{"id":15729,"date":"2024-05-24T13:35:53","date_gmt":"2024-05-24T11:35:53","guid":{"rendered":"https:\/\/www.laborberlin.com\/understanding-of-quality\/"},"modified":"2026-04-21T15:59:54","modified_gmt":"2026-04-21T13:59:54","slug":"understanding-of-quality","status":"publish","type":"page","link":"https:\/\/www.laborberlin.com\/en\/about-us\/understanding-of-quality\/","title":{"rendered":"Understanding of quality"},"content":{"rendered":"<div class=\"Module Banner Banner--small  Background Background--mikrobiologieFullTone Color Color--white\" >\n    <div class=\"container\">\n        <div class=\"grid grid--size12 \">\n            <div class=\"Banner__content grid--size5Tp\">\n                                    <h1 class=\"Banner__title\">Understanding of quality<\/h1>\n                \n                \n                                    <p>Laboratory analysis at the highest level<\/p>\n                \n                \n\n            <\/div>\n            <div class=\"grid--size12 grid--size7Tp\">\n                                                    <div class=\"Banner__image\">\n                        \n    <picture\n                class=\"Picture Banner__picture Picture--hero\"\n    >\n        <img decoding=\"async\"\n                src=\"\"\n                        data-srcset=\"https:\/\/www.laborberlin.com\/wp-content\/uploads\/2020\/06\/aaron-burden-B7TDIipUuas-unsplash-scaled.jpg 2560w, https:\/\/www.laborberlin.com\/wp-content\/uploads\/2020\/06\/aaron-burden-B7TDIipUuas-unsplash-768x576.jpg 768w, https:\/\/www.laborberlin.com\/wp-content\/uploads\/2020\/06\/aaron-burden-B7TDIipUuas-unsplash-1536x1152.jpg 1536w, https:\/\/www.laborberlin.com\/wp-content\/uploads\/2020\/06\/aaron-burden-B7TDIipUuas-unsplash-2048x1536.jpg 2048w, https:\/\/www.laborberlin.com\/wp-content\/uploads\/2020\/06\/aaron-burden-B7TDIipUuas-unsplash-1600x1200.jpg 1600w, https:\/\/www.laborberlin.com\/wp-content\/uploads\/2020\/06\/aaron-burden-B7TDIipUuas-unsplash-1024x768.jpg 1024w, https:\/\/www.laborberlin.com\/wp-content\/uploads\/2020\/06\/aaron-burden-B7TDIipUuas-unsplash-800x600.jpg 800w, https:\/\/www.laborberlin.com\/wp-content\/uploads\/2020\/06\/aaron-burden-B7TDIipUuas-unsplash-600x450.jpg 600w, https:\/\/www.laborberlin.com\/wp-content\/uploads\/2020\/06\/aaron-burden-B7TDIipUuas-unsplash-400x300.jpg 400w\"                class=\"lazyload Picture__image\"\n                alt=\"\"\n            title=\"aaron-burden-B7TDIipUuas-unsplash\"\/>\n\n                    <div class=\"Picture__tooltip\">\n                <div class=\"Picture__tooltipIcon\">\u00a9<\/div>\n                <div class=\"Picture__tooltipContent\">\n                    aaron-burden-B7TDIipUuas-unsplash                <\/div>\n            <\/div>\n        \n        <noscript>\n            <img decoding=\"async\" src=\"https:\/\/www.laborberlin.com\/wp-content\/uploads\/2020\/06\/aaron-burden-B7TDIipUuas-unsplash-1024x768.jpg\" alt=\"\" title=\"aaron-burden-B7TDIipUuas-unsplash\"\/>\n        <\/noscript>\n    <\/picture>\n\n                        <\/div>\n                            <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n    <div class=\"container\">\n        <div class=\"Breadcrumb\">\n    <ul class=\"Breadcrumb__list\" itemscope itemtype=\"https:\/\/schema.org\/BreadcrumbList\">\n        \n                <li itemprop=\"itemListElement\" itemscope itemtype=\"http:\/\/schema.org\/ListItem\" class=\"Breadcrumb__item breadcrumb__item--home\">\n        <a itemprop=\"item\" href=\"https:\/\/www.laborberlin.com\/en\/\" class=\"Breadcrumb__link\">\n            <span itemprop=\"name\">Labor Berlin<\/span>\n        <\/a>\n        <meta itemprop=\"position\" content=\"1\" \/>\n    <\/li>\n    \n                <li itemprop=\"itemListElement\" itemscope itemtype=\"http:\/\/schema.org\/ListItem\" class=\"Breadcrumb__item breadcrumb__item--current\">\n        <a itemprop=\"item\" href=\"https:\/\/www.laborberlin.com\/en\/wp-json\/wp\/v2\/pages\/15729\/\" class=\"Breadcrumb__link\">\n            <span itemprop=\"name\">Page<\/span>\n        <\/a>\n        <meta itemprop=\"position\" content=\"2\" \/>\n    <\/li>\n        <\/ul>\n<\/div>\n    <\/div>\n\n\n<div class=\"Module