality+Management+System"> <div class="image" > <picture><source srcset="/cdn-cgi/image/width=1024,format=auto/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg 1024w,/cdn-cgi/image/width=1280,format=auto/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg 1280w,/cdn-cgi/image/width=1440,format=auto/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg 1440w,/cdn-cgi/image/width=1920,format=auto/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg 1920w,/cdn-cgi/image/width=2048,format=auto/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg 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1920w,/cdn-cgi/image/width=2048,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 2048w,/cdn-cgi/image/width=2304,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 2304w,/cdn-cgi/image/width=2560,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 2560w,/cdn-cgi/image/width=2880,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 2880w,/cdn-cgi/image/width=3072,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 3072w,/cdn-cgi/image/width=3840,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 3840w,/cdn-cgi/image/width=4320,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 4320w,/cdn-cgi/image/width=5760,format=auto/globalassets/_shared-images/1536-x-1536-c02.01-header-imagevideo-header-image-mobile/business-assurance/medical/mdr-1536-x-1536-.jpg 5760w" sizes="100vw" media="" ><img src="/cdn-cgi/image/width=1024,format=auto/globalassets/_shared-images/1920-x-0785-c02.01-header-imagevideo-header-image-desktop/business-assurance/medical/mdr-1920-x-785.jpg" alt="Stethoscope on tablet" loading="eager" decoding="auto" fetchpriority="auto" class="heroImage" fetchpriority="auto" ></picture> </div> <div class="titleBlock"> <h1 class="heroTitle" > ISO 13485 인증,교육 및 참고자료 </h1> <p class="heroSummary" > 의료기기 산업의 품질 요구사항 준수 </p> <ul class="heroList" > <li class="heroListItem"> <a href="/ko-kr/iso-13485/#request-quote" class="arrowLink arrowLinkBold">견적 문의하기</a> </li> <li class="heroListItem"> <a href="/ko-kr/iso-13485/#transfer-to-lrqa" class="arrowLink arrowLinkBold">LRQA로 인증서 전환하기</a> </li> </ul> </div> </div><div class="stickyCtaContainer twoItems" id="Shared+KO-KR+sticky+CTA+-+BA"> <a href="tel: 02 736 6231" class="stickyCtaButton" > <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-phoneRinging"></use> </svg> </span> <span class="text"> 02 736 6231 </span> </a> <button type="button" class="stickyCtaButton modalButton" data-dialog="modal2" > <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-letter"></use> </svg> </span> <span class="text"> 문의하기 </span> </button> <dialog id="modal2"> <div class="dialogWrap"> <button type="button" class="innerDialogButton"> <svg focusable="false" class="white"> <title>닫기</title> <use href="/static/images/svg.svg#svg-close"></use> </svg> </button> <div class="dialogWrapInner"> <div class="stickyCtaDialog white"> <div class="stickyCtaDialogContent"> <h3 class="stickyCtaDialogHeader">문의하기</h3> <div class="stickyCtaDialogIframeContainer"> <iframe class="stickyCtaDialogIframe" src="https://info.lrqa.com/l/12702/2021-10-03/c3jcf4" loading="lazy" id="iFrameResizer2" style="overflow: hidden;" scrolling="no"> </iframe> </div> </div> </div> </div> </div> </dialog> </div> </section> <section class="grid stickyContentArea" > </section> <section class="grid mainContent" > <div class="quickLinks col-12 spacingSmall canvas canvasNavy" id="ISO+13485+Page+Tabs"> <div class="swipeNav col-12"> <div class="swipeNavWrap"> <ul class="swipeNavList" > <li class="swipeNavListItem"> <a href="/ko-kr/iso-13485/training/" class="swipeNavLink cta ctaTertiary"> <span class="text"> 교육 </span> </a> </li> </ul> </div> </div> </div><div class="textBlock col-6 canvas canvasWhite" id="Callout+intro"> <div class="wysiwyg" > <h2 style="text-align: left;">제품 개발 수명 주기를 간소화하고 프로세스를 최적화합니다.</h2> </div></div><div class="textBlock col-6 canvas canvasWhite" id="Introduction"> <div class="wysiwyg" > <p style="text-align: justify;">규정 준수 및 시장 진입의 효율성. ISO 13485는 의료기기에 대한 국제 품질 경영시스템(QMS) 표준입니다. 