{"id":2478,"date":"2023-09-01T15:40:08","date_gmt":"2023-09-01T15:40:08","guid":{"rendered":"https:\/\/qbcert.sa\/?page_id=2478"},"modified":"2025-12-13T18:22:37","modified_gmt":"2025-12-13T18:22:37","slug":"iso-13485-2016","status":"publish","type":"page","link":"https:\/\/qbcert.sa\/ar\/\u062c\u0648\u062f\u0629-\u0627\u0644\u0635\u0646\u0627\u0639\u0627\u062a-\u0627\u0644\u0637\u0628\u064a\u0629\/","title":{"rendered":"ISO 13485:2016"},"content":{"rendered":"<h2 class=\"wp-block-heading\" id=\"h-what-is-iso-13485-2016\">\u0645\u0627 \u0647\u0648 \u0645\u0639\u064a\u0627\u0631 ISO 13485:2016\u061f<\/h2>\n\n\n\n<p>The <strong>ISO 13485:2016<\/strong> \u0647\u0648 \u0645\u0639\u064a\u0627\u0631 \u062f\u0648\u0644\u064a \u064a\u062d\u062f\u062f \u0627\u0644\u0645\u062a\u0637\u0644\u0628\u0627\u062a <strong>Devices Quality Management System (DQMS)<\/strong> \u0644\u0644\u0634\u0631\u0643\u0627\u062a \u0648\u0627\u0644\u0645\u0646\u0638\u0645\u0627\u062a \u0627\u0644\u0639\u0627\u0645\u0644\u0629 \u0641\u064a <strong>\u062a\u0635\u0645\u064a\u0645 \u0648\u062a\u0637\u0648\u064a\u0631 \u0648\u062a\u0635\u0646\u064a\u0639 \u0648\u062a\u0648\u0632\u064a\u0639 \u0648\u0635\u064a\u0627\u0646\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629<\/strong>\u0648\u064a\u0647\u062f\u0641 \u0647\u0630\u0627 \u0627\u0644\u0645\u0639\u064a\u0627\u0631 \u0625\u0644\u0649 \u0636\u0645\u0627\u0646 \u0623\u0646 \u0627\u0644\u0645\u0646\u062a\u062c\u0627\u062a \u0627\u0644\u0637\u0628\u064a\u0629 \u0622\u0645\u0646\u0629 \u0648\u0641\u0639\u0627\u0644\u0629 \u0648\u062a\u0644\u0628\u064a \u0627\u0644\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a\u0629 \u0648\u0627\u0644\u0642\u0627\u0646\u0648\u0646\u064a\u0629 \u0641\u064a \u0627\u0644\u0623\u0633\u0648\u0627\u0642 \u0627\u0644\u0645\u062d\u0644\u064a\u0629 \u0648\u0627\u0644\u0639\u0627\u0644\u0645\u064a\u0629.<\/p>\n\n\n\n<p>\u064a\u064f\u0639\u062f ISO 13485 \u0645\u0646 \u0623\u0647\u0645 \u0627\u0644\u0645\u0639\u0627\u064a\u064a\u0631 \u0627\u0644\u0645\u0639\u062a\u0645\u062f\u0629 \u0639\u0627\u0644\u0645\u064a\u064b\u0627 \u0641\u064a \u0642\u0637\u0627\u0639 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629\u060c \u0648\u0647\u0648 \u0645\u0637\u0644\u0648\u0628 \u0623\u0648 \u0645\u0639\u062a\u0631\u0641 \u0628\u0647 \u0645\u0646 \u0642\u0628\u0644 \u0627\u0644\u0639\u062f\u064a\u062f \u0645\u0646 \u0627\u0644\u062c\u0647\u0627\u062a \u0627\u0644\u0631\u0642\u0627\u0628\u064a\u0629 \u0645\u062b\u0644 \u0627\u0644\u0627\u062a\u062d\u0627\u062f \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a \u0648\u0647\u064a\u0626\u0627\u062a \u0627\u0644\u0627\u0639\u062a\u0645\u0627\u062f \u0627\u0644\u062f\u0648\u0644\u064a\u0629.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-importance-of-iso-13485-2016-certification\">\u0623\u0647\u0645\u064a\u0629 \u0634\u0647\u0627\u062f\u0629 ISO 13485:2016<\/h2>\n\n\n\n<p>\u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0634\u0647\u0627\u062f\u0629 ISO 13485:2016 \u064a\u0645\u0646\u062d \u0627\u0644\u0645\u0624\u0633\u0633\u0627\u062a \u0627\u0644\u0639\u0627\u0645\u0644\u0629 \u0641\u064a \u0627\u0644\u0645\u062c\u0627\u0644 \u0627\u0644\u0637\u0628\u064a \u0627\u0644\u0639\u062f\u064a\u062f \u0645\u0646 \u0627\u0644\u0645\u0632\u0627\u064a\u0627\u060c \u0645\u0646 \u0623\u0628\u0631\u0632\u0647\u0627:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-improving-medical-device-quality\">\u062a\u062d\u0633\u064a\u0646 \u062c\u0648\u062f\u0629 \u0627\u0644\u0645\u0646\u062a\u062c\u0627\u062a \u0627\u0644\u0637\u0628\u064a\u0629<\/h3>\n\n\n\n<p>\u064a\u0633\u0627\u0639\u062f \u0627\u0644\u0645\u0639\u064a\u0627\u0631 \u0639\u0644\u0649 \u062a\u0637\u0628\u064a\u0642 \u0623\u0646\u0638\u0645\u0629 \u0631\u0642\u0627\u0628\u0629 \u0635\u0627\u0631\u0645\u0629 \u062a\u0636\u0645\u0646 \u062c\u0648\u062f\u0629 \u0627\u0644\u0645\u0646\u062a\u062c\u0627\u062a \u0641\u064a \u062c\u0645\u064a\u0639 \u0645\u0631\u0627\u062d\u0644 \u062f\u0648\u0631\u0629 \u062d\u064a\u0627\u062a\u0647\u0627.