{"id":65,"date":"2026-07-26T14:39:19","date_gmt":"2026-07-26T14:39:19","guid":{"rendered":"https:\/\/amcoconsultingservices.com\/?page_id=65"},"modified":"2026-07-26T14:40:31","modified_gmt":"2026-07-26T14:40:31","slug":"iso-13485-soms","status":"publish","type":"page","link":"https:\/\/amcoconsultingservices.com\/?page_id=65","title":{"rendered":"ISO 13485 \u2014 SOMS"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"65\" class=\"elementor elementor-65\">\n\t\t\t\t<div class=\"elementor-element elementor-element-886c8d0 e-con-full e-flex e-con e-parent\" data-id=\"886c8d0\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1ff8093 elementor-widget elementor-widget-html\" data-id=\"1ff8093\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t\t<!-- =========================================================\nAM-CO CONSULTING & SERVICES\nPAGE ISO 13485 \u2014 SOMS\nFoundation \/ Lead Implementer \/ Lead Auditor\nUn seul bloc HTML \/ CSS \/ JS compatible Elementor\n\nPalette exclusive :\n#C00000\n#0F172A\n#FFFFFF\n========================================================= -->\n\n<style>\n@import url(\"https:\/\/fonts.googleapis.com\/css2?family=Inter:wght@400;500;600;700;800&family=Sora:wght@500;600;700;800&display=swap\");\n\nhtml{scroll-behavior:smooth}\n.amco-iso13485,.amco-iso13485 *{box-sizing:border-box}\n.amco-iso13485{\n  --r:#C00000;\n  --n:#0F172A;\n  --w:#FFFFFF;\n  width:100vw;\n  max-width:100vw;\n  margin-left:calc(50% - 50vw);\n  overflow:hidden;\n  color:var(--n);\n  background:var(--w);\n  font-family:\"Inter\",Arial,sans-serif;\n}\n.amco-iso13485 h1,.amco-iso13485 h2,.amco-iso13485 h3,.amco-iso13485 h4,.amco-iso13485 p{margin-top:0}\n.amco-iso13485 h1,.amco-iso13485 h2,.amco-iso13485 h3,.amco-iso13485 h4{font-family:\"Sora\",Arial,sans-serif}\n.amco-iso13485 a{text-decoration:none!important}\n.iso-wrap{width:min(1180px,calc(100% - 40px));margin:0 auto;position:relative;z-index:2}\n.iso-section{position:relative}\n.iso-grid-dark{\n  position:absolute;inset:0;pointer-events:none;opacity:.10;\n  background-image:\n    linear-gradient(rgba(255,255,255,.08) 1px,transparent 1px),\n    linear-gradient(90deg,rgba(255,255,255,.08) 1px,transparent 1px);\n  background-size:54px 54px;\n}\n.iso-reveal{opacity:0;transform:translateY(24px);transition:.65s ease}\n.iso-reveal.iso-visible{opacity:1;transform:none}\n\n\/* HERO *\/\n.iso-hero{\n  min-height:720px;\n  display:flex;\n  align-items:center;\n  padding:95px 0 75px;\n  overflow:hidden;\n  color:var(--w);\n  background:\n    radial-gradient(circle at 82% 18%,rgba(192,0,0,.30),transparent 29%),\n    var(--n);\n}\n.iso-hero:after{\n  content:\"\";position:absolute;right:-180px;bottom:-230px;width:560px;height:560px;\n  border:70px solid rgba(255,255,255,.045);border-radius:50%;\n}\n.iso-hero-layout{display:grid;grid-template-columns:1.05fr .95fr;gap:70px;align-items:center}\n.iso-eyebrow{\n  display:inline-flex;align-items:center;gap:10px;padding:9px 14px;margin-bottom:20px;\n  border:1px solid rgba(255,255,255,.16);border-radius:999px;\n  color:var(--r);background:rgba(255,255,255,.06);\n  font-size:11px;font-weight:800;letter-spacing:1.4px;text-transform:uppercase;\n}\n.iso-eyebrow i{width:8px;height:8px;border-radius:50%;background:var(--r);box-shadow:0 0 0 7px rgba(192,0,0,.16);animation:isoPulse 2s infinite}\n.iso-hero h1{\n  margin-bottom:22px;color:var(--w);font-size:clamp(40px,5vw,62px);\n  font-weight:800;line-height:1.02;letter-spacing:-2.5px;\n}\n.iso-hero h1 span{color:var(--r)}\n.iso-hero p{max-width:690px;color:rgba(255,255,255,.72);font-size:16px;line-height:1.8;margin-bottom:28px}\n.iso-actions{display:flex;flex-wrap:wrap;gap:12px}\n.iso-btn{\n  min-height:52px;display:inline-flex;align-items:center;justify-content:center;\n  padding:13px 21px;border-radius:11px;font-size:13px;font-weight:800;\n  transition:.25s ease;\n}\n.iso-btn:hover{transform:translateY(-3px)}\n.iso-btn-primary{color:var(--w)!important;background:var(--r);box-shadow:0 15px 36px rgba(192,0,0,.30)}\n.iso-btn-secondary{color:var(--w)!important;border:1px solid rgba(255,255,255,.18);background:rgba(255,255,255,.07)}\n.iso-hero-stats{display:grid;grid-template-columns:repeat(3,1fr);gap:13px;margin-top:34px}\n.iso-hero-stat{padding:15px;border:1px solid rgba(255,255,255,.11);border-radius:14px;background:rgba(255,255,255,.045)}\n.iso-hero-stat strong{display:block;color:var(--w);font-family:\"Sora\";font-size:20px;margin-bottom:4px}\n.iso-hero-stat span{color:rgba(255,255,255,.56);font-size:10.5px;line-height:1.4}\n\n\/* VISUAL *\/\n.iso-visual{position:relative;min-height:500px}\n.iso-halo{position:absolute;top:50%;left:50%;width:380px;height:380px;transform:translate(-50%,-50%);border-radius:50%;background:radial-gradient(circle,rgba(192,0,0,.24),transparent 70%);animation:isoHalo 4.5s infinite}\n.iso-orbit{position:absolute;top:50%;left:50%;border:1px solid rgba(255,255,255,.12);border-radius:50%;transform:translate(-50%,-50%)}\n.iso-orbit.one{width:430px;height:430px;animation:isoRotate 24s linear infinite}\n.iso-orbit.two{width:315px;height:315px;border-style:dashed;animation:isoRotateRev 19s linear infinite}\n.iso-orbit.three{width:210px;height:210px}\n.iso-core{\n  position:absolute;z-index:5;top:50%;left:50%;width:190px;height:190px;\n  display:flex;flex-direction:column;align-items:center;justify-content:center;\n  transform:translate(-50%,-50%);border-radius:50%;\n  color:var(--w);background:var(--r);\n  box-shadow:0 30px 80px rgba(0,0,0,.38),0 0 70px rgba(192,0,0,.24);\n  animation:isoFloat 5s ease-in-out infinite;\n}\n.iso-core strong{font-size:28px}.iso-core span{font-size:9px;letter-spacing:1.2px;text-transform:uppercase;color:rgba(255,255,255,.72);margin-top:6px}\n.iso-node{\n  position:absolute;z-index:6;width:190px;min-height:88px;padding:15px;border-radius:15px;\n  border:1px solid rgba(255,255,255,.13);background:rgba(15,23,42,.90);\n  box-shadow:0 15px 38px rgba(0,0,0,.22);color:var(--w);animation:isoNode 5s ease-in-out infinite;\n}\n.iso-node strong{display:block;font-size:12px;line-height:1.35;margin-bottom:4px}\n.iso-node span{font-size:9.5px;line-height:1.45;color:rgba(255,255,255,.54)}\n.iso-node.a{top:5%;left:0}\n.iso-node.b{top:32%;right:-3%;animation-delay:.8s}\n.iso-node.c{right:8%;bottom:2%;animation-delay:1.4s}\n\n\/* TRUST *\/\n.iso-trust{padding:14px 0;background:var(--n);border-top:1px solid