{"id":2478,"date":"2023-09-01T15:40:08","date_gmt":"2023-09-01T15:40:08","guid":{"rendered":"https:\/\/qb.com.eg\/?page_id=2478"},"modified":"2026-01-01T14:51:37","modified_gmt":"2026-01-01T14:51:37","slug":"iso-13485-2016","status":"publish","type":"page","link":"https:\/\/qb.com.eg\/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>ISO 13485:2016 \u0647\u0648 \u0645\u0639\u064a\u0627\u0631 \u062f\u0648\u0644\u064a \u0635\u0627\u062f\u0631 \u0639\u0646 \u0627\u0644\u0645\u0646\u0638\u0645\u0629 \u0627\u0644\u062f\u0648\u0644\u064a\u0629 \u0644\u0644\u062a\u0648\u062d\u064a\u062f \u0627\u0644\u0642\u064a\u0627\u0633\u064a (ISO). \u0648\u0647\u0648 \u064a\u0648\u0641\u0631 \u0625\u0637\u0627\u0631\u064b\u0627 \u0634\u0627\u0645\u0644\u0627\u064b \u0644\u062a\u0637\u0628\u064a\u0642 \u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u062c\u0648\u062f\u0629 \u0627\u0644\u0645\u0635\u0645\u0645 \u062e\u0635\u064a\u0635\u064b\u0627 \u0644\u0635\u0646\u0627\u0639\u0629 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629.<br>\u064a\u0647\u062f\u0641 \u0627\u0644\u0645\u0639\u064a\u0627\u0631 \u0625\u0644\u0649 \u0636\u0645\u0627\u0646 \u0627\u0633\u062a\u064a\u0641\u0627\u0621 \u0627\u0644\u0645\u0646\u062a\u062c\u0627\u062a \u0627\u0644\u0637\u0628\u064a\u0629 \u0644\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\u060c \u0645\u0639 \u0627\u0644\u062a\u0631\u0643\u064a\u0632 \u0628\u0634\u0643\u0644 \u0643\u0628\u064a\u0631 \u0639\u0644\u0649 \u0633\u0644\u0627\u0645\u0629 \u0627\u0644\u0645\u0631\u0636\u0649 \u0648\u0641\u0639\u0627\u0644\u064a\u0629 \u0627\u0644\u0645\u0646\u062a\u062c \u0627\u0644\u0645\u0633\u062a\u0645\u0631\u0629.<\/p>\n\n\n\n<p>\u064a\u062e\u062a\u0644\u0641 \u0647\u0630\u0627 \u0627\u0644\u0645\u0639\u064a\u0627\u0631 \u0639\u0646 \u0645\u0639\u064a\u0627\u0631 ISO 9001 \u0641\u064a \u0623\u0646\u0647 \u0645\u0635\u0645\u0645 \u062e\u0635\u064a\u0635\u064b\u0627 \u0644\u0642\u0637\u0627\u0639 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629\u060c \u0645\u0639 \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0623\u0643\u062b\u0631 \u0635\u0631\u0627\u0645\u0629 \u062a\u062a\u0639\u0644\u0642 \u0628\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u0645\u062e\u0627\u0637\u0631 \u0648\u0627\u0644\u062a\u062a\u0628\u0639 \u0648\u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-importance-of-iso-13485-2016-for-companies\">\u0623\u0647\u0645\u064a\u0629 ISO 13485:2016 \u0644\u0644\u0634\u0631\u0643\u0627\u062a<\/h2>\n\n\n\n<p>\u062a\u0637\u0628\u064a\u0642 ISO 13485:2016 \u064a\u0645\u0646\u062d \u0627\u0644\u0645\u0624\u0633\u0633\u0627\u062a \u0627\u0644\u0639\u062f\u064a\u062f \u0645\u0646 \u0627\u0644\u0645\u0632\u0627\u064a\u0627 \u0627\u0644\u062a\u0646\u0627\u0641\u0633\u064a\u0629 \u0648\u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a\u0629\u060c \u0645\u0646 \u0623\u0647\u0645\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\u0639\u062f \u0627\u0644\u0645\u0639\u064a\u0627\u0631 \u0627\u0644\u0634\u0631\u0643\u0627\u062a \u0639\u0644\u0649 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u0647\u064a\u0626\u0627\u062a \u0627\u0644\u0631\u0642\u0627\u0628\u064a\u0629 \u0645\u062b\u0644 FDA \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629 \u0648\u0627\u0644\u0644\u0648\u0627\u0626\u062d \u0627\u0644\u0623\u0648\u0631\u0648\u0628\u064a\u0629 \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629.<\/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\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629<\/h3>\n\n\n\n<p>\u064a\u0633\u0627\u0647\u0645 \u0641\u064a \u062a\u0642\u0644\u064a\u0644 \u0627\u0644\u0639\u064a\u0648\u0628 \u0648\u0627\u0644\u0623\u062e\u0637\u0627\u0621 \u0645\u0646 \u062e\u0644\u0627\u0644 \u062a\u0648\u062d\u064a\u062f \u0627\u0644\u0639\u0645\u0644\u064a\u0627\u062a \u0648\u062a\u062d\u0633\u064a\u0646 \u0627\u0644\u0631\u0642\u0627\u0628\u0629 \u0639\u0644\u0649 \u0645\u0631\u0627\u062d\u0644 \u0627\u0644\u0625\u0646\u062a\u0627\u062c.