{"id":685,"date":"2022-10-11T16:55:18","date_gmt":"2022-10-11T14:55:18","guid":{"rendered":"https:\/\/bbmri.at\/?page_id=685"},"modified":"2025-11-10T11:03:22","modified_gmt":"2025-11-10T10:03:22","slug":"qualitaets-management","status":"publish","type":"page","link":"https:\/\/bbmri.at\/de\/fuer-forscherinnen\/qualitaets-management\/","title":{"rendered":"Qualit\u00e4tsmanagement"},"content":{"rendered":"    <div id=\"main_textblock_43629d4ca1963807ec0dec352335af5e\" class=\"content-row content-row-main_textno_margin\">\n        <div class=\"contentPart-main contentPart-main-main_text trans \">\n            <div class=\"contentPart_inner\">\n                \n                                    <h1 class=\"heading_main_txt HL_main\">\n                        Qualit\u00e4tsmanagement (QM) ist eine Schl\u00fcsselkompetenz bei BBMRI.at                     <\/h1>\n                \n                                    <h3 class=\"subheading_main_txt HL_sub\">\n                        Aktivit\u00e4ten von BBMRI.at und Partnern inkludieren:                     <\/h3>\n                \n                \n                            <\/div>\n\n\n\n            <div class=\"contentPart-sidebarDummy\"><\/div>\n        <\/div>\n\n    <\/div>\n\n\n    <div id=\"plain_textfieldblock_b6abd0febeea482e68ecdc31ec88cc53\" class=\"content-row content-row-plain_textfield\">\r\n        <div class=\"contentPart contentPart-main contentPart-main-plain_textfield trans  \">\r\n            <div class=\"contentPart_inner\">\r\n                                    <div class=\"plain_textfield text1624 \">\r\n                        <ul>\n<li>Entwicklung von ISO- und CEN Standards sowie Technischen Spezifikationen (TS) f\u00fcr die Proben-Pr\u00e4analytik<\/li>\n<li>Implementierung dieser Standards<\/li>\n<li>Information \u00fcber existierende und in Entwicklung befindliche Standards, die f\u00fcr das Biobanking relevant sind<\/li>\n<li>Beitrag zur Entwicklung eines BBMRI-Selbstbewertungstools f\u00fcr pr\u00e4analytische Prozesse<\/li>\n<li>Kostenloser Zugang zu den online <a href=\"https:\/\/www.bbmri-eric.eu\/services\/self-assessment-survey\/\">Selbstbewertungstools zur Pr\u00fcfung des aktuellen Stands pr\u00e4analytischer Prozesse<\/a><\/li>\n<li>Qualit\u00e4tsmanagement Cross-Audits in BBMRI.at Partnerbiobanken<\/li>\n<li>Qualit\u00e4tsmanagement Trainings<\/li>\n<li><a href=\"https:\/\/bbmri.at\/de\/news-2\/videos\/\">Videos<\/a> &amp; Vortr\u00e4ge \u00fcber die Relevanz von Pr\u00e4analytik und ISO\/CEN Standards in Bezug auf die In-vitro DiagnostikRegulierung (IVDR) und Reproduzierbarkeit\/Verl\u00e4sslichkeit von Forschungsergebnissen<\/li>\n<li><a href=\"https:\/\/bbmri.at\/de\/news-2\/publikationen\/\">Publikationen<\/a> \u00fcber die Bedeutung der Pr\u00e4analytik und der ISO- und CEN-Standards in Bezug auf IVDR und Reproduzierbarkeit\/Verl\u00e4sslichkeit von Forschungsergebnissen<\/li>\n<li><a href=\"https:\/\/bbmri.at\/wp-content\/uploads\/2023\/10\/Information_Relevanz-von-ISO-Standards_202111.pdf\" target=\"_blank\" rel=\"noopener\">Informationen<\/a> dar\u00fcber, warum Probenqualit\u00e4t und entsprechenden Standards f\u00fcr Forschung und Entwicklung von Bedeutung sind (auf englisch)<\/li>\n<li><a href=\"https:\/\/zenodo.org\/records\/8398685\" target=\"_blank\" rel=\"noopener\">Umfragetemplate<\/a> f\u00fcr Kundenzufriedenheit von Biobanken<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p style=\"font-weight: 400\">Mehrere Partner von BBMRI.at verf\u00fcgen \u00fcber Qualit\u00e4tsmanagementsysteme und sind ISO-zertifiziert. Alle Partnerbiobanken von BBMRI.at haben sich verpflichtet, biologische Proben von Patient:innen und Forschungsstudienteilnehmer:innen gem\u00e4\u00df dem aktuellen Stand der Technik zu behandeln, d.h. gem\u00e4\u00df CEN- und ISO-Standards f\u00fcr pr\u00e4analytische Prozesse.