이 표준은 조직이 QMS에 대한 위험 기반 접근 방식, 규제 요건에 대한 강화된 초점, 공급업체에 대한 통제 강화를 통해 제품이 엄격한 산업 규정을 충족하고 환자 안전을 지원한다는 것을 입증할 수 있도록 설계되었습니다. 이 표준은 기기를 제조하는 조직과 기기 제조업체를 지원하는 조직 모두에 적용되며, 프로세스를 최적화하고 제품 개발 수명 주기를 간소화할 수 있도록 지원합니다.</p> </div></div><div class="textBlock col-12 spacingSmall canvas canvasNavy" id="Our+services"> <div class="wysiwyg" > <h3 style="text-align: center;"><strong>LRQA의 ISO 13485 서비스</strong></h3> <p style="text-align: justify;">LRQA는 ISO 13485 요구사항에 따라 교육, 인증 및 심사 서비스를 제공합니다. 현장, 원격 또는 이 두 가지를 혼합하여 제공하는 유연한 서비스를 통해 비즈니스의 고유한 요구 사항을 충족하도록 맞춤화할 수 있습니다.</p> </div></div><div class="textBlock col-3 canvas canvasNavy" id="Training"> <div class="wysiwyg" > <p class="desktop-center"><img style="display: block; margin-left: auto; margin-right: auto;" src="/contentassets/f00d16feb942418083e786249683a6a2/training-icon/" alt="computer screen icon" width="150" height="90" /></p> <h4 style="text-align: center;">교육</h4> <p class="desktop-center">다양한 수준의 경험과 학습 스타일에 맞게 설계된 다양한 교육 과정을 통해 QMS 기본 사항에 대한 이해를 쌓을 수 있습니다.</p> </div></div><div class="textBlock col-3 canvas canvasNavy" id="Gap+analysis"> <div class="wysiwyg" > <h6 class="desktop-center" style="text-align: center;"><img style="display: block; margin-left: auto; margin-right: auto;" src="/contentassets/2c30f9f4de9c47b3b9247ca741ee5cb0/gap-analysis/" alt="image94kd3.png" /></h6> <h4 class="desktop-center" style="text-align: center;">차이점 분석</h4> <p class="desktop-center" style="text-align: center;">ISO 13485 심사를 받기 전에 LRQA 심사원이 귀사와 협력하여 기존 QMS의 부적합 사항을 사전에 파악할 수 있는 선택적 서비스 입니다.</p> </div></div><div class="textBlock col-3 canvas canvasNavy" id="Certification"> <div class="wysiwyg" > <h6 class="desktop-center" style="text-align: left;"><img style="display: block; margin-left: auto; margin-right: auto;" src="/contentassets/ecff9e4f78c14d2f8ada7e62a3d575cf/certification-icon/" alt="imageao21.png" /></h6> <h4 style="text-align: center;">인증</h4> <p class="desktop-center" style="text-align: center;">LRQA의 인증 프로세스는 ISO 13485에 따라 귀사의 QMS를 검증한 후 그 효과를 평가하여 역량을 입증함으로써 이해관계자와의 신뢰를 구축할 수 있도록 지원합니다.</p> </div></div><div class="textBlock col-3 canvas canvasNavy" id="Integrated+audit"> <div class="wysiwyg" > <h6 class="desktop-center" style="text-align: left;"><img style="display: block; margin-left: auto; margin-right: auto;" src="/contentassets/9dc2007c749c4712a1ac9a62399b5ffc/intgerated-services-icon.png" alt="intgerated services icon.png" /></h6> <h4 style="text-align: center;">통합 심사</h4> <p class="desktop-center">QMS를 통합하면 여러 기능 영역을 포괄하는 보다 효율적이고 비용 효율적인 통합 심사 및 모니터링 프로그램의 이점을 누릴 수 있습니다.</p> </div></div><div class="textBlock col-12 spacingSmall" id="Spacer+without+anchor-white"> <div class="wysiwyg" > </div></div><div class="textBlock col-12 spacingSmall canvas canvasNavy" id="Why+work+with+us"> <div class="wysiwyg" > <h3 style="text-align: center;"><strong>왜LRQA와 함께해야 할까요?</strong></h3> </div></div><div class="promoBlock themeMint promoBlockFrame col-3 canvas canvasNavy" id="Global+capability+promo"> <div class="container"> <div class="promoBlockWrap"> <div class="promoBlockWrapContent"> <h3 class="promoBlockHeading" > 글로벌 역량 </h3> <p class="promoBlockSummary" > <span class="promoBlockSummarySpacer"></span> LRQA는 자격을 갖춘 심사원으로 구성된 글로벌 네트워크를 보유하고 있습니다. 즉, 고객이 있는 곳이라면 어디든 갈 수 있으며, 전 세계적으로 일관된 접근 방식과 우수한 보증에 대한 헌신으로 현지 서비스를 제공할 수 있는 위치에 있습니다. LRQA 직원들은 품질 관리에 대한 심도 있는 지식을 갖춘 진정한 기술 전문가입니다. </p> </div> <div class="promoBlockImage" > <img src="/cdn-cgi/image/width=640,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/global-reach-local-insight----global-capability.jpg" srcset="/cdn-cgi/image/width=264,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/global-reach-local-insight----global-capability.jpg 264w,/cdn-cgi/image/width=304,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/global-reach-local-insight----global-capability.jpg 304w,/cdn-cgi/image/width=350,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/global-reach-local-insight----global-capability.jpg 