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-compliance-with-regulatory-requirements\">\u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0644\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a\u0629<\/h3>\n\n\n\n<p>\u064a\u0633\u0627\u0647\u0645 ISO 13485 \u0641\u064a \u062a\u062d\u0642\u064a\u0642 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0644\u0642\u0648\u0627\u0646\u064a\u0646 \u0648\u0627\u0644\u0644\u0648\u0627\u0626\u062d \u0627\u0644\u0645\u062d\u0644\u064a\u0629 \u0648\u0627\u0644\u062f\u0648\u0644\u064a\u0629 \u0627\u0644\u062e\u0627\u0635\u0629 \u0628\u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-enhancing-customer-and-regulatory-confidence\">\u062a\u0639\u0632\u064a\u0632 \u062b\u0642\u0629 \u0627\u0644\u0639\u0645\u0644\u0627\u0621 \u0648\u0627\u0644\u062c\u0647\u0627\u062a \u0627\u0644\u0631\u0642\u0627\u0628\u064a\u0629<\/h3>\n\n\n\n<p>\u0627\u0644\u0634\u0647\u0627\u062f\u0629 \u062a\u0639\u0643\u0633 \u0627\u0644\u062a\u0632\u0627\u0645 \u0627\u0644\u0645\u0624\u0633\u0633\u0629 \u0628\u0627\u0644\u062c\u0648\u062f\u0629 \u0648\u0627\u0644\u0633\u0644\u0627\u0645\u0629\u060c \u0645\u0645\u0627 \u064a\u0632\u064a\u062f \u0645\u0646 \u062b\u0642\u0629 \u0627\u0644\u0639\u0645\u0644\u0627\u0621 \u0648\u0627\u0644\u0634\u0631\u0643\u0627\u0621 \u0648\u0627\u0644\u0647\u064a\u0626\u0627\u062a \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a\u0629.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-facilitating-access-to-global-markets\">\u062a\u0633\u0647\u064a\u0644 \u0627\u0644\u062f\u062e\u0648\u0644 \u0625\u0644\u0649 \u0627\u0644\u0623\u0633\u0648\u0627\u0642 \u0627\u0644\u0639\u0627\u0644\u0645\u064a\u0629<\/h3>\n\n\n\n<p>\u064a\u064f\u0639\u062f \u0627\u0644\u0645\u0639\u064a\u0627\u0631 \u0634\u0631\u0637\u064b\u0627 \u0623\u0633\u0627\u0633\u064a\u064b\u0627 \u0623\u0648 \u0645\u064a\u0632\u0629 \u062a\u0646\u0627\u0641\u0633\u064a\u0629 \u0642\u0648\u064a\u0629 \u0644\u062f\u062e\u0648\u0644 \u0627\u0644\u0639\u062f\u064a\u062f \u0645\u0646 \u0627\u0644\u0623\u0633\u0648\u0627\u0642 \u0627\u0644\u062f\u0648\u0644\u064a\u0629.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-iso-13485-2016-requirements\">\u0645\u062a\u0637\u0644\u0628\u0627\u062a ISO 13485:2016<\/h2>\n\n\n\n<p>\u064a\u0639\u062a\u0645\u062f \u0627\u0644\u0645\u0639\u064a\u0627\u0631 \u0639\u0644\u0649 \u0645\u062c\u0645\u0648\u0639\u0629 \u0645\u0646 \u0627\u0644\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u0623\u0633\u0627\u0633\u064a\u0629 \u0627\u0644\u062a\u064a \u064a\u062c\u0628 \u0639\u0644\u0649 \u0627\u0644\u0645\u0624\u0633\u0633\u0627\u062a \u0627\u0644\u0627\u0644\u062a\u0632\u0627\u0645 \u0628\u0647\u0627\u060c \u0648\u0645\u0646\u0647\u0627:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-quality-management-system\">\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u062c\u0648\u062f\u0629 \u0627\u0644\u0634\u0627\u0645\u0644\u0629<\/h3>\n\n\n\n<p>\u0625\u0646\u0634\u0627\u0621 \u0648\u062a\u0648\u062b\u064a\u0642 \u0648\u062a\u0637\u0628\u064a\u0642 \u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u062c\u0648\u062f\u0629 \u0641\u0639\u0627\u0644 \u0648\u0645\u0646\u0627\u0633\u0628 \u0644\u0637\u0628\u064a\u0639\u0629 \u0627\u0644\u0623\u0646\u0634\u0637\u0629 \u0627\u0644\u0637\u0628\u064a\u0629.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-risk-management\">\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u0645\u062e\u0627\u0637\u0631<\/h3>\n\n\n\n<p>\u062a\u0637\u0628\u064a\u0642 \u0645\u0646\u0647\u062c\u064a\u0629 \u0648\u0627\u0636\u062d\u0629 \u0644\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u0645\u062e\u0627\u0637\u0631 \u0627\u0644\u0645\u0631\u062a\u0628\u0637\u0629 \u0628\u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0637\u0648\u0627\u0644 \u062f\u0648\u0631\u0629 \u062d\u064a\u0627\u0629 \u0627\u0644\u0645\u0646\u062a\u062c.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-documentation-and-records\">\u0627\u0644\u062a\u0648\u062b\u064a\u0642 \u0648\u0627\u0644\u0633\u062c\u0644\u0627\u062a<\/h3>\n\n\n\n<p>\u0627\u0644\u0627\u062d\u062a\u0641\u0627\u0638 \u0628\u0633\u062c\u0644\u0627\u062a \u062f\u0642\u064a\u0642\u0629 \u062a\u0634\u0645\u0644 \u0627\u0644\u062a\u0635\u0645\u064a\u0645\u060c \u0627\u0644\u062a\u0635\u0646\u064a\u0639\u060c \u0627\u0644\u0641\u062d\u0635\u060c \u0627\u0644\u062a\u062a\u0628\u0639\u060c \u0648\u0627\u0644\u0634\u0643\u0627\u0648\u0649.