rgba(255,255,255,.08)}\n.iso-trust-grid{display:grid;grid-template-columns:repeat(5,1fr);gap:12px}\n.iso-trust-item{display:flex;align-items:center;gap:8px;color:rgba(255,255,255,.76);font-size:11px}\n.iso-trust-dot{width:28px;height:28px;border-radius:50%;display:flex;align-items:center;justify-content:center;background:var(--r);color:var(--w);flex:0 0 auto}\n\n\/* LEVEL SELECTOR *\/\n.iso-levels{background:var(--w);border-bottom:1px solid rgba(15,23,42,.10);box-shadow:0 10px 24px rgba(15,23,42,.06)}\n.iso-levels-inner{display:grid;grid-template-columns:repeat(3,1fr)}\n.iso-levels-inner.iso-two-levels{grid-template-columns:repeat(2,1fr)}\n.iso-level-btn{\n  border:0;background:var(--w);padding:20px;text-align:left;cursor:pointer;\n  border-bottom:3px solid transparent;transition:.25s ease;\n}\n.iso-level-btn + .iso-level-btn{border-left:1px solid rgba(15,23,42,.08)}\n.iso-level-btn.active{border-bottom-color:var(--r);background:rgba(192,0,0,.03)}\n.iso-level-small{font-size:9px;font-weight:800;text-transform:uppercase;letter-spacing:1.4px;color:rgba(15,23,42,.48)}\n.iso-level-name{font-family:\"Sora\";font-size:15px;font-weight:700;color:var(--n);margin:4px 0}\n.iso-level-meta{font-size:10.5px;color:rgba(15,23,42,.58)}\n.iso-level-btn.active .iso-level-name,.iso-level-btn.active .iso-level-small{color:var(--r)}\n\n\/* CONTENT *\/\n.iso-content{padding:70px 0 100px;background:var(--w)}\n.iso-content-grid{display:grid;grid-template-columns:1fr 320px;gap:40px;align-items:start}\n.iso-main-card{\n  border:1px solid rgba(15,23,42,.10);border-radius:24px;background:var(--w);\n  box-shadow:0 20px 60px rgba(15,23,42,.08);overflow:hidden;\n}\n.iso-tabs{display:flex;overflow:auto;border-bottom:1px solid rgba(15,23,42,.08);background:var(--w)}\n.iso-tab-btn{\n  flex:0 0 auto;border:0;background:transparent;padding:16px 18px;cursor:pointer;\n  font-size:12px;font-weight:700;color:rgba(15,23,42,.58);border-bottom:3px solid transparent;\n}\n.iso-tab-btn.active{color:var(--r);border-bottom-color:var(--r)}\n.iso-panel{display:none;padding:32px}\n.iso-panel.active{display:block}\n.iso-kicker{font-size:10px;font-weight:800;text-transform:uppercase;letter-spacing:1.4px;color:var(--r);margin-bottom:8px}\n.iso-panel h2{font-size:28px;line-height:1.2;color:var(--n);margin-bottom:12px}\n.iso-panel p{font-size:14px;line-height:1.8;color:rgba(15,23,42,.66)}\n.iso-info-grid{display:grid;grid-template-columns:repeat(2,1fr);gap:14px;margin-top:22px}\n.iso-info-box{padding:17px;border:1px solid rgba(15,23,42,.09);border-left:3px solid var(--r);border-radius:12px;background:var(--w)}\n.iso-info-box strong{display:block;color:var(--n);font-size:13px;margin-bottom:5px}\n.iso-info-box span{font-size:12px;line-height:1.6;color:rgba(15,23,42,.60)}\n\n.iso-aud-grid{display:grid;grid-template-columns:repeat(2,1fr);gap:12px}\n.iso-aud-card{padding:17px;border:1px solid rgba(15,23,42,.09);border-top:3px solid var(--r);border-radius:12px}\n.iso-aud-card strong{display:block;font-size:13px;line-height:1.5;color:var(--n)}\n\n.iso-days{display:grid;gap:10px}\n.iso-day{border:1px solid rgba(15,23,42,.09);border-radius:12px;overflow:hidden}\n.iso-day-head{display:flex;gap:12px;align-items:center;padding:14px 16px;background:rgba(15,23,42,.025);cursor:pointer}\n.iso-day-n{padding:4px 9px;border-radius:6px;background:var(--r);color:var(--w);font-size:10px;font-weight:800}\n.iso-day-title{flex:1;font-size:13px;font-weight:700;color:var(--n)}\n.iso-day-body{display:none;padding:14px 18px}\n.iso-day.open .iso-day-body{display:block}\n.iso-day-body ul{margin:0;padding-left:18px}\n.iso-day-body li{margin:5px 0;color:rgba(15,23,42,.64);font-size:12.5px;line-height:1.55}\n\n.iso-check-list{display:grid;gap:10px}\n.iso-check{display:flex;gap:10px;align-items:flex-start}\n.iso-check i{width:21px;height:21px;border-radius:50%;background:var(--r);color:var(--w);display:flex;align-items:center;justify-content:center;font-style:normal;font-size:10px;flex:0 0 auto}\n.iso-check span{font-size:13px;line-height:1.6;color:rgba(15,23,42,.66)}\n\n.iso-domain-list{display:grid;gap:8px;margin-top:18px}\n.iso-domain{display:flex;gap:10px;padding:12px 14px;border:1px solid rgba(15,23,42,.08);border-radius:10px}\n.iso-domain b{color:var(--r);font-size:11px;white-space:nowrap}\n.iso-domain span{font-size:12.5px;color:rgba(15,23,42,.66)}\n\n.iso-cert-table{width:100%;border-collapse:collapse;font-size:12px;margin-top:18px}\n.iso-cert-table th{background:var(--n);color:var(--w);padding:12px;text-align:left}\n.iso-cert-table td{padding:12px;border-bottom:1px solid rgba(15,23,42,.08);vertical-align:top;color:rgba(15,23,42,.66)}\n.iso-cert-table tr:nth-child(even) td{background:rgba(15,23,42,.02)}\n\n.iso-benefits{display:grid;grid-template-columns:repeat(2,1fr);gap:14px}\n.iso-benefit{padding:18px;border:1px solid rgba(15,23,42,.09);border-radius:12px}\n.iso-benefit strong{display:block;font-size:13px;color:var(--n);margin-bottom:5px}\n.iso-benefit span{font-size:12px;color:rgba(15,23,42,.62);line-height:1.6}\n\n\/* SIDEBAR *\/\n.iso-sidebar{position:sticky;top:20px;display:grid;gap:14px}\n.iso-book{\n  border-radius:18px;overflow:hidden;background:var(--w);\n  border:1px solid rgba(15,23,42,.10);box-shadow:0 20px 55px rgba(15,23,42,.10);\n}\n.iso-book-head{padding:20px;background:var(--r);color:var(--w)}\n.iso-book-head small{display:block;font-size:9px;text-transform:uppercase;letter-spacing:1.4px;color:rgba(255,255,255,.66);margin-bottom:5px}\n.iso-book-head strong{font-size:16px}\n.iso-book-body{padding:18px}\n.iso-book-row{display:flex;justify-content:space-between;gap:14px;padding:9px 0;border-bottom:1px solid rgba(15,23,42,.07);font-size:12px}\n.iso-book-row:last-child{border-bottom:0}\n.iso-book-row span:first-child{color:rgba(15,23,42,.55)}\n.iso-book-row span:last-child{font-weight:700;color:var(--n);text-align:right}\n.iso-book-actions{padding:0 18px 18px;display:grid;gap:9px}\n.iso-book-actions a{display:flex;justify-content:center;align-items:center;min-height:48px;border-radius:10px;font-size:12px;font-weight:800}\n.iso-book-actions a:first-child{background:var(--r);color:var(--w)!important}\n.iso-book-actions a:last-child{border:1px solid rgba(15,23,42,.12);color:var(--n)!important}\n.iso-side-card{padding:18px;border:1px solid rgba(15,23,42,.10);border-radius:16px;background:var(--w)}\n.iso-side-card h4{font-size:14px;color:var(--n);margin-bottom:12px}\n.iso-side-link{display:block;padding:9px 0;border-bottom:1px solid rgba(15,23,42,.07);font-size:12px;color:rgba(15,23,42,.66)!important}\n.iso-side-link:last-child{border-bottom:0}\n\n\n\/* SECTION