<?xml version="1.0" encoding="UTF-8" ?><!-- generator=Zoho Sites --><rss version="2.0" xmlns:atom="http://www.w3.org/2005/Atom" xmlns:content="http://purl.org/rss/1.0/modules/content/"><channel><atom:link href="https://www.itsmf.ch/blogs/tag/iso/feed" rel="self" type="application/rss+xml"/><title>itSMF Switzerland - Blog #ISO</title><description>itSMF Switzerland - Blog #ISO</description><link>https://www.itsmf.ch/blogs/tag/iso</link><lastBuildDate>Thu, 10 Sep 2026 21:41:04 +0200</lastBuildDate><generator>http://zoho.com/sites/</generator><item><title><![CDATA[The ISO 27002:2022 standard: the new information security controls]]></title><link>https://www.itsmf.ch/blogs/post/the-iso-27002-2022-standard-the-new-information-security-controls</link><description><![CDATA[<img align="left" hspace="5" src="https://www.itsmf.ch/iso-27002-2022-new-standard-information-security-controls-news-checklist.png"/>ISO released its new 27002:2022 standard updating also the information security controls: let's take a closer look at all the news.]]></description><content:encoded><![CDATA[<div class="zpcontent-container blogpost-container "><div data-element-id="elm_eaocCKUWRQWj8hdYP5pfdA" data-element-type="section" class="zpsection "><style type="text/css"></style><div class="zpcontainer-fluid zpcontainer"><div data-element-id="elm_EZDc8gx4R1GuKfHeKhZ2iw" data-element-type="row" class="zprow zprow-container zpalign-items- zpjustify-content- " data-equal-column=""><style type="text/css"> [data-element-id="elm_EZDc8gx4R1GuKfHeKhZ2iw"].zprow{ border-radius:1px; } </style><div data-element-id="elm_PC-fd0JiQGy9ODIQOJc_6g" data-element-type="column" class="zpelem-col zpcol-12 zpcol-md-8 zpcol-sm-12 zpalign-self- "><style type="text/css"> [data-element-id="elm_PC-fd0JiQGy9ODIQOJc_6g"].zpelem-col{ border-radius:1px; margin-block-start:6px; } </style><div data-element-id="elm_DmKi1zQzpSrBY7HijFo4iw" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_DmKi1zQzpSrBY7HijFo4iw"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><p><span style="font-style:italic;">Reading time: ~ 4 min.</span><br/></p></div>
</div><div data-element-id="elm_2qjBSAuRzQlWAQ9It7Qvyg" data-element-type="image" class="zpelement zpelem-image "><style> @media (min-width: 992px) { [data-element-id="elm_2qjBSAuRzQlWAQ9It7Qvyg"] .zpimage-container figure img { width: 703px ; height: 421.80px ; } } @media (max-width: 991px) and (min-width: 768px) { [data-element-id="elm_2qjBSAuRzQlWAQ9It7Qvyg"] .zpimage-container figure img { width:723px ; height:433.80px ; } } @media (max-width: 767px) { [data-element-id="elm_2qjBSAuRzQlWAQ9It7Qvyg"] .zpimage-container figure img { width:415px ; height:249.00px ; } } [data-element-id="elm_2qjBSAuRzQlWAQ9It7Qvyg"].zpelem-image { border-radius:1px; } </style><div data-caption-color="" data-size-tablet="" data-size-mobile="" data-align="center" data-tablet-image-separate="false" data-mobile-image-separate="false" class="zpimage-container zpimage-align-center zpimage-tablet-align-center zpimage-mobile-align-center zpimage-size-fit zpimage-tablet-fallback-fit zpimage-mobile-fallback-fit hb-lightbox " data-lightbox-options="
                type:fullscreen,
                theme:dark"><figure role="none" class="zpimage-data-ref"><span class="zpimage-anchor" role="link" tabindex="0" aria-label="Open Lightbox" style="cursor:pointer;"><picture><img class="zpimage zpimage-style-none zpimage-space-none " src="/iso-27002-2022-new-standard-information-security-controls-news.jpg" width="415" height="249.00" loading="lazy" size="fit" data-lightbox="true"/></picture></span></figure></div>
</div><div data-element-id="elm_Uy2drJ_yPLPmFCRoHyz74Q" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_Uy2drJ_yPLPmFCRoHyz74Q"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">The Information Security: the controls set by the new ISO 27002:2022 standard<br/></h2></div>