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-process-control\">\u0645\u0631\u0627\u0642\u0628\u0629 \u0627\u0644\u0639\u0645\u0644\u064a\u0627\u062a<\/h3>\n\n\n\n<p>\u0636\u0645\u0627\u0646 \u0627\u0644\u062a\u062d\u0643\u0645 \u0641\u064a \u0639\u0645\u0644\u064a\u0627\u062a \u0627\u0644\u0625\u0646\u062a\u0627\u062c \u0648\u0627\u0644\u062a\u0648\u0632\u064a\u0639 \u0648\u0627\u0644\u062e\u062f\u0645\u0627\u062a \u0627\u0644\u0645\u0631\u062a\u0628\u0637\u0629 \u0628\u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-continuous-improvement\">\u0627\u0644\u062a\u062d\u0633\u064a\u0646 \u0627\u0644\u0645\u0633\u062a\u0645\u0631<\/h3>\n\n\n\n<p>\u0645\u0631\u0627\u062c\u0639\u0629 \u0627\u0644\u0623\u062f\u0627\u0621 \u0628\u0634\u0643\u0644 \u062f\u0648\u0631\u064a \u0648\u062a\u0646\u0641\u064a\u0630 \u0625\u062c\u0631\u0627\u0621\u0627\u062a \u062a\u0635\u062d\u064a\u062d\u064a\u0629 \u0648\u0648\u0642\u0627\u0626\u064a\u0629 \u0644\u062a\u062d\u0633\u064a\u0646 \u0627\u0644\u0646\u0638\u0627\u0645.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-difference-between-iso-13485-and-iso-9001\">\u0627\u0644\u0641\u0631\u0642 \u0628\u064a\u0646 ISO 13485 \u0648 ISO 9001<\/h2>\n\n\n\n<p>\u0639\u0644\u0649 \u0627\u0644\u0631\u063a\u0645 \u0645\u0646 \u0648\u062c\u0648\u062f \u062a\u0634\u0627\u0628\u0647 \u0628\u064a\u0646 \u0627\u0644\u0645\u0639\u064a\u0627\u0631\u064a\u0646\u060c \u0625\u0644\u0627 \u0623\u0646 \u0647\u0646\u0627\u0643 \u0627\u062e\u062a\u0644\u0627\u0641\u0627\u062a \u062c\u0648\u0647\u0631\u064a\u0629\u060c \u0645\u0646 \u0623\u0647\u0645\u0647\u0627:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-specialization\">\u0627\u0644\u062a\u062e\u0635\u0635<\/h3>\n\n\n\n<p>ISO 13485 \u0645\u062e\u0635\u0635 \u062d\u0635\u0631\u064a\u064b\u0627 \u0644\u0642\u0637\u0627\u0639 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629\u060c \u0628\u064a\u0646\u0645\u0627 ISO 9001 \u0645\u0639\u064a\u0627\u0631 \u0639\u0627\u0645 \u0644\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u062c\u0648\u062f\u0629 \u0641\u064a \u062c\u0645\u064a\u0639 \u0627\u0644\u0642\u0637\u0627\u0639\u0627\u062a.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-regulatory-requirements\">\u0627\u0644\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a\u0629<\/h3>\n\n\n\n<p>\u064a\u0631\u0643\u0632 ISO 13485 \u0628\u0634\u0643\u0644 \u0623\u0643\u0628\u0631 \u0639\u0644\u0649 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0644\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u0642\u0627\u0646\u0648\u0646\u064a\u0629 \u0648\u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a\u0629.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-risk-management-0\">\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u0645\u062e\u0627\u0637\u0631<\/h3>\n\n\n\n<p>\u064a\u062a\u0636\u0645\u0646 ISO 13485 \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0623\u0643\u062b\u0631 \u062a\u0641\u0635\u064a\u0644\u0627\u064b \u0641\u064a\u0645\u0627 \u064a\u062a\u0639\u0644\u0642 \u0628\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u0645\u062e\u0627\u0637\u0631 \u0627\u0644\u0645\u0631\u062a\u0628\u0637\u0629 \u0628\u0633\u0644\u0627\u0645\u0629 \u0627\u0644\u0645\u0631\u0636\u0649.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-steps-to-obtain-iso-13485-2016-certification\">\u062e\u0637\u0648\u0627\u062a \u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0634\u0647\u0627\u062f\u0629 ISO 13485:2016<\/h2>\n\n\n\n<p>\u0644\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0627\u0644\u0634\u0647\u0627\u062f\u0629\u060c \u062a\u0645\u0631 \u0627\u0644\u0645\u0624\u0633\u0633\u0629 \u0628\u0639\u062f\u0629 \u0645\u0631\u0627\u062d\u0644\u060c \u0623\u0647\u0645\u0647\u0627:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-gap-analysis\">\u062a\u062d\u0644\u064a\u0644 \u0627\u0644\u0641\u062c\u0648\u0629<\/h3>\n\n\n\n<p>\u062a\u0642\u064a\u064a\u0645 \u0627\u0644\u0648\u0636\u0639 \u0627\u0644\u062d\u0627\u0644\u064a \u0648\u0645\u0642\u0627\u0631\u0646\u062a\u0647 \u0628\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u0645\u0639\u064a\u0627\u0631.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-system-development\">\u0625\u0639\u062f\u0627\u062f \u0627\u0644\u0646\u0638\u0627\u0645<\/h3>\n\n\n\n<p>\u062a\u0637\u0648\u064a\u0631 \u0648\u062a\u0648\u062b\u064a\u0642 \u0633\u064a\u0627\u0633\u0627\u062a \u0648\u0625\u062c\u0631\u0627\u0621\u0627\u062a \u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u062c\u0648\u062f\u0629.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-training-and-implementation\">\u0627\u0644\u062a\u062f\u0631\u064a\u0628 \u0648\u0627\u0644\u062a\u0637\u0628\u064a\u0642<\/h3>\n\n\n\n<p>\u062a\u062f\u0631\u064a\u0628 \u0627\u0644\u0645\u0648\u0638\u0641\u064a\u0646 \u0639\u0644\u0649 \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u0645\u0639\u064a\u0627\u0631 \u0648\u062a\u0637\u0628\u064a\u0642 \u0627\u0644\u0646\u0638\u0627\u0645 \u0641\u0639\u0644\u064a\u064b\u0627.