ILLUSTR\u00c9E \u2014 IMAGE \u00c0 REMPLACER *\/\n.iso-immersive{\n  padding:95px 0;\n  background:var(--w);\n}\n\n.iso-immersive-grid{\n  display:grid;\n  grid-template-columns:1.15fr .85fr;\n  gap:42px;\n  align-items:center;\n}\n\n.iso-immersive-media{\n  position:relative;\n  min-height:520px;\n  overflow:hidden;\n  border-radius:26px;\n  background:var(--n);\n  box-shadow:0 28px 75px rgba(15,23,42,.18);\n}\n\n.iso-immersive-media:before{\n  content:\"\";\n  position:absolute;\n  inset:0;\n  z-index:2;\n  background:\n    linear-gradient(90deg,rgba(15,23,42,.05),rgba(15,23,42,.72)),\n    linear-gradient(180deg,transparent 55%,rgba(15,23,42,.72));\n  pointer-events:none;\n}\n\n.iso-immersive-media img{\n  width:100%;\n  height:100%;\n  min-height:520px;\n  display:block;\n  object-fit:cover;\n}\n\n.iso-immersive-placeholder{\n  min-height:520px;\n  display:flex;\n  align-items:center;\n  justify-content:center;\n  padding:30px;\n  border:1px dashed rgba(255,255,255,.22);\n  color:rgba(255,255,255,.72);\n  font-size:13px;\n  font-weight:700;\n  text-align:center;\n}\n\n.iso-immersive-badge{\n  position:absolute;\n  z-index:3;\n  left:24px;\n  bottom:24px;\n  max-width:340px;\n  padding:16px 18px;\n  border:1px solid rgba(255,255,255,.14);\n  border-radius:16px;\n  background:rgba(15,23,42,.78);\n  color:var(--w);\n  backdrop-filter:blur(14px);\n}\n\n.iso-immersive-badge strong{\n  display:block;\n  margin-bottom:5px;\n  font-family:\"Sora\";\n  font-size:14px;\n}\n\n.iso-immersive-badge span{\n  color:rgba(255,255,255,.62);\n  font-size:10.5px;\n  line-height:1.55;\n}\n\n.iso-immersive-copy .iso-kicker{\n  margin-bottom:10px;\n}\n\n.iso-immersive-copy h2{\n  margin-bottom:16px;\n  color:var(--n);\n  font-size:clamp(30px,4vw,46px);\n  line-height:1.08;\n  letter-spacing:-1.5px;\n}\n\n.iso-immersive-copy h2 span{\n  color:var(--r);\n}\n\n.iso-immersive-copy > p{\n  margin-bottom:24px;\n  color:rgba(15,23,42,.66);\n  font-size:14px;\n  line-height:1.8;\n}\n\n.iso-immersive-features{\n  display:grid;\n  gap:12px;\n}\n\n.iso-immersive-feature{\n  display:grid;\n  grid-template-columns:48px 1fr;\n  gap:14px;\n  align-items:center;\n  padding:16px;\n  border:1px solid rgba(15,23,42,.09);\n  border-radius:14px;\n  background:var(--w);\n  transition:transform .3s ease,border-color .3s ease,box-shadow .3s ease;\n}\n\n.iso-immersive-feature:hover{\n  transform:translateX(6px);\n  border-color:rgba(192,0,0,.32);\n  box-shadow:0 15px 35px rgba(15,23,42,.08);\n}\n\n.iso-immersive-feature-icon{\n  width:48px;\n  height:48px;\n  display:flex;\n  align-items:center;\n  justify-content:center;\n  border-radius:14px;\n  color:var(--w);\n  background:var(--n);\n  font-family:\"Sora\";\n  font-size:10px;\n  font-weight:800;\n}\n\n.iso-immersive-feature:hover .iso-immersive-feature-icon{\n  background:var(--r);\n}\n\n.iso-immersive-feature strong{\n  display:block;\n  margin-bottom:4px;\n  color:var(--n);\n  font-size:13px;\n}\n\n.iso-immersive-feature span{\n  color:rgba(15,23,42,.60);\n  font-size:11px;\n  line-height:1.55;\n}\n\n@media(max-width:950px){\n  .iso-immersive-grid{\n    grid-template-columns:1fr;\n  }\n}\n\n@media(max-width:620px){\n  .iso-immersive{\n    padding:72px 0;\n  }\n\n  .iso-immersive-media,\n  .iso-immersive-media img,\n  .iso-immersive-placeholder{\n    min-height:390px;\n  }\n\n  .iso-immersive-badge{\n    right:18px;\n    left:18px;\n    bottom:18px;\n  }\n}\n\n\n\/* CTA *\/\n.iso-cta{padding:80px 0;background:var(--w)}\n.iso-cta-box{\n  position:relative;overflow:hidden;display:grid;grid-template-columns:1fr auto;gap:30px;align-items:center;\n  padding:48px;border-radius:24px;background:var(--r);color:var(--w);box-shadow:0 26px 70px rgba(192,0,0,.22)\n}\n.iso-cta-box:after{content:\"\";position:absolute;right:-70px;bottom:-100px;width:260px;height:260px;border:35px solid rgba(255,255,255,.08);border-radius:50%}\n.iso-cta h2{position:relative;z-index:2;color:var(--w);font-size:36px;line-height:1.15;margin-bottom:10px}\n.iso-cta p{position:relative;z-index:2;color:rgba(255,255,255,.72);font-size:13px;line-height:1.7;margin:0}\n.iso-cta-actions{position:relative;z-index:2;display:grid;gap:9px}\n.iso-cta-actions a{min-width:210px;min-height:50px;display:flex;align-items:center;justify-content:center;border-radius:10px;font-size:12px;font-weight:800}\n.iso-cta-actions a:first-child{background:var(--w);color:var(--n)!important}\n.iso-cta-actions a:last-child{border:1px solid rgba(255,255,255,.35);color:var(--w)!important}\n\n@keyframes isoPulse{50%{transform:scale(1.3);opacity:.65}}\n@keyframes isoRotate{to{transform:translate(-50%,-50%) rotate(360deg)}}\n@keyframes isoRotateRev{to{transform:translate(-50%,-50%) rotate(-360deg)}}\n@keyframes isoHalo{50%{transform:translate(-50%,-50%) scale(1.08)}}\n@keyframes isoFloat{50%{transform:translate(-50%,-50%) translateY(-12px)}}\n@keyframes isoNode{50%{transform:translateY(-9px)}}\n\n@media(max-width:1050px){\n  .iso-hero-layout,.iso-content-grid{grid-template-columns:1fr}\n  .iso-visual{width:min(100%,590px);margin:0 auto}\n  .iso-sidebar{position:static}\n  .iso-trust-grid{grid-template-columns:repeat(2,1fr)}\n}\n@media(max-width:720px){\n  .iso-levels-inner{grid-template-columns:1fr}\n  .iso-level-btn + .iso-level-btn{border-left:0;border-top:1px solid rgba(15,23,42,.08)}\n  .iso-info-grid,.iso-aud-grid,.iso-benefits{grid-template-columns:1fr}\n  .iso-hero-stats{grid-template-columns:1fr}\n  .iso-cta-box{grid-template-columns:1fr}\n}\n@media(max-width:620px){\n  .iso-wrap{width:min(100% - 28px,1180px)}\n  .iso-hero{padding:84px 0 60px;min-height:auto}\n  .iso-hero h1{font-size:clamp(36px,12vw,50px)}\n  .iso-actions{flex-direction:column}\n  .iso-btn{width:100%}\n  .iso-visual{min-height:430px;transform:scale(.86);margin-top:-20px;margin-bottom:-35px}\n  .iso-orbit.one{width:330px;height:330px}\n  .iso-orbit.two{width:245px;height:245px}\n  .iso-core{width:155px;height:155px}\n  .iso-node{width:150px;padding:12px}\n  .iso-node.a{left:-10%}.iso-node.b{right:-12%}.iso-node.c{right:0}\n  .iso-panel{padding:22px}\n  .iso-panel h2{font-size:23px}\n  .iso-cert-table{display:block;overflow:auto}\n  .iso-trust-grid{grid-template-columns:1fr}\n  .iso-cta{padding:60px 0}.iso-cta-box{padding:34px 22px}.iso-cta h2{font-size:28px}\n}\n<\/style>\n\n<div class=\"amco-iso13485\">\n\n  <section class=\"iso-section iso-hero\">\n    <div class=\"iso-grid-dark\"><\/div>\n    <div class=\"iso-wrap\">\n      <div class=\"iso-hero-layout\">\n        <div class=\"iso-reveal\">\n          <div class=\"iso-eyebrow\"><i><\/i> Parcours certifiant PECB<\/div>\n          <h1>ISO <span>13485<\/span><br>Syst\u00e8me de management des qualit\u00e9 des dispositifs m\u00e9dicaux<\/h1>\n          <p>\n            D\u00e9veloppez les comp\u00e9tences n\u00e9cessaires pour comprendre, mettre en \u0153uvre\n            et auditer un Medical Devices Management System conforme \u00e0 ISO 13485.