<\/p>\n                    <\/div>\r\n                            <\/div>\r\n            <div class=\"contentPart-sidebarDummy\"><\/div>\r\n\r\n        <\/div>\r\n    <\/div>\r\n\n\n    <div id=\"single_headingblock_c3b26cd13a26be7857b768e8b8c56f66\" class=\"content-row content-row-single_heading\">\r\n        <div class=\"contentPart-main contentPart-main-single_heading trans \">\r\n            <div class=\"contentPart_inner\">\r\n                                    <div class=\"single_heading HL_main \">\r\n                        Neueste ISO- und CEN-Standards, die f\u00fcr Biobanken und Forscher relevant sind                    <\/div>\r\n                            <\/div>\r\n\r\n            <div class=\"contentPart-sidebarDummy\"><\/div>\r\n        <\/div>\r\n    <\/div>\r\n\n\n    <div id=\"plain_textfieldblock_9c9c6b44b719a89b271e587c7f09df69\" class=\"content-row content-row-plain_textfield\">\r\n        <div class=\"contentPart contentPart-main contentPart-main-plain_textfield trans  \">\r\n            <div class=\"contentPart_inner\">\r\n                                    <div class=\"plain_textfield text1624 \">\r\n                        <p><strong>Standard Reihe \u00a0&#8222;Molecular in vitro diagnostics \u2013 specifications for pre-examination processes&#8220;<\/strong><\/p>\n<p>Das Europ\u00e4ische Komitee f\u00fcr Normung (CEN) und die Internationale Organisation f\u00fcr Normung (ISO) haben Standards f\u00fcr die Pr\u00e4analytik von Bioproben ver\u00f6ffentlicht, die f\u00fcr molekulare Analysen vorgesehen sind.\u00a0 Vertreter:innen von BBMRI.at haben diese Standards unter anderem im EU Projekt <a href=\"http:\/\/www.spidia.eu\">SPIDIA4P<\/a> mitentwickelt. Die Standards beschreiben Anforderungen an die pr\u00e4analytische Phase und gelten als State-of-the-Art f\u00fcr pr\u00e4analytische Arbeitsabl\u00e4ufe.<\/p>\n<p>Diese Standards k\u00f6nnen bei Normeninstituten wie dem <a href=\"https:\/\/www.austrian-standards.at\/en\" target=\"_blank\" rel=\"noopener\">Austrian Standards Insitute (ASI)<\/a> erworben werden.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Qualit\u00e4tsmanagement Standards\u00a0<\/strong><\/p>\n                    <\/div>\r\n                            <\/div>\r\n            <div class=\"contentPart-sidebarDummy\"><\/div>\r\n\r\n        <\/div>\r\n    <\/div>\r\n\n\n    <div id=\"two_col_textfieldblock_481ca68021560e8dffd347d46a93d3d8\" class=\"content-row content-row-two_col_textfield\">\r\n        <div class=\"contentPart-main contentPart-main-two_col_textfield trans \">\r\n            <div class=\"contentPart_inner\">\r\n                <div class=\"two_col_textfieldBox flex\">\r\n                                            <div class=\"two_col_textfield textfield_left text1624 \">\r\n                            <ul>\n<li><span style=\"color: #ff6600\"><a style=\"color: #ff6600\" href=\"https:\/\/shop.austrian-standards.at\/action\/en\/public\/details\/685069\/OEVE_OENORM_EN_ISO_20387_2020_11_01\" target=\"_blank\" rel=\"noopener\">EN ISO 20387:2018<\/a>\u00a0<\/span>Biotechnologie &#8211; Biobanking &#8211; Allgemeine Anforderungen an das Biobanking (Ausgabe 2020-11-01)<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li><span style=\"color: #ff6600\"><a style=\"color: #ff6600\" href=\"https:\/\/shop.austrian-standards.at\/action\/en\/public\/details\/639886\/ISO_20387_2018_2018_08_03\" target=\"_blank\" rel=\"noopener\">EN ISO 20387:2018<\/a><\/span> Biotechnology &#8212; Biobanking &#8212; General requirements for biobanking (first edition 2018-08)<\/li>\n<\/ul>\n                        <\/div>\r\n                                                                <div class=\"two_col_textfield textfield_right text1624 \">\r\n                            <ul>\n<li><span style=\"color: #ff6600\"><a style=\"color: #ff6600\" href=\"https:\/\/www.austrian-standards.at\/de\/shop\/onorm-en-iso-15189-2024-08-01~p3713002\" target=\"_blank\" rel=\"noopener\">EN ISO 15189:2022<\/a><\/span> Medizinische Laboratorien &#8211; Anforderungen an die Qualit\u00e4t und Kompetenz (konsolidierte Fassung 2024-08-01)<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li><span style=\"color: #ff6600\"><a style=\"color: #ff6600\" href=\"https:\/\/www.austrian-standards.at\/de\/shop\/onorm-en-iso-15189-2024-08-01~p3713002\" target=\"_blank\" rel=\"noopener\">EN ISO 15189:2022<\/a><\/span> Medical laboratories &#8211; Requirements for quality and competence (consolidated version 2024-0801)<\/li>\n<\/ul>\n                        <\/div>\r\n                                    <\/div>\r\n            <\/div>\r\n\r\n            <div class=\"contentPart-sidebarDummy\"><\/div>\r\n\r\n        <\/div>\r\n    <\/div>\r\n\n\n    <div id=\"single_bigImgblock_26b50a0d6899e34c104485d75d28911a\" class=\"content-row content-row-single_bigImg\">\r\n        <div class=\"contentPart-main contentPart-main-single_bigImg trans \">\r\n            <div class=\"contentPart_inner\">\r\n                <div class=\"single_bigImg_inner\">\r\n                                        <a  class=\"img_link\" >\r\n                                                                    <img decoding=\"async\" src=\"https:\/\/bbmri.at\/wp-content\/uploads\/2025\/04\/Prean-ther-QM-standards-per-March-2025_BBMRI.at_.png\" alt=\"\" class=\"single_bigImg\">\r\n                                                    <span class=\"img-capt\"><\/span>\r\n                                                                <\/a>\r\n                <\/div>\r\n            <\/div>\r\n            <div class=\"contentPart-sidebarDummy\"><\/div>\r\n\r\n        <\/div>\r\n    <\/div>\r\n\n\n    <div id=\"single_headingblock_b2db9da4f559a59f1513454869ba76f2\" class=\"content-row content-row-single_heading\">\r\n        <div class=\"contentPart-main contentPart-main-single_heading trans \">\r\n            <div class=\"contentPart_inner\">\r\n                                    <div class=\"single_heading HL_main \">\r\n                        Relevanz von Probenqualit\u00e4t und Qualit\u00e4tsstandards f\u00fcr die Forschung                    <\/div>\r\n                            <\/div>\r\n\r\n            <div class=\"contentPart-sidebarDummy\"><\/div>\r\n        <\/div>\r\n    <\/div>\r\n\n\n    <div id=\"plain_textfieldblock_00a5e06fb07200c7aee9fe64e8ca529a\" class=\"content-row content-row-plain_textfield\">\r\n        <div class=\"contentPart contentPart-main contentPart-main-plain_textfield trans  \">\r\n            <div class=\"contentPart_inner\">\r\n                                    <div class=\"plain_textfield text1624 \">\r\n                        <p><strong>ISO und CEN Standards gelten als State-of-the-art and Good Scientific Practice f\u00fcr die Grundlagen- und transnationale Forschung\u00a0<\/strong><\/p>\n<p>Besonders die pr\u00e4analytische Phase ist eine \u00e4u\u00dferst kritische Phase im Analyseworkflow. Fehler k\u00f6nnen leicht in allen pr\u00e4analytischen Schritten passieren, wie beispielsweise bei der Beschriftung, der Probenentnahme, dem Transport, der Verarbeitung, der Lagerung, der Isolation von DNA\/RNA usw. Pr\u00e4analytische Fehler haben sich als eine der Hauptursachen herausgestellt, warum vielversprechende Ergebnisse in der Biomarker-Forschung bei der Validierung scheitern, da Daten in gro\u00dfem Ma\u00dfstab nicht reproduzierbar sind. Auch in der Diagnostik k\u00f6nnen pr\u00e4analytische Variablen zu unzuverl\u00e4ssigen oder falschen Testergebnissen f\u00fchren.<\/p>\n<p>Daher sind die pr\u00e4analytische Qualit\u00e4t von Proben und das Vorhandensein von (Meta)daten \u00fcber diese Phase &#8211; eine Voraussetzung f\u00fcr zuverl\u00e4ssige und reproduzierbare Analyseergebnisse &#8211; von gro\u00dfer Bedeutung.<\/p>\n<p>&nbsp;<\/p>\n                    <\/div>\r\n                            <\/div>\r\n            <div class=\"contentPart-sidebarDummy\"><\/div>\r\n\r\n        <\/div>\r\n    <\/div>\r\n\n\n    <div id=\"videos_displayblock_0c25cbb450d59d441ff5c21d49589ba5\" class=\"content-row content-row-videos_display\">\n        <div class=\"contentPart-main contentPart-main-videos_display trans  \">\n            <div class=\"contentPart_inner\">\n                <div class=\"news_displayBox flex\">\n                                                            <a href=\"https:\/\/www.youtube.com\/watch?v=pvfQNiZZhdQ\" class=\"news_display_article_link\" target=\"_blank\">\n                            <div class=\"news_display_inner\">\n                                <div class=\"part_img_news_display\">\n                                    <div