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-internal-audit\">\u0627\u0644\u062a\u062f\u0642\u064a\u0642 \u0627\u0644\u062f\u0627\u062e\u0644\u064a<\/h3>\n\n\n\n<p>\u0625\u062c\u0631\u0627\u0621 \u0645\u0631\u0627\u062c\u0639\u0629 \u062f\u0627\u062e\u0644\u064a\u0629 \u0644\u0644\u062a\u0623\u0643\u062f \u0645\u0646 \u0627\u0644\u0627\u0644\u062a\u0632\u0627\u0645 \u0627\u0644\u0643\u0627\u0645\u0644 \u0628\u0627\u0644\u0645\u062a\u0637\u0644\u0628\u0627\u062a.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-external-audit\">\u0627\u0644\u062a\u062f\u0642\u064a\u0642 \u0627\u0644\u062e\u0627\u0631\u062c\u064a<\/h3>\n\n\n\n<p>\u062a\u0646\u0641\u064a\u0630 \u062a\u062f\u0642\u064a\u0642 \u0645\u0646 \u062c\u0647\u0629 \u0627\u0639\u062a\u0645\u0627\u062f \u0645\u0639\u062a\u0631\u0641 \u0628\u0647\u0627 \u0644\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0627\u0644\u0634\u0647\u0627\u062f\u0629.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-who-needs-iso-13485-2016\">\u0645\u0646 \u064a\u062d\u062a\u0627\u062c \u0625\u0644\u0649 ISO 13485:2016\u061f<\/h2>\n\n\n\n<p>\u064a\u0633\u062a\u0647\u062f\u0641 \u0647\u0630\u0627 \u0627\u0644\u0645\u0639\u064a\u0627\u0631 \u062c\u0645\u064a\u0639 \u0627\u0644\u062c\u0647\u0627\u062a \u0627\u0644\u0639\u0627\u0645\u0644\u0629 \u0641\u064a \u0633\u0644\u0633\u0644\u0629 \u062a\u0648\u0631\u064a\u062f \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629\u060c \u0645\u062b\u0644:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-medical-device-manufacturers\">\u0627\u0644\u0634\u0631\u0643\u0627\u062a \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629<\/h3>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-medical-device-suppliers-and-distributors\">\u0645\u0648\u0631\u062f\u064a \u0648\u0645\u0648\u0632\u0639\u064a \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629<\/h3>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-sterilization-and-medical-service-companies\">\u0634\u0631\u0643\u0627\u062a \u0627\u0644\u062a\u0639\u0642\u064a\u0645 \u0648\u0627\u0644\u062e\u062f\u0645\u0627\u062a \u0627\u0644\u0637\u0628\u064a\u0629<\/h3>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-medical-design-and-development-companies\">\u0634\u0631\u0643\u0627\u062a \u0627\u0644\u062a\u0635\u0645\u064a\u0645 \u0648\u0627\u0644\u062a\u0637\u0648\u064a\u0631 \u0627\u0644\u0637\u0628\u064a<\/h3>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-frequently-asked-questions-about-iso-13485-2016\">\u0627\u0644\u0623\u0633\u0626\u0644\u0629 \u0627\u0644\u0634\u0627\u0626\u0639\u0629 \u062d\u0648\u0644 ISO 13485:2016<\/h2>\n\n\n\n<div class=\"schema-faq wp-block-yoast-faq-block\"><div class=\"schema-faq-section\" id=\"faq-question-1765645087867\"><strong class=\"schema-faq-question\">\u0645\u0627 \u0645\u062f\u0629 \u0635\u0644\u0627\u062d\u064a\u0629 \u0634\u0647\u0627\u062f\u0629 ISO 13485\u061f<\/strong> <p class=\"schema-faq-answer\">\u0639\u0627\u062f\u0629\u064b \u0645\u0627 \u062a\u0643\u0648\u0646 \u0635\u0644\u0627\u062d\u064a\u0629 \u0627\u0644\u0634\u0647\u0627\u062f\u0629 \u062b\u0644\u0627\u062b \u0633\u0646\u0648\u0627\u062a\u060c \u0645\u0639 \u0625\u062c\u0631\u0627\u0621 \u062a\u062f\u0642\u064a\u0642 \u0633\u0646\u0648\u064a \u0644\u0644\u0645\u0631\u0627\u0642\u0628\u0629.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1765645107100\"><strong class=\"schema-faq-question\">\u0647\u0644 ISO 13485 \u0625\u0644\u0632\u0627\u0645\u064a\u061f<\/strong> <p class=\"schema-faq-answer\">\u0641\u064a \u0628\u0639\u0636 \u0627\u0644\u062f\u0648\u0644 \u0648\u0627\u0644\u0642\u0637\u0627\u0639\u0627\u062a \u064a\u0639\u062a\u0628\u0631 \u0625\u0644\u0632\u0627\u0645\u064a\u064b\u0627\u060c \u0648\u0641\u064a \u062d\u0627\u0644\u0627\u062a \u0623\u062e\u0631\u0649 \u064a\u0643\u0648\u0646 \u0645\u062a\u0637\u0644\u0628\u064b\u0627 \u0623\u0633\u0627\u0633\u064a\u064b\u0627 \u0644\u062f\u062e\u0648\u0644 \u0627\u0644\u0633\u0648\u0642.