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-enhancing-customer-confidence\">\u062a\u0639\u0632\u064a\u0632 \u062b\u0642\u0629 \u0627\u0644\u0639\u0645\u0644\u0627\u0621<\/h3>\n\n\n\n<p>\u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0634\u0647\u0627\u062f\u0629 ISO 13485 \u064a\u0639\u0632\u0632 \u062b\u0642\u0629 \u0627\u0644\u0639\u0645\u0644\u0627\u0621 \u0648\u0627\u0644\u0634\u0631\u0643\u0627\u0621 \u0641\u064a \u062c\u0648\u062f\u0629 \u0627\u0644\u0645\u0646\u062a\u062c\u0627\u062a \u0648\u0633\u0644\u0627\u0645\u062a\u0647\u0627.<\/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 \u0634\u0631\u0637\u064b\u0627 \u0623\u0633\u0627\u0633\u064a\u064b\u0627 \u0623\u0648 \u0645\u064a\u0632\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-core-requirements-of-iso-13485-2016\">\u0645\u062a\u0637\u0644\u0628\u0627\u062a ISO 13485:2016 \u0627\u0644\u0623\u0633\u0627\u0633\u064a\u0629<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-quality-management-system\">\u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u062c\u0648\u062f\u0629<\/h3>\n\n\n\n<p>\u064a\u062c\u0628 \u0639\u0644\u0649 \u0627\u0644\u0645\u0624\u0633\u0633\u0629 \u0625\u0646\u0634\u0627\u0621 \u0648\u062a\u0648\u062b\u064a\u0642 \u0646\u0638\u0627\u0645 \u0625\u062f\u0627\u0631\u0629 \u062c\u0648\u062f\u0629 \u0641\u0639\u0627\u0644 \u064a\u063a\u0637\u064a \u062c\u0645\u064a\u0639 \u0627\u0644\u0639\u0645\u0644\u064a\u0627\u062a \u0627\u0644\u0645\u0624\u062b\u0631\u0629 \u0639\u0644\u0649 \u062c\u0648\u062f\u0629 \u0627\u0644\u062c\u0647\u0627\u0632 \u0627\u0644\u0637\u0628\u064a.<\/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>\u064a\u062a\u0637\u0644\u0628 \u0627\u0644\u0645\u0639\u064a\u0627\u0631 \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 \u0637\u0648\u0627\u0644 \u062f\u0648\u0631\u0629 \u062d\u064a\u0627\u0629 \u0627\u0644\u0645\u0646\u062a\u062c\u060c \u0628\u062f\u0621\u064b\u0627 \u0645\u0646 \u0627\u0644\u062a\u0635\u0645\u064a\u0645 \u0648\u062d\u062a\u0649 \u0645\u0627 \u0628\u0639\u062f \u0627\u0644\u062a\u0633\u0648\u064a\u0642.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-design-and-development-control\">\u0627\u0644\u062a\u062d\u0643\u0645 \u0641\u064a \u0627\u0644\u062a\u0635\u0645\u064a\u0645 \u0648\u0627\u0644\u062a\u0637\u0648\u064a\u0631<\/h3>\n\n\n\n<p>\u064a\u0634\u0645\u0644 \u0630\u0644\u0643 \u0627\u0644\u062a\u062e\u0637\u064a\u0637\u060c \u0648\u0627\u0644\u062a\u062d\u0642\u0642\u060c \u0648\u0627\u0644\u062a\u0635\u062f\u064a\u0642\u060c \u0648\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u062a\u063a\u064a\u064a\u0631\u0627\u062a \u0627\u0644\u062a\u0635\u0645\u064a\u0645\u064a\u0629 \u0628\u0634\u0643\u0644 \u062f\u0642\u064a\u0642.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-traceability-and-product-records\">\u0627\u0644\u062a\u062a\u0628\u0639 \u0648\u0633\u062c\u0644\u0627\u062a \u0627\u0644\u0645\u0646\u062a\u062c<\/h3>\n\n\n\n<p>\u064a\u0634\u062f\u062f \u0627\u0644\u0645\u0639\u064a\u0627\u0631 \u0639\u0644\u0649 \u0623\u0647\u0645\u064a\u0629 \u0627\u0644\u062a\u062a\u0628\u0639 \u0627\u0644\u0643\u0627\u0645\u0644 \u0644\u0644\u0645\u0646\u062a\u062c\u0627\u062a \u0648\u0633\u062c\u0644\u0627\u062a \u0627\u0644\u062f\u064f\u0641\u0639\u0627\u062a \u0644\u0636\u0645\u0627\u0646 \u0633\u0647\u0648\u0644\u0629 \u0627\u0644\u0633\u062d\u0628 \u0639\u0646\u062f \u0627\u0644\u062d\u0627\u062c\u0629.