{"id":12910,"date":"2026-03-12T15:03:57","date_gmt":"2026-03-12T14:03:57","guid":{"rendered":"https:\/\/www.entecerma.it\/significant-achievement-ecm-expands-iso-13485-accreditation-scope-to-include-sterilization\/"},"modified":"2026-03-12T15:14:18","modified_gmt":"2026-03-12T14:14:18","slug":"significant-achievement-ecm-expands-iso-13485-accreditation-scope-to-include-sterilization","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/significant-achievement-ecm-expands-iso-13485-accreditation-scope-to-include-sterilization\/","title":{"rendered":"Significant Achievement: ECM Expands ISO 13485 Accreditation Scope to Include Sterilization"},"content":{"rendered":"\n<p>We are proud to announce that ECM has officially obtained the extension of its ISO 17021 accreditation for the Quality Management Systems certification scheme according to the EN ISO 13485:2016 \/ UNI CEI EN ISO 13485:2021 standard, specifically for the medical device sector.<\/p>\n\n<p>This extension represents a fundamental step forward in our mission to provide high-profile certification services, ensuring manufacturers a solid and competent partner for the compliance of their processes.<\/p>\n\n<div style=\"height:28px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"wp-block-heading has-vivid-cyan-blue-color has-text-color has-link-color wp-elements-e817a9c307a562772d49e57cac5cc5a8\"><strong>NEW ACCREDITED TECHNICAL AREAS<\/strong><\/h3>\n\n<p>The extension specifically covers sterilization activities, a critical process for medical device safety. As of today, ECM is accredited to certify the following technical areas:<\/p>\n\n<ul class=\"wp-block-list\">\n<li><strong>1.5.A.<\/strong> Ethylene Oxide Gas Sterilization (EOG);<\/li>\n<\/ul>\n\n<ul class=\"wp-block-list\">\n<li><strong>1.5.B.<\/strong> Moist heat sterilization;<\/li>\n<\/ul>\n\n<ul class=\"wp-block-list\">\n<li><strong>1.5.D<\/strong>. Radiation sterilization (e.g., gamma rays, electron beam).<\/li>\n<\/ul>\n\n<div style=\"height:28px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"wp-block-heading has-vivid-cyan-blue-color has-text-color has-link-color wp-elements-a3b1cd84826f3c9ae43ce9022e91f954\"><strong>WHY CHOOSING ECM CERTIFICATION?<\/strong><\/h3>\n\n<p>An accredited ISO 13485 certificate is not just a matter of compliance, but a hallmark of <strong>reliability<\/strong> and <strong>safety<\/strong> in the global market. Thanks to this extension, ECM confirms its position as a leading body for companies seeking a serious, authoritative certification path focused on technical excellence within the medical sector.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>We are proud to announce that ECM has officially obtained the extension of its ISO&#8230;<\/p>\n","protected":false},"author":2,"featured_media":12903,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-12910","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Significant Achievement: ECM Expands ISO 13485 Accreditation Scope to Include Sterilization - Ente Certificazione Macchine<\/title>\n<meta name=\"description\" content=\"We are proud to announce that ECM has officially obtained the extension of its ISO 17021 accreditation for the Quality Management Systems certification scheme according to the EN ISO 13485:2016 \/ UNI CEI EN ISO 13485:2021 standard, specifically for the medical device sector.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.entecerma.it\/en\/significant-achievement-ecm-expands-iso-13485-accreditation-scope-to-include-sterilization\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Significant Achievement: ECM Expands ISO 13485 Accreditation Scope to Include Sterilization - 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