ISO 13485 | Medische hulpmiddelen

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class="text">Endpoint Detection and Response (EDR) (EN)</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/en/virtual-ciso/" target="_blank"> <span class="text">Virtual CISO Services (EN)</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/en/digital-forensics-and-incident-response/" target="_blank"> <span class="text">Digital Forensics and Incident Response (EN)</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/en/managed-vulnerability-scanning/" target="_blank"> <span class="text">Vulnerability Scanning (EN)</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> 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href="/nl-nl/red-teaming/" target="_blank"> <span class="text">Red Teaming</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/nl-nl/purple-teaming/" target="_blank"> <span class="text">Purple Teaming (EN)</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/nl-nl/social-engineering/" target="_blank"> <span class="text">Social Engineering (EN)</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/en/bug-bounty-program/" target="_blank"> <span class="text">Bug Bounty Program (EN)</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"> 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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"> Verificatie & report assurance </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"> Terug naar het menu </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/nl-nl/assurance-diensten/" target="_self"> <span class="text">Verificatie & report assurance</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/nl-nl/organisatorische-broeikasgas-verificatie/" target="_self"> <span class="text">Organisatorische broeikasgas 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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"> Training </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"> Terug naar het menu </span> </button> </li> <li class="navigationListItem parentLink"> <p class="navigationListItemLink"> <span class="text">Training</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"> Alle trainingen </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"> Terug naar het menu </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/nl-nl/training/overview/" target="_self"> <span class="text">Alle trainingen</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/nl-nl/training/kwaliteit-milieu-gezondheid-en-veiligheid/" target="_self"> <span class="text">Kwaliteit, milieu & gezondheid en veiligheid trainingen</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/nl-nl/training/voeding-drank-horeca/" target="_self"> <span class="text">Voeding, drank & horeca trainingen</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/nl-nl/training/medische-hulpmiddelen/" target="_self"> <span class="text">Medische hulpmiddelen trainingen</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/nl-nl/training/informatiebeveiliging-cybersecurity/" target="_self"> <span class="text">Cyber security & informatiebeveiliging trainingen</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/nl-nl/training/klimaatverandering-duurzaamheid/" target="_self"> <span class="text">Klimaatverandering & duurzaamheid trainingen</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/nl-nl/training/automotive-luchtvaart-ruimtevaart-vervoer/" target="_self"> <span class="text">Automotive, lucht- en ruimtevaart & transport 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href="/nl-nl/training/virtuele-klassikale-trainingen/" target="_self"> <span class="text">Remote trainingen</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/nl-nl/training/elearning-trainingen/" target="_self"> <span class="text">eLearning</span> </a> </li> </ul> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/nl-nl/training-academy/" target="_self"> <span class="text">LRQA Training Academy</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/nl-nl/training/opleidingstrajecten/" target="_self"> <span