Text Background Background--transparent\" >\n    <div class=\"container\">\n            <Header class=\"Module__header\">\n                    <h2>The quality management of Labor Berlin<\/h2>\n        \n        \n        \n\n    <\/Header>\n\n\n                                <div class=\"Text__content\">\n                <p>Optimum quality in findings and processes is one of the cornerstones of Labor Berlin: this is why all specialist areas are already accredited in accordance with the currently valid DIN EN ISO 15189 standard and the specialist areas of Forensic Toxicology and Forensic Genetics are accredited in accordance with DIN EN ISO\/IEC 17025.<\/p>\n<p>The centralised quality management system that has been introduced ensures that each department is supported by qualified QM officers on site. Comprehensive audit, complaint and error management ensures that the quality of laboratory analyses is always carried out at the best possible level.<\/p>\n            <\/div>\n            <\/div>\n<\/div>\n\n\n\n\n<div class=\"Module AccordionModule Background Background--mikrobiologie\" >\n    <div class=\"container\">\n        \n        <div class=\"Accordion\">\n                            <ul role=\"presentation\" class=\"Accordion__list\">\n                                                                    <li class=\"Accordion__item\" id=\"internal-and-external-quality-assurance\">\n                            <button role=\"heading\" aria-expanded=\"false\" class=\"Accordion__title\" type=\"button\">\n                                Internal and external quality assurance                            <\/button>\n\n                            <div class=\"Accordion__wrapper\">\n                                <div class=\"Accordion__content\">\n                                                                                                                                                                        <p>The entire analysis of all specialised areas is continuously checked by internal and external quality controls:<\/p>\n<ul>\n<li>The most recent guidelines of the German Medical Association (RILIB\u00c4K) are the benchmark for this. In addition, all parameters not subject to certification are checked in accordance with the guidelines.<\/li>\n<li>Participation in external quality controls (interlaboratory tests) takes place at national interlaboratory test organisations such as INSTAND and DGKL.<\/li>\n<li>The departments are headed by highly qualified scientists, some of whom work closely with reference institutes or carry out target value analyses for the Reference Institute for Bioanalysis. Other departments act as reference laboratories themselves.<\/li>\n<\/ul>\n                                                                                                                                                        <\/div>\n                            <\/div>\n                        <\/li>\n                                                                    <li class=\"Accordion__item\" id=\"reference-laboratories-determination-of-target-values\">\n                            <button role=\"heading\" aria-expanded=\"false\" class=\"Accordion__title\" type=\"button\">\n                                Reference laboratories\/determination of target values                            <\/button>\n\n                            <div class=\"Accordion__wrapper\">\n                                <div class=\"Accordion__content\">\n                                                                                                                                                                        <p><strong>Campus Virchow Clinic<\/strong><br \/>\nLaboratory medicine Central laboratory<br \/>\nReference laboratory for haemoglobinopathies<\/p>\n<p><strong>Campus Mitte<\/strong><br \/>\nVirology<br \/>\nNational consiliary laboratory for hantaviruses<\/p>\n<p><strong>Location Klinikum im Friedrichshain<\/strong><br \/>\nLaboratory medicine presence laboratory<br \/>\nUrinary stone analyses<\/p>\n<p><strong>Campus Virchow Clinic<\/strong><br \/>\nImmunology<\/p>\n<ul>\n<li>Standardisation of cytokine measurements at the DGKL (Deutsche Vereinigte Gesellschaft f\u00fcr Klinische Chemie und Laboratoriumsmedizin e.V.)