{"id":30285,"date":"2023-09-20T08:00:33","date_gmt":"2023-09-20T06:00:33","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=30285"},"modified":"2023-09-19T17:24:25","modified_gmt":"2023-09-19T15:24:25","slug":"what-is-meant-by-documents-or-list-of-external-origin","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2023\/09\/20\/what-is-meant-by-documents-or-list-of-external-origin\/","title":{"rendered":"What is meant by documents (or list) of external origin?"},"content":{"rendered":"<p>Documents of external origin are considered to be regulations, laws, binding and\/or applicable regulations, technical standards and any other public or private act necessary for the development and implementation of the Quality Management System as well as the production\/provision of the service.<\/p>\n<p>Examples of such documents include ISO 13485 or other standards used in medical device design and development, certificates issued by Notified Bodies and Regulatory Authorities or other documents containing regulatory requirements and customer information.<\/p>\n<p>The list of documents of external origin contains the list of laws, standards and regulations demonstrating that the organisation transposes product and system regulatory requirements according to the state of the art. This document is subject to control by Notified Bodies, Certifying Bodies and Regulatory Authorities.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Documents of external origin are considered to be regulations, laws, binding and\/or applicable regulations, technical standards and any other public or  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[892,1613],"tags":[],"class_list":["post-30285","post","type-post","status-publish","format-standard","hentry","category-faq-en","category-regulatory-update"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>What is meant by documents (or list) of external origin? - Thema Med<\/title>\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.thema-med.com\/en\/2023\/09\/20\/what-is-meant-by-documents-or-list-of-external-origin\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"What is meant by documents (or list) of external origin? - Thema Med\" \/>\n<meta property=\"og:description\" content=\"Documents of external origin are considered to be regulations, laws, binding and\/or applicable regulations, technical standards and any other public or [...]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.thema-med.com\/en\/2023\/09\/20\/what-is-meant-by-documents-or-list-of-external-origin\/\" \/>\n<meta property=\"og:site_name\" content=\"Thema Med\" \/>\n<meta property=\"article:published_time\" content=\"2023-09-20T06:00:33+00:00\" \/>\n<meta name=\"author\" content=\"ufficiomarketing\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"ufficiomarketing\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.thema-med.com\/en\/2023\/09\/20\/what-is-meant-by-documents-or-list-of-external-origin\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2023\/09\/20\/what-is-meant-by-documents-or-list-of-external-origin\/\"},\"author\":{\"name\":\"ufficiomarketing\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/48e37298d13e3cf7f6d907af6a0d796d\"},\"headline\":\"What is meant by documents (or list) of external origin?\",\"datePublished\":\"2023-09-20T06:00:33+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2023\/09\/20\/what-is-meant-by-documents-or-list-of-external-origin\/\"},\"wordCount\":133,\"publisher\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/#organization\"},\"articleSection\":[\"FAQ\",\"Regulatory update\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.thema-med.com\/en\/2023\/09\/20\/what-is-meant-by-documents-or-list-of-external-origin\/\",\"url\":\"https:\/\/www.thema-med.com\/en\/2023\/09\/20\/what-is-meant-by-documents-or-list-of-external-origin\/\",\"name\":\"What is meant by documents (or list) of external origin? - Thema Med\",\"isPartOf\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/#website\"},\"datePublished\":\"2023-09-20T06:00:33+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2023\/09\/20\/what-is-meant-by-documents-or-list-of-external-origin\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.thema-med.com\/en\/2023\/09\/20\/what-is-meant-by-documents-or-list-of-external-origin\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.thema-med.com\/en\/2023\/09\/20\/what-is-meant-by-documents-or-list-of-external-origin\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.thema-med.com\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"What is meant by documents (or list) of external origin?\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#website\",\"url\":\"https:\/\/www.thema-med.com\/en\/\",\"name\":\"Thema Med\",\"description\":\"Quality and Regulatory Affairs for Medical Devices\",\"publisher\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.thema-med.com\/en\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":[\"Organization\",\"Place\"],\"@id\":\"https:\/\/www.thema-med.com\/en\/#organization\",\"name\":\"Thema\",\"alternateName\":\"Thema\",\"url\":\"https:\/\/www.thema-med.com\/en\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png\",\"contentUrl\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png\",\"width\":2440,\"height\":2851,\"caption\":\"Thema\"},\"image\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.linkedin.com\/company\/thema-s-r-l-\/\"],\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2023\/09\/20\/what-is-meant-by-documents-or-list-of-external-origin\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/48e37298d13e3cf7f6d907af6a0d796d\",\"name\":\"ufficiomarketing\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/61aa792ee358880e0c04a758e6f9078a28e175950ffc09fbeb595cd0ce2f89e2?