<div data-element-id="elm_X09Gj-KrQW6A8yA8s176qw" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_X09Gj-KrQW6A8yA8s176qw"].zpelem-text { border-radius:1px; margin-block-start:20px; } </style><div class="zptext zptext-align-center " data-editor="true"><div><div><div style="line-height:1.5;"><div style="text-align:left;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;line-height:1.5;text-align:left;"><div style="color:inherit;line-height:1.5;"><div style="color:inherit;line-height:1.5;"><div style="color:inherit;line-height:1.5;"><div style="color:inherit;line-height:1.5;"><p style="line-height:1.5;"><span style="font-size:16px;"><span style="color:inherit;"><span>The International Organization for Standardization (ISO) has recently released the updated version of the <span style="font-weight:bold;">guideline for the application</span> of the operational controls for the <span style="background-color:rgb(4, 234, 119);">ISO/IEC standard 27002:2022</span>, also known as the <span style="color:inherit;"><span>«Information security, cybersecurity and privacy protection - Information security controls<span style="background-color:rgb(234, 234, 4);"></span>».</span></span></span></span></span></p><p style="line-height:1.5;"><span style="font-family:&quot;open sans&quot;;font-size:16px;"><span style="color:inherit;"><span><br/></span></span></span></p><span style="font-size:16px;"><span style="font-family:&quot;open sans&quot;;"></span><span style="font-family:&quot;open sans&quot;;"><span>The new edition of </span><span style="font-weight:bold;">ISO 27001:2022 Information Security Management Systems </span><span>standard that the <span style="font-style:italic;">worldwide known Organization</span> released some weeks ago <span style="color:inherit;"><span>– we gave you an update on our <a href="https://www.itsmf.ch/blogs/post/information-security-management-system-iso27001-2022" title="last post here" rel=""><span style="text-decoration:underline;">post here</span></a> –</span></span> refers to <span style="font-style:italic;">Annex A<span style="background-color:rgb(234, 234, 4);"></span></span> controls of ISO 27002 standard. <br/></span></span><div style="color:inherit;"><span></span><p style="text-align:justify;"><span style="font-family:&quot;open sans&quot;;"><span><br/></span></span></p><span></span><p style="text-align:left;"><span style="font-family:&quot;open sans&quot;;"><span>The ISO 27002 standard recognizes </span><span style="font-weight:bold;">4 large groups </span>(clauses or themes)&nbsp;<span style="font-weight:bold;"></span>of <span style="font-weight:bold;">operational controls</span><span>:</span></span></p></div></span></div></div></div></div></div>
</div></div></div></div></div></div></div></div></div><div data-element-id="elm_nnHS-o4J6cwLIC1fDeQ-Jg" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_nnHS-o4J6cwLIC1fDeQ-Jg"].zpelem-text { border-radius:1px; margin-block-start:30px; } </style><div class="zptext zptext-align-left " data-editor="true"><span style="font-size:16px;"><span></span></span><ol><li><span style="font-size:16px;"><span><span style="font-weight:bold;">Organization Controls</span> (aspects related to the organization)</span></span></li><li><span style="font-size:16px;"><span><span style="font-weight:bold;">People Controls</span> (details on single individual)</span></span></li><li><span style="font-size:16px;"><span><span style="font-weight:bold;">Physical Controls</span> (objects and aspects related to physical &amp; environmental matters)</span></span></li><li><span style="font-size:16px;"><span><span style="font-weight:bold;">Technological Controls</span> (aspects related to the technology)<br/></span></span></li></ol></div>
</div><div data-element-id="elm_ID8C6EsxCLZUd8X0NlUe-g" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_ID8C6EsxCLZUd8X0NlUe-g"].zpelem-text { border-radius:1px; margin-block-start:34px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="color:inherit;text-align:left;"><span style="font-size:16px;"><span>For each single control, the <span style="background-color:rgb(4, 234, 119);">ISO 27002:2022</span> standard </span><span style="font-weight:bold;">recognizes five attributes </span><span>that constitute different ways you can adopt on considering the control.</span></span></div><div style="color:inherit;text-align:left;"><span style="font-size:16px;"><span><br/></span></span></div><div style="color:inherit;text-align:left;"><span style="font-size:16px;"><span>In particular, <span style="font-weight:bold;">5 different views</span> are defined which represent <span style="font-style:italic;">different categorizations</span> of the controls seen from different perspectives:</span><br/></span></div><div style="color:inherit;text-align:left;"><span style="font-size:16px;"><br/></span></div><div style="color:inherit;text-align:left;"><span style="font-size:16px;"></span><div style="color:inherit;"><span></span><ul><li><span><span style="font-size:12pt;">The <span style="background-color:rgb(234, 234, 4);">control type</span> («when and how control changes risk» perspective);</span></span></li><li><span><span