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-supplier-control\">\u0627\u0644\u0631\u0642\u0627\u0628\u0629 \u0639\u0644\u0649 \u0627\u0644\u0645\u0648\u0631\u062f\u064a\u0646<\/h3>\n\n\n\n<p>\u064a\u062c\u0628 \u062a\u0642\u064a\u064a\u0645 \u0627\u0644\u0645\u0648\u0631\u062f\u064a\u0646 \u0648\u0645\u0631\u0627\u0642\u0628\u0629 \u0623\u062f\u0627\u0626\u0647\u0645 \u0644\u0636\u0645\u0627\u0646 \u062c\u0648\u062f\u0629 \u0627\u0644\u0645\u0648\u0627\u062f \u0648\u0627\u0644\u062e\u062f\u0645\u0627\u062a \u0627\u0644\u0645\u0642\u062f\u0645\u0629.<\/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<h3 class=\"wp-block-heading\" id=\"h-application-form-submission\">\u062a\u0639\u0628\u0626\u0629 \u0627\u0644\u0646\u0645\u0648\u0630\u062c<\/h3>\n\n\n\n<p>\u062a\u0628\u062f\u0623 \u0639\u0645\u0644\u064a\u0629 \u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0634\u0647\u0627\u062f\u0629 ISO 13485:2016 \u0628\u062a\u0639\u0628\u0626\u0629 \u0646\u0645\u0648\u0630\u062c \u0637\u0644\u0628 \u0627\u0644\u0634\u0647\u0627\u062f\u0629 \u0644\u062f\u0649 \u062c\u0647\u0629 \u0645\u0646\u062d \u0627\u0644\u0634\u0647\u0627\u062f\u0627\u062a. \u064a\u062a\u0636\u0645\u0646 \u0647\u0630\u0627 \u0627\u0644\u0646\u0645\u0648\u0630\u062c \u0645\u0639\u0644\u0648\u0645\u0627\u062a \u0623\u0633\u0627\u0633\u064a\u0629 \u0639\u0646 \u0627\u0644\u0645\u0646\u0638\u0645\u0629\u060c \u0645\u062b\u0644 \u0637\u0628\u064a\u0639\u0629 \u0623\u0646\u0634\u0637\u062a\u0647\u0627\u060c \u0648\u0639\u062f\u062f \u0645\u0648\u0638\u0641\u064a\u0647\u0627\u060c \u0648\u0645\u0648\u0627\u0642\u0639\u0647\u0627\u060c \u0648\u0646\u0637\u0627\u0642 \u0646\u0638\u0627\u0645 \u0627\u0644\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u0628\u064a\u0626\u064a\u0629 \u0627\u0644\u0645\u0637\u0644\u0648\u0628 \u0627\u0639\u062a\u0645\u0627\u062f\u0647.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u0625\u0639\u062f\u0627\u062f \u062e\u0637\u0629 \u0627\u0644\u062a\u062f\u0642\u064a\u0642 (Audit Plan)<\/h3>\n\n\n\n<p>\u0628\u0639\u062f \u0645\u0631\u0627\u062c\u0639\u0629 \u0627\u0644\u0646\u0645\u0648\u0630\u062c\u060c \u064a\u062a\u0645 \u0625\u0639\u062f\u0627\u062f \u062e\u0637\u0629 \u0627\u0644\u062a\u062f\u0642\u064a\u0642 \u0648\u0627\u0644\u062a\u064a \u062a\u0648\u0636\u062d \u0645\u0648\u0627\u0639\u064a\u062f \u0627\u0644\u062a\u062f\u0642\u064a\u0642\u060c \u0646\u0637\u0627\u0642\u0647\u060c \u0627\u0644\u0639\u0645\u0644\u064a\u0627\u062a \u0627\u0644\u0645\u0634\u0645\u0648\u0644\u0629\u060c \u0648\u0623\u0633\u0645\u0627\u0621 \u0641\u0631\u064a\u0642 \u0627\u0644\u062a\u062f\u0642\u064a\u0642. \u062a\u0647\u062f\u0641 \u0647\u0630\u0647 \u0627\u0644\u062e\u0637\u0629 \u0625\u0644\u0649 \u062a\u0646\u0638\u064a\u0645 \u0639\u0645\u0644\u064a\u0629 \u0627\u0644\u0645\u0631\u0627\u062c\u0639\u0629 \u0648\u0636\u0645\u0627\u0646 \u062a\u063a\u0637\u064a\u0629 \u062c\u0645\u064a\u0639 \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u0645\u0639\u064a\u0627\u0631.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u0627\u0644\u062a\u062f\u0642\u064a\u0642 \u2013 \u0627\u0644\u0645\u0631\u062d\u0644\u0629 \u0627\u0644\u0623\u0648\u0644\u0649 (Audit Stage 1)<\/h3>\n\n\n\n<p>\u062a\u0647\u062f\u0641 \u0627\u0644\u0645\u0631\u062d\u0644\u0629 \u0627\u0644\u0623\u0648\u0644\u0649 \u0645\u0646 \u0627\u0644\u062a\u062f\u0642\u064a\u0642 \u0625\u0644\u0649 \u062a\u0642\u064a\u064a\u0645 \u062c\u0627\u0647\u0632\u064a\u0629 \u0627\u0644\u0645\u0646\u0638\u0645\u0629 \u0644\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0627\u0644\u0634\u0647\u0627\u062f\u0629. \u0648\u062a\u0634\u0645\u0644 \u0647\u0630\u0647 \u0627\u0644\u0645\u0631\u062d\u0644\u0629 \u0645\u0631\u0627\u062c\u0639\u0629 \u0627\u0644\u0648\u062b\u0627\u0626\u0642 \u0648\u0627\u0644\u0633\u064a\u0627\u0633\u0627\u062a \u0627\u0644\u0628\u064a\u0626\u064a\u0629\u060c \u0648\u0627\u0644\u062a\u062d\u0642\u0642 \u0645\u0646 \u0641\u0647\u0645 \u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0645\u0639\u064a\u0627\u0631 ISO 13485:2016\u060c \u0648\u0627\u0644\u062a\u0623\u0643\u062f \u0645\u0646 \u062a\u0637\u0628\u064a\u0642\u0647\u0627 \u0627\u0644\u0623\u0648\u0644\u064a\u060c \u0645\u0639 \u062a\u062d\u062f\u064a\u062f \u0623\u064a \u062b\u063a\u0631\u0627\u062a \u064a\u062c\u0628 \u0645\u0639\u0627\u0644\u062c\u062a\u0647\u0627 \u0642\u0628\u0644 \u0627\u0644\u0627\u0646\u062a\u0642\u0627\u0644 \u0625\u0644\u0649 \u0627\u0644\u0645\u0631\u062d\u0644\u0629 \u0627\u0644\u062a\u0627\u0644\u064a\u0629.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u0627\u0644\u062a\u062f\u0642\u064a\u0642 \u2013 \u0627\u0644\u0645\u0631\u062d\u0644\u0629 \u0627\u0644\u062b\u0627\u0646\u064a\u0629 (Audit Stage 2)<\/h3>\n\n\n\n<p>\u0641\u064a \u0647\u0630\u0647 \u0627\u0644\u0645\u0631\u062d\u0644\u0629\u060c \u062a\u064f\u062c\u0631\u0649 \u0639\u0645\u0644\u064a\u0629 \u062a\u062f\u0642\u064a\u0642 \u0645\u064a\u062f\u0627\u0646\u064a\u0629\u060c \u062d\u064a\u062b \u064a\u0631\u0627\u062c\u0639 \u0627\u0644\u0645\u062f\u0642\u0642\u0648\u0646 \u0627\u0644\u062a\u0637\u0628\u064a\u0642 \u0627\u0644\u0641\u0639\u0644\u064a \u0644\u0646\u0638\u0627\u0645 \u0627\u0644\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u0628\u064a\u0626\u064a\u0629 \u062f\u0627\u062e\u0644 \u0627\u0644\u0645\u0646\u0638\u0645\u0629\u060c \u0648\u064a\u062a\u062d\u0642\u0642\u0648\u0646 \u0645\u0646 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0627\u0644\u0643\u0627\u0645\u0644 \u0644\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0645\u0639\u064a\u0627\u0631 ISO 13485:2016. \u0648\u0641\u064a \u062d\u0627\u0644 \u0639\u062f\u0645 \u0648\u062c\u0648\u062f \u0623\u064a \u0645\u062e\u0627\u0644\u0641\u0627\u062a \u062c\u0648\u0647\u0631\u064a\u0629\u060c \u0623\u0648 \u0628\u0639\u062f \u0645\u0639\u0627\u0644\u062c\u062a\u0647\u0627\u060c \u062a\u064f\u0642\u062f\u0651\u0645 \u062a\u0648\u0635\u064a\u0629 \u0628\u0645\u0646\u062d \u0627\u0644\u0634\u0647\u0627\u062f\u0629.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-who-needs-to-implement-iso-13485-2016\">\u0645\u0646 \u064a\u062d\u062a\u0627\u062c \u0625\u0644\u0649 \u062a\u0637\u0628\u064a\u0642 ISO 13485:2016\u061f<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u0645\u0635\u0646\u0651\u0639\u0648 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629<\/li>\n\n\n\n<li>\u0634\u0631\u0643\u0627\u062a \u062a\u0635\u0645\u064a\u0645 \u0648\u062a\u0637\u0648\u064a\u0631 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629<\/li>\n\n\n\n<li>\u0645\u0648\u0631\u0651\u062f\u0648 \u0648\u0645\u0648\u0632\u0639\u0648 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629<\/li>\n\n\n\n<li>\u0634\u0631\u0643\u0627\u062a \u0627\u0644\u0635\u064a\u0627\u0646\u0629 \u0648\u0627\u0644\u062a\u0639\u0642\u064a\u0645<\/li>\n\n\n\n<li>\u0645\u0642\u062f\u0645\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<\/li>\n<\/ul>\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-1767278241670\"><strong class=\"schema-faq-question\"><strong>\u0645\u0627 \u0627\u0644\u0641\u0631\u0642 \u0628\u064a\u0646 ISO 13485 \u0648ISO 9001\u061f<\/strong><\/strong> <p class=\"schema-faq-answer\">ISO 13485 \u0645\u062e\u0635\u0635 \u0644\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0648\u064a\u0631\u0643\u0632 \u0639\u0644\u0649 \u0627\u0644\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a\u0629 \u0648\u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u0645\u062e\u0627\u0637\u0631\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 \u0645\u062e\u062a\u0644\u0641 \u0627\u0644\u0642\u0637\u0627\u0639\u0627\u062a.