class=\"imgBox_news_display\">\n\n                                                                                <img decoding=\"async\" src=\"https:\/\/bbmri.at\/wp-content\/uploads\/2023\/10\/SPIDIA4P-Lecture-320x180.jpg\" alt=\"\" class=\"img_video_img\">\n\n                                    <\/div>\n                                <\/div>\n\n                                <div class=\"part_info_news_display\">\n\n                                    <div class=\"part_title text1624\">\n                                        Verl\u00e4sslichkeit der Diagnostik mithilfe von Standards verbessern                                    <\/div>\n\n                                    <div class=\"part_excerpt text1624\">\n                                        Gespr\u00e4ch mit SPIDIA4P-Koordinator Uwe Oelmueller                                    <\/div>\n\n                                <\/div>\n                            <\/div>\n                        <\/a>\n                                            <a href=\"https:\/\/www.youtube.com\/watch?v=gwIssbFHYAw\" class=\"news_display_article_link\" target=\"_blank\">\n                            <div class=\"news_display_inner\">\n                                <div class=\"part_img_news_display\">\n                                    <div class=\"imgBox_news_display\">\n\n                                                                                <img decoding=\"async\" src=\"https:\/\/bbmri.at\/wp-content\/uploads\/2024\/05\/Oelmueller-preanalytic-standards-320x177.jpg\" alt=\"\" class=\"img_video_img\">\n\n                                    <\/div>\n                                <\/div>\n\n                                <div class=\"part_info_news_display\">\n\n                                    <div class=\"part_title text1624\">\n                                        Bedeutung von pr\u00e4analytischen ISO- und CEN-Standards f\u00fcr IVD-Hersteller                                    <\/div>\n\n                                    <div class=\"part_excerpt text1624\">\n                                        Pr\u00e4sentation von Uwe Oelmueller                                    <\/div>\n\n                                <\/div>\n                            <\/div>\n                        <\/a>\n                                            <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC9104691\/\" class=\"news_display_article_link\" target=\"_blank\">\n                            <div class=\"news_display_inner\">\n                                <div class=\"part_img_news_display\">\n                                    <div class=\"imgBox_news_display\">\n\n                                                                                <img decoding=\"async\" src=\"https:\/\/bbmri.at\/wp-content\/uploads\/2023\/11\/N1A2556-320x480.jpg\" alt=\"\" class=\"img_video_img\">\n\n                                    <\/div>\n                                <\/div>\n\n                                <div class=\"part_info_news_display\">\n\n                                    <div class=\"part_title text1624\">\n                                        The Pre-Analytical CEN\/TS Standard for Microbiome Diagnostics\u2014How Can Research and Development Benefit?                                    <\/div>\n\n                                    <div class=\"part_excerpt text1624\">\n                                        Publikation mitverfasst von BBMRI.at-Partnern (2022)                                    <\/div>\n\n                                <\/div>\n                            <\/div>\n                        <\/a>\n                                                    <\/div>\n                <div class=\"contentPart-sidebarDummy\"><\/div>\n            <\/div>\n        <\/div>\n    <\/div>\n\n\n    <div id=\"plain_textfieldblock_75a15646091f2810802f5e8f6c623bfc\" class=\"content-row content-row-plain_textfield\">\r\n        <div class=\"contentPart contentPart-main contentPart-main-plain_textfield trans  \">\r\n            <div class=\"contentPart_inner\">\r\n                                    <div class=\"plain_textfield text1624 \">\r\n                        <p><strong>ISO und CEN Standards<\/strong><\/p>\n<p>Das Europ\u00e4ische Komitee f\u00fcr Normung (CEN) und die Internationale Normungsorganisation (ISO) haben sich dieses Problems angenommen und Standards f\u00fcr die Pr\u00e4analyse von Bioproben, die f\u00fcr die molekulare Analyse vorgesehen sind, ver\u00f6ffentlicht. Diese Standards beschreiben Anforderungen und gelten als State-of-the-Art f\u00fcr pr\u00e4analytische Arbeitsabl\u00e4ufe.