{"id":7978,"date":"2024-08-02T15:50:12","date_gmt":"2024-08-02T14:50:12","guid":{"rendered":"https:\/\/amtivo.com\/us\/?post_type=resources-filter&#038;p=7978"},"modified":"2025-01-10T11:21:54","modified_gmt":"2025-01-10T11:21:54","slug":"iso-9001-section-8-3-1-1-explained","status":"publish","type":"resources-filter","link":"https:\/\/amtivo.com\/us\/resources\/insights\/iso-9001-section-8-3-1-1-explained\/","title":{"rendered":"ISO 9001 Section 8.3.1.1 Explained"},"content":{"rendered":"<p><a href=\"https:\/\/amtivo.com\/us\/iso-certification\/iso-9001\/\">ISO 9001&#8217;s<\/a> requirements, Section 8.3.1, apply to product and manufacturing process design and development and focus on error prevention rather than detection.<\/p>\r\n<p>A documented design and development process is required. It was not required in the past, but it is now.<\/p>\r\n<p>Many organizations are overlapping design and production because of a need for speed to market. This means it is critical to document the process.<\/p>\r\n<h3>Tips for Design &amp; Development<\/h3>\r\n<p>When planning the Design &amp; Development, consider these ISO requirements:<\/p>\r\n<ul>\r\n\t<li>Nature, duration and complexity<\/li>\r\n\t<li>Required process stages, including reviews<\/li>\r\n\t<li>Required verification and validation activities<\/li>\r\n\t<li>Responsibilities and authorities<\/li>\r\n\t<li>Internal and external resource needs<\/li>\r\n\t<li>Controlling interfaces<\/li>\r\n\t<li>Involving customers<\/li>\r\n\t<li>Requirements for manufacturing\/service delivery<\/li>\r\n\t<li>Level of control expected by customers<\/li>\r\n\t<li>Documented information needed to demonstrate requirements have been met<\/li>\r\n<\/ul>","protected":false},"excerpt":{"rendered":"Interested in learning more about ISO 9001 Section 8.3.1.1? Read our top tips to improve your design &amp; development process.","protected":false},"author":24,"featured_media":8548,"template":"","resource":[23],"resource-tag":[41],"class_list":["post-7978","resources-filter","type-resources-filter","status-publish","has-post-thumbnail","hentry","resource-insights","resource-tag-iso-9001"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>ISO 9001 Section 8.3.1.1 Explained - Amtivo<\/title>\n<meta name=\"description\" content=\"Interested in learning more about ISO 9001 and how Section 8.3.1.1 works? 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