{"id":1957,"date":"2019-11-12T18:25:23","date_gmt":"2019-11-12T17:25:23","guid":{"rendered":"https:\/\/www.germersdorf-beratung.de\/beratungsbereich\/quality-management\/"},"modified":"2019-12-29T12:10:31","modified_gmt":"2019-12-29T11:10:31","slug":"quality-management","status":"publish","type":"portfolio","link":"https:\/\/www.germersdorf-beratung.de\/en\/consulting-areas\/quality-management\/","title":{"rendered":"Quality Management"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-jkraf66f-9f4c9eb5bbcbf3211653628acadbce17\">\n.avia-section.av-jkraf66f-9f4c9eb5bbcbf3211653628acadbce17 .av-parallax .av-parallax-inner{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.germersdorf-beratung.de\/wp-content\/uploads\/2018\/07\/slide-6_qualitaetsmanagement.jpg);\nbackground-position:50% 50%;\nbackground-attachment:scroll;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-jkraf66f-9f4c9eb5bbcbf3211653628acadbce17 main_color avia-section-default avia-no-border-styling  avia-builder-el-0  el_before_av_heading  avia-builder-el-first  av-parallax-section avia-bg-style-parallax av-minimum-height av-minimum-height-25 av-height-25  container_wrap fullsize'  data-section-bg-repeat='no-repeat' data-av_minimum_height_pc='25' data-av_min_height_opt='25'><div class='av-parallax' data-avia-parallax-ratio='0.3' ><div class='av-parallax-inner main_color avia-full-stretch'><\/div><\/div><div class='container av-section-cont-open' ><main  role=\"main\" itemprop=\"mainContentOfPage\"  class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-1957'><div class='entry-content-wrapper clearfix'><\/div><\/div><\/main><!-- close content main element --><\/div><\/div><div id='after_section_1'  class='main_color av_default_container_wrap container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-1957'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_heading-6e6ff32c6f2b5cd7b46c6d40f4da2ea9\">\n#top .av-special-heading.av-av_heading-6e6ff32c6f2b5cd7b46c6d40f4da2ea9{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-6e6ff32c6f2b5cd7b46c6d40f4da2ea9 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-6e6ff32c6f2b5cd7b46c6d40f4da2ea9 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-6e6ff32c6f2b5cd7b46c6d40f4da2ea9 av-special-heading-h1 blockquote modern-quote  avia-builder-el-1  el_after_av_section  el_before_av_three_fifth  avia-builder-el-first '><h1 class='av-special-heading-tag '  itemprop=\"headline\"  >Quality Management<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-sgly-59b44796961a032b6432cc27a4370713\">\n.flex_column.av-sgly-59b44796961a032b6432cc27a4370713{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-sgly-59b44796961a032b6432cc27a4370713 av_three_fifth  avia-builder-el-2  el_after_av_heading  el_before_av_two_fifth  first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-jkraho6o-a78796a09e6258a6f6920e8ba03b9c8e '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p id=\"cc-m-13689774835\" class=\"j-module n j-text \">Quality management systems affect several processes, products and services worldwide.<\/p>\n<p class=\"j-module n j-text \">Depending on the risk potential of the products, the requirement for &#8220;surveillance&#8221; (Audits) of the manufacturer often arises. This is then performed by a notified body (NoBo).<\/p>\n<p>The ISO 9001 standard makes an important contribution to the CE conformity of products and services. For ATEX \/ IECEx manufacturers it can be understood as a starting point and is supplemented by the requirements of ISO 80079-34. Annex X of the Machinery Directive 2006\/42 \/ EC also states that an effective Quality management System is justified.<\/p>\n<div><\/div>\n<div><\/div>\n<div><\/div>\n<div><\/div>\n<div><\/div>\n<div><\/div>\n<div id=\"cc-m-13797537835\" class=\"j-module n j-spacing \">\n<p class=\"cc-m-spacer\">In terms of product liability and associated risk minimization, an effective QMS is often indispensable.