<\/li>\n<li>Standardised immunodiagnostics after transplantation as part of the EU networks &#8220;RISET&#8221; and &#8220;The one Study&#8221;<\/li>\n<\/ul>\n                                                                                                                                                        <\/div>\n                            <\/div>\n                        <\/li>\n                                                                    <li class=\"Accordion__item\" id=\"accreditations-authorisations\">\n                            <button role=\"heading\" aria-expanded=\"false\" class=\"Accordion__title\" type=\"button\">\n                                Accreditations &#038; authorisations                            <\/button>\n\n                            <div class=\"Accordion__wrapper\">\n                                <div class=\"Accordion__content\">\n                                                                                                                                                                        <h3>Accreditations<\/h3>\n<ul>\n<li><strong>Labor Berlin \u2013 Charit\u00e9 Vivantes Services GmbH<\/strong>\n<ul>\n<li><a href=\"\/wp-content\/uploads\/2025\/01\/D-ML-19677-01-00_Urkunde-gueltig-ab-12Jan2026.pdf\">process number D-ML-13440-03-00<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2025\/01\/D-ML-19677-01-00_Urkunde-gueltig-ab-12Jan2026.pdf\">attachment D-ML-19677-01<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/urkunden\/LBS-Flexibler_Akkreditierungsbereich-UA_F_ML-19677-01.xlsx\">flexible accreditation area D-ML-19677-01<\/a><\/li>\n<\/ul>\n<\/li>\n<li><strong>Labor Berlin \u2013 Charit\u00e9 Vivantes GmbH<\/strong>\n<ul>\n<li><a href=\"\/wp-content\/uploads\/2022\/01\/260306_D-ML-13440-03-01_Urkunde.pdf\">process number D-ML-13440-03<\/a><\/li>\n<li><a href=\"https:\/\/www.laborberlin.com\/wp-content\/uploads\/2026\/04\/260306_D-ML-13440-03-01-Anlage.pdf\">attachment D-ML-13440-03<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/urkunden\/LB-Flexibler_Akkreditierungsbereich-UA_F_ML-13440-03.xlsx\">flexible accreditation area D-ML-13440-03-00<\/a><\/li>\n<\/ul>\n<ul>\n<li><strong>Test field: Forensic toxicology D-PL-13440-03<\/strong>\n<ul>\n<li><a href=\"\/wp-content\/uploads\/2021\/08\/260306_D-PL-13440-03-00_Urkunde.pdf\">process number\u00a0D-PL-13440-03<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2021\/08\/260306_D-PL-13440-03-01_Anlage.pdf\">attachment\u00a0D-PL-13440-03<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2025\/04\/251210_LB-Flexibler-Akkreditierungsbereich-UA_F_PL-13440-03.xlsx\">flexible accreditation area\u00a0 D-PL-13440-03<\/a><\/li>\n<\/ul>\n<\/li>\n<li><strong>Test field: Forensic genetics (trace evidence) D-PL-13440-04<\/strong>\n<ul>\n<li><a href=\"\/wp-content\/uploads\/2022\/04\/220422_Akkreditierungsurkunde_Verfahrensnummer-D-PL-13440-04-00_Labor-Berlin-Charite-Vivantes-GmbH.pdf\">process number\u00a0D-PL-13440-04<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2022\/04\/220422_Anlage_Akkreditierungsurkunde_Verfahrensnummer-D-PL-13440-04-00_Labor-Berlin-Charite-Vivantes-GmbH.pdf\">attachment\u00a0D-PL-13440-04<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2025\/08\/250822_LB-Flexibler-Akkreditierungsbereich-UA_F_PL-13440-04.xlsx\">flexible accreditation area\u00a0 D-PL-13440-04<\/a><\/li>\n<\/ul>\n<\/li>\n<li><strong>Test field: Forensic genetics (parentage according to GenDG) PL-13440-05<\/strong>\n<ul>\n<li><a href=\"https:\/\/www.laborberlin.com\/wp-content\/uploads\/2026\/04\/260421_D-PL-13440-05-00_Akkreditierungsurkunde.pdf\">process number\u00a0D-PL-13440-05<\/a><\/li>\n<li><a href=\"https:\/\/www.laborberlin.com\/wp-content\/uploads\/2026\/04\/260421_D-PL-13440-05-00_Anlage-zur-Urkunde.pdf\">attachment\u00a0D-PL-13440-05<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2025\/08\/250822_LB-Flexibler-Akkreditierungsbereich-UA_F_PL-13440-05.xlsx\">flexible accreditation area\u00a0 D-PL-13440-05<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<li><strong>Tumor cytogenetics<\/strong>\n<ul>\n<li><a