style="font-size:12pt;"><span><span style="font-size:12pt;">The <span style="background-color:rgb(234, 234, 4);">information security properties</span> (integrity, availability and confidentiality perspectives);</span></span></span></span></li><li><span><span style="font-size:12pt;"><span><span style="font-size:12pt;"><span><span style="font-size:12pt;">The <span style="background-color:rgb(234, 234, 4);">cybersecurity concepts</span> (application of controls to information security perspective);</span></span></span></span></span></span></li><li><span><span style="font-size:12pt;"><span><span style="font-size:12pt;"><span><span style="font-size:12pt;"><span><span style="font-size:12pt;">The <span style="background-color:rgb(234, 234, 4);">operational capabilities</span> (information security operations perspective);</span></span></span></span></span></span></span></span></li><li><span><span style="font-size:12pt;"><span><span style="font-size:12pt;"><span><span style="font-size:12pt;"><span><span style="font-size:12pt;"><span><span style="font-size:12pt;">The <span style="background-color:rgb(234, 234, 4);">security domains</span> (governance, protection, defense and resilience perspectives).</span></span></span></span></span></span></span></span></span></span></li></ul></div><div style="text-align:left;"><span style="font-size:16px;"><p style="text-align:justify;"></p></span><div style="text-align:left;"><br/><span style="font-size:16px;"><p style="text-align:justify;"><span></span></p></span></div></div><div style="text-align:left;"><div style="text-align:left;"><span style="font-size:16px;"><p style="text-align:justify;"><span>To better understand the way <span style="font-weight:bold;">ISO 27002:2022 standard</span> refers to the controls, you can take a look at this infographic:</span></p></span></div><span style="font-size:16px;"><p style="text-align:justify;"><span></span></p></span></div></div></div>
</div><div data-element-id="elm_GFnfX20BavvT3JdeAV7txQ" data-element-type="image" class="zpelement zpelem-image "><style> @media (min-width: 992px) { [data-element-id="elm_GFnfX20BavvT3JdeAV7txQ"] .zpimage-container figure img { width: 703px ; height: 527.25px ; } } @media (max-width: 991px) and (min-width: 768px) { [data-element-id="elm_GFnfX20BavvT3JdeAV7txQ"] .zpimage-container figure img { width:723px ; height:542.25px ; } } @media (max-width: 767px) { [data-element-id="elm_GFnfX20BavvT3JdeAV7txQ"] .zpimage-container figure img { width:415px ; height:311.25px ; } } [data-element-id="elm_GFnfX20BavvT3JdeAV7txQ"] .zpimage-container figure figcaption .zpimage-caption-content { font-family:'open sans'; font-size:14px; font-weight:400; line-height:0px; } [data-element-id="elm_GFnfX20BavvT3JdeAV7txQ"].zpelem-image { border-radius:1px; margin-block-start:32px; } </style><div data-caption-color="" data-size-tablet="" data-size-mobile="" data-align="center" data-tablet-image-separate="false" data-mobile-image-separate="false" class="zpimage-container zpimage-align-center zpimage-tablet-align-center zpimage-mobile-align-center zpimage-size-fit zpimage-tablet-fallback-fit zpimage-mobile-fallback-fit hb-lightbox " data-lightbox-options="
                type:fullscreen,
                theme:dark"><figure role="none" class="zpimage-data-ref"><span class="zpimage-anchor" role="link" tabindex="0" aria-label="Open Lightbox" style="cursor:pointer;"><picture><img class="zpimage zpimage-style-none zpimage-space-none " src="/ISO-27002-2022-standard-information-security-controls.png" width="415" height="311.25" loading="lazy" size="fit" data-lightbox="true"/></picture></span><figcaption class="zpimage-caption zpimage-caption-align-left"><span class="zpimage-caption-content">by Andrea Leonardi (VP of Minerva Group Service, MP of Alpemi Consulting &amp; itSMF Swizerland board member).</span></figcaption></figure></div>
</div><div data-element-id="elm_TfdZWL_yTMJsiNXtziZt3A" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_TfdZWL_yTMJsiNXtziZt3A"].zpelem-heading { border-radius:1px; margin-block-start:14px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">A closer look at attributes of the controls set by the ISO 27002:2022 standard on Information Security<br/></h2></div>