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/61aa792ee358880e0c04a758e6f9078a28e175950ffc09fbeb595cd0ce2f89e2?s=96&d=mm&r=g\",\"caption\":\"ufficiomarketing\"},\"url\":\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"What is meant by documents (or list) of external origin? - Thema Med","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.thema-med.com\/en\/2023\/09\/20\/what-is-meant-by-documents-or-list-of-external-origin\/","og_locale":"en_US","og_type":"article","og_title":"What is meant by documents (or list) of external origin? - Thema Med","og_description":"Documents of external origin are considered to be regulations, laws, binding and\/or applicable regulations, technical standards and any other public or [...]","og_url":"https:\/\/www.thema-med.com\/en\/2023\/09\/20\/what-is-meant-by-documents-or-list-of-external-origin\/","og_site_name":"Thema Med","article_published_time":"2023-09-20T06:00:33+00:00","author":"ufficiomarketing","twitter_card":"summary_large_image","twitter_misc":{"Written by":"ufficiomarketing","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.thema-med.com\/en\/2023\/09\/20\/what-is-meant-by-documents-or-list-of-external-origin\/#article","isPartOf":{"@id":"https:\/\/www.thema-med.com\/en\/2023\/09\/20\/what-is-meant-by-documents-or-list-of-external-origin\/"},"author":{"name":"ufficiomarketing","@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/48e37298d13e3cf7f6d907af6a0d796d"},"headline":"What is meant by documents (or list) of external origin?","datePublished":"2023-09-20T06:00:33+00:00","mainEntityOfPage":{"@id":"https:\/\/www.thema-med.com\/en\/2023\/09\/20\/what-is-meant-by-documents-or-list-of-external-origin\/"},"wordCount":133,"publisher":{"@id":"https:\/\/www.thema-med.com\/en\/#organization"},"articleSection":["FAQ","Regulatory update"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.thema-med.com\/en\/2023\/09\/20\/what-is-meant-by-documents-or-list-of-external-origin\/","url":"https:\/\/www.thema-med.com\/en\/2023\/09\/20\/what-is-meant-by-documents-or-list-of-external-origin\/","name":"What is meant by documents (or list) of external origin? - Thema Med","isPartOf":{"@id":"https:\/\/www.thema-med.com\/en\/#website"},"datePublished":"2023-09-20T06:00:33+00:00","breadcrumb":{"@id":"https:\/\/www.thema-med.com\/en\/2023\/09\/20\/what-is-meant-by-documents-or-list-of-external-origin\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.thema-med.com\/en\/2023\/09\/20\/what-is-meant-by-documents-or-list-of-external-origin\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.thema-med.com\/en\/2023\/09\/20\/what-is-meant-by-documents-or-list-of-external-origin\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.thema-med.com\/en\/"},{"@type":"ListItem","position":2,"name":"What is meant by documents (or list) of external origin?"}]},{"@type":"WebSite","@id":"https:\/\/www.thema-med.com\/en\/#website","url":"https:\/\/www.thema-med.com\/en\/","name":"Thema Med","description":"Quality and Regulatory Affairs for Medical Devices","publisher":{"@id":"https:\/\/www.thema-med.com\/en\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.thema-med.com\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":["Organization","Place"],"@id":"https:\/\/www.thema-med.com\/en\/#organization","name":"Thema","alternateName":"Thema","url":"https:\/\/www.thema-med.com\/en\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/logo\/image\/","url":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png","contentUrl":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png","width":2440,"height":2851,"caption":"Thema"},"image":{"@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.linkedin.com\/company\/thema-s-r-l-\/"],"mainEntityOfPage":{"@id":"https:\/\/www.thema-med.com\/en\/2023\/09\/20\/what-is-meant-by-documents-or-list-of-external-origin\/"}},{"@type":"Person","@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/48e37298d13e3cf7f6d907af6a0d796d","name":"ufficiomarketing","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/61aa792ee358880e0c04a758e6f9078a28e175950ffc09fbeb595cd0ce2f89e2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/61aa792ee358880e0c04a758e6f9078a28e175950ffc09fbeb595cd0ce2f89e2?s=96&d=mm&r=g","caption":"ufficiomarketing"},"url":"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/"}]}},"_links":{"self":[{"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/posts\/30285","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/users\/115"}],"replies":[{"embeddable":true,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/comments?post=30285"}],"version-history":[{"count":1,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/posts\/30285\/revisions"}],"predecessor-version":[{"id":30299,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/posts\/30285\/revisions\/30299"}],"wp:attachment":[{"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/media?parent=30285"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/categories?post=30285"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/tags?post=30285"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}