class="text">LRQA’s Opleidingstrajecten</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/nl-nl/management-system-solutions/" target="_self"> <span class="text">Management System Solutions</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="https://training-portal.lrqa.com/lmt/clmsBrowseV2.prMain?site=lrqaext&in_region=nl&in_lang=nl" target="_blank"> <span class="text">Training portal</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"> Advisory Services </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"> Terug naar het menu </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/nl-nl/advisory-services/" target="_blank"> <span class="text">Advisory Services</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/nl-nl/esg/" target="_blank"> <span class="text">ESG Advisory</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/nl-nl/csddd/" target="_self"> <span class="text">CSDDD</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/nl-nl/csrd/" target="_self"> <span class="text">CSRD</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"> Diagnostiek </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"> Terug naar het menu </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/nl-nl/diagnostiek/" target="_blank"> <span class="text">Diagnostiek</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/nl-nl/responsible-sourcing/" target="_blank"> <span class="text">Responsible sourcing</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/nl-nl/human-rights-impact-assessments/" target="_blank"> <span class="text">Human Rights Impact Assessment</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/nl-nl/netto-nul/" target="_blank"> <span class="text">Netto nul</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/nl-nl/dubbele-materialiteit/" target="_blank"> <span class="text">Dubbele materialiteit</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"> Strategie en ontwerp </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"> Terug naar het menu </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/nl-nl/strategie-en-ontwerp/" target="_blank"> <span class="text">Strategie en 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href="/nl-nl/betrokkenheid-bij-afval-en-emissies-supply-chain/" target="_blank"> <span class="text">Betrokkenheid bij afval en emissies supply chain</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"> Reporting en openbaarmaking </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"> Terug naar het menu </span> </button> </li> <li class="navigationListItem parentLink"> <a class="navigationListItemLink" href="/nl-nl/reporting-en-openbaarmaking/" target="_blank"> <span class="text">Reporting en openbaarmaking</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/nl-nl/klimaatrapportage/" target="_blank"> <span class="text">Klimaatrapportage</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/nl-nl/duurzaamheidsrapportage/" target="_blank"> <span class="text">Duurzaamheidsrapportage</span> </a> </li> </ul> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/nl-nl/programmamanagement/" target="_blank"> <span class="text">Programmamanagement</span> </a> </li> <li class="navigationListItem"> <a class="navigationListItemLink" href="/nl-nl/technische-adviesdiensten/" target="_self"> <span class="text">Technische Advies Services</span> </a> </li> <li class="navigationListItem"> <button class="navigationListItemLink hasSubNav"> <span class="icon"> <svg focusable="false" class="arrow-mobile"> 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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 certificering voor medische hulpmiddelen </h1> <p class="heroSummary" > Voldoe aan de eisen van de industrie van medische hulpmiddelen </p> <ul class="heroList" > <li class="heroListItem"> <a href="/nl-nl/iso-13485/#request-quote" class="arrowLink arrowLinkBold">Vraag een offerte aan</a> </li> <li class="heroListItem"> <a href="/nl-nl/iso-13485/#transfer-to-lrqa" class="arrowLink arrowLinkBold">Stap