350w,/cdn-cgi/image/width=415,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/global-reach-local-insight----global-capability.jpg 415w,/cdn-cgi/image/width=452,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/global-reach-local-insight----global-capability.jpg 452w,/cdn-cgi/image/width=528,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/global-reach-local-insight----global-capability.jpg 528w,/cdn-cgi/image/width=560,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/global-reach-local-insight----global-capability.jpg 560w,/cdn-cgi/image/width=608,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/global-reach-local-insight----global-capability.jpg 608w,/cdn-cgi/image/width=640,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/global-reach-local-insight----global-capability.jpg 640w,/cdn-cgi/image/width=700,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/global-reach-local-insight----global-capability.jpg 700w,/cdn-cgi/image/width=792,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/global-reach-local-insight----global-capability.jpg 792w,/cdn-cgi/image/width=830,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/global-reach-local-insight----global-capability.jpg 830w,/cdn-cgi/image/width=904,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/global-reach-local-insight----global-capability.jpg 904w,/cdn-cgi/image/width=912,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/global-reach-local-insight----global-capability.jpg 912w,/cdn-cgi/image/width=1050,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/global-reach-local-insight----global-capability.jpg 1050w,/cdn-cgi/image/width=1120,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/global-reach-local-insight----global-capability.jpg 1120w,/cdn-cgi/image/width=1245,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/global-reach-local-insight----global-capability.jpg 1245w,/cdn-cgi/image/width=1280,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/global-reach-local-insight----global-capability.jpg 1280w,/cdn-cgi/image/width=1356,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/global-reach-local-insight----global-capability.jpg 1356w,/cdn-cgi/image/width=1680,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/global-reach-local-insight----global-capability.jpg 1680w,/cdn-cgi/image/width=1920,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/global-reach-local-insight----global-capability.jpg 1920w" sizes="(min-width: 1440px) 640px, (min-width: 1280px) calc((100vw - 160px) / 2), (min-width: 1024px) calc((100vw - 120px) / 2), (min-width: 768px) calc((100vw - 80px) / 2), calc(100vw - 20px)" alt="LRQA auditors having a conversation with a client" loading="lazy" decoding="auto" fetchpriority="auto" class="promoBlockImageImg" width="1000" height="667" /> </div> </div> </div> </div><div class="promoBlock themeMint promoBlockFrame col-3 canvas canvasNavy" id="Flexible+delivery+promo"> <div class="container"> <div class="promoBlockWrap"> <div class="promoBlockWrapContent"> <h3 class="promoBlockHeading" > 유연한 심사 서비스 </h3> <p class="promoBlockSummary" > <span class="promoBlockSummarySpacer"></span> ISO 13485 교육 및 인증 서비스는 비즈니스의 필요에 따라 맞춤화할 수 있으며, 현장 또는 원격으로 제공하거나 혼합 방식을 통해 제공할 수 있습니다. 후자를 선택하면 동일한 고품질 서비스에 유연성과 빠른 배송이라는 추가적인 이점을 누릴 수 있습니다. </p> </div> <div class="promoBlockImage" > <img src="/cdn-cgi/image/width=640,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/flexible-delivery-02.jpg" srcset="/cdn-cgi/image/width=264,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/flexible-delivery-02.jpg 264w,/cdn-cgi/image/width=304,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/flexible-delivery-02.jpg 304w,/cdn-cgi/image/width=350,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/flexible-delivery-02.jpg 350w,/cdn-cgi/image/width=415,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/flexible-delivery-02.jpg 415w,/cdn-cgi/image/width=452,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/flexible-delivery-02.jpg 452w,/cdn-cgi/image/width=528,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/flexible-delivery-02.jpg 