<\/p>\n<\/div>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-vtiq-8d193fe31691c16581df71feba6e0d2f\">\n.flex_column.av-vtiq-8d193fe31691c16581df71feba6e0d2f{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-vtiq-8d193fe31691c16581df71feba6e0d2f av_two_fifth  avia-builder-el-4  el_after_av_three_fifth  el_before_av_hr  flex_column_div av-animated-generic right-to-left av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_heading-02b020ea072780bb45ddd43c5ad990f5\">\n#top .av-special-heading.av-av_heading-02b020ea072780bb45ddd43c5ad990f5{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-02b020ea072780bb45ddd43c5ad990f5 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-02b020ea072780bb45ddd43c5ad990f5 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-02b020ea072780bb45ddd43c5ad990f5 av-special-heading-h6  avia-builder-el-5  el_before_av_textblock  avia-builder-el-first '><h6 class='av-special-heading-tag '  itemprop=\"headline\"  >Important items<\/h6><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-jlpwn5eb-36ff055a0eaea4b407bf09acbb8c140a '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock important-points'  itemprop=\"text\" ><ul>\n<li>Contribution of the QMS to CE conformity<\/li>\n<li>Implementation of ISO 9001: 2015<\/li>\n<li>Implementation of ISO 80079-34<\/li>\n<li>Audit Program, Internal Audits, External Audits<\/li>\n<li>QMS and the safe production of products<\/li>\n<li>Appoint, empower and coach ex- authorities<\/li>\n<li>Make documented information meaningful<\/li>\n<\/ul>\n<\/div><\/section><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-jt2wg5yv-82d127af65d2dfa7faafe372b3468722\">\n#top .hr.hr-invisible.av-jt2wg5yv-82d127af65d2dfa7faafe372b3468722{\nheight:50px;\n}\n<\/style>\n<div  class='hr av-jt2wg5yv-82d127af65d2dfa7faafe372b3468722 hr-invisible  avia-builder-el-7  el_after_av_two_fifth  el_before_av_one_full '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><\/p>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-29xly-98f743a413eab4728f640891fef9f147\">\n.flex_column.av-29xly-98f743a413eab4728f640891fef9f147{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-29xly-98f743a413eab4728f640891fef9f147 av_one_full  avia-builder-el-8  el_after_av_hr  el_before_av_three_fifth  first flex_column_div av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-jl9jf2c3-79ca48354b385c7969c5a50a83b5ed2c\">\n#top .av-special-heading.av-jl9jf2c3-79ca48354b385c7969c5a50a83b5ed2c{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-jl9jf2c3-79ca48354b385c7969c5a50a83b5ed2c .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-jl9jf2c3-79ca48354b385c7969c5a50a83b5ed2c .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-jl9jf2c3-79ca48354b385c7969c5a50a83b5ed2c av-special-heading-h3 blockquote modern-quote  avia-builder-el-9  avia-builder-el-no-sibling '><h3 class='av-special-heading-tag '  itemprop=\"headline\"  >Topics around quality management systems<\/h3><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3yfm-cd85e6b71e9d48e3d77d41c39ac636d6\">\n.flex_column.av-3yfm-cd85e6b71e9d48e3d77d41c39ac636d6{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3yfm-cd85e6b71e9d48e3d77d41c39ac636d6 av_three_fifth  avia-builder-el-10  el_after_av_one_full  el_before_av_two_fifth  first flex_column_div av-zero-column-padding  column-top-margin'     ><div  class='togglecontainer av-jkrakdm6-a127110eca1f2d13d95b9731ca9902ba  avia-builder-el-11  avia-builder-el-no-sibling  toggle_close_all' >\n<section class='av_toggle_section av-17zt24-0a19dd543949874958e46a298bf124d0'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-1' data-fake-id='#toggle-id-1' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-1' data-slide-speed=\"200\" data-title=\"ISO 9001:2015\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: ISO 9001:2015\" data-aria_expanded=\"Click to collapse: ISO 9001:2015\">ISO 9001:2015<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-1' aria-labelledby='toggle-toggle-id-1' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>This International Standard is based on the <strong>principles of quality management<\/strong> described in ISO 9000. The descriptions include a statement on each principle, a rationale for why the principle is important to the <strong>organization<\/strong>, some examples of policy benefits and examples of typical measures to <strong>enhance the organization&#8217;s performance<\/strong> in applying the principles.<span class=\"Apple-converted-space\"> <\/span><\/p>\n<p>The <strong>principles of quality management <\/strong>are as follows:<\/p>\n<ul>\n<li>customer focus<\/li>\n<li>leadership<\/li>\n<li>inclusion of persons<\/li>\n<li>process-oriented approach<\/li>\n<li>improvement<\/li>\n<li>evidence-based decision-making<\/li>\n<li>relationship management<\/li>\n<\/ul>\n<p>The current revision of ISO 9001 is the <strong>ISO 9001: 2015.<\/strong> A certificate is <strong>valid for 3 years<\/strong>.