href=\"\/wp-content\/uploads\/250815_Tumorzytogenetik_Flexible-Akkreditierung-FISH-Sonden.xlsx\">flexible accreditation FISH-probes<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n                                                                                                                                                        <\/div>\n                            <\/div>\n                        <\/li>\n                                                                    <li class=\"Accordion__item\" id=\"measurement-uncertainties\">\n                            <button role=\"heading\" aria-expanded=\"false\" class=\"Accordion__title\" type=\"button\">\n                                Measurement uncertainties                            <\/button>\n\n                            <div class=\"Accordion__wrapper\">\n                                <div class=\"Accordion__content\">\n                                                                                                                                                                        <p>Every measurement result is subject to a certain degree of uncertainty. Knowing this measurement uncertainty can be very helpful when it comes to assessing the significance of medical laboratory findings.<\/p>\n<p>In other words: How does the parameter relate to the reference range? Does the current value deviate significantly from a previous value (follow-up)?<\/p>\n<p>According to ISO\/DIN 3534-1, the measurement uncertainty is defined as an estimated value that specifies the range in which the true value can be expected. A number of the points that determine the &#8220;overall measurement uncertainty&#8221; are strongly dependent on the individual circumstances of the patient.<\/p>\n<p>The doctors in the laboratory are always available to discuss the significance of a finding. They bring current data on analytical measurement uncertainty and considerations on pre-analysis into the discussion of individual findings.<\/p>\n<p>Information on measurement uncertainty is provided by the individual departments in writing or by telephone on request.<\/p>\n                                                                                                                                                        <\/div>\n                            <\/div>\n                        <\/li>\n                                                                    <li class=\"Accordion__item\" id=\"medical-device-safety\">\n                            <button role=\"heading\" aria-expanded=\"false\" class=\"Accordion__title\" type=\"button\">\n                                Medical device safety                            <\/button>\n\n                            <div class=\"Accordion__wrapper\">\n                                <div class=\"Accordion__content\">\n                                                                                                                                                                        <p>In accordance with \u00a7 6 of the Medical Devices Operator Ordinance (MPBetreibV), a Medical Device Safety Officer is available to you at Labor Berlin.<\/p>\n<p>Its tasks include, among others:<\/p>\n<p>\u00b7 Contact person for authorities, manufacturers and distributors in connection with reports on the risks of medical devices and the implementation of safety corrective measures at our company and other necessary corrective measures,<\/p>\n<p>\u00b7 Coordination of internal processes to fulfil the reporting and cooperation obligations of users and operators,<\/p>\n<p>\u00b7 Coordination of the implementation of corrective measures and safety corrective measures at our company.