<\/p>\n                    <\/div>\r\n                            <\/div>\r\n            <div class=\"contentPart-sidebarDummy\"><\/div>\r\n\r\n        <\/div>\r\n    <\/div>\r\n\n\n    <div id=\"links_downloadsblock_51b900e411482e7309451d3a333e0559\" class=\"content-row content-row-links_downloads  \">\r\n        <div class=\"contentPart-main contentPart-main-links_downloads trans \">\r\n            <div class=\"contentPart_inner contentPart_inner-links_downloads  flex_col\">\r\n                                    <div class=\"linkBox column\">\r\n                                                                                    <div class=\"links_inner\">\r\n                                    <div class=\"btnBox\">\r\n                                        <a href=\"https:\/\/www.youtube.com\/watch?v=XMjQY2QzZ_U&#038;list=PLdF-R_TmJXfgqxLlcUfEml45_Ph_55ECe\" target=\"_self\" class=\"btnBox_inner_link btnBox_links_inner_left flex\">\r\n                                            <span class=\"main_btn_icon main_btn_icon_links_downloads\"><\/span>\r\n                                            <span class=\"main_btn_icon_hover main_btn_icon_hover_downloads\"><\/span>\r\n                                            <span class=\"main_btn_font btnBox_inner\">Erfahren Sie, warum Standards generell wichtig sind<\/span>\r\n                                        <\/a>\r\n                                    <\/div>\r\n                                <\/div>\r\n                                                                        <\/div>\r\n                \r\n\r\n\r\n                            <\/div>\r\n\r\n            <div class=\"contentPart-sidebarDummy\"><\/div>\r\n\r\n        <\/div>\r\n    <\/div>\r\n\n\n    <div id=\"single_headingblock_309ac2de69793203602b068ff1ffd136\" class=\"content-row content-row-single_heading\">\r\n        <div class=\"contentPart-main contentPart-main-single_heading trans \">\r\n            <div class=\"contentPart_inner\">\r\n                                    <div class=\"single_heading HL_main \">\r\n                        Bewerten Sie Ihre pr\u00e4analytischen Probenverarbeitungsprozesse                    <\/div>\r\n                            <\/div>\r\n\r\n            <div class=\"contentPart-sidebarDummy\"><\/div>\r\n        <\/div>\r\n    <\/div>\r\n\n\n    <div id=\"plain_textfieldblock_e405e5a8a5b501c24ff1d4d637be3f34\" class=\"content-row content-row-plain_textfield\">\r\n        <div class=\"contentPart contentPart-main contentPart-main-plain_textfield trans  \">\r\n            <div class=\"contentPart_inner\">\r\n                                    <div class=\"plain_textfield text1624 \">\r\n                        <p><strong>Erf\u00fcllt Ihr Labor die pr\u00e4analytischen Anforderungen der CEN\/TS- und ISO-Standards?\u00a0<\/strong><\/p>\n<p>Verwenden Sie die BBMRI-Selbsteinsch\u00e4tzungsumfragen, um dies herauszufinden?<\/p>\n<ul>\n<li>General Requirements for Biobanking; ISO 20387:2018<\/li>\n<li>Frozen tissue &#8211; Part 1: Isolated RNA; ISO 20184-1:2018<\/li>\n<li>Frozen tissue &#8211; Part 2: Isolated proteins; ISO 20184-2:2018<\/li>\n<li>FFPE tissue &#8211; Part 1: Isolated RNA; ISO 20166-1:2018<\/li>\n<li>FFPE tissue &#8211; Part 2: Isolated proteins; ISO 20166-2:2018<\/li>\n<li>FFPE tissue &#8211; Part 3: Isolated DNA; ISO 20166-3:2018<\/li>\n<li>Venous whole blood &#8211; Part 1: Isolated cellular RNA; ISO 20186-1:2019<\/li>\n<li>Venous whole blood &#8211; Part 2: Isolated genomic DNA; ISO 20186-2:2019<\/li>\n<li>Venous whole blood &#8211; Part 3: Isolated ccfDNA from plasma; ISO 20186-3:2019<\/li>\n<li>Metabolomics in urine; CEN\/TS 16945:2016<\/li>\n<\/ul>\n                    <\/div>\r\n                            <\/div>\r\n            <div class=\"contentPart-sidebarDummy\"><\/div>\r\n\r\n        <\/div>\r\n    <\/div>\r\n\n\n    <div id=\"links_downloadsblock_6da4031628023e3e5446a6e426825ad6\" class=\"content-row content-row-links_downloads  \">\r\n        <div class=\"contentPart-main contentPart-main-links_downloads trans \">\r\n            <div class=\"contentPart_inner contentPart_inner-links_downloads  flex_col\">\r\n                                    <div class=\"linkBox column\">\r\n                                                                                    <div class=\"links_inner\">\r\n                                    <div class=\"btnBox\">\r\n                                        <a href=\"https:\/\/www.bbmri-eric.eu\/services\/self-assessment-survey\/\" target=\"_self\" class=\"btnBox_inner_link btnBox_links_inner_left flex\">\r\n                                            <span class=\"main_btn_icon main_btn_icon_links_downloads\"><\/span>\r\n                                            <span class=\"main_btn_icon_hover main_btn_icon_hover_downloads\"><\/span>\r\n                                            <span class=\"main_btn_font btnBox_inner\">Bewerten Sie Ihre pr\u00e4analytischen Prozesse selbst<\/span>\r\n                                        <\/a>\r\n                                    <\/div>\r\n                                <\/div>\r\n                                                                        <\/div>\r\n                \r\n\r\n\r\n                            <\/div>\r\n\r\n            <div class=\"contentPart-sidebarDummy\"><\/div>\r\n\r\n        <\/div>\r\n    <\/div>\r\n\n\n    <div id=\"single_headingblock_40a1f7c086db7ff0eb6c9776750d03be\" class=\"content-row content-row-single_heading\">\r\n        <div class=\"contentPart-main contentPart-main-single_heading trans \">\r\n            <div class=\"contentPart_inner\">\r\n                                    <div class=\"single_heading HL_main \">\r\n                        Software Vorlage f\u00fcr Dokumentation von pr\u00e4analytischen Daten                     <\/div>\r\n                            <\/div>\r\n\r\n            <div class=\"contentPart-sidebarDummy\"><\/div>\r\n        <\/div>\r\n    <\/div>\r\n\n\n    <div id=\"plain_textfieldblock_1d479fe0b0e90b19fc04495f4b4682c5\" class=\"content-row content-row-plain_textfield\">\r\n        <div class=\"contentPart contentPart-main contentPart-main-plain_textfield trans  \">\r\n            <div class=\"contentPart_inner\">\r\n                                    <div class=\"plain_textfield text1624 \">\r\n                        <p><strong>Dokumentation von pr\u00e4analytischen Daten ist State-of-the-Art und Good Scientific Practice<\/strong><\/p>\n<p>Es gibt mehrere CEN\/TS- und ISO-Standards f\u00fcr Voruntersuchungsprozesse, die die Dokumentation von pr\u00e4analytischen Daten aus menschlichen Proben erfordern. Auch die Verordnung \u00fcber In-vitro-Diagnostika erw\u00e4hnt ausdr\u00fccklich die Pr\u00e4analytik und verlangt pr\u00e4analytische Daten in der technischen Dokumentation f\u00fcr In-vitro-Diagnostikger\u00e4te.<\/p>\n<p>Um Forscher bei ihren Bem\u00fchungen zur Optimierung ihrer pr\u00e4analytischen Arbeitsabl\u00e4ufe zu unterst\u00fctzen, hat BBMRI.at in Zusammenarbeit mit SPIDIA4P (H2020, F\u00f6rderkennzeichen 222916), der Biobank Graz und CyBiobank (H2020, F\u00f6rderkennzeichen 8571222) eine Softwarevorlage zur Dokumentation von pr\u00e4analytischen Daten entwickelt. Diese Vorlage basiert auf REDCap als IT-Rahmen und verwendet die ISO-Standards (ISO 20184-1:2018; ISO 20184-2:2018) als Quelle f\u00fcr pr\u00e4analytische Anforderungen.<\/p>\n<p><strong>Laden Sie die kostenlose Softwarevorlage f\u00fcr pr\u00e4analytisches gefrorenes Gewebe herunter<\/strong><\/p>\n<p>Die Software kann als Datei heruntergeladen werden und soll als Vorlage dienen, die von den Benutzern (die mit REDCap vertraut sind) an lokale oder individuelle Anforderungen angepasst werden kann. Wie die installierte Software und die Dateneingabemaske f\u00fcr gefrorenes Gewebe aussehen, kann <a href=\"https:\/\/redcap.medunigraz.at\/surveys\/?s=J4AA94CT7M\" target=\"_blank\" rel=\"noopener\">hier<\/a> eingesehen werden.