528w,/cdn-cgi/image/width=560,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/flexible-delivery-02.jpg 560w,/cdn-cgi/image/width=608,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/flexible-delivery-02.jpg 608w,/cdn-cgi/image/width=640,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/flexible-delivery-02.jpg 640w,/cdn-cgi/image/width=700,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/flexible-delivery-02.jpg 700w,/cdn-cgi/image/width=792,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/flexible-delivery-02.jpg 792w,/cdn-cgi/image/width=830,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/flexible-delivery-02.jpg 830w,/cdn-cgi/image/width=904,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/flexible-delivery-02.jpg 904w,/cdn-cgi/image/width=912,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/flexible-delivery-02.jpg 912w,/cdn-cgi/image/width=1050,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/flexible-delivery-02.jpg 1050w,/cdn-cgi/image/width=1120,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/flexible-delivery-02.jpg 1120w,/cdn-cgi/image/width=1245,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/flexible-delivery-02.jpg 1245w,/cdn-cgi/image/width=1280,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/flexible-delivery-02.jpg 1280w,/cdn-cgi/image/width=1356,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/flexible-delivery-02.jpg 1356w,/cdn-cgi/image/width=1680,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/flexible-delivery-02.jpg 1680w,/cdn-cgi/image/width=1920,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/flexible-delivery-02.jpg 1920w" sizes="(min-width: 1440px) 640px, (min-width: 1280px) calc((100vw - 160px) / 2), (min-width: 1024px) calc((100vw - 120px) / 2), (min-width: 768px) calc((100vw - 80px) / 2), calc(100vw - 20px)" alt="Group video call on a laptop" loading="lazy" decoding="auto" fetchpriority="auto" class="promoBlockImageImg" width="1000" height="667" /> </div> </div> </div> </div><div class="promoBlock themeMint promoBlockFrame col-3 canvas canvasNavy" id="History+of+firsts+promo"> <div class="container"> <div class="promoBlockWrap"> <div class="promoBlockWrapContent"> <h3 class="promoBlockHeading" > 최초의 역사 </h3> <p class="promoBlockSummary" > <span class="promoBlockSummarySpacer"></span> 당사는 전 세계 다양한 표준에 대한 인증 서비스를 제공하기 위해 최초로 UKAS 인증을 받았습니다. 당사는 다양한 분야에서 다양한 특정 표준과 프레임워크를 개발하는 데 지속적으로 기여하고 있습니다. </p> </div> <div class="promoBlockImage" > <img src="/cdn-cgi/image/width=640,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/a-history-of-firsts.jpg" srcset="/cdn-cgi/image/width=264,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/a-history-of-firsts.jpg 264w,/cdn-cgi/image/width=304,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/a-history-of-firsts.jpg 304w,/cdn-cgi/image/width=350,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/a-history-of-firsts.jpg 350w,/cdn-cgi/image/width=415,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/a-history-of-firsts.jpg 415w,/cdn-cgi/image/width=452,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/a-history-of-firsts.jpg 452w,/cdn-cgi/image/width=528,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/a-history-of-firsts.jpg 528w,/cdn-cgi/image/width=560,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/a-history-of-firsts.jpg 560w,/cdn-cgi/image/width=608,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/a-history-of-firsts.jpg 608w,/cdn-cgi/image/width=640,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/a-history-of-firsts.jpg 640w,/cdn-cgi/image/width=700,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/a-history-of-firsts.jpg 700w,/cdn-cgi/image/width=792,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/a-history-of-firsts.jpg 792w,/cdn-cgi/image/width=830,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/a-history-of-firsts.jpg 830w,/cdn-cgi/image/width=904,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/a-history-of-firsts.jpg 904w,/cdn-cgi/image/width=912,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/a-history-of-firsts.jpg 