<\/p>\n<p>You can reach our Medical Device Safety Officer at the following e-mail address: <a href=\"mailto:Medizinproduktesicherheit@laborberlin.com\">Medizinproduktesicherheit@laborberlin.com<\/a><\/p>\n                                                                                                                                                        <\/div>\n                            <\/div>\n                        <\/li>\n                                                                    <li class=\"Accordion__item\" id=\"ivdr\">\n                            <button role=\"heading\" aria-expanded=\"false\" class=\"Accordion__title\" type=\"button\">\n                                IVDR                            <\/button>\n\n                            <div class=\"Accordion__wrapper\">\n                                <div class=\"Accordion__content\">\n                                                                                                                                                                        <p><strong>Declaration pursuant to Art. 5 para. 5 lit. f of Regulation (EU) 2017\/746 on in vitro diagnostic medical devices (IVDR) on the in-house manufacture of devices in the healthcare establishment<\/strong><\/p>\n<p>The healthcare institution &#8220;Labor Berlin &#8211; Charit\u00e9 Vivantes GmbH&#8221;, Sylter Stra\u00dfe 2, 13353 Berlin, hereby declares that the devices listed in Annexes 1-7 are manufactured and used exclusively in the healthcare institution and meet the essential safety and performance requirements in accordance with Annex I of Regulation (EU) 2017\/746 (IVDR), insofar as these are applicable to the devices. The products are manufactured in-house on a non-industrial scale.<\/p>\n<ul>\n<li><a href=\"\/wp-content\/uploads\/2024\/07\/250504_Anlage-1-zur-Erklaerung-Laboratoriumsmedizin_V5.pdf\" target=\"_blank\" rel=\"noopener\">Appendix 1 to the declaration &#8211; Laboratory medicine<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/05\/250725_Anlage-2-zur-Erklaerung-Immunologie-2.pdf\" target=\"_blank\" rel=\"noopener\">Appendix 2 to the declaration &#8211; Immunology<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/05\/250504_Anlage-3-zur-Erklaerung-Haematologie-Onkologie_V2.pdf\" target=\"_blank\" rel=\"noopener\">Appendix 3 to the declaration &#8211; Hematology &amp; Oncology<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/05\/251128_Anlage-4-zur-Erklaerung-Toxikologie_V3.pdf\" target=\"_blank\" rel=\"noopener\">Appendix 4 to the declaration &#8211; Toxicology<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/05\/Anlage-5-zur-Erklaerung-Endokrinologie-Stoffwechsel_V2.pdf\" target=\"_blank\" rel=\"noopener\">Appendix 5 to the declaration &#8211; Endocrinology &amp; Metabolism<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/05\/251128_Anlage-6-zur-Erklaerung-Humangenetik_V6.pdf\" target=\"_blank\" rel=\"noopener\">Appendix 6 to the declaration &#8211; Human genetics<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/05\/Anlage-7-zur-Erklaerung-Virologie-Mikrobiologie-1.pdf\" target=\"_blank\" rel=\"noopener\">Appendix 7 to the declaration &#8211; Virology &amp; Microbiology<\/a><\/li>\n<\/ul>\n<p>23.05.2024<\/p>\n<p>Labor Berlin \u2013 Charit\u00e9 Vivantes GmbH<\/p>\n<p>&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;<\/p>\n<p>The healthcare institution &#8220;Labor Berlin &#8211; Charit\u00e9 Vivantes Services GmbH&#8221;, Sylter Stra\u00dfe 2, 13353 Berlin, hereby declares that the devices listed in the annex are manufactured and used exclusively in the healthcare institution and meet the essential safety and performance requirements in accordance with Annex I of Regulation (EU) 2017\/746 (IVDR), insofar as these are applicable to the devices. The products are manufactured in-house on a non-industrial scale.<\/p>\n<ul>\n<li><a href=\"https:\/\/www.laborberlin.com\/wp-content\/uploads\/2025\/04\/250429_Anlage_zurErklaerung_Laboratoriumsmedizin_LBS_V2.pdf\" target=\"_blank\" rel=\"noopener\">Annex to the declaration &#8211; Laboratory medicine LBS<\/a><\/li>\n<\/ul>\n<p>26.05.2024<\/p>\n<p>Labor Berlin \u2013 Charit\u00e9 Vivantes Services GmbH<\/p>\n                                                                                                                                                        <\/div>\n                            <\/div>\n                        <\/li>\n                                    <\/ul>\n                    <\/div>\n    <\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":16044,"menu_order":71,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-15729","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.7 - 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