over naar LRQA</a> </li> </ul> </div> </div><div class="stickyCtaContainer twoItems" id="NL-BA+Shared+global+sticky+CTA+-+BA"> <div class="stickyCtaButtons"> <div class="stickyCtaButtonsInner"> <a href="tel:+31 10 899 7300" class="stickyCtaButton" > <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-phoneRinging"></use> </svg> </span> <span class="text"> Bel ons direct: +31 10 899 7300 </span> </a> <a href="/nl-nl/neem-contact-op/" class="stickyCtaButton" > <span class="icon"> <svg focusable="false"> <use href="/static/images/svg.svg#svg-letter"></use> </svg> </span> <span class="text"> Vraag een offerte aan </span> </a> </div> </div> </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="/nl-nl/iso-13485/training/" class="swipeNavLink cta ctaTertiary"> <span class="text"> ISO 13485 Training </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;">Wat is de</h2> <h2 style="text-align: left;"><strong>ISO 13485 norm?</strong>  </h2> </div></div><div class="textBlock col-6 canvas canvasWhite" id="Introduction"> <div class="wysiwyg" > <p style="text-align: justify;">ISO 13485 is de internationale norm voor kwaliteitsmanagementsystemen (QMS) voor medische hulpmiddelen. De norm is ontworpen om organisaties te helpen aantonen dat hun producten voldoen aan strenge industriële regelgeving en ondersteund de veiligheid van patiënten door middel van een risicogebaseerde benadering van het QMS, een verbeterde focus op wettelijke vereisten en meer controle over leveranciers.</p> <p>LRQA begeleidt klanten bij hun inzet om te voldoen aan de strenge eisen van ISO 13485, waarbij de levenscycli van productontwikkeling worden verfijnd om een tijdige marktintroductie te waarborgen.</p> <p style="text-align: justify;">De ISO 13485 norm is van toepassing op zowel organisaties die hulpmiddelen fabriceren als organisaties die hulpmiddelenfabrikanten ondersteunen, zodat ze hun processen kunnen optimaliseren en de levenscycli van productontwikkeling kunnen stroomlijnen.</p> </div></div><div class="textBlock col-12 spacingSmall canvas canvasNavy" id="Our+services"> <div class="wysiwyg" > <h2 style="text-align: center;"><strong>Onze ISO 13485 services</strong></h2> <p style="text-align: justify;">LRQA biedt training, certificering en assessment services volgens de ISO 13485 eisen. Onze flexibele services kunnen op locatie, remote of door een combinatie van beide worden geleverd en kunnen worden aangepast aan de unieke behoeften van uw organisatie.</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;">ISO 13485 Training</h4> <p class="desktop-center">Vergroot uw inzicht in de basisprincipes van QMS met onze reeks trainingen die zijn ontworpen voor verschillende ervaringsniveaus en leerstijlen.</p> </div></div><div class="textBlock col-3 canvas canvasNavy" id="Gap+analysis"> <div class="wysiwyg" > <h4 class="desktop-center"><img style="display: block; margin-left: auto; margin-right: auto;" src="/contentassets/2c30f9f4de9c47b3b9247ca741ee5cb0/gap-analysis/?epslanguage=en" alt="" width="94" height="90" /></h4> <h4 class="desktop-center" style="text-align: center;">Gap-analyse</h4> <p class="desktop-center" style="text-align: center;">Een optionele service waarbij een LRQA auditor met u samenwerkt om eventuele non-conformiteiten in uw bestaande QMS te identificeren voorafgaand aan uw ISO 13485 audit.</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/?epslanguage=en" alt="imageao21.png" /></h6> <h4 style="text-align: center;">ISO 13485 Certificering</h4> <p class="desktop-center" style="text-align: center;">Ons certificeringsproces valideert uw QMS volgens ISO 13485 en beoordeelt vervolgens de effectiviteit ervan om de capaciteiten aan te tonen, zodat u vertrouwen kunt opbouwen bij stakeholders.</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?epslanguage=en" alt="intgerated services icon.png" /></h6> <h4 style="text-align: center;">Geïntegreerde audit</h4> <p class="desktop-center">Door uw QMS te integreren kunt u profiteren van een efficiënter en kosten effectiever geïntegreerd audit- en bewakingsprogramma dat meerdere functionele gebieden omvat.