912w,/cdn-cgi/image/width=1050,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/a-history-of-firsts.jpg 1050w,/cdn-cgi/image/width=1120,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/a-history-of-firsts.jpg 1120w,/cdn-cgi/image/width=1245,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/a-history-of-firsts.jpg 1245w,/cdn-cgi/image/width=1280,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/a-history-of-firsts.jpg 1280w,/cdn-cgi/image/width=1356,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/a-history-of-firsts.jpg 1356w,/cdn-cgi/image/width=1680,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/a-history-of-firsts.jpg 1680w,/cdn-cgi/image/width=1920,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/a-history-of-firsts.jpg 1920w" sizes="(min-width: 1440px) 640px, (min-width: 1280px) calc((100vw - 160px) / 2), (min-width: 1024px) calc((100vw - 120px) / 2), (min-width: 768px) calc((100vw - 80px) / 2), calc(100vw - 20px)" alt="Group of people having a discussion in a meeting room" loading="lazy" decoding="auto" fetchpriority="auto" class="promoBlockImageImg" width="1000" height="667" /> </div> </div> </div> </div><div class="promoBlock themeMint promoBlockFrame col-3 canvas canvasNavy" id="Total+assurance+promo"> <div class="container"> <div class="promoBlockWrap"> <div class="promoBlockWrapContent"> <h3 class="promoBlockHeading" > 종합 보증 </h3> <p class="promoBlockSummary" > <span class="promoBlockSummarySpacer"></span> 당사의 서비스는 규정 준수에서 멈추지 않습니다. LRQA 전문가는 시스템에 대한 효과적이고 강력한 감사를 통해 부가가치를 창출하기 위해 노력하는 진정한 전문가입니다. </p> </div> <div class="promoBlockImage" > <img src="/cdn-cgi/image/width=640,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/continuous-assurance-approved-total-assurance.jpg" srcset="/cdn-cgi/image/width=264,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/continuous-assurance-approved-total-assurance.jpg 264w,/cdn-cgi/image/width=304,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/continuous-assurance-approved-total-assurance.jpg 304w,/cdn-cgi/image/width=350,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/continuous-assurance-approved-total-assurance.jpg 350w,/cdn-cgi/image/width=415,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/continuous-assurance-approved-total-assurance.jpg 415w,/cdn-cgi/image/width=452,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/continuous-assurance-approved-total-assurance.jpg 452w,/cdn-cgi/image/width=528,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/continuous-assurance-approved-total-assurance.jpg 528w,/cdn-cgi/image/width=560,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/continuous-assurance-approved-total-assurance.jpg 560w,/cdn-cgi/image/width=608,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/continuous-assurance-approved-total-assurance.jpg 608w,/cdn-cgi/image/width=640,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/continuous-assurance-approved-total-assurance.jpg 640w,/cdn-cgi/image/width=700,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/continuous-assurance-approved-total-assurance.jpg 700w,/cdn-cgi/image/width=792,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/continuous-assurance-approved-total-assurance.jpg 792w,/cdn-cgi/image/width=830,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/continuous-assurance-approved-total-assurance.jpg 830w,/cdn-cgi/image/width=904,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/continuous-assurance-approved-total-assurance.jpg 904w,/cdn-cgi/image/width=912,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/continuous-assurance-approved-total-assurance.jpg 912w,/cdn-cgi/image/width=1050,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/continuous-assurance-approved-total-assurance.jpg 1050w,/cdn-cgi/image/width=1120,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/continuous-assurance-approved-total-assurance.jpg 1120w,/cdn-cgi/image/width=1245,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/continuous-assurance-approved-total-assurance.jpg 