<\/p>\n                    <\/div>\r\n                            <\/div>\r\n            <div class=\"contentPart-sidebarDummy\"><\/div>\r\n\r\n        <\/div>\r\n    <\/div>\r\n\n\n    <div id=\"links_downloadsblock_9fea5f4614757209a9e98b5f6cbf186b\" class=\"content-row content-row-links_downloads  \">\r\n        <div class=\"contentPart-main contentPart-main-links_downloads trans \">\r\n            <div class=\"contentPart_inner contentPart_inner-links_downloads extra_gap flex_col\">\r\n                \r\n\r\n\r\n                                    <div class=\"downloadsBox\">\r\n\r\n                        <div class=\"download_heading\">\r\n                                                    <\/div>\r\n\r\n                        \r\n                            <div class=\"download_btnBox\">\r\n                                <a href=\"https:\/\/bbmri.at\/documents\/10194\/68479\/D3.6_Appendix2_Ext_SAS_FrozenTissue_ISO20186-1%2B2_REDCapTool_v20210602.xml\/3edf3862-399c-4509-86e1-5bc8233f9ed4\" target=\"_blank\" class=\"btnBox_downloads_inner fl_center_vr fl_between\">\r\n                                    <span class=\"text_download\">Download hier<\/span>\r\n                                    <span class=\"download_btn_icon\"><\/span>\r\n                                <\/a>\r\n                            <\/div>\r\n\r\n                                            <\/div>\r\n                            <\/div>\r\n\r\n            <div class=\"contentPart-sidebarDummy\"><\/div>\r\n\r\n        <\/div>\r\n    <\/div>\r\n\n\n    <div id=\"links_downloadsblock_771799c27ea4bf0412d2930fa73f86db\" class=\"content-row content-row-links_downloads  \">\r\n        <div class=\"contentPart-main contentPart-main-links_downloads trans \">\r\n            <div class=\"contentPart_inner contentPart_inner-links_downloads  flex_col\">\r\n                                    <div class=\"linkBox column\">\r\n                                                                                    <div class=\"links_inner\">\r\n                                    <div class=\"btnBox\">\r\n                                        <a href=\"https:\/\/bbmri.at\/news\/courses\/\" target=\"_self\" class=\"btnBox_inner_link btnBox_links_inner_left flex\">\r\n                                            <span class=\"main_btn_icon main_btn_icon_links_downloads\"><\/span>\r\n                                            <span class=\"main_btn_icon_hover main_btn_icon_hover_downloads\"><\/span>\r\n                                            <span class=\"main_btn_font btnBox_inner\">Trainings zu Qualit\u00e4tsmanagement-Themen, die von Partnern von BBMRI.at angeboten werden.<\/span>\r\n                                        <\/a>\r\n                                    <\/div>\r\n                                <\/div>\r\n                                                                                                                <div class=\"links_inner\">\r\n                                    <div class=\"btnBox\">\r\n                                        <a href=\"https:\/\/brd.nci.nih.gov\/brd\/\" target=\"_self\" class=\"btnBox_inner_link btnBox_links_inner_left flex\">\r\n                                            <span class=\"main_btn_icon main_btn_icon_links_downloads\"><\/span>\r\n                                            <span class=\"main_btn_icon_hover main_btn_icon_hover_downloads\"><\/span>\r\n                                            <span class=\"main_btn_font btnBox_inner\">Neueste Publikationen zu Themen der Proben-Qualit\u00e4t<\/span>\r\n                                        <\/a>\r\n                                    <\/div>\r\n                                <\/div>\r\n                                                                        <\/div>\r\n                \r\n\r\n\r\n                            <\/div>\r\n\r\n            <div class=\"contentPart-sidebarDummy\"><\/div>\r\n\r\n        <\/div>\r\n    <\/div>\r\n\n\n    <div id=\"single_headingblock_3259c2fe04bd35a1775cf5a1f6bb2189\" class=\"content-row