</p> </div></div><div class="textBlock col-12" id="Benefits+ISO+13485"> <div class="wysiwyg" > <h3 style="text-align: center;"><strong>Wat zijn de voordelen van ISO 13485?</strong></h3> <p style="text-align: center;"><strong>Stroomlijn de levenscycli van productontwikkeling en optimaliseer processen</strong></p> <ul> <li><strong>Risicomanagement: </strong>Identificeer en evalueer potentiële risico's verbonden aan medische hulpmiddelen. Implementeer maatregelen om geïdentificeerde risico's te verminderen of te elimineren.</li> <li><strong>Continue verbetering: </strong>Voer regelmatig interne audits uit om de effectiviteit van het KMS te beoordelen. Daarbij worden corrigerende en preventieve maatregelen bepaald waarbij er processen geïmplementeerd kunnen worden om non-conformiteiten aan te pakken en herhaling te voorkomen.</li> <li><strong>Verbeterde traceerbaarheid: </strong>ISO 13485 vereist uitgebreide documentatie en traceerbaarheid van medische hulpmiddelen, van ontwerp tot productie en distributie. Dit is cruciaal in geval van klachten, defecten of recalls, waardoor sneller en effectiever actie kan worden ondernomen.</li> <li><strong>Efficiëntie en kostenbesparing: </strong>Door gestandaardiseerde processen en duidelijke documentatie te implementeren, worden inefficiënties en dubbel werk verminderd. Problemen worden proactief voorkomen, wat kostenbesparingen oplevert op lange termijn (bijvoorbeeld minder recalls, reparaties en juridische kwesties).</li> </ul> <p> </p> <p style="text-align: center;"><strong>Wilt u meer weten?</strong></p> <p style="text-align: center;"><a href="/nl-nl/iso-13485/#request-quote" class="cta">Vraag meer informatie aan</a></p> </div></div><div class="textBlock col-6 canvas canvasNavy" id="Eisen+ISO+13485+certification"> <div class="wysiwyg" > <h3 style="text-align: center;"><strong>Eisen voor ISO 13485 certificering</strong></h3> <p>De drie kerngebieden van ISO 13485 — productveiligheid en risicomanagement, naleving van regelgeving, en documentatie en traceerbaarheid — zijn ontworpen om de kwaliteit van medische hulpmiddelen te waarborgen en risico’s te minimaliseren. Door deze eisen na te leven, kunnen organisaties voldoen aan de verwachtingen van zowel regelgevende instanties als klanten.</p> <ul> <li><strong>Documentatie en traceerbaarheid:</strong> Nauwkeurige en volledige documentatie en traceerbaarheid om consistentie en kwaliteit te garanderen. Daarbij wordt de technische documentatie bijgehouden, zoals ontwerp- en ontwikkelingsdossiers, validatierapporten, en gebruiksaanwijzingen. Dit zorgt voor volledige traceerbaarheid. Daarbij moeten alle relevante processen vastgelegd worden, inclusief wijzigingen en klachtenafhandeling.</li> <li><strong style="font-size: 0.875rem; color: var(--text-colour); font-family: var(--font-family-body);">Productveiligheid en risicomanagement: </strong><span style="font-size: 0.875rem; color: var(--text-colour); font-family: var(--font-family-body);">De veiligheid van medische hulpmiddelen waarborgen gedurende hun volledige levenscyclus. De implementatie van een risicomanagementproces is effectief om risico’s te identificeren, analyseren en beheersen tijdens ontwerp, productie en gebruik van medische hulpmiddelen.</span></li> <li><strong>Voldoen aan regelgevende eisen: </strong>De ISO 13485 norm zorgt ervoor dat medische hulpmiddelen voldoen aan relevante wettelijke en regelgevende eisen.</li> </ul> </div></div><div class="textBlock col-6 canvas canvasNavy" id="Productrealisation"> <div class="wysiwyg" > <h3 style="text-align: center;"><strong>Productrealisatie</strong></h3> <h3 style="text-align: center;"><strong>met ISO 13485</strong></h3> <p>Productrealisatie is een kernonderdeel van ISO 13485 en vormt de basis voor het voldoen aan kwaliteits- en veiligheidsnormen bij medische hulpmiddelen. Door een goed ingericht productrealisatieproces dat voldoet aan de eisen van ISO 13485, kunnen bedrijven de kwaliteit van hun producten waarborgen en voldoen aan wettelijke vereisten. ISO 13485 legt sterke nadruk op het proces van productrealisatie om te zorgen dat medische hulpmiddelen veilig zijn, voldoen aan de functionele en wettelijke eisen en consistent van hoge kwaliteit worden geproduceerd.