\n          <\/p>\n          <div class=\"iso-actions\">\n            <a href=\"#iso13485-levels\" class=\"iso-btn iso-btn-primary\">Choisir un niveau \u2192<\/a>\n            <a href=\"https:\/\/amcoconsultingservices.com\/contactez-nous\/\" class=\"iso-btn iso-btn-secondary\">Demander un accompagnement<\/a>\n          <\/div>\n          <div class=\"iso-hero-stats\">\n            <div class=\"iso-hero-stat\"><strong>3<\/strong><span>Niveaux de formation<\/span><\/div>\n            <div class=\"iso-hero-stat\"><strong>PECB<\/strong><span>Certification officielle<\/span><\/div>\n            <div class=\"iso-hero-stat\"><strong>2 \u00e0 5 j<\/strong><span>Selon le niveau choisi<\/span><\/div>\n          <\/div>\n        <\/div>\n\n        <div class=\"iso-visual iso-reveal\">\n          <div class=\"iso-halo\"><\/div>\n          <div class=\"iso-orbit one\"><\/div>\n          <div class=\"iso-orbit two\"><\/div>\n          <div class=\"iso-orbit three\"><\/div>\n          <div class=\"iso-core\"><strong>13485<\/strong><span>Medical Devices<\/span><\/div>\n          <div class=\"iso-node a\"><strong>Foundation<\/strong><span>Ma\u00eetriser les exigences et principes du SMQDM<\/span><\/div>\n          <div class=\"iso-node b\"><strong>Lead Implementer<\/strong><span>Concevoir, d\u00e9ployer et maintenir le SMQDM<\/span><\/div>\n          <div class=\"iso-node c\"><strong>Lead Auditor<\/strong><span>Planifier, conduire et cl\u00f4turer les audits du SMQDM<\/span><\/div>\n        <\/div>\n      <\/div>\n    <\/div>\n  <\/section>\n\n  <div class=\"iso-trust\">\n    <div class=\"iso-wrap\">\n      <div class=\"iso-trust-grid\">\n        <div class=\"iso-trust-item\"><span class=\"iso-trust-dot\">\u2713<\/span>Certification PECB incluse<\/div>\n        <div class=\"iso-trust-item\"><span class=\"iso-trust-dot\">\ud83c\udf93<\/span>Formateurs certifi\u00e9s<\/div>\n        <div class=\"iso-trust-item\"><span class=\"iso-trust-dot\">\u21bb<\/span>Rattrapage gratuit<\/div>\n        <div class=\"iso-trust-item\"><span class=\"iso-trust-dot\">\ud83d\udcc4<\/span>Cr\u00e9dits DPC<\/div>\n        <div class=\"iso-trust-item\"><span class=\"iso-trust-dot\">\ud83c\udf0d<\/span>Reconnaissance internationale<\/div>\n      <\/div>\n    <\/div>\n  <\/div>\n\n\n  <section class=\"iso-section iso-immersive\">\n    <div class=\"iso-wrap\">\n      <div class=\"iso-immersive-grid\">\n\n        <div class=\"iso-immersive-media iso-reveal\">\n\n          <!--\n          REMPLACE CE BLOC PAR TON IMAGE :\n\n          <img decoding=\"async\"\n            src=\"TON-LIEN-IMAGE\"\n            alt=\"Production et contr\u00f4le de la qualit\u00e9 des dispositifs m\u00e9dicaux ISO 13485\"\n          >\n          -->\n\n          <div class=\"iso-immersive-placeholder\">\n            Ajoute ici ton image ISO 13485 \u2014 dispositifs m\u00e9dicaux\n          <\/div>\n\n          <div class=\"iso-immersive-badge\">\n            <strong>ISO 13485 \u2014 Medical Devices<\/strong>\n            <span>\n              Une approche structur\u00e9e pour ma\u00eetriser la qualit\u00e9, la conformit\u00e9 et la s\u00e9curit\u00e9 des dispositifs m\u00e9dicaux.\n            <\/span>\n          <\/div>\n        <\/div>\n\n        <div class=\"iso-immersive-copy iso-reveal\">\n          <div class=\"iso-kicker\">Norme internationale<\/div>\n\n          <h2>\n            Un cadre pour des qualit\u00e9 des dispositifs m\u00e9dicaux\n            <span>ma\u00eetris\u00e9es et responsables.<\/span>\n          <\/h2>\n\n          <p>\n            ISO 13485 aide les organisations \u00e0 concevoir, mettre en \u0153uvre, surveiller et am\u00e9liorer un syst\u00e8me de management de la qualit\u00e9 adapt\u00e9 au cycle de vie des dispositifs m\u00e9dicaux, aux exigences r\u00e9glementaires et \u00e0 la s\u00e9curit\u00e9 des patients.\n          <\/p>\n\n          <div class=\"iso-immersive-features\">\n\n            <div class=\"iso-immersive-feature\">\n              <div class=\"iso-immersive-feature-icon\">QMS<\/div>\n              <div>\n                <strong>Ma\u00eetrise des processus<\/strong>\n                <span>Organisation, contr\u00f4le et am\u00e9lioration des processus de conception, production et distribution.<\/span>\n              <\/div>\n            <\/div>\n\n            <div class=\"iso-immersive-feature\">\n              <div class=\"iso-immersive-feature-icon\">RISK<\/div>\n              <div>\n                <strong>Ma\u00eetrise des risques<\/strong>\n                <span>Identification, \u00e9valuation et ma\u00eetrise des risques li\u00e9s aux dispositifs m\u00e9dicaux.<\/span>\n              <\/div>\n            <\/div>\n\n            <div class=\"iso-immersive-feature\">\n              <div class=\"iso-immersive-feature-icon\">MED<\/div>\n              <div>\n                <strong>Reconnaissance internationale<\/strong>\n                <span>Un r\u00e9f\u00e9rentiel reconnu pour les organisations de la secteur des dispositifs m\u00e9dicaux.<\/span>\n              <\/div>\n            <\/div>\n\n          <\/div>\n        <\/div>\n\n      <\/div>\n    <\/div>\n  <\/section>\n\n  <section class=\"iso-levels\" id=\"iso13485-levels\">\n    <div class=\"iso-wrap\">\n      <div class=\"iso-levels-inner iso-two-levels\">\n        <button class=\"iso-level-btn active\" data-level=\"implementer\">\n          <div class=\"iso-level-small\">Niveau 1<\/div>\n          <div class=\"iso-level-name\">ISO 13485 Lead Implementer<\/div>\n          <div class=\"iso-level-meta\">5 jours \u00b7 Examen 3 heures \u00b7 31 DPC<\/div>\n        <\/button>\n        <button class=\"iso-level-btn\" data-level=\"auditor\">\n          <div class=\"iso-level-small\">Niveau 2<\/div>\n          <div class=\"iso-level-name\">ISO 13485 Lead Auditor<\/div>\n          <div class=\"iso-level-meta\">5 jours \u00b7 Examen 3 heures \u00b7 31 DPC<\/div>\n        <\/button>\n      <\/div>\n    <\/div>\n  <\/section>\n\n  <section class=\"iso-content\">\n    <div class=\"iso-wrap\">\n      <div class=\"iso-content-grid\">\n\n        <div class=\"iso-main-card iso-reveal\">\n          <div class=\"iso-tabs\">\n            <button class=\"iso-tab-btn active\" data-tab=\"presentation\">Pr\u00e9sentation<\/button>\n            <button class=\"iso-tab-btn\" data-tab=\"audience\">Public cible<\/button>\n            <button class=\"iso-tab-btn\" data-tab=\"programme\">Programme<\/button>\n            <button class=\"iso-tab-btn\" data-tab=\"objectifs\">Objectifs<\/button>\n            <button class=\"iso-tab-btn\" data-tab=\"certification\">Certification<\/button>\n            <button class=\"iso-tab-btn\" data-tab=\"avantages\">Points forts<\/button>\n          <\/div>\n\n          <div class=\"iso-panel active\" data-panel=\"presentation\">\n            <div class=\"iso-kicker\">\u00c0 propos<\/div>\n            <h2 id=\"iso-title\"><\/h2>\n            <p id=\"iso-description\"><\/p>\n            <div class=\"iso-info-grid\" id=\"iso-info-grid\"><\/div>\n          <\/div>\n\n          <div class=\"iso-panel\" data-panel=\"audience\">\n            <div class=\"iso-kicker\">Participants<\/div>\n            <h2>\u00c0 qui s\u2019adresse cette formation ?<\/h2>\n            <div class=\"iso-aud-grid\" id=\"iso-audience\"><\/div>\n          <\/div>\n\n          <div class=\"iso-panel\" data-panel=\"programme\">\n            <div class=\"iso-kicker\">Contenu p\u00e9dagogique<\/div>\n            <h2>Programme de la formation<\/h2>\n            <div class=\"iso-days\" id=\"iso-days\"><\/div>\n          <\/div>\n\n          <div class=\"iso-panel\" data-panel=\"objectifs\">\n            <div class=\"iso-kicker\">Comp\u00e9tences acquises<\/div>\n            <h2>Objectifs de la formation<\/h2>\n            <div class=\"iso-check-list\" id=\"iso-objectifs\"><\/div>\n            <div class=\"iso-domain-list\" id=\"iso-domaines\"><\/div>\n          <\/div>\n\n          <div class=\"iso-panel\" data-panel=\"certification\">\n            <div class=\"iso-kicker\">Apr\u00e8s l\u2019examen<\/div>\n            <h2>Certification obtenue<\/h2>\n            <p id=\"iso-cert-intro\"><\/p>\n            <div style=\"overflow:auto\">\n              <table class=\"iso-cert-table\">\n                <thead>\n                  <tr>\n                    <th>Qualification<\/th>\n                    <th>Exp\u00e9rience professionnelle<\/th>\n                    <th>Exp\u00e9rience projet \/ audit<\/th>\n                    <th>Autres exigences<\/th>\n                  <\/tr>\n                <\/thead>\n                <tbody id=\"iso-cert-rows\"><\/tbody>\n              <\/table>\n            <\/div>\n          <\/div>\n\n          <div class=\"iso-panel\" data-panel=\"avantages\">\n            <div class=\"iso-kicker\">Inclus dans la formation<\/div>\n            <h2>Points forts et avantages<\/h2>\n            <div class=\"iso-benefits\" id=\"iso-benefits\"><\/div>\n          <\/div>\n        <\/div>\n\n        <aside class=\"iso-sidebar iso-reveal\">\n          <div class=\"iso-book\">\n            <div class=\"iso-book-head\">\n              <small>Formation s\u00e9lectionn\u00e9e<\/small>\n              <strong id=\"iso-book-title\"><\/strong>\n            <\/div>\n            <div class=\"iso-book-body\">\n              <div class=\"iso-book-row\"><span>Dur\u00e9e<\/span><span id=\"iso-book-duration\"><\/span><\/div>\n              <div class=\"iso-book-row\"><span>Examen<\/span><span id=\"iso-book-exam\"><\/span><\/div>\n              <div class=\"iso-book-row\"><span>Format<\/span><span>Pr\u00e9sentiel \/ Distanciel<\/span><\/div>\n              <div class=\"iso-book-row\"><span>Lieu<\/span><span>Dakar, S\u00e9n\u00e9gal<\/span><\/div>\n              <div class=\"iso-book-row\"><span>Langue<\/span><span>Fran\u00e7ais<\/span><\/div>\n              <div class=\"iso-book-row\"><span>Cr\u00e9dits<\/span><span id=\"iso-book-credits\"><\/span><\/div>\n            <\/div>\n            <div class=\"iso-book-actions\">\n              <a href=\"mailto:secretariat@amcoconsultingservices.com\">S\u2019inscrire \u00e0 la formation<\/a>\n              <a href=\"tel:+221338425202\">Demander un devis<\/a>\n            <\/div>\n          <\/div>\n\n          <div class=\"iso-side-card\">\n            <h4>Les niveaux ISO 13485<\/h4>\n            <a href=\"#iso13485-levels\" class=\"iso-side-link\">ISO 13485 Lead Implementer<\/a>\n            <a href=\"#iso13485-levels\" class=\"iso-side-link\">ISO 13485 Lead Auditor<\/a>\n          <\/div>\n\n          <div class=\"iso-side-card\">\n            <h4>Contact AM-CO<\/h4>\n            <a class=\"iso-side-link\" href=\"tel:+221338425202\">+221 33 842 52 02<\/a>\n            <a class=\"iso-side-link\" href=\"tel:+221773686219\">+221 77 368 62 19<\/a>\n            <a class=\"iso-side-link\" href=\"mailto:secretariat@amcoconsultingservices.com\">secretariat@amcoconsultingservices.com<\/a>\n          <\/div>\n        <\/aside>\n\n      <\/div>\n    <\/div>\n  <\/section>\n\n  <section class=\"iso-cta\">\n    <div class=\"iso-wrap\">\n      <div class=\"iso-cta-box iso-reveal\">\n        <div>\n          <h2>D\u00e9marrez votre parcours ISO 13485.<\/h2>\n          <p>AM-CO vous accompagne vers les certifications Lead Implementer et Lead Auditor en management de la qualit\u00e9 des dispositifs m\u00e9dicaux.<\/p>\n        <\/div>\n        <div class=\"iso-cta-actions\">\n          <a href=\"https:\/\/amcoconsultingservices.com\/contactez-nous\/\">Demander un devis<\/a>\n          <a href=\"tel:+221338425202\">+221 33 842 52 02<\/a>\n        <\/div>\n      <\/div>\n    <\/div>\n  <\/section>\n\n<\/div>\n\n<script>\n(function(){\n  const data={\n    implementer:{\n      title:\"ISO 13485 Lead Implementer\",\n      description:\"Cette formation permet d\u2019acqu\u00e9rir l\u2019expertise n\u00e9cessaire pour accompagner un organisme dans l\u2019\u00e9tablissement, la mise en \u0153uvre, la gestion et la tenue \u00e0 jour d\u2019un Syst\u00e8me de management de la qualit\u00e9 des dispositifs m\u00e9dicaux conforme \u00e0 ISO 13485.