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1765645121819\"><strong class=\"schema-faq-question\">\u0647\u0644 \u064a\u0645\u0643\u0646 \u0644\u0644\u0634\u0631\u0643\u0627\u062a \u0627\u0644\u0635\u063a\u064a\u0631\u0629 \u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 ISO 13485\u061f<\/strong> <p class=\"schema-faq-answer\">\u0646\u0639\u0645\u060c \u0627\u0644\u0645\u0639\u064a\u0627\u0631 \u0642\u0627\u0628\u0644 \u0644\u0644\u062a\u0637\u0628\u064a\u0642 \u0639\u0644\u0649 \u0627\u0644\u0634\u0631\u0643\u0627\u062a \u0628\u062c\u0645\u064a\u0639 \u0623\u062d\u062c\u0627\u0645\u0647\u0627 \u0637\u0627\u0644\u0645\u0627 \u0643\u0627\u0646\u062a \u062a\u0639\u0645\u0644 \u0641\u064a \u0645\u062c\u0627\u0644 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1765645136252\"><strong class=\"schema-faq-question\">\u0645\u0627 \u0627\u0644\u0641\u0631\u0642 \u0628\u064a\u0646 ISO 13485:2016 \u0648\u0627\u0644\u0625\u0635\u062f\u0627\u0631\u0627\u062a \u0627\u0644\u0633\u0627\u0628\u0642\u0629\u061f<\/strong> <p class=\"schema-faq-answer\">\u0625\u0635\u062f\u0627\u0631 2016 \u064a\u0631\u0643\u0632 \u0628\u0634\u0643\u0644 \u0623\u0643\u0628\u0631 \u0639\u0644\u0649 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u0645\u062e\u0627\u0637\u0631\u060c \u0648\u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a\u060c \u0648\u0627\u0644\u062a\u062d\u0643\u0645 \u0641\u064a \u0633\u0644\u0633\u0644\u0629 \u0627\u0644\u062a\u0648\u0631\u064a\u062f.<\/p> <\/div> <\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-conclusion\"><strong>\u0627\u0644\u062e\u0644\u0627\u0635\u0629<\/strong><\/h2>\n\n\n\n<p id=\"h-conclusion\">\u0645\u0639\u064a\u0627\u0631 ISO 13485:2016 \u0647\u0648 \u0645\u0639\u064a\u0627\u0631 \u062f\u0648\u0644\u064a \u0645\u062a\u062e\u0635\u0635 \u0641\u064a \u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u062c\u0648\u062f\u0629 \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629\u060c \u064a\u0647\u062f\u0641 \u0625\u0644\u0649 \u0636\u0645\u0627\u0646 \u0633\u0644\u0627\u0645\u0629 \u0648\u062c\u0648\u062f\u0629 \u0627\u0644\u0645\u0646\u062a\u062c\u0627\u062a \u0627\u0644\u0637\u0628\u064a\u0629 \u0648\u0627\u0644\u0627\u0644\u062a\u0632\u0627\u0645 \u0628\u0627\u0644\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a\u0629 \u0648\u0627\u0644\u0642\u0627\u0646\u0648\u0646\u064a\u0629. \u064a\u0633\u0627\u0639\u062f \u0647\u0630\u0627 \u0627\u0644\u0645\u0639\u064a\u0627\u0631 \u0627\u0644\u0634\u0631\u0643\u0627\u062a \u0639\u0644\u0649 \u062a\u062d\u0633\u064a\u0646 \u0627\u0644\u0639\u0645\u0644\u064a\u0627\u062a\u060c \u062a\u0642\u0644\u064a\u0644 \u0627\u0644\u0645\u062e\u0627\u0637\u0631\u060c \u062a\u0639\u0632\u064a\u0632 \u062b\u0642\u0629 \u0627\u0644\u0639\u0645\u0644\u0627\u0621\u060c \u0648\u062a\u0633\u0647\u064a\u0644 \u062f\u062e\u0648\u0644 \u0627\u0644\u0623\u0633\u0648\u0627\u0642 \u0627\u0644\u0645\u062d\u0644\u064a\u0629 \u0648\u0627\u0644\u0639\u0627\u0644\u0645\u064a\u0629. \u0648\u064a\u064f\u0639\u062f \u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0634\u0647\u0627\u062f\u0629 ISO 13485 \u062e\u0637\u0648\u0629 \u0623\u0633\u0627\u0633\u064a\u0629 \u0644\u0643\u0644 \u0645\u0624\u0633\u0633\u0629 \u062a\u0639\u0645\u0644 \u0641\u064a \u062a\u0635\u0646\u064a\u0639 \u0623\u0648 \u062a\u0648\u0631\u064a\u062f \u0623\u0648 \u062a\u0648\u0632\u064a\u0639 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0648\u062a\u0633\u0639\u0649 \u0625\u0644\u0649 \u0627\u0644\u062a\u0645\u064a\u0632 \u0648\u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0627\u0644\u062f\u0648\u0644\u064a.<br><\/p>","protected":false},"excerpt":{"rendered":"<p>What is ISO 13485:2016? The ISO 13485:2016 standard is an international standard that specifies the requirements for a Devices Quality Management System (DQMS) for companies and organizations involved in the design, development, manufacturing, distribution, and servicing of medical devices. The standard aims to ensure that medical products are safe, effective, and meet regulatory and legal [&hellip;]<\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":10,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-2478","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.0 (Yoast SEO v25.6) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>ISO 13485:2016 - QB Cert Saudi Arabia<\/title>\n<meta name=\"description\" content=\"ISO 13485:2016 is the globally recognized quality management system for medical devices, ensuring regulatory compliance.