<\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-aoy3w-4800cbce894c934b5ca7743c3c84be66'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-2' data-fake-id='#toggle-id-2' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-2' data-slide-speed=\"200\" data-title=\"ISO 80079-34 for ATEX\/IECEx\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: ISO 80079-34 for ATEX\/IECEx\" data-aria_expanded=\"Click to collapse: ISO 80079-34 for ATEX\/IECEx\">ISO 80079-34 for ATEX\/IECEx<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-2' aria-labelledby='toggle-toggle-id-2' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><div>This standard specifies <strong>requirements for a quality management system<\/strong> that can be used by an organization for the <strong>manufacture of ex-products and for ex-service.<\/strong> It may also be used by third parties, including <strong>certification bodies<\/strong>, to assess the organization&#8217;s ability to meet the system requirements conformity assessment and \/ or regulatory requirements.<\/div>\n<div>\n<div>The application of this standard is intended for both <strong>electrical and non-electrical equipment, protective systems, safety devices, ex- components and their combinations.<\/strong><\/div>\n<div>Quality requirements are an integral part of most certification systems and therefore this standard has been adopted against the background of <strong>IECEx system requirements (QAR)<\/strong>, it is also intended to support the requirements of <strong>ATEX (QAN) <\/strong>and may be used in other national or regional certification schemes designed for the manufacture of ex-products and ex-service.<\/div>\n<\/div>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-8fst8-e4dbd959ed6405ccc4d884dbb27af8e1'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-3' data-fake-id='#toggle-id-3' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-3' data-slide-speed=\"200\" data-title=\"Documented information acc. ISO9001:2015\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: Documented information acc. ISO9001:2015\" data-aria_expanded=\"Click to collapse: Documented information acc. ISO9001:2015\">Documented information acc. ISO9001:2015<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-3' aria-labelledby='toggle-toggle-id-3' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p style=\"font-weight: 300\">The following list should give you an overview of the <strong>21 &#8220;Documented Information&#8221;<\/strong> required in ISO9001: 2015.<\/p>\n<p style=\"font-weight: 300\">The standard sections can be found in the brackets:<\/p>\n<ol>\n<li style=\"font-weight: 300\"><strong>Scope<\/strong> of QMS (4.3)<\/li>\n<li style=\"font-weight: 300\"><strong>Process<\/strong> documentation (4.4)<\/li>\n<li style=\"font-weight: 300\">QMS-<strong>Policy<\/strong> (5.2.2)<\/li>\n<li style=\"font-weight: 300\">Information about <strong>quality targets<\/strong> (6.2.1)<\/li>\n<li style=\"font-weight: 300\">The suitability of resources for <strong>monitoring and measurement<\/strong> (7.1.5)<\/li>\n<li style=\"font-weight: 300\">The basis for <strong>calibration or verification<\/strong> (7.1.5)<\/li>\n<li style=\"font-weight: 300\">Proof of <strong>competence<\/strong>(7.2)<\/li>\n<li style=\"font-weight: 300\">Proof that the <strong>processes are carried out as planned<\/strong> (8.1)<\/li>\n<li style=\"font-weight: 300\">Results of the <strong>review of customer requirements.<\/strong><\/li>\n<li style=\"font-weight: 300\">Confirmation that the <strong>development requirements and any development changes<\/strong> have been fulfilled (8.3.2, 8.3.6)<\/li>\n<li style=\"font-weight: 300\">Results of <strong>assessments, performance and re-assessment <\/strong>of external providers (8.4.1)<\/li>\n<li style=\"font-weight: 300\"><strong>Characteristics<\/strong> of the products and services provided (8.5.1a)<\/li>\n<li style=\"font-weight: 300\"><strong>Activities to be carried out<\/strong> and results to be achieved (8.5.1b)<\/li>\n<li style=\"font-weight: 300\"> Information needed to maintain <strong>traceability<\/strong> where appropriate (8.5.2)<\/li>\n<li style=\"font-weight: 300\"><strong>Review of changes<\/strong> in production or service provision (8.5.6)<\/li>\n<li style=\"font-weight: 300\"><strong>Authorization<\/strong> of the release of products and services to the customer (8.6)<\/li>\n<li style=\"font-weight: 300\">Implemented measures regarding <strong>non-compliant process results, products and services<\/strong> (8.7)<\/li>\n<li style=\"font-weight: 300\">Proof of the results of the <strong>monitoring and control activities<\/strong> (9.1)<\/li>\n<li style=\"font-weight: 300\">Internal <strong>audit