<div data-element-id="elm_S02qcauVtOkHFl6HgvpBsw" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_S02qcauVtOkHFl6HgvpBsw"].zpelem-text { border-radius:1px; margin-block-start:33px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><p><span style="font-size:12pt;"><span style="color:inherit;"><span style="font-size:12pt;">As we already suggested on the previous paragraph, the new <span style="font-weight:bold;">ISO 27002:2022 standard</span> on Information security, cybersecurity and privacy protection - Information Security Controls sets <span style="background-color:rgb(244, 244, 78);"><span style="font-weight:bold;">4 macroscopic groups</span> of operational controls</span>.</span></span></span></p><p><span style="font-size:12pt;"><span style="color:inherit;"><span style="font-size:12pt;"><br/></span></span></span></p><p><span style="font-size:12pt;"><span style="color:inherit;"><span style="font-size:12pt;">Let's take a closer look at each of which, considering the <span style="font-weight:bold;">5 attributes</span> and how they affect the way you can put them in perspective.<br/></span></span></span></p></div></div></div>
</div></div><div data-element-id="elm_yC9G0kyzRg5mZup3wTRe8Q" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_yC9G0kyzRg5mZup3wTRe8Q"].zpelem-heading { border-radius:1px; margin-block-start:41px; } </style><h3
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">1. The Control Type attribute on ISO 27002:2022 standard<br/></h3></div>
<div data-element-id="elm_VMNlCpfoZPWsSIHJYnzvWg" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_VMNlCpfoZPWsSIHJYnzvWg"].zpelem-text { border-radius:1px; margin-block-start:29px; } </style><div class="zptext zptext-align-left " data-editor="true"><div></div><p>The first ISO 27002:2022 standard <span style="font-style:italic;">control attribute</span> we are going to analyse - according to our infographic - is the «<span style="font-weight:bold;">Control Type</span>» one.</p><p><br/></p><p>This one sets the way you can look at the controls from a perspective of «<span style="background-color:rgb(4, 234, 119);"><span style="font-style:italic;">when and how the control modifies the risk</span></span>» with regard to the occurence of an <span style="font-weight:bold;">information security incident</span>.<br/></p><div><br/></div><div>The <span style="color:inherit;"><span style="font-size:16px;"><span>«Control Type» <span style="background-color:rgba(4, 234, 119, 0);">attribute values</span> consist of:</span></span></span></div><p></p></div>
</div><div data-element-id="elm_WjyhZ2cVqZZPSeoCAvi3gw" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_WjyhZ2cVqZZPSeoCAvi3gw"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><ul><li><div style="color:inherit;"><span style="font-size:16px;"><span style="font-weight:bold;">Preventive</span><span> (the control that i<span style="font-style:italic;">s intended to prevent the occurrence</span> of an information security incident);</span></span><span style="font-size:16px;"><span style="font-weight:bold;"></span></span></div></li><li><div style="color:inherit;"><span style="font-size:16px;"><span style="font-weight:bold;">Detective </span><span>(the control acts <span style="font-style:italic;">when an information security incident occurs</span>);</span></span><span style="font-size:16px;"><span style="font-weight:bold;"></span></span></div></li><li><div style="color:inherit;"><span style="font-size:16px;"><span style="font-weight:bold;">Corrective</span><span> (the control acts <span style="font-style:italic;">after an information security incident occurs</span>).</span></span></div></li></ul></div>
</div><div data-element-id="elm_EzBkBII6me65EN3runamNw" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_EzBkBII6me65EN3runamNw"].zpelem-heading { border-radius:1px; margin-block-start:20px; } </style><h3
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">2. The Information Security Properties controls attribute according to ISO 27002:2022 standard<br/></h3></div>
<div data-element-id="elm_mzpjqztMBGXgrZcx6AZIMg" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_mzpjqztMBGXgrZcx6AZIMg"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><p>The second of the controls attributes set by the ISO 27002:2022 standard we take into consideration is the «<span style="font-weight:bold;">Information Security Properties</span>» one.</p><p><br/></p><p>In this case, the attribute set a <span style="font-weight:bold;">point of view</span> of the controls according to the perspective of <br/></p><div style="color:inherit;"><p style="text-align:left;"><span style="font-size:16px;"><span>«<span style="background-color:rgb(4, 234, 119);"><span style="font-style:italic;">which characteristic of information the control will contribute to preserving</span></span>».</span></span></p><p style="text-align:left;"><br/><span style="font-size:16px;"></span></p><p style="text-align:left;"><span style="font-size:16px;">The <span style="background-color:rgba(4, 234, 119, 0);">attribute values </span>consist of:<br/></span></p></div><p></p></div>
