{"id":269,"date":"2021-09-09T09:53:34","date_gmt":"2021-09-09T08:53:34","guid":{"rendered":"https:\/\/rayner.com\/us\/?page_id=269"},"modified":"2023-09-13T15:18:39","modified_gmt":"2023-09-13T14:18:39","slug":"quality-and-regulatory-affairs","status":"publish","type":"page","link":"https:\/\/rayner.com\/us\/about-us\/quality-and-regulatory-affairs\/","title":{"rendered":"Rayner Group Quality Management System"},"content":{"rendered":"<p>Rayner has established and maintains a quality management system based upon and satisfying the management system standard ISO 13485.<\/p>\n<p>The Quality Policy for the Rayner QMS is contained in the following statements.<\/p>\n<ul>\n<li class=\"dash\">We will provide products and services that fully and consistently meet the agreed requirements of our customers.<\/li>\n<li class=\"dash\">We will satisfy the requirements of all appropriate national and international regulations. This includes compliance with the following legislation:<\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>\n<div class=\"ql-block\" data-block-id=\"block-711d061c-03f5-4317-a8a3-b415d50d45dd\">Australian Therapeutic Goods Act 1989<\/div>\n<\/li>\n<li>\n<div class=\"ql-block\" data-block-id=\"block-711d061c-03f5-4317-a8a3-b415d50d45dd\">Australian &#8211; The Therapeutic Goods (Medical Device) Regulations 2002<\/div>\n<\/li>\n<li>\n<div class=\"ql-block\" data-block-id=\"block-711d061c-03f5-4317-a8a3-b415d50d45dd\">Brazilian Regulations RDC 751\/2022<\/div>\n<\/li>\n<li>\n<div class=\"ql-block\" data-block-id=\"block-711d061c-03f5-4317-a8a3-b415d50d45dd\">Canadian Medical Devices Regulations, SOR\/98-282<\/div>\n<\/li>\n<li>\n<div class=\"ql-block\" data-block-id=\"block-711d061c-03f5-4317-a8a3-b415d50d45dd\">Chinese Good Manufacturing Practice for Medical Devices in accordance with the Regulations for the Supervision and Administration of Medical Devices and Administrative Measures for the Supervision of Medical Device Manufacturing<\/div>\n<\/li>\n<li>\n<div class=\"ql-block\" data-block-id=\"block-711d061c-03f5-4317-a8a3-b415d50d45dd\">European Medical Devices Directive (MDD) 93\/42\/EEC<\/div>\n<\/li>\n<li>\n<div class=\"ql-block\" data-block-id=\"block-711d061c-03f5-4317-a8a3-b415d50d45dd\">European Medical Device Regulation (MDR) EU 2017\/745<\/div>\n<\/li>\n<li>\n<div class=\"ql-block\" data-block-id=\"block-711d061c-03f5-4317-a8a3-b415d50d45dd\">Food and Drug Administration (FDA); Federal Food, Drug, and Cosmetic Act (FD&amp;C Act), 21 Code of Federal Regulations (CFR), 820 Quality System Regulation (QSR)<\/div>\n<\/li>\n<li>\n<div class=\"ql-block\" data-block-id=\"block-711d061c-03f5-4317-a8a3-b415d50d45dd\">Korean Standards of Medical Device Good Manufacturing Practices (Ministry of Food and Drug Safety Public Notification No. 2021-28, April 1, 2021)<\/div>\n<\/li>\n<li>\n<div class=\"ql-block\" data-block-id=\"block-711d061c-03f5-4317-a8a3-b415d50d45dd\">Taiwan&#8217;s Pharmaceutical Affairs Act, 2018-01-31<\/div>\n<\/li>\n<li>\n<div class=\"ql-block\" data-block-id=\"block-711d061c-03f5-4317-a8a3-b415d50d45dd\">Ukrainian Technical Regulation on Medical Devices, approved by the Cabinet of Ministers of Ukraine No. 753 of 02.10.2013<\/div>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li class=\"dash\">The commitment to quality by every employee is essential to the maintenance of this policy. The requirements of the quality management system apply to all staff and there must be no unauthorized deviations from them.<\/li>\n<li class=\"dash\">Top Management will review the quality system compliance at regular intervals to ensure it maintains its effectiveness. Resources will be allocated and improvements implemented where necessary.<\/li>\n<li class=\"dash\">We will continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.<\/li>\n<\/ul>\n<p><strong>Management will ensure that the Quality Policy is understood, implemented and maintained at all levels in the organisation and at all sites. <\/strong><\/p>\n<p><strong>The policy is reviewed annually to confirm that it accurately reflects the current quality related goals and objectives of Rayner.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Rayner has established and maintains a quality management system based upon and satisfying the management system standard ISO 13485. The Quality Policy for the Rayner QMS is contained in the following statements. We will provide products and services that fully and consistently meet the agreed requirements of our customers. We will satisfy the requirements of<\/p>\n","protected":false},"author":4,"featured_media":0,"parent":2456,"menu_order":12,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Rayner Group Quality Management System - Rayner : USA<\/title>\n<meta name=\"description\" content=\"Rayner has established and maintains a quality management system based upon and satisfying the management system standard 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:\/\/rayner.com\/us\/about-us\/quality-and-regulatory-affairs\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Rayner Group Quality Management System - 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