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/qbcert.sa\/ar\/\u062c\u0648\u062f\u0629-\u0627\u0644\u0635\u0646\u0627\u0639\u0627\u062a-\u0627\u0644\u0637\u0628\u064a\u0629\/\" \/>\n<meta property=\"og:locale\" content=\"ar_AR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 13485:2016\" \/>\n<meta property=\"og:description\" content=\"ISO 13485 is quality management systems in the medical devices industry. Implementing brings numerous benefits to organizations\" \/>\n<meta property=\"og:url\" content=\"https:\/\/qbcert.sa\/ar\/\u062c\u0648\u062f\u0629-\u0627\u0644\u0635\u0646\u0627\u0639\u0627\u062a-\u0627\u0644\u0637\u0628\u064a\u0629\/\" \/>\n<meta property=\"og:site_name\" content=\"QB Cert Saudi Arabia\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/qbcert\/\" \/>\n<meta property=\"article:modified_time\" content=\"2025-12-13T18:22:37+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/qbcert.sa\/wp-content\/uploads\/2023\/09\/qbcert-logo-200-200.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"200\" \/>\n\t<meta property=\"og:image:height\" content=\"200\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:description\" content=\"ISO 13485 is quality management systems in the medical devices industry. Implementing brings numerous benefits to organizations\" \/>\n<meta name=\"twitter:site\" content=\"@qbcert\" \/>\n<meta name=\"twitter:label1\" content=\"\u0648\u0642\u062a \u0627\u0644\u0642\u0631\u0627\u0621\u0629 \u0627\u0644\u0645\u064f\u0642\u062f\u0651\u0631\" \/>\n\t<meta name=\"twitter:data1\" content=\"3 \u062f\u0642\u0627\u0626\u0642\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":[\"WebPage\",\"FAQPage\"],\"@id\":\"https:\/\/qbcert.sa\/iso-13485-2016\/\",\"url\":\"https:\/\/qbcert.sa\/iso-13485-2016\/\",\"name\":\"ISO 13485:2016 - QB Cert Saudi Arabia\",\"isPartOf\":{\"@id\":\"https:\/\/qbcert.sa\/#website\"},\"datePublished\":\"2023-09-01T15:40:08+00:00\",\"dateModified\":\"2025-12-13T18:22:37+00:00\",\"description\":\"ISO 13485:2016 is the globally recognized quality management system for medical devices, ensuring regulatory compliance.\",\"breadcrumb\":{\"@id\":\"https:\/\/qbcert.sa\/iso-13485-2016\/#breadcrumb\"},\"mainEntity\":[{\"@id\":\"https:\/\/qbcert.sa\/iso-13485-2016\/#faq-question-1765645087867\"},{\"@id\":\"https:\/\/qbcert.sa\/iso-13485-2016\/#faq-question-1765645107100\"},{\"@id\":\"https:\/\/qbcert.sa\/iso-13485-2016\/#faq-question-1765645121819\"},{\"@id\":\"https:\/\/qbcert.sa\/iso-13485-2016\/#faq-question-1765645136252\"}],\"inLanguage\":\"ar\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/qbcert.sa\/iso-13485-2016\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/qbcert.sa\/iso-13485-2016\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/qbcert.sa\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"ISO 13485:2016\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/qbcert.sa\/#website\",\"url\":\"https:\/\/qbcert.sa\/\",\"name\":\"QB Cert Saudi Arabia\",\"description\":\"QB Cert ISO certification Body in Saudi Arabia\",\"publisher\":{\"@id\":\"https:\/\/qbcert.sa\/#organization\"},\"alternateName\":\"QB Cert ISO certification Body\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/qbcert.sa\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"ar\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/qbcert.sa\/#organization\",\"name\":\"QB cert ISO certification Body Saudi Arabia\",\"alternateName\":\"QB cert Saudi Arabia\",\"url\":\"https:\/\/qbcert.sa\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"ar\",\"@id\":\"https:\/\/qbcert.sa\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/qbcert.sa\/wp-content\/uploads\/2024\/09\/qb-cert-logo.webp\",\"contentUrl\":\"https:\/\/qbcert.sa\/wp-content\/uploads\/2024\/09\/qb-cert-logo.webp\",\"width\":350,\"height\":350,\"caption\":\"QB cert ISO certification Body Saudi Arabia\"},\"image\":{\"@id\":\"https:\/\/qbcert.sa\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.facebook.com\/qbcert\/\",\"https:\/\/x.com\/qbcert\",\"https:\/\/www.linkedin.com\/company\/qbcert\/\"],\"description\":\"\u0643\u064a\u0648 \u0628\u064a \u0633\u064a\u0631\u062a \u0634\u0631\u0643\u0629 \u062a\u0639\u0645\u0644 \u0641\u064a \u0645\u062c\u0627\u0644 \u0645\u0646\u062d \u0634\u0647\u0627\u062f\u0627\u062a \u0627\u0644\u062c\u0648\u062f\u0629 \u0627\u0644\u0639\u0627\u0644\u0645\u064a\u0629 \u0645\u062b\u0644 ISO 9001 \u0648 ISO 14001 \u0648 ISO 45001 \u0648 ISO 22000 \u0648\u062a\u0639\u0645\u0644 \u0641\u064a \u0645\u062c\u0627\u0644 \u0627\u0644\u062a\u062f\u0631\u064a\u0628 \u0648\u0645\u0639\u062a\u0645\u062f\u0629 \u0645\u0646 \u0627\u0644\u0645\u0644\u062c\u0633 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a \u0644\u0644\u0623\u0639\u062a\u0645\u0627\u062f UAF\",\"email\":\"info@qbcert.sa\",\"telephone\":\"+966562394701\",\"legalName\":\"QB Cert Saudi Arabia\",\"foundingDate\":\"2023-05-25\",\"numberOfEmployees\":{\"@type\":\"QuantitativeValue\",\"minValue\":\"51\",\"maxValue\":\"200\"}},{\"@type\":\"Question\",\"@id\":\"https:\/\/qbcert.sa\/iso-13485-2016\/#faq-question-1765645087867\",\"position\":1,\"url\":\"https:\/\/qbcert.sa\/iso-13485-2016\/#faq-question-1765645087867\",\"name\":\"What is the validity period of the ISO 13485 certificate?