\",\n      duration:\"5 jours\",\n      exam:\"3 heures\",\n      credits:\"31 DPC\",\n      info:[\n        [\"Pr\u00e9requis\",\"Connaissance g\u00e9n\u00e9rale d\u2019ISO 13485 recommand\u00e9e\"],\n        [\"Approche\",\"Planification, mise en \u0153uvre et am\u00e9lioration d\u2019un SMQDM\"],\n        [\"R\u00e9sultat\",\"Pr\u00e9paration \u00e0 la certification Lead Implementer\"],\n        [\"Support\",\"Plus de 450 pages de contenu et d\u2019exemples pratiques\"]\n      ],\n      audience:[\n        \"Responsables ou consultants impliqu\u00e9s dans le management de la qualit\u00e9 des dispositifs m\u00e9dicaux\",\n        \"Conseillers sp\u00e9cialis\u00e9s souhaitant ma\u00eetriser la mise en \u0153uvre d\u2019un SMQDM\",\n        \"Personnes responsables du maintien de la conformit\u00e9 aux exigences du SMQDM\",\n        \"Membres d\u2019une \u00e9quipe du SMQDM\"\n      ],\n      days:[\n        [\"Jour 1\",\"Introduction \u00e0 ISO 13485 et initialisation d\u2019un SMQDM\",[\"Objectifs et structure de la formation\",\"Cadres normatifs et r\u00e9glementaires\",\"Syst\u00e8mes de management de la qualit\u00e9 des dispositifs m\u00e9dicaux\",\"Principes fondamentaux du SMQDM\",\"Initialisation de la mise en \u0153uvre du SMQDM\"]],\n        [\"Jour 2\",\"Planification de la mise en \u0153uvre d\u2019un SMQDM\",[\"Compr\u00e9hension de l\u2019organisme et clarification des objectifs qualit\u00e9\",\"Analyse du syst\u00e8me de management existant\",\"Leadership et approbation du projet SMQDM\",\"P\u00e9rim\u00e8tre du SMQDM\",\"Politiques du SMQDM\",\"Structure de l\u2019organisme et management de la qualit\u00e9\"]],\n        [\"Jour 3\",\"Mise en \u0153uvre d\u2019un SMQDM\",[\"D\u00e9finition d\u2019un processus de gestion de la documentation\",\"Conception des contr\u00f4les\",\"R\u00e9daction des politiques et proc\u00e9dures\",\"Plan de communication\",\"Plan de formation et de sensibilisation\",\"R\u00e9alisation du produit\",\"Gestion des op\u00e9rations\"]],\n        [\"Jour 4\",\"Surveillance, mesure, am\u00e9lioration et pr\u00e9paration \u00e0 l\u2019audit\",[\"Surveillance, mesure, analyse et \u00e9valuation\",\"Audit interne\",\"Revue de direction\",\"Traitement des non-conformit\u00e9s\",\"Am\u00e9lioration continue\",\"Pr\u00e9paration de l\u2019audit de certification\",\"Comp\u00e9tence et \u00e9valuation des implementers\"]],\n        [\"Jour 5\",\"Examen de certification\",[\"Examen PECB Certified ISO 13485 Lead Implementer\"]]\n      ],\n      objectifs:[\n        \"Comprendre la corr\u00e9lation entre ISO 13485 et les autres normes et cadres r\u00e9glementaires\",\n        \"Ma\u00eetriser les concepts, approches, m\u00e9thodes et techniques n\u00e9cessaires pour mettre en \u0153uvre et g\u00e9rer efficacement un SMQDM\",\n        \"Interpr\u00e9ter les exigences d\u2019ISO 13485 dans le contexte sp\u00e9cifique d\u2019un organisme\",\n        \"Accompagner un organisme dans la planification, la mise en \u0153uvre, la gestion, la surveillance et la tenue \u00e0 jour du SMQDM\",\n        \"Conseiller un organisme sur les meilleures pratiques relatives au management de la qualit\u00e9 des dispositifs m\u00e9dicaux\"\n      ],\n      domaines:[\n        [\"Domaine 1\",\"Principes et concepts fondamentaux du SMQDM\"],\n        [\"Domaine 2\",\"Syst\u00e8me de management de la qualit\u00e9 des dispositifs m\u00e9dicaux\"],\n        [\"Domaine 3\",\"Planification de la mise en \u0153uvre d\u2019un SMQDM selon ISO 13485\"],\n        [\"Domaine 4\",\"Mise en \u0153uvre d\u2019un SMQDM conforme \u00e0 ISO 13485\"],\n        [\"Domaine 5\",\"\u00c9valuation de la performance, surveillance et mesure du SMQDM\"],\n        [\"Domaine 6\",\"Am\u00e9lioration continue du SMQDM\"],\n        [\"Domaine 7\",\"Pr\u00e9paration de l\u2019audit de certification du SMQDM\"]\n      ],\n      certIntro:\"Apr\u00e8s r\u00e9ussite de l\u2019examen, le participant peut demander une qualification PECB ISO 13485 Implementer selon son exp\u00e9rience professionnelle.\",\n      cert:[\n        [\"Provisional Implementer\",\"Aucune\",\"Aucune\",\"Signer le Code de d\u00e9ontologie PECB\"],\n        [\"Implementer\",\"2 ans dont 1 an en management de la qualit\u00e9 des dispositifs m\u00e9dicaux\",\"200 heures de projet\",\"Signer le Code de d\u00e9ontologie PECB\"],\n        [\"Lead Implementer\",\"5 ans dont 2 ans en management de la qualit\u00e9 des dispositifs m\u00e9dicaux\",\"300 heures de projet\",\"Signer le Code de d\u00e9ontologie PECB\"],\n        [\"Master\",\"10 ans dont 6 ans en management de la qualit\u00e9 des dispositifs m\u00e9dicaux\",\"500 heures de projet et 500 heures d\u2019audit\",\"Signer le Code de d\u00e9ontologie PECB\"]\n      ],\n      benefits:[\n        [\"Frais inclus\",\"Les frais de certification et d\u2019examen sont inclus.\"],\n        [\"Support complet\",\"Plus de 450 pages d\u2019informations et d\u2019exemples pratiques.\"],\n        [\"31 cr\u00e9dits DPC\",\"Un certificat de participation de 31 cr\u00e9dits DPC est d\u00e9livr\u00e9.\"],\n        [\"Rattrapage gratuit\",\"L\u2019examen peut \u00eatre repass\u00e9 gratuitement dans les 12 mois.\"]\n      ]\n    },\n    auditor:{\n      title:\"ISO 13485 Lead Auditor\",\n      description:\"Cette formation permet d\u2019acqu\u00e9rir l\u2019expertise n\u00e9cessaire pour r\u00e9aliser des audits de Syst\u00e8mes de management de la qualit\u00e9 des dispositifs m\u00e9dicaux en appliquant les principes, proc\u00e9dures et techniques d\u2019audit reconnues conform\u00e9ment \u00e0 ISO 19011 et au processus de certification ISO\/IEC 17021-1.\",\n      duration:\"5 jours\",\n      exam:\"3 heures\",\n      credits:\"31 DPC\",\n      info:[\n        [\"Pr\u00e9requis\",\"Connaissance d\u2019ISO 13485 et des principes d\u2019audit recommand\u00e9e\"],\n        [\"Approche\",\"Planification, r\u00e9alisation et cl\u00f4ture des audits du SMQDM\"],\n        [\"R\u00e9sultat\",\"Pr\u00e9paration \u00e0 la certification Lead Auditor\"],\n        [\"Support\",\"Plus de 450 pages de contenu et d\u2019exemples pratiques\"]\n      ],\n      audience:[\n        \"Auditeurs souhaitant r\u00e9aliser et diriger des audits de certification du SMQDM\",\n        \"Responsables ou consultants d\u00e9sirant ma\u00eetriser le processus d\u2019audit du SMQDM\",\n        \"Personnes responsables du maintien de la conformit\u00e9 aux exigences du SMQDM\",\n        \"Experts techniques d\u00e9sirant pr\u00e9parer un audit du SMQDM\",\n        \"Conseillers sp\u00e9cialis\u00e9s en management de la qualit\u00e9 des dispositifs m\u00e9dicaux\"\n      ],\n      days:[\n        [\"Jour 1\",\"Introduction au SMQDM et \u00e0 ISO 13485\",[\"Objectifs et structure de la formation\",\"Cadres normatifs et r\u00e9glementaires\",\"Processus de certification\",\"Principes fondamentaux du SMQDM\",\"Syst\u00e8me de management de la qualit\u00e9 des