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1767278257303\"><strong class=\"schema-faq-question\"><strong>\u0647\u0644 \u0634\u0647\u0627\u062f\u0629 ISO 13485 \u0625\u0644\u0632\u0627\u0645\u064a\u0629\u061f<\/strong><\/strong> <p class=\"schema-faq-answer\">\u0644\u064a\u0633\u062a \u0625\u0644\u0632\u0627\u0645\u064a\u0629 \u0641\u064a \u062c\u0645\u064a\u0639 \u0627\u0644\u062f\u0648\u0644\u060c \u0644\u0643\u0646\u0647\u0627 \u063a\u0627\u0644\u0628\u064b\u0627 \u0645\u0637\u0644\u0648\u0628\u0629 \u0623\u0648 \u0645\u0639\u062a\u0631\u0641 \u0628\u0647\u0627 \u0645\u0646 \u0642\u0628\u0644 \u0627\u0644\u062c\u0647\u0627\u062a \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a\u0629 \u0648\u0627\u0644\u0623\u0633\u0648\u0627\u0642 \u0627\u0644\u0639\u0627\u0644\u0645\u064a\u0629.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1767278275366\"><strong class=\"schema-faq-question\"><strong>\u0643\u0645 \u0645\u062f\u0629 \u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0634\u0647\u0627\u062f\u0629 ISO 13485:2016\u061f<\/strong><\/strong> <p class=\"schema-faq-answer\">\u062a\u062e\u062a\u0644\u0641 \u0627\u0644\u0645\u062f\u0629 \u062d\u0633\u0628 \u062d\u062c\u0645 \u0627\u0644\u0645\u0624\u0633\u0633\u0629 \u0648\u062c\u0627\u0647\u0632\u064a\u062a\u0647\u0627\u060c \u0648\u063a\u0627\u0644\u0628\u064b\u0627 \u062a\u062a\u0631\u0627\u0648\u062d \u0628\u064a\u0646 3 \u0625\u0644\u0649 6 \u0623\u064a\u0627\u0645<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1767278290648\"><strong class=\"schema-faq-question\"><strong>\u0647\u0644 \u064a\u0645\u0643\u0646 \u0644\u0644\u0634\u0631\u0643\u0627\u062a \u0627\u0644\u0635\u063a\u064a\u0631\u0629 \u062a\u0637\u0628\u064a\u0642 ISO 13485\u061f<\/strong><\/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 \u062c\u0645\u064a\u0639 \u0623\u062d\u062c\u0627\u0645 \u0627\u0644\u0645\u0624\u0633\u0633\u0627\u062a \u0628\u0634\u0631\u0637 \u062a\u0643\u064a\u064a\u0641 \u0627\u0644\u0646\u0638\u0627\u0645 \u0645\u0639 \u062d\u062c\u0645 \u0648\u0637\u0628\u064a\u0639\u0629 \u0627\u0644\u0646\u0634\u0627\u0637.<\/p> <\/div> <\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-summary\"><strong>\u0627\u0644\u062e\u0644\u0627\u0635\u0629<\/strong><\/h2>\n\n\n\n<p>ISO 13485:2016 \u0647\u0648 \u0645\u0639\u064a\u0627\u0631 \u062f\u0648\u0644\u064a \u0645\u062a\u062e\u0635\u0635 \u0641\u064a \u0623\u0646\u0638\u0645\u0629 \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 \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. \u064a\u0633\u0627\u0639\u062f \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 \u0627\u0644\u062f\u062e\u0648\u0644 \u0625\u0644\u0649 \u0627\u0644\u0623\u0633\u0648\u0627\u0642 \u0627\u0644\u0639\u0627\u0644\u0645\u064a\u0629. \u062a\u0637\u0628\u064a\u0642\u0647 \u0645\u0646\u0627\u0633\u0628 \u0644\u062c\u0645\u064a\u0639 \u0627\u0644\u0645\u0624\u0633\u0633\u0627\u062a \u0627\u0644\u0639\u0627\u0645\u0644\u0629 \u0641\u064a \u0645\u062c\u0627\u0644 \u0627\u0644\u0623\u062c\u0647\u0632\u0629 \u0627\u0644\u0637\u0628\u064a\u0629 \u0628\u063a\u0636 \u0627\u0644\u0646\u0638\u0631 \u0639\u0646 \u062d\u062c\u0645\u0647\u0627\u060c \u0648\u064a\u064f\u0639\u062f \u062e\u0637\u0648\u0629 \u0623\u0633\u0627\u0633\u064a\u0629 \u0644\u0644\u062a\u0645\u064a\u0632 \u0648\u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0641\u064a \u0647\u0630\u0627 \u0627\u0644\u0642\u0637\u0627\u0639 \u0627\u0644\u062d\u0633\u0627\u0633.