</p> <p>Een aantal belangrijke aspecten van productrealisatie in ISO 13485 zijn:</p> <ul> <li><strong><span>Ontwerp en ontwikkeling:</span></strong><span> ISO 13485 beschrijft de processen voor het implementeren van productontwerp, risicoanalyses, verificatie en validatie.</span></li> <li><strong><span>Productie en dienstverlening:</span></strong><span> ISO 13485 biedt een kader voor gecontroleerde productieprocessen en passende productidentificatie.</span></li> <li><strong><span>Inkoop:</span></strong><span> ISO 13485 stelt criteria voor leveranciersevaluatie, -selectie en -monitoring.</span></li> </ul> </div></div><div class="textBlock col-12" id="Difference+ISO+9001+and+ISO+13485"> <div class="wysiwyg" > <h3 style="text-align: center;"><strong>Wat is het verschil tussen ISO 9001 en ISO 13485?</strong></h3> <p>ISO 9001 en ISO 13485 zijn normen voor kwaliteitsmanagement, maar verschillen in focus en toepassing. <strong>ISO 9001</strong> is een algemene norm die voor elke sector geschikt is en gericht is op klanttevredenheid en procesverbetering. <strong>ISO 13485</strong> is specifiek ontwikkeld voor de medische hulpmiddelenindustrie en legt nadruk op productveiligheid, naleving van regelgeving en risicobeheersing.</p> <p>Een belangrijk verschil is de focus op regelgeving. ISO 13485 is volledig afgestemd op strikte naleving van regelgeving. Ook vereist ISO 13485 een formeel risicomanagementproces gedurende de levenscyclus van medische hulpmiddelen, terwijl ISO 9001 risico gebaseerd denken introduceert zonder specifieke richtlijnen.</p> <p>Verder ligt bij ISO 9001 de nadruk op continue verbetering van processen en klanttevredenheid. ISO 13485 richt zich primair op consistente naleving en productveiligheid, met uitgebreide documentatie- en traceerbaarheidsvereisten.</p> <p>ISO 13485 stelt strengere eisen, zoals validatie van kritische processen. Hoewel beide normen overlappen, zoals in procesbeheer en kwaliteitscontrole, is ISO 13485 onmisbaar voor bedrijven in de medische hulpmiddelenindustrie, terwijl ISO 9001 geschikt is voor algemene bedrijfsvoering.</p> </div></div><div class="textBlock col-12 spacingSmall canvas canvasNavy" id="Why+work+with+us"> <div class="wysiwyg" > <h2 style="text-align: center;"><strong>Waarom met ons werken?</strong></h2> </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" > Wereldwijde capaciteit </h3> <p class="promoBlockSummary" > <span class="promoBlockSummarySpacer"></span> LRQA heeft een wereldwijd netwerk van gekwalificeerde auditors. Dit betekent dat we overal zijn waar u bent, waardoor we een lokale service kunnen bieden met een wereldwijd consistente aanpak en toewijding aan uitmuntendheid in assurance. Onze mensen zijn echte technische experts met diepgaande kennis van kwaliteitsmanagement. </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" > Flexibele levering </h3> <p class="promoBlockSummary" > <span class="promoBlockSummarySpacer"></span> Onze ISO 13485 training- en certificeringsservices kunnen worden afgestemd op de behoeften van uw organisatie en kunnen ter plekke of remote worden gegeven, of via een gecombineerde aanpak. Als u voor het laatste kiest, krijgt u dezelfde hoogwaardige service met de extra voordelen van flexibiliteit en snelle levering. </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" > Geschiedenis als voorloper </h3> <p class="promoBlockSummary" > <span class="promoBlockSummarySpacer"></span> Wij waren de eersten die UKAS-accreditatie ontvingen om wereldwijd certificeringsservices te leveren voor een scala aan normen. We blijven een belangrijke rol spelen in de ontwikkeling van een verscheidenheid aan specifieke normen en frameworks in verschillende sectoren. </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" > Total assurance </h3> <p class="promoBlockSummary" > <span class="promoBlockSummarySpacer"></span> Onze service stopt niet bij naleving. LRQA experts zijn echte specialisten die waarde toevoegen door middel van een effectieve en robuuste audit van uw systeem. </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>Bent u al ISO 13485 gecertificeerd en wilt u overstappen?