dispositifs m\u00e9dicaux\"]],\n        [\"Jour 2\",\"Principes, pr\u00e9paration et d\u00e9clenchement de l\u2019audit\",[\"Principes et concepts fondamentaux d\u2019audit\",\"Approche d\u2019audit fond\u00e9e sur les preuves\",\"D\u00e9clenchement de l\u2019audit\",\"\u00c9tape 1 de l\u2019audit\",\"Pr\u00e9paration de l\u2019\u00e9tape 2\",\"Premi\u00e8re partie de l\u2019audit sur site\"]],\n        [\"Jour 3\",\"Activit\u00e9s d\u2019audit sur site\",[\"Deuxi\u00e8me partie de l\u2019audit sur site\",\"Communication pendant l\u2019audit\",\"Proc\u00e9dures d\u2019audit\",\"R\u00e9daction des plans de tests\",\"Constats d\u2019audit\",\"Rapports de non-conformit\u00e9\"]],\n        [\"Jour 4\",\"Cl\u00f4ture de l\u2019audit\",[\"Documentation et revue qualit\u00e9\",\"Cl\u00f4ture de l\u2019audit\",\"\u00c9valuation des plans d\u2019actions\",\"Avantages de l\u2019audit initial\",\"Management d\u2019un programme d\u2019audit interne\",\"Comp\u00e9tence et \u00e9valuation des auditeurs\"]],\n        [\"Jour 5\",\"Examen de certification\",[\"Examen PECB Certified ISO 13485 Lead Auditor\"]]\n      ],\n      objectifs:[\n        \"Comprendre le fonctionnement d\u2019un SMQDM conforme \u00e0 ISO 13485\",\n        \"Expliquer la corr\u00e9lation entre ISO 13485 et les autres normes et cadres r\u00e9glementaires\",\n        \"Comprendre le r\u00f4le d\u2019un auditeur dans la planification, la direction et le suivi d\u2019un audit de syst\u00e8me de management\",\n        \"Diriger un audit et une \u00e9quipe d\u2019audit\",\n        \"Interpr\u00e9ter les exigences d\u2019ISO 13485 dans le contexte d\u2019un audit du SMQDM\",\n        \"Planifier un audit, r\u00e9diger les rapports et assurer le suivi conform\u00e9ment \u00e0 ISO 19011\"\n      ],\n      domaines:[\n        [\"Domaine 1\",\"Principes et concepts fondamentaux du SMQDM\"],\n        [\"Domaine 2\",\"Syst\u00e8me de management de la qualit\u00e9 des dispositifs m\u00e9dicaux\"],\n        [\"Domaine 3\",\"Principes et concepts fondamentaux de l\u2019audit\"],\n        [\"Domaine 4\",\"Pr\u00e9paration d\u2019un audit ISO 13485\"],\n        [\"Domaine 5\",\"R\u00e9alisation d\u2019un audit ISO 13485\"],\n        [\"Domaine 6\",\"Cl\u00f4ture d\u2019un audit ISO 13485\"],\n        [\"Domaine 7\",\"Gestion d\u2019un programme d\u2019audit ISO 13485\"]\n      ],\n      certIntro:\"Apr\u00e8s r\u00e9ussite de l\u2019examen, le participant peut demander une qualification PECB ISO 13485 Auditor selon son exp\u00e9rience professionnelle.\",\n      cert:[\n        [\"Provisional Auditor\",\"Aucune\",\"Aucune\",\"Signer le Code de d\u00e9ontologie PECB\"],\n        [\"Auditor\",\"2 ans dont 1 an en management de la qualit\u00e9 des dispositifs m\u00e9dicaux\",\"200 heures d\u2019audit\",\"Signer le Code de d\u00e9ontologie PECB\"],\n        [\"Lead Auditor\",\"5 ans dont 2 ans en management de la qualit\u00e9 des dispositifs m\u00e9dicaux\",\"300 heures d\u2019audit\",\"Signer le Code de d\u00e9ontologie PECB\"],\n        [\"Master\",\"10 ans dont 6 ans en management de la qualit\u00e9 des dispositifs m\u00e9dicaux\",\"500 heures d\u2019audit et 500 heures de projet\",\"Signer le Code de d\u00e9ontologie PECB\"]\n      ],\n      benefits:[\n        [\"Frais inclus\",\"Les frais de certification et d\u2019examen sont inclus.\"],\n        [\"Support complet\",\"Plus de 450 pages d\u2019informations et d\u2019exemples pratiques.\"],\n        [\"31 cr\u00e9dits DPC\",\"Un certificat de participation de 31 cr\u00e9dits DPC est d\u00e9livr\u00e9.\"],\n        [\"Rattrapage gratuit\",\"L\u2019examen peut \u00eatre repass\u00e9 gratuitement dans les 12 mois.\"]\n      ]\n    }\n  };\n\n  const page=document.querySelector(\".amco-iso13485\");\n  if(!page)return;\n\n  const levelButtons=page.querySelectorAll(\".iso-level-btn\");\n  const tabButtons=page.querySelectorAll(\".iso-tab-btn\");\n  let current=\"implementer\";\n\n  function render(level){\n    current=level;\n    const d=data[level];\n\n    levelButtons.forEach(b=>b.classList.toggle(\"active\",b.dataset.level===level));\n\n    page.querySelector(\"#iso-title\").textContent=d.title;\n    page.querySelector(\"#iso-description\").textContent=d.description;\n    page.querySelector(\"#iso-book-title\").textContent=d.title;\n    page.querySelector(\"#iso-book-duration\").textContent=d.duration;\n    page.querySelector(\"#iso-book-exam\").textContent=d.exam;\n    page.querySelector(\"#iso-book-credits\").textContent=d.credits;\n\n    page.querySelector(\"#iso-info-grid\").innerHTML=d.info.map(x=>`<div class=\"iso-info-box\"><strong>${x[0]}<\/strong><span>${x[1]}<\/span><\/div>`).join(\"\");\n    page.querySelector(\"#iso-audience\").innerHTML=d.audience.map(x=>`<div class=\"iso-aud-card\"><strong>${x}<\/strong><\/div>`).join(\"\");\n    page.querySelector(\"#iso-days\").innerHTML=d.days.map((x,i)=>`\n      <div class=\"iso-day ${i===0?\"open\":\"\"}\">\n        <div class=\"iso-day-head\">\n          <span class=\"iso-day-n\">${x[0]}<\/span>\n          <span class=\"iso-day-title\">${x[1]}<\/span>\n          <span>\u2304<\/span>\n        <\/div>\n        <div class=\"iso-day-body\"><ul>${x[2].map(y=>`<li>${y}<\/li>`).join(\"\")}<\/ul><\/div>\n      <\/div>`).join(\"\");\n    page.querySelector(\"#iso-objectifs\").innerHTML=d.objectifs.map(x=>`<div class=\"iso-check\"><i>\u2713<\/i><span>${x}<\/span><\/div>`).join(\"\");\n    page.querySelector(\"#iso-domaines\").innerHTML=d.domaines.map(x=>`<div class=\"iso-domain\"><b>${x[0]}<\/b><span>${x[1]}<\/span><\/div>`).join(\"\");\n    page.querySelector(\"#iso-cert-intro\").textContent=d.certIntro;\n    page.querySelector(\"#iso-cert-rows\").innerHTML=d.cert.map(x=>`<tr><td>${x[0]}<\/td><td>${x[1]}<\/td><td>${x[2]}<\/td><td>${x[3]}<\/td><\/tr>`).join(\"\");\n    page.querySelector(\"#iso-benefits\").innerHTML=d.benefits.map(x=>`<div class=\"iso-benefit\"><strong>${x[0]}<\/strong><span>${x[1]}<\/span><\/div>`).join(\"\");\n\n    page.querySelectorAll(\".iso-day-head\").forEach(head=>{\n      head.addEventListener(\"click\",()=>head.parentElement.classList.toggle(\"open\"));\n    });\n  }\n\n  levelButtons.forEach(btn=>btn.addEventListener(\"click\",()=>render(btn.dataset.level)));\n\n  tabButtons.forEach(btn=>{\n    btn.addEventListener(\"click\",()=>{\n      tabButtons.forEach(b=>b.classList.remove(\"active\"));\n      btn.classList.add(\"active\");\n      page.querySelectorAll(\".iso-panel\").forEach(p=>p.classList.remove(\"active\"));\n      