1245w,/cdn-cgi/image/width=1280,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/continuous-assurance-approved-total-assurance.jpg 1280w,/cdn-cgi/image/width=1356,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/continuous-assurance-approved-total-assurance.jpg 1356w,/cdn-cgi/image/width=1680,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/continuous-assurance-approved-total-assurance.jpg 1680w,/cdn-cgi/image/width=1920,format=auto/siteassets/lrqa-shared-content/02-main-page-content/why-work-with-us/continuous-assurance-approved-total-assurance.jpg 1920w" sizes="(min-width: 1440px) 640px, (min-width: 1280px) calc((100vw - 160px) / 2), (min-width: 1024px) calc((100vw - 120px) / 2), (min-width: 768px) calc((100vw - 80px) / 2), calc(100vw - 20px)" alt="Aerial shot of container ships" loading="lazy" decoding="auto" fetchpriority="auto" class="promoBlockImageImg" width="1000" height="667" /> </div> </div> </div> </div><div class="textBlock col-12 spacingSmall" id="Transfer+to+LRQA"> <div class="wysiwyg" > <h3 style="text-align: center;"><a id="transfer-to-lrqa"></a><strong>기존 보유하고 있는 ISO 13485 인증을 LRQA로 전환을 생각하고 계신가요?</strong></h3> <p style="text-align: justify;">다른 인증기관으로부터 유효한 공인 인증서를 보유하고 있고 LRQA로 이전을 고려하고 있다면 ISO 13485 인증을 이전하는 것은 간단합니다. 인증 이전이 순조롭게 진행될 수 있도록 귀사를 지원해드립니다.<a id="request-quote"></a></p> </div></div> </section> <section class="grid bottomContent" > <div class="textBlock col-12 spacingSmall" id="Transfer+to+LRQA-shared+global"> <div class="wysiwyg" > <p style="text-align: center;"><a href="/ko-kr/transfer-certification-to-lrqa/?epslanguage=ko-KR" class="cta">LRQA로 인증 전환하기</a></p> </div></div><div class="iframeBlock col-12" id="General+enquiry"> <iframe class="iframeBlockFrame" src="https://info.lrqa.com/l/12702/2021-10-03/c3jcf4?website_url=%2Fko-kr%2Fiso-13485%2F&website_sector=&website_business_stream=" height="1800" loading="lazy" id="175595" scrolling="no"></iframe></div><div class="carouselBlock canvas canvasWhite col-12" id="S03.02+Generic+case+study+-+Sectors"> <h2 class="carouselBlockHeading" > <strong>케이스스터디</strong> </h2> <div class="carousel"> <div class="carouselContent"> <ul class="carouselContentList"> <li> <div class="imageTextWrap themeMint"> <div class="imageText"> <h3 class="imageTextTitle"> [ISO 27001, CSA STAR 사례] 이지케어텍: 헬스케어 시스템의 환자... </h3> <div class="imageTextImgWrap"> <img src="/cdn-cgi/image/width=432,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png" srcset="/cdn-cgi/image/width=210,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png 210w,/cdn-cgi/image/width=280,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png 280w,/cdn-cgi/image/width=324,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png 324w,/cdn-cgi/image/width=335,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png 335w,/cdn-cgi/image/width=420,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png 420w,/cdn-cgi/image/width=432,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png 432w,/cdn-cgi/image/width=526,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png 526w,/cdn-cgi/image/width=560,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png 560w,/cdn-cgi/image/width=560,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png 560w,/cdn-cgi/image/width=606,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png 606w,/cdn-cgi/image/width=630,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png 630w,/cdn-cgi/image/width=648,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png 648w,/cdn-cgi/image/width=670,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png 670w,/cdn-cgi/image/width=776,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png 776w,/cdn-cgi/image/width=840,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png 840w,/cdn-cgi/image/width=864,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png 864w,/cdn-cgi/image/width=972,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png 972w,/cdn-cgi/image/width=1005,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png 