</div><div data-element-id="elm_enaNf7e79kNHGQcGtvjIqQ" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_enaNf7e79kNHGQcGtvjIqQ"].zpelem-text { border-radius:1px; margin-block-start:10px; } </style><div class="zptext zptext-align-left " data-editor="true"><ul><li><div style="color:inherit;"><div><span style="font-size:16px;"><span></span></span><p style="text-align:left;"><span style="font-size:16px;">Confidentiality;</span></p></div></div></li><li><div style="color:inherit;"><div><p style="text-align:left;"><span style="font-size:16px;">Integrity;</span><span style="font-size:16px;"></span></p></div></div></li><li><div style="color:inherit;"><div><p><span style="font-size:16px;">Availability.<span><br/></span></span></p></div></div>
</li></ul></div></div><div data-element-id="elm_7PQTByZyM3tpOuXd88FTzA" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_7PQTByZyM3tpOuXd88FTzA"].zpelem-heading { border-radius:1px; margin-block-start:27px; } </style><h3
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">3. The cybersecurity concepts controls attribute set by ISO 27002:2022 standard<br/></h3></div>
<div data-element-id="elm_eRffV_LAEMjDcDgm4NoWvQ" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_eRffV_LAEMjDcDgm4NoWvQ"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><p>The third of all the controls attributes recognised by the ISO 27002:2022 standard we are considering is the «<span style="font-weight:bold;">Cybersecurity concepts</span>» one.</p><div style="color:inherit;"><div><p><span style="font-size:16px;"><span><br/></span></span></p><p style="text-align:left;"><span style="font-size:16px;"><span>This attribute suggests the way you can view the controls from a perspective of «<span style="font-style:italic;">the association of controls to cybersecurity concepts</span>», as defined in the cybersecurity framework described in the <span style="background-color:rgb(4, 234, 119);">ISO/IEC TS 27110</span>.</span></span></p><p style="text-align:left;"><span style="font-size:16px;"><span><br/></span></span></p><p style="text-align:left;"><span style="font-size:16px;"><span>In this case, the attribute value consist of:<br/></span></span></p></div></div><p></p></div>
</div><div data-element-id="elm_ROiTpTPVEPdeg7YHY4Hzrw" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_ROiTpTPVEPdeg7YHY4Hzrw"].zpelem-text { border-radius:1px; margin-block-start:-2px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="color:inherit;"><ul><li><span style="font-size:16px;">Identify; </span></li><li style="text-align:justify;"><span style="font-size:16px;">Protect; </span></li><li style="text-align:justify;"><span style="font-size:16px;">Detect; </span></li><li style="text-align:justify;"><span style="font-size:16px;">Respond; </span></li><li style="text-align:justify;"><span style="font-size:16px;">Recover.</span></li></ul></div></div>
</div><div data-element-id="elm_BlIZiH7KCQiztZcCDbhZnA" data-element-type="image" class="zpelement zpelem-image "><style> @media (min-width: 992px) { [data-element-id="elm_BlIZiH7KCQiztZcCDbhZnA"] .zpimage-container figure img { width: 703px ; height: 469.25px ; } } @media (max-width: 991px) and (min-width: 768px) { [data-element-id="elm_BlIZiH7KCQiztZcCDbhZnA"] .zpimage-container figure img { width:723px ; height:482.60px ; } } @media (max-width: 767px) { [data-element-id="elm_BlIZiH7KCQiztZcCDbhZnA"] .zpimage-container figure img { width:415px ; height:277.01px ; } } [data-element-id="elm_BlIZiH7KCQiztZcCDbhZnA"].zpelem-image { border-radius:1px; margin-block-start:26px; } </style><div data-caption-color="" data-size-tablet="" data-size-mobile="" data-align="center" data-tablet-image-separate="false" data-mobile-image-separate="false" class="zpimage-container zpimage-align-center zpimage-tablet-align-center zpimage-mobile-align-center zpimage-size-fit zpimage-tablet-fallback-fit zpimage-mobile-fallback-fit hb-lightbox " data-lightbox-options="
                type:fullscreen,
                theme:dark"><figure role="none" class="zpimage-data-ref"><span class="zpimage-anchor" role="link" tabindex="0" aria-label="Open Lightbox" style="cursor:pointer;"><picture><img class="zpimage zpimage-style-none zpimage-space-none " src="/ISO-27002-2022-information-security-controls-standard-details.jpg" width="415" height="277.01" loading="lazy" size="fit" data-lightbox="true"/></picture></span></figure></div>
