{"id":5392,"date":"2026-10-07T03:10:07","date_gmt":"2026-10-07T03:10:07","guid":{"rendered":"https:\/\/miconos.co.id\/?p=5392"},"modified":"2026-10-07T03:48:04","modified_gmt":"2026-10-07T03:48:04","slug":"audit-surveillance-iso-13485-pt-miconos","status":"publish","type":"post","link":"https:\/\/miconos.co.id\/en\/audit-surveillance-iso-13485-pt-miconos\/","title":{"rendered":"Uncompromising Quality: PT Miconos Retains ISO 13485:2016 Certification"},"content":{"rendered":"<figure id=\"attachment_5394\" aria-describedby=\"caption-attachment-5394\" style=\"width: 1024px\" class=\"wp-caption aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" class=\"wp-image-5394 size-large\" src=\"https:\/\/miconos.co.id\/wp-content\/uploads\/2026\/10\/WhatsApp-Image-2026-10-02-at-13.32.23-1024x682.jpeg\" alt=\"\" width=\"1024\" height=\"682\" srcset=\"https:\/\/miconos.co.id\/wp-content\/uploads\/2026\/10\/WhatsApp-Image-2026-10-02-at-13.32.23-1024x682.jpeg 1024w, https:\/\/miconos.co.id\/wp-content\/uploads\/2026\/10\/WhatsApp-Image-2026-10-02-at-13.32.23-300x200.jpeg 300w, https:\/\/miconos.co.id\/wp-content\/uploads\/2026\/10\/WhatsApp-Image-2026-10-02-at-13.32.23-768x512.jpeg 768w, https:\/\/miconos.co.id\/wp-content\/uploads\/2026\/10\/WhatsApp-Image-2026-10-02-at-13.32.23-18x12.jpeg 18w, https:\/\/miconos.co.id\/wp-content\/uploads\/2026\/10\/WhatsApp-Image-2026-10-02-at-13.32.23.jpeg 1280w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><figcaption id=\"caption-attachment-5394\" class=\"wp-caption-text\">PT Miconos team taking a group photo with the auditor from PT T\u00dcV NORD Indonesia in front of the ISO 13485:2016 Surveillance Audit banner. Source: PT Miconos<\/figcaption><\/figure>\n<p>&nbsp;<\/p>\n<p data-path-to-node=\"5\">Maintaining consistent manufacturing quality is not merely a regulatory obligation. It represents a long-term commitment by PT Miconos to deliver safe and precise medical devices for the healthcare industry. Therefore, PT Miconos completed its ISO 13485:2016 Surveillance Audit on September 28\u201329, 2026, at its internal facility.<\/p>\n<h5 data-path-to-node=\"6\">Quality Management System Evaluation with T\u00dcV NORD<\/h5>\n<p data-path-to-node=\"7\">The evaluation agenda was directly reviewed by Mr. Usman Suwandi. He served as the official auditor from the certification body PT. T\u00dcV NORD Indonesia. Furthermore, the audit aimed to evaluate the effectiveness of the Quality Management System for medical devices. This procedure ensures that all operational processes at PT Miconos align with global regulations.<\/p>\n<h5 data-path-to-node=\"8\">Comprehensive Cross-Departmental Review<\/h5>\n<p data-path-to-node=\"9\">The inspection process was conducted by verifying Standard Operating Procedure (SOP) documents. Additionally, the auditor reviewed technical implementations on the field directly. This thorough evaluation involved all key departments across the company.<\/p>\n<p data-path-to-node=\"10\">The Management Representative division oversaw the quality system governance. Meanwhile, the Research and Development division was audited for product design safety. On the other hand, the Purchasing division was evaluated on raw material quality assurance. Consequently, the Sales, Quality Control, and Production divisions were also assessed to ensure manufacturing consistency and after-sales service quality.<\/p>\n<h5 data-path-to-node=\"11\">Quality Assurance for Healthcare Facilities<\/h5>\n<p data-path-to-node=\"12\">Through the success of this evaluation, PT Miconos strengthens its consistent quality management system. Thus, quality assurance remains the main foundation for the company. This commitment provides safety and confidence for partners and hospitals utilizing PT Miconos medical equipment.<\/p>","protected":false},"excerpt":{"rendered":"<p>&nbsp; Menjaga konsistensi kualitas manufaktur bukan sekadar kewajiban regulasi. Hal ini merupakan komitmen jangka panjang PT Miconos dalam menghadirkan perangkat [&hellip;]<\/p>","protected":false},"author":1,"featured_media":5394,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"_joinchat":[],"footnotes":""},"categories":[4],"tags":[30,34,38],"class_list":["post-5392","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-berita","tag-mikroskop","tag-optilab","tag-pt-miconos"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Menjaga Mutu Tanpa Kompromi: Audit ISO 13485 PT Miconos<\/title>\n<meta name=\"description\" content=\"PT Miconos sukses merampungkan Audit Surveillance ISO 13485:2016 bersama PT T\u00dcV NORD Indonesia guna menjaga konsistensi mutu alat kesehatan.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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href=\"https:\/\/miconos.co.id\/en\/category\/berita\/\" rel=\"category tag\">berita<\/a>","rttpg_excerpt":"&nbsp; Menjaga konsistensi kualitas manufaktur bukan sekadar kewajiban regulasi. Hal ini merupakan komitmen jangka panjang PT Miconos dalam menghadirkan perangkat [&hellip;]","_links":{"self":[{"href":"https:\/\/miconos.co.id\/en\/wp-json\/wp\/v2\/posts\/5392","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/miconos.co.id\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/miconos.co.id\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/miconos.co.id\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/miconos.co.id\/en\/wp-json\/wp\/v2\/comments?post=5392"}],"version-history":[{"count":2,"href":"https:\/\/miconos.co.id\/en\/wp-json\/wp\/v2\/posts\/5392\/revisions"}],"predecessor-version":[{"id":5401,"href":"https:\/\/miconos.co.id\/en\/wp-json\/wp\/v2\/posts\/5392\/revisions\/5401"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/miconos.co.id\/en\/wp-json\/wp\/v2\/media\/5394"}],"wp:attachment":[{"href":"https:\/\/miconos.co.id\/en\/wp-json\/wp\/v2\/media?parent=5392"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/miconos.co.id\/en\/wp-json\/wp\/v2\/categories?post=5392"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/miconos.co.id\/en\/wp-json\/wp\/v2\/tags?post=5392"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}