programs<\/strong> and audit results (9.2)<\/li>\n<li style=\"font-weight: 300\">Results of <strong>Management Review<\/strong>(9.3)<\/li>\n<li style=\"font-weight: 300\"><strong>Non-conformities<\/strong> and results of corrective actions (10.2)<\/li>\n<\/ol>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-av_toggle-9a868514cf8f6b347eb5f47a3072f5c8'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-4' data-fake-id='#toggle-id-4' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-4' data-slide-speed=\"200\" data-title=\"Ex-Authority acc. ISO 80079-34\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: Ex-Authority acc. ISO 80079-34\" data-aria_expanded=\"Click to collapse: Ex-Authority acc. ISO 80079-34\">Ex-Authority acc. ISO 80079-34<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-4' aria-labelledby='toggle-toggle-id-4' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><div id=\"cc-m-13870393035\" class=\"j-module n j-header \">\n<p id=\"cc-m-header-13870393035\">An Ex- authority acc. ISO 80079-34 with <strong>stated and documented<\/strong> <strong>responsibilities<\/strong> <strong>shall<\/strong> be appointed to ensure that the following requirements are met:<\/p>\n<p>a) the <strong>effective coordination of activities<\/strong> with regard to ex-products<\/p>\n<p>(b) <strong>cooperation with the notified \/certification body responsible for issuing the Ex certificate<\/strong> (if not issued by the manufacturer) with regard to any intended changes to the design specified in the Ex certificate and the related technical file<\/p>\n<p>c) <strong>cooperation with the person<\/strong> responsible for the <strong>quality management system assessment<\/strong><\/p>\n<p>d) the <strong>authorization of releases and changes<\/strong> to production drawings, if appropriate<\/p>\n<p>e) the <strong>authorization of special <\/strong>releases (see 8.7 f)<\/p>\n<p>f) the <strong>accuracy of the ex-product information<\/strong> given to the customer in sales information and installation instructions (which must include the specific conditions of use and restrictions)<\/p>\n<p>g) the <strong>effective coordination of manufacturing processes of Ex products<\/strong>, including the <strong>externally provided products, services and processes<\/strong> listed in 8.4; For manufacturers with multiple manufacturing sites, an ex-authority with the appropriate responsibilities per site must be appointed.<\/p>\n<\/div>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-qloxo-78e4490059643170dd4b690b38902bb0'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-5' data-fake-id='#toggle-id-5' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-5' data-slide-speed=\"200\" data-title=\"Risk management\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: Risk management\" data-aria_expanded=\"Click to collapse: Risk management\">Risk management<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-5' aria-labelledby='toggle-toggle-id-5' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><div>Meeting the requirements requires the organization to <strong>plan and implement actions<\/strong> that address <strong>risks and opportunities.<\/strong> The treatment of both risks and opportunities forms the basis for increasing the effectiveness of the quality management system, for achieving improved results and for avoiding negative effects.<\/div>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-lq2ek-8838552a413d19e6b949cd67459abfa3'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-6' data-fake-id='#toggle-id-6' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-6' data-slide-speed=\"200\" data-title=\"Process-oriented approach\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: Process-oriented approach\" data-aria_expanded=\"Click to collapse: Process-oriented approach\">Process-oriented approach<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-6' aria-labelledby='toggle-toggle-id-6' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>ISO 9001: 2015 requires a <strong>process-oriented approach<\/strong> of the organization.<\/p>\n<p>In principle, it is possible to work according to the IPO model (input, processing, output). It makes sense to describe the main processes and divide them into <strong>support, core, and management<\/strong> processes. Recommendation: <strong>Process owners <\/strong>should now be determined.