</div><div data-element-id="elm_vX9L3SK9cQ1Z0TT5TKSIBw" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_vX9L3SK9cQ1Z0TT5TKSIBw"].zpelem-heading { border-radius:1px; } </style><h3
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">4. The ISO 27002:2022 operational capabilites controls attribute<br/></h3></div>
<div data-element-id="elm_ANXMBIJSjYN2oYnJw5J8Ng" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_ANXMBIJSjYN2oYnJw5J8Ng"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><p>The fourth attribute of the updated version of ISO 27002:2022 standard we are going to consider is the «<span style="font-weight:bold;">operational capabilities</span>» one.<br/></p><p><br/></p><p>This attribute helps us to view the controls from a «<span style="background-color:rgb(4, 234, 119);"><span style="font-style:italic;">practioner's perspective of information security capabilities</span></span>».</p><p><br/></p><p>In this case, the attribute values are:<br/></p></div>
</div><div data-element-id="elm_P8lt2Z8xkfNzl1z5mLHHqQ" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_P8lt2Z8xkfNzl1z5mLHHqQ"].zpelem-text { border-radius:1px; margin-block-start:-4px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="color:inherit;"><ul><li><span style="font-size:16px;">Governance; </span></li><li><span style="font-size:16px;">Asset Management; </span></li><li><span style="font-size:16px;">Information Protection; </span></li><li><span style="font-size:16px;">Human Resource Security; </span></li><li><span style="font-size:16px;">Physical Security, System and Network Security; </span></li><li><span style="font-size:16px;">Application Security; </span></li><li><span style="font-size:16px;">Secure Configuration;</span></li><li><span style="font-size:16px;">Identity and Access Management; </span></li><li><span style="font-size:16px;">Threat and Vulnerability Management; </span></li><li><span style="font-size:16px;">Continuity; </span></li><li><span style="font-size:16px;">Supplier Relationships Security; </span></li><li><span style="font-size:16px;">Legal and Compliance; </span></li><li><span style="font-size:16px;">Information Security Event Management;</span><span style="font-size:16px;"></span></li><li><span style="font-size:16px;"><span>Information Security Assurance.</span></span></li></ul></div></div>
</div><div data-element-id="elm_n_EKJny0Wdd11wK1wKJSIg" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_n_EKJny0Wdd11wK1wKJSIg"].zpelem-heading { border-radius:1px; } </style><h3
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">5. The security domains controls attribute according to ISO 27002:2022 standard<br/></h3></div>
<div data-element-id="elm_DmssbPmGrz2sYr-0OWz3ew" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_DmssbPmGrz2sYr-0OWz3ew"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><p>The last of all the ISO 27002:2022 standard controls attributes we are going to mention is the one known as «<span style="font-weight:bold;">Security domains</span>».</p><p><br/></p><p>This attribute provides us a controls view according to the «<span style="background-color:rgb(4, 234, 119);"><span style="font-style:italic;">perspective of four information security domains</span></span>», which are<span style="font-size:16px;"></span>:</p></div>
</div><div data-element-id="elm_L4gBXgkHQUcNGZIv-uIKPA" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_L4gBXgkHQUcNGZIv-uIKPA"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="color:inherit;"><div style="text-align:left;"><span style="font-family:&quot;open sans&quot;;"><span style="font-size:16px;"></span></span><ol><li style="text-align:left;"><span style="font-family:&quot;open sans&quot;;"><span style="font-size:16px;"><span>«</span><span style="font-weight:bold;">Governance &amp; Ecosystem</span><span>» that includes the «<span style="background-color:rgba(4, 234, 119, 0);"><span style="font-style:italic;">Information System Security Governance &amp; Risk Management</span>» and the «<span style="font-style:italic;">Ecosystem cybersecurity management</span>»</span> (considering also the internal &amp; external stakeholders);</span></span></span><span style="font-family:&quot;open sans&quot;;"><span style="font-size:16px;"><span style="font-weight:bold;"></span></span></span></li><li style="text-align:left;"><span><span style="font-family:&quot;open sans&quot;;"><span