{"id":2149,"date":"2018-09-14T15:56:04","date_gmt":"2018-09-14T20:56:04","guid":{"rendered":"https:\/\/plexusintl.com\/?page_id=2149"},"modified":"2021-12-21T18:34:08","modified_gmt":"2021-12-21T23:34:08","slug":"as9100d-requirements-documented-infor","status":"publish","type":"page","link":"https:\/\/plexusintl.com\/us\/blog\/as9100d-requirements-documented-infor\/","title":{"rendered":"AS9100D: Requirements for Documented Information"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"2149\" class=\"elementor elementor-2149\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5884b277 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5884b277\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-17f3021b\" data-id=\"17f3021b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-71ad8730 elementor-widget elementor-widget-heading\" data-id=\"71ad8730\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">AS9100D: Requirements for Documented Information<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5fa448a7 elementor-widget elementor-widget-text-editor\" data-id=\"5fa448a7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h4>December 5, 2019<\/h4>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3046c70a elementor-widget elementor-widget-text-editor\" data-id=\"3046c70a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The new standard allows flexibility in the way organizations choose to document their QMS. The term \u201cdocumented information\u201d was introduced to replace \u201cdocument, documented procedures and records needed\u201d; however, it\u2019s still important to distinguish between documents and records, which are very important in the aviation, space and defense industry. When the standard discusses \u201cmaintaining\u201d documented information, it is referring to procedures and documents. When it mentions \u201cretain\u201d documented information it refers to a form, form record or data.<\/p><p>Documented information must be retained by an organization for the purpose of providing evidence of results achieved (records). The new standard enables each individual organization to determine the correct amount of documented information needed in order to demonstrate the effective planning, operation, and control of its processes and the implementation and continual improvement of the effectiveness of its QMS.<\/p><p>An organization\u2019s need for, and the extent and type of, documented information will vary greatly due to the context of the organization, its size, culture, nature of products and services, applicable statutory and regulatory requirements, customer requirements regarding the risks on products, etc. Although the new standard does not specifically require any of these, here are some examples of documents that can add value to a QMS:<\/p><ul><li>Organization Charts<\/li><li>Process maps, flow charts, and descriptions<\/li><li>Procedures<\/li><li>Work and\/or test instructions<\/li><li>Specifications<\/li><li>Documents containing internal communications<\/li><li>Production schedules<\/li><li>Approved supplier lists<\/li><li>Test and inspection plans<\/li><li>Quality plans<\/li><li>Quality manuals<\/li><li>Strategic plans<\/li><li>Forms<\/li><\/ul><p>Documented information is the basis of the objective evidence presented during an audit or assessment of an organization to show that effective means are in place and compliance to the standard can be determined. Many organizations choose to manage all or most of its documented information in electronic formats. This is acceptable, but certain provisions have to be taken and shown to be effective. Such provisions include loss prevention (i.e. back-ups and data recovery), demonstration that the organization\u2019s personnel can readily access the documented information necessary to perform their tasks and understand the processes they execute, and change control assurance that ensures documentation is effectively communicated.<\/p><p>While the change to the term documented information is new to the standard, there is no change to the expectations of the documentation needed for the quality management system definition. As well, there is no change to the objective evidence required for proof that all activities were carried out as required per the requirements of the standard, the process or the product being delivered to the customer.<\/p><p>If you missed the blog from last week on Risk-Based Thinking, <a href=\"https:\/\/plexusintl.com\/us\/blog\/what-risk-based-thinking\/\">click here<\/a>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-726793\" data-id=\"726793\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-25bfffe elementor-widget elementor-widget-spacer\" data-id=\"25bfffe\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div 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elementor-col-100 elementor-top-column elementor-element elementor-element-406c7827\" data-id=\"406c7827\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-52336c00 elementor-widget elementor-widget-related-content-block\" data-id=\"52336c00\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"related-content-block.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t    \r\n      <div class=\"row\">\r\n          <div class=\"col\">\r\n              <div class=\"related-content\">\r\n                  <h2 >People also viewed<\/h2>\r\n\r\n                  <div class=\"row\">\r\n                      <div class=\"col-12 col-md-4 mb-3\">\r\n                          <div class=\"page page-1\">\r\n                              <div class=\"content-type\"><\/div>\r\n                              <div class=\"content-title\"><a href=\"https:\/\/plexusintl.com\/us\/catalog\/essentials-transitioning-as9100d-elearning\/\" class=\"cta\" >Essentials for Transitioning to AS9100D - eLearning<\/a><\/div>\r\n                              <div class=\"content-description\"><p >This online training course examines the key changes from AS9100C to AS9100D and is designed to prepare you and your organization for the transition to AS9100D.<\/p><\/div>\r\n                          <\/div>\r\n                      <\/div>\r\n                      <div class=\"col-12 col-md-4 mb-3\">\r\n                          <div class=\"page page-2\">\r\n                              <div class=\"content-type\"><\/div>\r\n                              <div class=\"content-title\"><a href=\"https:\/\/plexusintl.com\/us\/catalog\/as9100d-understanding-and-internal-quality-auditing\/\" class=\"cta\" >AS9100D Understanding and Internal Quality Auditing<\/a><\/div>\r\n                              <div class=\"content-description\"><p >This internal auditor course is designed for both new auditors and existing internal auditors who need a thorough refresher of how to perform an internal audit to AS9100.<\/p><\/div>\r\n                          <\/div>\r\n                      <\/div>\r\n                      <div class=\"col-xs-12 col-md-4 mb-3\">\r\n                          <div class=\"page page-3\">\r\n                              <div class=\"content-type\"><\/div>\r\n                              <div class=\"content-title\"><a href=\"https:\/\/plexusintl.com\/us\/blog\/carrying-out-plan-do-check-act-cycle-guidance-and-tools-continual-management-system-improvement\/\" class=\"cta\" >Carrying Out the Plan-Do-Check-Act Cycle: Guidance and Tools for Continual Management System Improvement<\/a><\/div>\r\n                              <div class=\"content-description\"><p >The PDCA (Plan-Do-Check-Act) cycle is an iterative process bringing management systems closer to the desired result each time the cycle is completed.<\/p><\/div>\r\n                          <\/div>\r\n                      <\/div>\r\n                  <\/div>\r\n              <\/div>\r\n          <\/div>\r\n      <\/div>\r\n    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