</strong></h3> <p style="text-align: justify;">Als je in het bezit bent van een geldig geaccrediteerd certificaat van goedkeuring bij een andere provider en je overweegt over te stappen, dan is het eenvoudig om je ISO 13485 certificering over te dragen aan LRQA. Wij werken met u samen om ervoor te zorgen dat de overstap zo soepel mogelijk verloopt.<a id="request-quote"></a></p> </div></div> </section> <section class="grid bottomContent" > <div class="textBlock col-12 spacingSmall" id="Transfer+to+LRQA-shared+NL"> <div class="wysiwyg" > <p style="text-align: center;"><a href="/nl-nl/stap-over-naar-lrqa/?epslanguage=nl-NL" class="cta">Stap over naar LRQA</a></p> </div></div><div class="embedBlock col-12" id="Contact+Enquiry+Form-Dutch-NL"> <div data-form-id='4318c967-b9bb-ef11-b8e8-7c1e5265929e' data-form-api-url='https://public-gbr.mkt.dynamics.com/api/v1.0/orgs/f01b650e-3e3d-ef11-8e4c-0022481a27a6/landingpageforms' data-cached-form-url='https://assets-gbr.mkt.dynamics.com/f01b650e-3e3d-ef11-8e4c-0022481a27a6/digitalassets/forms/4318c967-b9bb-ef11-b8e8-7c1e5265929e' ></div> <script src = 'https://cxppusa1formui01cdnsa01-endpoint.azureedge.net/gbr/FormLoader/FormLoader.bundle.js' ></script> <script>document.documentElement.lang = navigator.language;</script></div><div class="carouselBlock canvas canvasWhite col-12" id="S03.02+Generic+case+study+-+BA"> <h2 class="carouselBlockHeading" > <strong>CASE STUDIES</strong> </h2> <div class="carousel"> <div class="carouselContent"> <ul class="carouselContentList"> <li> <div class="imageTextWrap themeMint"> <div class="imageText"> <h3 class="imageTextTitle"> Case Study: Van Oord </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/532x421-van-oord.jpg" 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/532x421-van-oord.jpg 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/532x421-van-oord.jpg 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/532x421-van-oord.jpg 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/532x421-van-oord.jpg 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/532x421-van-oord.jpg 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/532x421-van-oord.jpg 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/532x421-van-oord.jpg 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/532x421-van-oord.jpg 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/532x421-van-oord.jpg 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/532x421-van-oord.jpg 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/532x421-van-oord.jpg 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/532x421-van-oord.jpg 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/532x421-van-oord.jpg 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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/532x421-van-oord.jpg 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/532x421-van-oord.jpg 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/532x421-van-oord.jpg 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/532x421-van-oord.jpg 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/532x421-van-oord.jpg 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/532x421-van-oord.jpg 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/532x421-van-oord.jpg 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/532x421-van-oord.jpg 1818w" alt="Van Oord behaalt ISO 27001-certificering met LRQA" loading="lazy" decoding="auto" fetchpriority="auto" width="532" height="421" class="imageTextImg"> </div> <p class="promoBlockLabel imageTextLabel"> Case Study pagina </p> <p class="imageTextSummary"> Van Oord behaalt ISO 27001-certificering met LRQA. Versterking van informatiebeveiliging en voortzetting van een vruchtbare samenwerking. Lees