\",\"answerCount\":1,\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"The certificate is usually valid for three years, with annual surveillance audits conducted.\",\"inLanguage\":\"ar\"},\"inLanguage\":\"ar\"},{\"@type\":\"Question\",\"@id\":\"https:\/\/qbcert.sa\/iso-13485-2016\/#faq-question-1765645107100\",\"position\":2,\"url\":\"https:\/\/qbcert.sa\/iso-13485-2016\/#faq-question-1765645107100\",\"name\":\"Is ISO 13485 mandatory?\",\"answerCount\":1,\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"In some countries and sectors it is mandatory, while in others it is a key requirement for market access.\",\"inLanguage\":\"ar\"},\"inLanguage\":\"ar\"},{\"@type\":\"Question\",\"@id\":\"https:\/\/qbcert.sa\/iso-13485-2016\/#faq-question-1765645121819\",\"position\":3,\"url\":\"https:\/\/qbcert.sa\/iso-13485-2016\/#faq-question-1765645121819\",\"name\":\"Can small companies obtain ISO 13485?\",\"answerCount\":1,\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes, the standard is applicable to companies of all sizes as long as they operate in the medical device field.\",\"inLanguage\":\"ar\"},\"inLanguage\":\"ar\"},{\"@type\":\"Question\",\"@id\":\"https:\/\/qbcert.sa\/iso-13485-2016\/#faq-question-1765645136252\",\"position\":4,\"url\":\"https:\/\/qbcert.sa\/iso-13485-2016\/#faq-question-1765645136252\",\"name\":\"What is the difference between ISO 13485:2016 and previous versions?\",\"answerCount\":1,\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"The 2016 edition places greater emphasis on risk management, regulatory compliance, and supply chain control.\",\"inLanguage\":\"ar\"},\"inLanguage\":\"ar\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"ISO 13485:2016 - QB Cert Saudi Arabia","description":"ISO 13485:2016 is the globally recognized quality management system for medical devices, ensuring regulatory compliance.","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:\/\/qbcert.sa\/ar\/\u062c\u0648\u062f\u0629-\u0627\u0644\u0635\u0646\u0627\u0639\u0627\u062a-\u0627\u0644\u0637\u0628\u064a\u0629\/","og_locale":"ar_AR","og_type":"article","og_title":"ISO 13485:2016","og_description":"ISO 13485 is quality management systems in the medical devices industry. Implementing brings numerous benefits to organizations","og_url":"https:\/\/qbcert.sa\/ar\/\u062c\u0648\u062f\u0629-\u0627\u0644\u0635\u0646\u0627\u0639\u0627\u062a-\u0627\u0644\u0637\u0628\u064a\u0629\/","og_site_name":"QB Cert Saudi Arabia","article_publisher":"https:\/\/www.facebook.com\/qbcert\/","article_modified_time":"2025-12-13T18:22:37+00:00","og_image":[{"width":200,"height":200,"url":"https:\/\/qbcert.sa\/wp-content\/uploads\/2023\/09\/qbcert-logo-200-200.jpg","type":"image\/jpeg"}],"twitter_card":"summary_large_image","twitter_description":"ISO 13485 is quality management systems in the medical devices industry. Implementing brings numerous benefits to organizations","twitter_site":"@qbcert","twitter_misc":{"\u0648\u0642\u062a \u0627\u0644\u0642\u0631\u0627\u0621\u0629 \u0627\u0644\u0645\u064f\u0642\u062f\u0651\u0631":"3 \u062f\u0642\u0627\u0626\u0642"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":["WebPage","FAQPage"],"@id":"https:\/\/qbcert.sa\/iso-13485-2016\/","url":"https:\/\/qbcert.sa\/iso-13485-2016\/","name":"ISO 13485:2016 - QB Cert Saudi Arabia","isPartOf":{"@id":"https:\/\/qbcert.sa\/#website"},"datePublished":"2023-09-01T15:40:08+00:00","dateModified":"2025-12-13T18:22:37+00:00","description":"ISO 13485:2016 is the globally recognized quality management system for medical devices, ensuring regulatory compliance.","breadcrumb":{"@id":"https:\/\/qbcert.sa\/iso-13485-2016\/#breadcrumb"},"mainEntity":[{"@id":"https:\/\/qbcert.sa\/iso-13485-2016\/#faq-question-1765645087867"},{"@id":"https:\/\/qbcert.sa\/iso-13485-2016\/#faq-question-1765645107100"},{"@id":"https:\/\/qbcert.sa\/iso-13485-2016\/#faq-question-1765645121819"},{"@id":"https:\/\/qbcert.sa\/iso-13485-2016\/#faq-question-1765645136252"}],"inLanguage":"ar","potentialAction":[{"@type":"ReadAction","target":["https:\/\/qbcert.sa\/iso-13485-2016\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/qbcert.sa\/iso-13485-2016\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/qbcert.sa\/"},{"@type":"ListItem","position":2,"name":"ISO 