1005w,/cdn-cgi/image/width=1052,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png 1052w,/cdn-cgi/image/width=1052,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png 1052w,/cdn-cgi/image/width=1164,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png 1164w,/cdn-cgi/image/width=1212,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png 1212w,/cdn-cgi/image/width=1296,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png 1296w,/cdn-cgi/image/width=1578,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png 1578w,/cdn-cgi/image/width=1818,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/cyber-security/healthcare-records-532x421.png 1818w" alt="healthcare records" loading="lazy" decoding="auto" fetchpriority="auto" width="532" height="421" class="imageTextImg"> </div> <p class="promoBlockLabel imageTextLabel"> 케이스 스터디 </p> <p class="imageTextSummary"> 이지케어텍은 로이드인증원으로부터 ISO 27001과 CSA STAR 인증을 받아, 클라우드 컴퓨팅 네트워크가 효과적으로 보안을 관리하고 있음을 입증하였습니다. </p> <a href="/ko-kr/case-studies/ezcaretech/" class="imageTextLink arrowLink arrowLinkBold"> </a> </div> </div> </li> <li> <div class="imageTextWrap themeMint"> <div class="imageText"> <h3 class="imageTextTitle"> Helping NGO, Terre de Hommes, help children globally.... </h3> <div class="imageTextImgWrap"> <img src="/cdn-cgi/image/width=432,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/" srcset="/cdn-cgi/image/width=210,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/ 210w,/cdn-cgi/image/width=280,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/ 280w,/cdn-cgi/image/width=324,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/ 324w,/cdn-cgi/image/width=335,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/ 335w,/cdn-cgi/image/width=420,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/ 420w,/cdn-cgi/image/width=432,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/ 432w,/cdn-cgi/image/width=526,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/ 526w,/cdn-cgi/image/width=560,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/ 560w,/cdn-cgi/image/width=560,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/ 560w,/cdn-cgi/image/width=606,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/ 606w,/cdn-cgi/image/width=630,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/ 630w,/cdn-cgi/image/width=648,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/ 648w,/cdn-cgi/image/width=670,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/ 670w,/cdn-cgi/image/width=776,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/ 776w,/cdn-cgi/image/width=840,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/ 840w,/cdn-cgi/image/width=864,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/ 864w,/cdn-cgi/image/width=972,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/ 972w,/cdn-cgi/image/width=1005,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/ 1005w,/cdn-cgi/image/width=1052,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/ 1052w,/cdn-cgi/image/width=1052,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/ 1052w,/cdn-cgi/image/width=1164,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/ 1164w,/cdn-cgi/image/width=1212,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/ 1212w,/cdn-cgi/image/width=1296,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/ 1296w,/cdn-cgi/image/width=1578,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/ 1578w,/cdn-cgi/image/width=1818,format=auto/globalassets/_shared-images/0532-x-0421-t5.1-news-individualt6.1-article-individualt9-case-study-page-promo-desktop-image/business-assurance/case-studies/case-studies-terre-des-hommes-lr/ 1818w" alt="Child asleep on a shoulder" loading="lazy" decoding="auto" fetchpriority="auto" width="532" height="420" class="imageTextImg"> </div> <p class="promoBlockLabel imageTextLabel"> 케이스 스터디 </p> <p class="imageTextSummary"> Helping Terre de Hommes help children globally. Certification to ISO 9001:2015 redesigns the NGO’s operating structure. 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