de... </p> <a href="/nl-nl/case-studies/van-oord-behaalt-iso-27001-certificering-met-lrqa/" class="imageTextLink arrowLink arrowLinkBold"> </a> </div> </div> </li> <li> <div class="imageTextWrap themeMint"> <div class="imageText"> <h3 class="imageTextTitle"> Case Study: Heijmans </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/general/532x421-heijmans.jpg" 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/general/532x421-heijmans.jpg 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/general/532x421-heijmans.jpg 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/general/532x421-heijmans.jpg 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/general/532x421-heijmans.jpg 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/general/532x421-heijmans.jpg 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/general/532x421-heijmans.jpg 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/general/532x421-heijmans.jpg 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/general/532x421-heijmans.jpg 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/general/532x421-heijmans.jpg 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/general/532x421-heijmans.jpg 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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/general/532x421-heijmans.jpg 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/general/532x421-heijmans.jpg 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/general/532x421-heijmans.jpg 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/general/532x421-heijmans.jpg 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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/general/532x421-heijmans.jpg 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/general/532x421-heijmans.jpg 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/general/532x421-heijmans.jpg 1818w" alt="Heijmans" loading="lazy" decoding="auto" fetchpriority="auto" width="532" height="421" class="imageTextImg"> </div> <p class="promoBlockLabel imageTextLabel"> Case Study pagina </p> <p class="imageTextSummary"> Met de missie 'een gezonde leefomgeving creëren' zet Heijmans in op verbetering, verslimming en verduurzaming. LRQA... </p> <a href="/nl-nl/case-studies/de-verduurzamingsopgave-van-heijmans/" class="imageTextLink arrowLink arrowLinkBold"> </a> </div> </div> </li> </ul> </div> <button type="button" disabled class="carouselBtn prev"> <span class="icon carouselButtonIcon"> <svg focusable="false" class="carouselButtonIcon"> <title>Vorige</title> <use href="/static/images/svg.svg#svg-arrowSharp"></use> </svg> </span> </button> <button type="button" disabled class="carouselBtn next"> <span class="icon carouselButtonIcon"> <svg focusable="false" class="carouselButtonIcon"> <title>Volgende</title> <use href="/static/images/svg.svg#svg-arrowSharp"></use> </svg> </span> </button> </div> <div class="carouselBlockLinkWrap"> <a class="carouselBlockLink arrowLink arrowLinkBold" href="/nl-nl/case-studies/">Meer praktijkvoorbeelden bekijken</a> </div> </div><div class="carouselBlock canvas canvasNavy col-12" id="Shared+Insights%2c+News+and+Events+-+Services"> <h2 class="carouselBlockHeading" > <strong>Laatste nieuws, inzichten en evenementen</strong> </h2> <div class="carousel"> <div class="carouselContent"> <ul class="carouselContentList"> <li> <div class="imageTextWrap themePink"> <div class="imageText"> <h3 class="imageTextTitle"> HKZ-certificering in de jeugdzorg voor kwaliteitsborging </h3> <div class="imageTextImgWrap"> <img src="/cdn-cgi/image/width=432,format=auto/globalassets/_shared-images/1280-x-0720-t5.1-t6.1-t9-mainpromo-mob-c02.17-c02.12.1-image-c03.10.1-main/business-assurance/medical/jeugdzorg---article.jpg" srcset="/cdn-cgi/image/width=210,format=auto/globalassets/_shared-images/1280-x-0720-t5.1-t6.1-t9-mainpromo-mob-c02.17-c02.12.1-image-c03.10.1-main/business-assurance/medical/jeugdzorg---article.jpg 210w,/cdn-cgi/image/width=280,format=auto/globalassets/_shared-images/1280-x-0720-t5.1-t6.1-t9-mainpromo-mob-c02.17-c02.12.1-image-c03.10.1-main/business-assurance/medical/jeugdzorg---article.jpg 