<\/p>","protected":false},"excerpt":{"rendered":"<p>What is ISO 13485:2016? ISO 13485:2016 is an international standard issued by the International Organization for Standardization (ISO). It provides a comprehensive framework for implementing a quality management system specifically tailored to the medical devices industry.The standard aims to ensure that medical products meet regulatory and legal requirements, with a strong focus on patient safety [&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<\/title>\n<meta name=\"description\" content=\"ISO 13485 is quality management systems in the medical devices industry. Implementing brings numerous benefits to organizations ( ISO 13485 ).\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/qb.com.eg\/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:\/\/qb.com.eg\/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\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/qbcert\/\" \/>\n<meta property=\"article:modified_time\" content=\"2026-01-01T14:51:37+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/qb.com.eg\/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=\"4 \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:\/\/qb.com.eg\/iso-13485-2016\/\",\"url\":\"https:\/\/qb.com.eg\/iso-13485-2016\/\",\"name\":\"ISO 13485:2016 - QB Cert\",\"isPartOf\":{\"@id\":\"https:\/\/qb.com.eg\/#website\"},\"datePublished\":\"2023-09-01T15:40:08+00:00\",\"dateModified\":\"2026-01-01T14:51:37+00:00\",\"description\":\"ISO 13485 is quality management systems in the medical devices industry. Implementing brings numerous benefits to organizations ( ISO 13485 ).\",\"breadcrumb\":{\"@id\":\"https:\/\/qb.com.eg\/iso-13485-2016\/#breadcrumb\"},\"mainEntity\":[{\"@id\":\"https:\/\/qb.com.eg\/iso-13485-2016\/#faq-question-1767278241670\"},{\"@id\":\"https:\/\/qb.com.eg\/iso-13485-2016\/#faq-question-1767278257303\"},{\"@id\":\"https:\/\/qb.com.eg\/iso-13485-2016\/#faq-question-1767278275366\"},{\"@id\":\"https:\/\/qb.com.eg\/iso-13485-2016\/#faq-question-1767278290648\"}],\"inLanguage\":\"ar\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/qb.com.eg\/iso-13485-2016\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/qb.com.eg\/iso-13485-2016\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/qb.com.eg\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"ISO 13485:2016\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/qb.com.eg\/#website\",\"url\":\"https:\/\/qb.com.eg\/\",\"name\":\"QB Cert\",\"description\":\"QB Cert ISO certification Body\",\"publisher\":{\"@id\":\"https:\/\/qb.com.eg\/#organization\"},\"alternateName\":\"QB Cert ISO certification Body\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/qb.com.eg\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"ar\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/qb.com.eg\/#organization\",\"name\":\"QB cert ISO certification Body\",\"alternateName\":\"QB cert\",\"url\":\"https:\/\/qb.com.eg\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"ar\",\"@id\":\"https:\/\/qb.com.eg\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/qb.com.eg\/wp-content\/uploads\/2024\/09\/qb-cert-logo.webp\",\"contentUrl\":\"https:\/\/qb.com.eg\/wp-content\/uploads\/2024\/09\/qb-cert-logo.webp\",\"width\":350,\"height\":350,\"caption\":\"QB cert ISO certification Body\"},\"image\":{\"@id\":\"https:\/\/qb.com.eg\/#\/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\u0648\u0637\u0646\u064a \u0644\u0644\u0623\u0639\u062a\u0645\u0627\u062f EGAC\",\"email\":\"info@qb.com.eg\",\"telephone\":\"+201099337474\",\"legalName\":\"QB Cert\",\"numberOfEmployees\":{\"@type\":\"QuantitativeValue\",\"minValue\":\"51\",\"maxValue\":\"200\"}},{\"@type\":\"Question\",\"@id\":\"https:\/\/qb.com.eg\/iso-13485-2016\/#faq-question-1767278241670\",\"position\":1,\"url\":\"https:\/\/qb.com.eg\/iso-13485-2016\/#faq-question-1767278241670\",\"name\":\"What is the difference between ISO 13485 and ISO 9001?