page.querySelector(`[data-panel=\"${btn.dataset.tab}\"]`).classList.add(\"active\");\n    });\n  });\n\n  page.querySelectorAll('a[href^=\"#\"]').forEach(link=>{\n    link.addEventListener(\"click\",e=>{\n      const target=page.querySelector(link.getAttribute(\"href\"));\n      if(target){e.preventDefault();target.scrollIntoView({behavior:\"smooth\",block:\"start\"});}\n    });\n  });\n\n  const reveal=page.querySelectorAll(\".iso-reveal\");\n  if(\"IntersectionObserver\" in window){\n    const obs=new IntersectionObserver((entries,o)=>{\n      entries.forEach(entry=>{\n        if(entry.isIntersecting){entry.target.classList.add(\"iso-visible\");o.unobserve(entry.target);}\n      });\n    },{threshold:.1,rootMargin:\"0px 0px -35px 0px\"});\n    reveal.forEach((el,i)=>{el.style.transitionDelay=((i%4)*70)+\"ms\";obs.observe(el);});\n  }else{reveal.forEach(el=>el.classList.add(\"iso-visible\"));}\n\n  render(current);\n})();\n<\/script>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Parcours certifiant PECB ISO 13485Syst\u00e8me de management des qualit\u00e9 des dispositifs m\u00e9dicaux D\u00e9veloppez les comp\u00e9tences n\u00e9cessaires pour comprendre, mettre en \u0153uvre et auditer un Medical Devices Management System conforme \u00e0&hellip;<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-65","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ISO 13485 \u2014 SOMS - AM-CO Consulting &amp; Services<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/amcoconsultingservices.com\/?page_id=65\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 13485 \u2014 SOMS - AM-CO Consulting &amp; Services\" \/>\n<meta property=\"og:description\" content=\"Parcours certifiant PECB ISO 13485Syst\u00e8me de management des qualit\u00e9 des dispositifs m\u00e9dicaux D\u00e9veloppez les comp\u00e9tences n\u00e9cessaires pour comprendre, mettre en \u0153uvre et auditer un Medical Devices Management System conforme \u00e0&hellip;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/amcoconsultingservices.com\/?page_id=65\" \/>\n<meta property=\"og:site_name\" content=\"AM-CO Consulting &amp; Services\" \/>\n<meta property=\"article:modified_time\" content=\"2026-07-26T14:40:31+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data1\" content=\"6 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/amcoconsultingservices.com\\\/?page_id=65\",\"url\":\"https:\\\/\\\/amcoconsultingservices.com\\\/?page_id=65\",\"name\":\"ISO 13485 \u2014 SOMS - AM-CO Consulting &amp; Services\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/amcoconsultingservices.com\\\/#website\"},\"datePublished\":\"2026-07-26T14:39:19+00:00\",\"dateModified\":\"2026-07-26T14:40:31+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/amcoconsultingservices.com\\\/?page_id=65#breadcrumb\"},\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/amcoconsultingservices.com\\\/?page_id=65\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/amcoconsultingservices.com\\\/?page_id=65#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Accueil\",\"item\":\"https:\\\/\\\/amcoconsultingservices.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"ISO 13485 \u2014 SOMS\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/amcoconsultingservices.com\\\/#website\",\"url\":\"https:\\\/\\\/amcoconsultingservices.com\\\/\",\"name\":\"AM-CO Consulting &amp; Services\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/amcoconsultingservices.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"fr-FR\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"ISO 13485 \u2014 SOMS - AM-CO Consulting &amp; Services","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/amcoconsultingservices.com\/?page_id=65","og_locale":"fr_FR","og_type":"article","og_title":"ISO 13485 \u2014 SOMS - AM-CO Consulting &amp; Services","og_description":"Parcours certifiant PECB ISO 13485Syst\u00e8me de management des qualit\u00e9 des dispositifs m\u00e9dicaux D\u00e9veloppez les comp\u00e9tences n\u00e9cessaires pour comprendre, mettre en \u0153uvre et auditer un Medical Devices Management System conforme \u00e0&hellip;","og_url":"https:\/\/amcoconsultingservices.com\/?page_id=65","og_site_name":"AM-CO Consulting &amp; Services","article_modified_time":"2026-07-26T14:40:31+00:00","twitter_card":"summary_large_image","twitter_misc":{"Dur\u00e9e de lecture estim\u00e9e":"6 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/amcoconsultingservices.com\/?page_id=65","url":"https:\/\/amcoconsultingservices.com\/?page_id=65","name":"ISO 13485 \u2014 SOMS - AM-CO Consulting &amp; Services","isPartOf":{"@id":"https:\/\/amcoconsultingservices.com\/#website"},"datePublished":"2026-07-26T14:39:19+00:00","dateModified":"2026-07-26T14:40:31+00:00","breadcrumb":{"@id":"https:\/\/amcoconsultingservices.com\/?page_id=65#breadcrumb"},"inLanguage":"fr-FR","potentialAction":[{"@type":"ReadAction","target":["https:\/\/amcoconsultingservices.com\/?page_id=65"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/amcoconsultingservices.com\/?page_id=65#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Accueil","item":"https:\/\/amcoconsultingservices.com\/"},{"@type":"ListItem","position":2,"name":"ISO 13485 \u2014 SOMS"}]},{"@type":"WebSite","@id":"https:\/\/amcoconsultingservices.com\/#website","url":"https:\/\/amcoconsultingservices.com\/","name":"AM-CO Consulting &amp; Services","description":"","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/amcoconsultingservices.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"fr-FR"}]}},"_links":{"self":[{"href":"https:\/\/amcoconsultingservices.com\/index.php?rest_route=\/wp\/v2\/pages\/65","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/amcoconsultingservices.com\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/amcoconsultingservices.com\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/amcoconsultingservices.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/amcoconsultingservices.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=65"}],"version-history":[{"count":4,"href":"https:\/\/amcoconsultingservices.com\/index.php?rest_route=\/wp\/v2\/pages\/65\/revisions"}],"predecessor-version":[{"id":69,"href":"https:\/\/amcoconsultingservices.com\/index.php?rest_route=\/wp\/v2\/pages\/65\/revisions\/69"}],"wp:attachment":[{"href":"https:\/\/amcoconsultingservices.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=65"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}