{"id":13753,"date":"2024-07-26T13:14:37","date_gmt":"2024-07-26T11:14:37","guid":{"rendered":"https:\/\/blog.biomed.de\/independent-quality-control-rili-baek-ivdr-iso-15189\/"},"modified":"2024-07-31T10:50:38","modified_gmt":"2024-07-31T08:50:38","slug":"independent-quality-control-rili-baek-ivdr-iso-15189","status":"publish","type":"post","link":"https:\/\/blog.biomed.de\/en\/independent-quality-control-rili-baek-ivdr-iso-15189\/","title":{"rendered":"Independent quality control &#8211; Rili-B\u00c4K, IVDR, ISO 15189"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1331.2px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p>\u201cIt all began with the calibration law,\u201d wrote Dr. Gabriele Egert in her article \u201cIndependent quality control \u2013 Rili-B\u00c4K, IVDR, ISO 15189\u201d in issue 2\/2021 of the journal Trillium Diagnostik.<\/p>\n<p><img decoding=\"async\" src=\"data:image\/png;base64,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\" alt=\"pastedGraphic.png\" \/>In the calibration law in the \u201cfield of medicine, i.e. also in the medical laboratory\u201d, the control criteria for the correct performance of analyses and measurements have been specified since July 1, 1970. In 1971, the practice regulation was defined by the German Medical Association in a guideline, the so-called Rili-B\u00c4K. In 2001, this migrated from the Verification Act to the Medical Devices Act and the Medical Devices Operator Ordinance.<\/p>\n<p>Requirements for the competence of medical laboratories were also regulated globally. In 1999, for example with the ISO\/IEC 17025 and ISO 15189, which is based on it. Or the European IVDR Regulation, which came into force in 2017 and regulates the placing on the market of <i>in vitro<\/i> diagnostic medical devices.<\/p>\n<p>The primary goal of all these regulations is to ensure the quality of measurements for the benefit of the patient. There are internal error limits and weaknesses to be considered. These can be avoided, for example, through the use of independent control material or through external quality assurance, such as participation in interlaboratory tests.<\/p>\n<p>By the way, we, <a href=\"https:\/\/www.trillium.de\/zeitschriften\/trillium-diagnostik-ausgaben-2021\/innovation-und-markt\/biomed-labordiagnostik-gmbh.html\">BIOMED Labordiagnostik GmbH,<\/a> are named as an independent supplier of multiparameter controls for serum, urine and cerebrospinal fluid in Trillium-Diagnostik.<\/p>\n<p><a href=\"https:\/\/www.trillium.de\/zeitschriften\/trillium-diagnostik-ausgaben-2021\/td-heft-2\/2021\/unabhaengige-qualitaetskontrolle.html\">Here<\/a> you can find the whole article published in German.<\/p>\n<\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;margin-top:30px;margin-bottom:30px;width:100%;\"><\/div><div ><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" target=\"_self\" href=\"https:\/\/blog.biomed.de\/en\/news\/\"><span class=\"fusion-button-text\">Blog overview<\/span><\/a><\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":34415,"featured_media":13751,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1677,1634,1730,1728,208,1729],"tags":[1641,1732,1678,1640,1731],"class_list":["post-13753","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-clinical-chemistry","category-independent-control-material","category-iso-13485-en","category-ivdr-en","category-latest-publications-en","category-rili-baek-en","tag-independent-quality-control","tag-iso-13584-en","tag-ivdr-en","tag-laboratory-diagnostics","tag-rili-baek-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Independent quality control - Rili-B\u00c4K, IVDR, ISO 15189<\/title>\n<meta name=\"description\" content=\"Independent quality control - Rili-B\u00c4K, IVDR, ISO 15189 require independent quality controls to improve the quality of treatment.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/blog.biomed.de\/unabhaengige-qualitaetskontrolle-rili-baek-ivdr-iso-15189\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Independent quality control - Rili-B\u00c4K, IVDR, ISO 15189\" \/>\n<meta property=\"og:description\" content=\"Independent quality control - Rili-B\u00c4K, IVDR, ISO 15189 require independent quality controls to improve the quality of treatment.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/blog.biomed.de\/unabhaengige-qualitaetskontrolle-rili-baek-ivdr-iso-15189\/\" \/>\n<meta property=\"og:site_name\" content=\"BIOMED Labordiagnostik GmbH\" \/>\n<meta property=\"article:published_time\" content=\"2024-07-26T11:14:37+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-07-31T08:50:38+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/blog.biomed.de\/wp-content\/uploads\/2024\/07\/Unabhaengige-Qualitaetskontrolle-Rili-BAeK-IVDR-ISO-15189.png\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Yvonne Blank\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Yvonne Blank\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/blog.biomed.de\/unabhaengige-qualitaetskontrolle-rili-baek-ivdr-iso-15189\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/blog.biomed.de\/unabhaengige-qualitaetskontrolle-rili-baek-ivdr-iso-15189\/\"},\"author\":{\"name\":\"Yvonne Blank\",\"@id\":\"https:\/\/blog.biomed.de\/#\/schema\/person\/db6966efcb9d4d89f3bf1c62dec1ce25\"},\"headline\":\"Independent quality control &#8211; 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