\",\"answerCount\":1,\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"ISO 13485 is specific to medical devices and focuses on regulatory requirements and risk management, while ISO 9001 is a general quality management standard applicable across various industries.\",\"inLanguage\":\"ar\"},\"inLanguage\":\"ar\"},{\"@type\":\"Question\",\"@id\":\"https:\/\/qb.com.eg\/iso-13485-2016\/#faq-question-1767278257303\",\"position\":2,\"url\":\"https:\/\/qb.com.eg\/iso-13485-2016\/#faq-question-1767278257303\",\"name\":\"Is ISO 13485 certification mandatory?\",\"answerCount\":1,\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"It is not mandatory in all countries, but it is often required or widely recognized by regulatory authorities and global markets.\",\"inLanguage\":\"ar\"},\"inLanguage\":\"ar\"},{\"@type\":\"Question\",\"@id\":\"https:\/\/qb.com.eg\/iso-13485-2016\/#faq-question-1767278275366\",\"position\":3,\"url\":\"https:\/\/qb.com.eg\/iso-13485-2016\/#faq-question-1767278275366\",\"name\":\"How long does it take to obtain ISO 13485:2016 certification?\",\"answerCount\":1,\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"The duration depends on the organization\u2019s size and readiness, typically ranging from 3 to 6 Days.\",\"inLanguage\":\"ar\"},\"inLanguage\":\"ar\"},{\"@type\":\"Question\",\"@id\":\"https:\/\/qb.com.eg\/iso-13485-2016\/#faq-question-1767278290648\",\"position\":4,\"url\":\"https:\/\/qb.com.eg\/iso-13485-2016\/#faq-question-1767278290648\",\"name\":\"Can small companies implement ISO 13485?\",\"answerCount\":1,\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes, the standard is applicable to organizations of all sizes, provided the system is adapted to the size and nature of the business.\",\"inLanguage\":\"ar\"},\"inLanguage\":\"ar\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"ISO 13485:2016 - QB Cert","description":"ISO 13485 is quality management systems in the medical devices industry. Implementing brings numerous benefits to organizations ( ISO 13485 ).","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:\/\/qb.com.eg\/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:\/\/qb.com.eg\/ar\/\u062c\u0648\u062f\u0629-\u0627\u0644\u0635\u0646\u0627\u0639\u0627\u062a-\u0627\u0644\u0637\u0628\u064a\u0629\/","og_site_name":"QB Cert","article_publisher":"https:\/\/www.facebook.com\/qbcert\/","article_modified_time":"2026-01-01T14:51:37+00:00","og_image":[{"width":200,"height":200,"url":"https:\/\/qb.com.eg\/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":"4 \u062f\u0642\u0627\u0626\u0642"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":["WebPage","FAQPage"],"@id":"https:\/\/qb.com.eg\/iso-13485-2016\/","url":"https:\/\/qb.com.eg\/iso-13485-2016\/","name":"ISO 13485:2016 - QB Cert","isPartOf":{"@id":"https:\/\/qb.com.eg\/#website"},"datePublished":"2023-09-01T15:40:08+00:00","dateModified":"2026-01-01T14:51:37+00:00","description":"ISO 13485 is quality management systems in the medical devices industry. Implementing brings numerous benefits to organizations ( ISO 13485 ).","breadcrumb":{"@id":"https:\/\/qb.com.eg\/iso-13485-2016\/#breadcrumb"},"mainEntity":[{"@id":"https:\/\/qb.com.eg\/iso-13485-2016\/#faq-question-1767278241670"},{"@id":"https:\/\/qb.com.eg\/iso-13485-2016\/#faq-question-1767278257303"},{"@id":"https:\/\/qb.com.eg\/iso-13485-2016\/#faq-question-1767278275366"},{"@id":"https:\/\/qb.com.eg\/iso-13485-2016\/#faq-question-1767278290648"}],"inLanguage":"ar","potentialAction":[{"@type":"ReadAction","target":["https:\/\/qb.com.eg\/iso-13485-2016\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/qb.com.eg\/iso-13485-2016\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/qb.com.eg\/"},{"@type":"ListItem","position":2,"name":"ISO 