280w,/cdn-cgi/image/width=324,format=auto/globalassets/_shared-images/1280-x-0720-t5.1-t6.1-t9-mainpromo-mob-c02.17-c02.12.1-image-c03.10.1-main/business-assurance/medical/jeugdzorg---article.jpg 324w,/cdn-cgi/image/width=335,format=auto/globalassets/_shared-images/1280-x-0720-t5.1-t6.1-t9-mainpromo-mob-c02.17-c02.12.1-image-c03.10.1-main/business-assurance/medical/jeugdzorg---article.jpg 335w,/cdn-cgi/image/width=420,format=auto/globalassets/_shared-images/1280-x-0720-t5.1-t6.1-t9-mainpromo-mob-c02.17-c02.12.1-image-c03.10.1-main/business-assurance/medical/jeugdzorg---article.jpg 420w,/cdn-cgi/image/width=432,format=auto/globalassets/_shared-images/1280-x-0720-t5.1-t6.1-t9-mainpromo-mob-c02.17-c02.12.1-image-c03.10.1-main/business-assurance/medical/jeugdzorg---article.jpg 432w,/cdn-cgi/image/width=526,format=auto/globalassets/_shared-images/1280-x-0720-t5.1-t6.1-t9-mainpromo-mob-c02.17-c02.12.1-image-c03.10.1-main/business-assurance/medical/jeugdzorg---article.jpg 526w,/cdn-cgi/image/width=560,format=auto/globalassets/_shared-images/1280-x-0720-t5.1-t6.1-t9-mainpromo-mob-c02.17-c02.12.1-image-c03.10.1-main/business-assurance/medical/jeugdzorg---article.jpg 560w,/cdn-cgi/image/width=560,format=auto/globalassets/_shared-images/1280-x-0720-t5.1-t6.1-t9-mainpromo-mob-c02.17-c02.12.1-image-c03.10.1-main/business-assurance/medical/jeugdzorg---article.jpg 560w,/cdn-cgi/image/width=606,format=auto/globalassets/_shared-images/1280-x-0720-t5.1-t6.1-t9-mainpromo-mob-c02.17-c02.12.1-image-c03.10.1-main/business-assurance/medical/jeugdzorg---article.jpg 606w,/cdn-cgi/image/width=630,format=auto/globalassets/_shared-images/1280-x-0720-t5.1-t6.1-t9-mainpromo-mob-c02.17-c02.12.1-image-c03.10.1-main/business-assurance/medical/jeugdzorg---article.jpg 630w,/cdn-cgi/image/width=648,format=auto/globalassets/_shared-images/1280-x-0720-t5.1-t6.1-t9-mainpromo-mob-c02.17-c02.12.1-image-c03.10.1-main/business-assurance/medical/jeugdzorg---article.jpg 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972w,/cdn-cgi/image/width=1005,format=auto/globalassets/_shared-images/1280-x-0720-t5.1-t6.1-t9-mainpromo-mob-c02.17-c02.12.1-image-c03.10.1-main/business-assurance/medical/jeugdzorg---article.jpg 1005w,/cdn-cgi/image/width=1052,format=auto/globalassets/_shared-images/1280-x-0720-t5.1-t6.1-t9-mainpromo-mob-c02.17-c02.12.1-image-c03.10.1-main/business-assurance/medical/jeugdzorg---article.jpg 1052w,/cdn-cgi/image/width=1052,format=auto/globalassets/_shared-images/1280-x-0720-t5.1-t6.1-t9-mainpromo-mob-c02.17-c02.12.1-image-c03.10.1-main/business-assurance/medical/jeugdzorg---article.jpg 1052w,/cdn-cgi/image/width=1164,format=auto/globalassets/_shared-images/1280-x-0720-t5.1-t6.1-t9-mainpromo-mob-c02.17-c02.12.1-image-c03.10.1-main/business-assurance/medical/jeugdzorg---article.jpg 1164w,/cdn-cgi/image/width=1212,format=auto/globalassets/_shared-images/1280-x-0720-t5.1-t6.1-t9-mainpromo-mob-c02.17-c02.12.1-image-c03.10.1-main/business-assurance/medical/jeugdzorg---article.jpg 1212w,/cdn-cgi/image/width=1296,format=auto/globalassets/_shared-images/1280-x-0720-t5.1-t6.1-t9-mainpromo-mob-c02.17-c02.12.1-image-c03.10.1-main/business-assurance/medical/jeugdzorg---article.jpg 1296w,/cdn-cgi/image/width=1578,format=auto/globalassets/_shared-images/1280-x-0720-t5.1-t6.1-t9-mainpromo-mob-c02.17-c02.12.1-image-c03.10.1-main/business-assurance/medical/jeugdzorg---article.jpg 1578w,/cdn-cgi/image/width=1818,format=auto/globalassets/_shared-images/1280-x-0720-t5.1-t6.1-t9-mainpromo-mob-c02.17-c02.12.1-image-c03.10.1-main/business-assurance/medical/jeugdzorg---article.jpg 1818w" alt="" loading="lazy" decoding="auto" fetchpriority="auto" width="5333" height="3000" class="imageTextImg"> </div> <p class="promoBlockLabel imageTextLabel"> Artikel </p> <p class="imageTextSummary"> Ontdek waarom een HKZ-certificering essentieel is voor jeugdzorgorganisaties. 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ISO 13485 | Medische hulpmiddelen | LRQA