13485:2016"}]},{"@type":"WebSite","@id":"https:\/\/qbcert.sa\/#website","url":"https:\/\/qbcert.sa\/","name":"QB Cert Saudi Arabia","description":"QB Cert ISO certification Body in Saudi Arabia","publisher":{"@id":"https:\/\/qbcert.sa\/#organization"},"alternateName":"QB Cert ISO certification Body","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/qbcert.sa\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"ar"},{"@type":"Organization","@id":"https:\/\/qbcert.sa\/#organization","name":"QB cert ISO certification Body Saudi Arabia","alternateName":"QB cert Saudi Arabia","url":"https:\/\/qbcert.sa\/","logo":{"@type":"ImageObject","inLanguage":"ar","@id":"https:\/\/qbcert.sa\/#\/schema\/logo\/image\/","url":"https:\/\/qbcert.sa\/wp-content\/uploads\/2024\/09\/qb-cert-logo.webp","contentUrl":"https:\/\/qbcert.sa\/wp-content\/uploads\/2024\/09\/qb-cert-logo.webp","width":350,"height":350,"caption":"QB cert ISO certification Body Saudi Arabia"},"image":{"@id":"https:\/\/qbcert.sa\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/qbcert\/","https:\/\/x.com\/qbcert","https:\/\/www.linkedin.com\/company\/qbcert\/"],"description":"\u0643\u064a\u0648 \u0628\u064a \u0633\u064a\u0631\u062a \u0634\u0631\u0643\u0629 \u062a\u0639\u0645\u0644 \u0641\u064a \u0645\u062c\u0627\u0644 \u0645\u0646\u062d \u0634\u0647\u0627\u062f\u0627\u062a \u0627\u0644\u062c\u0648\u062f\u0629 \u0627\u0644\u0639\u0627\u0644\u0645\u064a\u0629 \u0645\u062b\u0644 ISO 9001 \u0648 ISO 14001 \u0648 ISO 45001 \u0648 ISO 22000 \u0648\u062a\u0639\u0645\u0644 \u0641\u064a \u0645\u062c\u0627\u0644 \u0627\u0644\u062a\u062f\u0631\u064a\u0628 \u0648\u0645\u0639\u062a\u0645\u062f\u0629 \u0645\u0646 \u0627\u0644\u0645\u0644\u062c\u0633 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a \u0644\u0644\u0623\u0639\u062a\u0645\u0627\u062f UAF","email":"info@qbcert.sa","telephone":"+966562394701","legalName":"QB Cert Saudi Arabia","foundingDate":"2023-05-25","numberOfEmployees":{"@type":"QuantitativeValue","minValue":"51","maxValue":"200"}},{"@type":"Question","@id":"https:\/\/qbcert.sa\/iso-13485-2016\/#faq-question-1765645087867","position":1,"url":"https:\/\/qbcert.sa\/iso-13485-2016\/#faq-question-1765645087867","name":"What is the validity period of the ISO 13485 certificate?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"The certificate is usually valid for three years, with annual surveillance audits conducted.","inLanguage":"ar"},"inLanguage":"ar"},{"@type":"Question","@id":"https:\/\/qbcert.sa\/iso-13485-2016\/#faq-question-1765645107100","position":2,"url":"https:\/\/qbcert.sa\/iso-13485-2016\/#faq-question-1765645107100","name":"Is ISO 13485 mandatory?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"In some countries and sectors it is mandatory, while in others it is a key requirement for market access.","inLanguage":"ar"},"inLanguage":"ar"},{"@type":"Question","@id":"https:\/\/qbcert.sa\/iso-13485-2016\/#faq-question-1765645121819","position":3,"url":"https:\/\/qbcert.sa\/iso-13485-2016\/#faq-question-1765645121819","name":"Can small companies obtain ISO 13485?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"Yes, the standard is applicable to companies of all sizes as long as they operate in the medical device field.","inLanguage":"ar"},"inLanguage":"ar"},{"@type":"Question","@id":"https:\/\/qbcert.sa\/iso-13485-2016\/#faq-question-1765645136252","position":4,"url":"https:\/\/qbcert.sa\/iso-13485-2016\/#faq-question-1765645136252","name":"What is the difference between ISO 13485:2016 and previous versions?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"The 2016 edition places greater emphasis on risk management, regulatory compliance, and supply chain control.","inLanguage":"ar"},"inLanguage":"ar"}]}},"_links":{"self":[{"href":"https:\/\/qbcert.sa\/ar\/wp-json\/wp\/v2\/pages\/2478","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/qbcert.sa\/ar\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/qbcert.sa\/ar\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/qbcert.sa\/ar\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/qbcert.sa\/ar\/wp-json\/wp\/v2\/comments?post=2478"}],"version-history":[{"count":0,"href":"https:\/\/qbcert.sa\/ar\/wp-json\/wp\/v2\/pages\/2478\/revisions"}],"wp:attachment":[{"href":"https:\/\/qbcert.sa\/ar\/wp-json\/wp\/v2\/media?parent=2478"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}