style="font-size:16px;"><span style="font-weight:bold;"><span style="font-weight:400;">«</span>Protection</span><span>» that considers all these topics: «IT Security Architecture», «IT Security Administration», «Identity and access management», «IT Security Maintenance» and «Physical and environmental<span>&nbsp; </span>security»;</span></span></span></span><span style="font-family:&quot;open sans&quot;;"><span style="font-size:16px;"><span style="font-weight:bold;"></span></span></span></li><li style="text-align:left;"><span><span style="font-family:&quot;open sans&quot;;"><span style="font-size:16px;"><span style="font-weight:bold;"><span style="font-weight:400;">«</span>Defence<span style="font-weight:400;">»</span></span><span>that contains the «Detection» and «Computer Security Incident Management» matters;</span></span></span></span><span style="font-family:&quot;open sans&quot;;"><span style="font-size:16px;"><span style="font-weight:bold;"></span></span></span></li><li style="text-align:left;"><span><span style="font-family:&quot;open sans&quot;;"><span style="font-size:16px;"><span style="font-weight:bold;"><span style="font-weight:400;">«</span><span style="font-weight:400;"></span>Resilience</span><span>» that includes «Continuity of operations» and «Crisis management».</span></span></span></span></li></ol></div></div></div>
</div><div data-element-id="elm_vEZyBvmbpE25ewcyrBS-EA" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_vEZyBvmbpE25ewcyrBS-EA"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true">The attribute values consist of:<br/></div>
</div><div data-element-id="elm_A6WrKqgWCO_kN8_Ex5zspg" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_A6WrKqgWCO_kN8_Ex5zspg"].zpelem-text { border-radius:1px; margin-block-start:0px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="color:inherit;"><ul><li><div><div><div><div><span style="font-size:16px;">Governance_and_Ecosystem</span><span style="font-size:16px;"></span></div></div></div></div></li><li><div><div><div><div><span style="font-size:16px;">Protection;<span></span></span></div></div></div></div></li><li><div><div><div><div><span style="font-size:16px;"><span>Defence and Resilience.</span></span></div></div></div></div></li></ul></div></div>
</div><div data-element-id="elm_Wt1JpneCSpWKNxV7KRB51g" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_Wt1JpneCSpWKNxV7KRB51g"].zpelem-heading { border-radius:1px; margin-block-start:21px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true"><span><span><span style="font-size:28px;">Our «breakdown» on ISO 27002:2022 Organizational, People, Physical and Technological Controls<span style="color:inherit;"><span></span></span></span></span></span></h2></div>
<div data-element-id="elm_IkPuS9IVhs3uScR-pG9CSg" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_IkPuS9IVhs3uScR-pG9CSg"].zpelem-text { border-radius:1px; margin-block-start:33px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="color:inherit;"><p><span>At the ending stage of our overview on the new <span style="background-color:rgb(4, 234, 119);">ISO 27002:2022 standard</span> on <span style="color:inherit;"><span style="font-size:16px;"><span>«Information security, cybersecurity and privacy protection - Information security controls» we'd like to provide you our <span style="font-style:italic;">breakdown on Organizational, People, Physical and Technological controls</span>.</span></span></span></span></p><span></span></div></div>
</div><div data-element-id="elm_02nuLAWQqbPZnlgZFFdl1Q" data-element-type="image" class="zpelement zpelem-image "><style> @media (min-width: 992px) { [data-element-id="elm_02nuLAWQqbPZnlgZFFdl1Q"] .zpimage-container figure img { width: 703px ; height: 421.80px ; } } @media (max-width: 991px) and (min-width: 768px) { [data-element-id="elm_02nuLAWQqbPZnlgZFFdl1Q"] .zpimage-container figure img { width:723px ; height:433.80px ; } } @media (max-width: 767px) { [data-element-id="elm_02nuLAWQqbPZnlgZFFdl1Q"] .zpimage-container figure img { width:415px ; height:249.00px ; } } [data-element-id="elm_02nuLAWQqbPZnlgZFFdl1Q"].zpelem-image { border-radius:1px; } </style><div data-caption-color="" data-size-tablet="" data-size-mobile="" data-align="center" data-tablet-image-separate="false" data-mobile-image-separate="false" class="zpimage-container zpimage-align-center zpimage-tablet-align-center zpimage-mobile-align-center zpimage-size-fit zpimage-tablet-fallback-fit zpimage-mobile-fallback-fit hb-lightbox " data-lightbox-options="