<\/p>\n<div id=\"attachment_1807\" style=\"width: 581px\" class=\"wp-caption alignnone\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-1807\" class=\" wp-image-1048\" src=\"https:\/\/www.germersdorf-beratung.de\/wp-content\/uploads\/2018\/06\/Bildschirmfoto-2018-10-02-um-14.09.24.png\" alt=\"\" width=\"571\" height=\"272\" srcset=\"https:\/\/www.germersdorf-beratung.de\/wp-content\/uploads\/2018\/06\/Bildschirmfoto-2018-10-02-um-14.09.24.png 1208w, https:\/\/www.germersdorf-beratung.de\/wp-content\/uploads\/2018\/06\/Bildschirmfoto-2018-10-02-um-14.09.24-300x143.png 300w, https:\/\/www.germersdorf-beratung.de\/wp-content\/uploads\/2018\/06\/Bildschirmfoto-2018-10-02-um-14.09.24-768x366.png 768w, https:\/\/www.germersdorf-beratung.de\/wp-content\/uploads\/2018\/06\/Bildschirmfoto-2018-10-02-um-14.09.24-1030x490.png 1030w, https:\/\/www.germersdorf-beratung.de\/wp-content\/uploads\/2018\/06\/Bildschirmfoto-2018-10-02-um-14.09.24-180x86.png 180w, https:\/\/www.germersdorf-beratung.de\/wp-content\/uploads\/2018\/06\/Bildschirmfoto-2018-10-02-um-14.09.24-705x336.png 705w, https:\/\/www.germersdorf-beratung.de\/wp-content\/uploads\/2018\/06\/Bildschirmfoto-2018-10-02-um-14.09.24-450x214.png 450w\" sizes=\"auto, (max-width: 571px) 100vw, 571px\" \/><p id=\"caption-attachment-1807\" class=\"wp-caption-text\">Processes of ISO 9001<\/p><\/div>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-g83v0-77558b52ecfd09acafcce191e34f7722'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-7' data-fake-id='#toggle-id-7' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-7' data-slide-speed=\"200\" data-title=\"Context of the organization\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: Context of the organization\" data-aria_expanded=\"Click to collapse: Context of the organization\">Context of the organization<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-7' aria-labelledby='toggle-toggle-id-7' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><div>\n<p>The organization must identify <strong>external and internal issues<\/strong> that are relevant to its purpose and strategic direction and that affect its ability to achieve the intended outcomes of its quality management system.<span class=\"Apple-converted-space\"> <\/span><\/p>\n<p>With regard to the ISO 80079-34 standard, the context of the organization must ensure that <strong>all Ex products comply with their certificate and technical documentation.<\/strong><\/p>\n<\/div>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-av_toggle-c816997c44060cbf46142eeb1d30f13a'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-8' data-fake-id='#toggle-id-8' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-8' data-slide-speed=\"200\" data-title=\"Interested parties\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: Interested parties\" data-aria_expanded=\"Click to collapse: Interested parties\">Interested parties<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-8' aria-labelledby='toggle-toggle-id-8' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>Due to their <strong>impact or potential impact<\/strong> on the organization&#8217;s ability to consistently deliver products and services that meet customer requirements and applicable regulatory and regulatory requirements, the organization shall identify the <strong>interested parties<\/strong> relevant to their quality management system and the requirements of those interested parties relevant to their quality management system. <strong>quality management system.<\/strong><\/p>\n<\/div><\/div><\/div><\/section>\n<\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-akqvd-47ab9d261aef3d9408714b30632432c1\">\n.flex_column.av-akqvd-47ab9d261aef3d9408714b30632432c1{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-akqvd-47ab9d261aef3d9408714b30632432c1 av_two_fifth  avia-builder-el-12  el_after_av_three_fifth  avia-builder-el-last  flex_column_div av-zero-column-padding  column-top-margin'     ><p>\n<style 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contact!<\/span><\/a><\/div><\/p><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":1704,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"tags":[],"portfolio_entries":[24],"class_list":["post-1957","portfolio","type-portfolio","status-publish","has-post-thumbnail","hentry","portfolio_entries-consulting-areas"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Quality Management - GERMERSDORF CONSULTING<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.germersdorf-beratung.de\/en\/consulting-areas\/quality-management\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" 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