13485:2016"}]},{"@type":"WebSite","@id":"https:\/\/qb.com.eg\/#website","url":"https:\/\/qb.com.eg\/","name":"QB Cert","description":"QB Cert ISO certification Body","publisher":{"@id":"https:\/\/qb.com.eg\/#organization"},"alternateName":"QB Cert ISO certification Body","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/qb.com.eg\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"ar"},{"@type":"Organization","@id":"https:\/\/qb.com.eg\/#organization","name":"QB cert ISO certification Body","alternateName":"QB cert","url":"https:\/\/qb.com.eg\/","logo":{"@type":"ImageObject","inLanguage":"ar","@id":"https:\/\/qb.com.eg\/#\/schema\/logo\/image\/","url":"https:\/\/qb.com.eg\/wp-content\/uploads\/2024\/09\/qb-cert-logo.webp","contentUrl":"https:\/\/qb.com.eg\/wp-content\/uploads\/2024\/09\/qb-cert-logo.webp","width":350,"height":350,"caption":"QB cert ISO certification Body"},"image":{"@id":"https:\/\/qb.com.eg\/#\/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\u0648\u0637\u0646\u064a \u0644\u0644\u0623\u0639\u062a\u0645\u0627\u062f EGAC","email":"info@qb.com.eg","telephone":"+201099337474","legalName":"QB Cert","numberOfEmployees":{"@type":"QuantitativeValue","minValue":"51","maxValue":"200"}},{"@type":"Question","@id":"https:\/\/qb.com.eg\/iso-13485-2016\/#faq-question-1767278241670","position":1,"url":"https:\/\/qb.com.eg\/iso-13485-2016\/#faq-question-1767278241670","name":"What is the difference between ISO 13485 and ISO 9001?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"ISO 13485 is specific to medical devices and focuses on regulatory requirements and risk management, while ISO 9001 is a general quality management standard applicable across various industries.","inLanguage":"ar"},"inLanguage":"ar"},{"@type":"Question","@id":"https:\/\/qb.com.eg\/iso-13485-2016\/#faq-question-1767278257303","position":2,"url":"https:\/\/qb.com.eg\/iso-13485-2016\/#faq-question-1767278257303","name":"Is ISO 13485 certification mandatory?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"It is not mandatory in all countries, but it is often required or widely recognized by regulatory authorities and global markets.","inLanguage":"ar"},"inLanguage":"ar"},{"@type":"Question","@id":"https:\/\/qb.com.eg\/iso-13485-2016\/#faq-question-1767278275366","position":3,"url":"https:\/\/qb.com.eg\/iso-13485-2016\/#faq-question-1767278275366","name":"How long does it take to obtain ISO 13485:2016 certification?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"The duration depends on the organization\u2019s size and readiness, typically ranging from 3 to 6 Days.","inLanguage":"ar"},"inLanguage":"ar"},{"@type":"Question","@id":"https:\/\/qb.com.eg\/iso-13485-2016\/#faq-question-1767278290648","position":4,"url":"https:\/\/qb.com.eg\/iso-13485-2016\/#faq-question-1767278290648","name":"Can small companies implement ISO 13485?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"Yes, the standard is applicable to organizations of all sizes, provided the system is adapted to the size and nature of the business.","inLanguage":"ar"},"inLanguage":"ar"}]}},"_links":{"self":[{"href":"https:\/\/qb.com.eg\/ar\/wp-json\/wp\/v2\/pages\/2478","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/qb.com.eg\/ar\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/qb.com.eg\/ar\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/qb.com.eg\/ar\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/qb.com.eg\/ar\/wp-json\/wp\/v2\/comments?post=2478"}],"version-history":[{"count":0,"href":"https:\/\/qb.com.eg\/ar\/wp-json\/wp\/v2\/pages\/2478\/revisions"}],"wp:attachment":[{"href":"https:\/\/qb.com.eg\/ar\/wp-json\/wp\/v2\/media?parent=2478"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}