content-row-single_heading\">\r\n        <div class=\"contentPart-main contentPart-main-single_heading trans \">\r\n            <div class=\"contentPart_inner\">\r\n                                    <div class=\"single_heading HL_main \">\r\n                        Vorlage zur Umfrage f\u00fcr Benutzerzufriedenheit von BBMRI-ERIC                    <\/div>\r\n                            <\/div>\r\n\r\n            <div class=\"contentPart-sidebarDummy\"><\/div>\r\n        <\/div>\r\n    <\/div>\r\n\n\n    <div id=\"plain_textfieldblock_98a3e11ba30677f722f6ed5c07ec774e\" class=\"content-row content-row-plain_textfield\">\r\n        <div class=\"contentPart contentPart-main contentPart-main-plain_textfield trans  \">\r\n            <div class=\"contentPart_inner\">\r\n                                    <div class=\"plain_textfield text1624 \">\r\n                        <p><strong>Gemeinsam mit BMRI-ERIC Experten von BBMRI.at und vielen anderen BBMRI-ERIC-Nationalknoten wurde eine Vorlage f\u00fcr eine Benutzerzufriedenheitsumfrage f\u00fcr Biobanken entwickelt. Diese Umfragevorlage steht jetzt f\u00fcr Biobanken zur Verf\u00fcgung und kann \u00fcber die Open Science-Plattform Zenodo abgerufen werden<\/strong><\/p>\n<p>Die BBMRI-ERIC Vorlage f\u00fcr die Benutzerzufriedenheitsumfrage soll Biobanken dabei unterst\u00fctzen, ihre Dienstleistungen regelm\u00e4\u00dfig von ihren Nutzern bewerten zu lassen und Feedback hinsichtlich zuk\u00fcnftiger Leistungen sowie Vorschl\u00e4ge zur Verbesserung der Biobankprozesse zu sammeln. Auf diese Weise erf\u00fcllen sie die Anforderung, Feedback einzuholen, wie es beispielsweise in den ISO-Standards 20387:2018 und ISO 9001:2015 gefordert wird. Die Umfragevorlage, die auch von Vertreter*innen von BBMRI.at mitverfasst wurde (C. Stumptner, H. Haslacher), bildet die Grundlage f\u00fcr die Benutzerumfrage und muss von jeder Biobank individuell angepasst werden, bevor sie zur Bewertung der Benutzerzufriedenheit verwendet werden kann. Zur Unterst\u00fctzung dieses Prozesses enth\u00e4lt das Dokument auch einen Implementierungsleitfaden.<\/p>\n                    <\/div>\r\n                            <\/div>\r\n            <div class=\"contentPart-sidebarDummy\"><\/div>\r\n\r\n        <\/div>\r\n    <\/div>\r\n\n\n    <div id=\"links_downloadsblock_6ece93fd55f46719a92d3cebbc8530e2\" class=\"content-row content-row-links_downloads  \">\r\n        <div class=\"contentPart-main contentPart-main-links_downloads trans \">\r\n            <div class=\"contentPart_inner contentPart_inner-links_downloads  flex_col\">\r\n                                    <div class=\"linkBox column\">\r\n                                                                                    <div class=\"links_inner\">\r\n                                    <div class=\"btnBox\">\r\n                                        <a href=\"https:\/\/zenodo.org\/records\/8398685\" target=\"_self\" class=\"btnBox_inner_link btnBox_links_inner_left flex\">\r\n                                            <span class=\"main_btn_icon main_btn_icon_links_downloads\"><\/span>\r\n                                            <span class=\"main_btn_icon_hover main_btn_icon_hover_downloads\"><\/span>\r\n                                            <span class=\"main_btn_font btnBox_inner\">BBMRI-ERIC Benutzerzufriedenheitsumfrage Vorlage (Zenodo)<\/span>\r\n                                        <\/a>\r\n                                    <\/div>\r\n                                <\/div>\r\n                                                                        <\/div>\r\n                \r\n\r\n\r\n                            <\/div>\r\n\r\n            <div class=\"contentPart-sidebarDummy\"><\/div>\r\n\r\n        <\/div>\r\n    <\/div>\r\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":5668,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_coblocks_attr":"","_coblocks_dimensions":"","_coblocks_responsive_height":"","_coblocks_accordion_ie_support":"","footnotes":""},"class_list":["post-685","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - 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