{"id":90823,"date":"2025-02-27T09:56:54","date_gmt":"2025-02-27T15:56:54","guid":{"rendered":"https:\/\/beta.globalstd.com\/en\/blog\/"},"modified":"2025-03-13T10:46:01","modified_gmt":"2025-03-13T16:46:01","slug":"applicability-design-and-development","status":"publish","type":"post","link":"https:\/\/beta.globalstd.com\/en\/blog\/applicability-design-and-development\/","title":{"rendered":"Applicability, Design, and Development.\u00a0\u00a0"},"content":{"rendered":"\n<p><span data-contrast=\"auto\">Different approaches are used to determine the applicability of design and development in management systems and certification scopes, so it is necessary to understand the intent of the standard&#8217;s requirements.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p>\u00a0<\/p>\n<p><span data-contrast=\"auto\">ISO 9000 defines Design and Development as the set of processes that transform requirements for an objective into more detailed requirements for that objective.\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p>\u00a0<\/p>\n<p><span data-contrast=\"auto\">The requirement generally intends to ensure that the organization establishes, implements, and maintains a design and development process to ensure that products or services meet the requirements defining their characteristics.\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p>\u00a0<\/p>\n<p><strong>The requirements to be considered in the design and development process are as follows:\u00a0<\/strong><\/p>\n<p>\u00a0<\/p>\n<p><span data-contrast=\"auto\">a) Design and development planning to determine the activities and tasks required.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p>\u00a0<\/p>\n<p><span data-contrast=\"auto\">b) When determining inputs for design and development projects, these inputs must be unambiguous, complete, and consistent with the requirements that define the characteristics of the product or service. <\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">c) Design and development controls and review, verification, and validation activities are essential to control the design and development process. <\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p>\u00a0<\/p>\n<p><span data-contrast=\"auto\">d) <\/span><span data-contrast=\"auto\">Ensure that design and development outputs precisely provide the necessary information to all processes required to deliver the intended products and services.<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p>\u00a0<\/p>\n<p><span data-contrast=\"auto\">e) Determine, review, and control changes made during or after the design and development. <\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p><span data-contrast=\"auto\">Upon further review of these requirements, organizations could determine the applicability of all, some, or none of the requirements of the Design and Development section. For example, they could consider only the requirements for design and development changes or not consider any requirements of the Design and Development section because all product specifications come from a customer.\u00a0<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p>\u00a0<\/p>\n<p><strong>Some criteria that could help determine the applicability of the Design and Development requirements in organizations are:\u00a0\u00a0<\/strong><\/p>\n<p>\u00a0<\/p>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">When the organization has the ability to offer new products or services to its customers; or modify the characteristics of those it is already offering, the design and development requirement becomes applicable.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<p>\u00a0<\/p>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">When the organization owns the intellectual property of the product or service, Design and Development are applicable.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<p>\u00a0<\/p>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Adjustments in the process are not design and development.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<p>\u00a0<\/p>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">In management systems, design, and development are synonymous<\/span><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<p>\u00a0<\/p>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"5\" data-aria-level=\"1\"><span data-contrast=\"auto\">Design and development are exclusive to products and services, not to processes.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<p>\u00a0<\/p>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"6\" data-aria-level=\"1\"><span data-contrast=\"auto\">Sections may be excluded from the design and development requirements, even if they apply to you.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<p>\u00a0<\/p>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"7\" data-aria-level=\"1\"><span data-contrast=\"auto\">Design and development are sets that cannot be applied separately.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<p>\u00a0<\/p>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"8\" data-aria-level=\"1\"><span data-contrast=\"auto\">When design and development are not applicable in the scope of the management system, the scope of certification cannot refer to <\/span><span data-contrast=\"none\">the word <\/span><span data-contrast=\"auto\">design and development, or design or development, even if they are found in the name of a main process of the organization.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<p>\u00a0<\/p>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"9\" data-aria-level=\"1\"><span data-contrast=\"auto\">Design and development do not apply to product packaging processes in non-functional packaging.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<p>\u00a0<\/p>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"10\" data-aria-level=\"1\"><span data-contrast=\"auto\">Design and development do not apply to maquiladora plants.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<p>\u00a0<\/p>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"11\" data-aria-level=\"1\"><span data-contrast=\"auto\">The following terms may be included in the scope of the certificate when design and development apply:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<p>\u00a0<\/p>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"2\"><span data-contrast=\"auto\">Design of&#8230;<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<p>\u00a0<\/p>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"2\"><span data-contrast=\"auto\">Development of&#8230;<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<p>\u00a0<\/p>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"2\"><span data-contrast=\"auto\">D&amp;D of&#8230;<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<p>\u00a0<\/p>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"4\" data-aria-level=\"2\"><span data-contrast=\"auto\">Design Management&#8230;<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<p>\u00a0<\/p>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"5\" data-aria-level=\"2\"><span data-contrast=\"auto\">Provision of D&amp;D Services of&#8230; <\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"6\" data-aria-level=\"2\"><span data-contrast=\"auto\">Course development&#8230;<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p>\u00a0<\/p>\n<p><i><span data-contrast=\"auto\"><strong>Note:<\/strong> The terms scope of the quality management system and scope of certification are not the same; the former is based on the nature of the organization&#8217;s products and services for which the organization decides to implement the requirements of the standard; it includes the processes and activities for the realization of the final product or service delivery, while the scope of certification is a term used to refer to the scope in the certification document (certificate). Usually, it is a statement that describes the &#8220;type of activities, products, and services applicable at each site without being misleading or ambiguous.&#8221;<\/span><\/i><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><strong>References:\u00a0\u00a0<\/strong><\/p>\n<p><span data-contrast=\"auto\">ISO 9001 Auditing Practices Group (ISO &amp; IAF) &#8211; <\/span><a href=\"https:\/\/committee.iso.org\/files\/live\/sites\/tc176\/files\/PDF%20APG%20New%20Disclaimer%2012-2023\/ISO-TC%20176-TF_APG-Design%26Development.pdf\"><span data-contrast=\"none\">Guidance: Design and Development Process<\/span><\/a><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><a href=\"https:\/\/www.iso.org\/standard\/62085.html\"><span data-contrast=\"none\">ISO 9001:2015 Quality Management System<\/span><\/a><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p>\u00a0<\/p>\n<p><span data-contrast=\"auto\">Guide for the application of UNE-EN ISO 9001:2015<\/span><span data-ccp-props=\"{&quot;335551550&quot;:6,&quot;335551620&quot;:6}\">\u00a0<\/span><\/p>\n<p><a href=\"https:\/\/www.iso.org\/standard\/66204.html\"><span data-contrast=\"none\">ISO\/TS 9002:2016 Guidelines for the implementation of ISO 9001:2015.<\/span><\/a><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><a href=\"https:\/\/www.iso.org\/standard\/45481.html\"><span data-contrast=\"none\">ISO 9000:2015 Quality Management System &#8211; Fundamentals and\u00a0<\/span><\/a><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Different approaches are used to determine the applicability of design and development in management systems and certification scopes, so it is necessary to understand the intent of the standard&#8217;s requirements.\u00a0 \u00a0 ISO 9000 defines Design and Development as the set of processes that transform requirements for an objective into more detailed requirements for that objective.\u00a0\u00a0<\/p>\n","protected":false},"author":2604,"featured_media":90824,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[711],"tags":[],"class_list":["post-90823","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-quality"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Applicability, Design, and Development.\u00a0\u00a0<\/title>\n<meta name=\"description\" content=\"Find out how the design and development clause is applied in the scope of management and certification systems, as well as its key points\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" 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