                type:fullscreen,
                theme:dark"><figure role="none" class="zpimage-data-ref"><span class="zpimage-anchor" role="link" tabindex="0" aria-label="Open Lightbox" style="cursor:pointer;"><picture><img class="zpimage zpimage-style-none zpimage-space-none " src="/iso-27002-2022-information-security-breakdown-on-controls-cover.png" width="415" height="249.00" loading="lazy" size="fit" data-lightbox="true"/></picture></span><figcaption class="zpimage-caption zpimage-caption-align-center"><span class="zpimage-caption-content">Our breakdown document on the Organizational, People, Physical and Technological controls.</span></figcaption></figure></div>
</div><div data-element-id="elm_N9exP7TqnI_WQVZR0rvyPg" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_N9exP7TqnI_WQVZR0rvyPg"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><p>If you want to download our breakdown document, subscribe to our newsletter. Every month we update you with all the most relevant topics for our ICT Service Management professional community and we give you some preview of «what is happening behind the scenes».<br/></p></div>
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</div></div></div></div></div></div> ]]></content:encoded><pubDate>Wed, 23 Nov 2022 00:04:32 +0100</pubDate></item><item><title><![CDATA[Software as a Medical Device (SWaaMD) and the ISO Management Systems]]></title><link>https://www.itsmf.ch/blogs/post/software-as-a-medical-device-swaamd-and-the-iso-management-systems</link><description><![CDATA[<img align="left" hspace="5" src="https://www.itsmf.ch/swaamd-software-as-a-medical-device-and-the-iso-management-systems-gdpr-lpd.png"/>Let's check out more details about Software as a Medical Device & ISO Management Systems and the compliance with EU regulations.]]></description><content:encoded><![CDATA[<div class="zpcontent-container blogpost-container "><div data-element-id="elm_eaocCKUWRQWj8hdYP5pfdA" data-element-type="section" class="zpsection "><style type="text/css"></style><div class="zpcontainer-fluid zpcontainer"><div data-element-id="elm_EZDc8gx4R1GuKfHeKhZ2iw" data-element-type="row" class="zprow zprow-container zpalign-items- zpjustify-content- " data-equal-column=""><style type="text/css"> [data-element-id="elm_EZDc8gx4R1GuKfHeKhZ2iw"].zprow{ border-radius:1px; } </style><div data-element-id="elm_PC-fd0JiQGy9ODIQOJc_6g" data-element-type="column" class="zpelem-col zpcol-12 zpcol-md-8 zpcol-sm-12 zpalign-self- "><style type="text/css"> [data-element-id="elm_PC-fd0JiQGy9ODIQOJc_6g"].zpelem-col{ border-radius:1px; } </style><div data-element-id="elm_x6wEYR35H-vRh_ndc9qjAg" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_x6wEYR35H-vRh_ndc9qjAg"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><p><span style="font-style:italic;">Reading time: ~ 4 min.</span><br></p></div>
</div><div data-element-id="elm_inqAeAvYLtrUD7tmrUWHNA" data-element-type="image" class="zpelement zpelem-image "><style> @media (min-width: 992px) { [data-element-id="elm_inqAeAvYLtrUD7tmrUWHNA"] .zpimage-container figure img { width: 703px ; height: 468.48px ; } } @media (max-width: 991px) and (min-width: 768px) { [data-element-id="elm_inqAeAvYLtrUD7tmrUWHNA"] .zpimage-container figure img { width:723px ; height:481.81px ; } } @media (max-width: 767px) { [data-element-id="elm_inqAeAvYLtrUD7tmrUWHNA"] .zpimage-container figure img { width:415px ; height:276.56px ; } } [data-element-id="elm_inqAeAvYLtrUD7tmrUWHNA"].zpelem-image { border-radius:1px; } </style><div data-caption-color="" data-size-tablet="" data-size-mobile="" data-align="center" data-tablet-image-separate="false" data-mobile-image-separate="false" class="zpimage-container zpimage-align-center zpimage-size-fit zpimage-tablet-fallback-fit zpimage-mobile-fallback-fit hb-lightbox " data-lightbox-options="
                type:fullscreen,
                theme:dark"><figure role="none" class="zpimage-data-ref"><span class="zpimage-anchor" role="link" tabindex="0" aria-label="Open Lightbox" style="cursor:pointer;"><picture><img class="zpimage zpimage-style-none zpimage-space-none " src="/software-as-a-medical-device-iso-management-systems.jpg" width="415" height="276.56" loading="lazy" size="fit" data-lightbox="true"/></picture></span></figure></div>
</div><div data-element-id="elm_Uy2drJ_yPLPmFCRoHyz74Q" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_Uy2drJ_yPLPmFCRoHyz74Q"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">Software as a Medical Device: a booming market<br></h2></div>
<div data-element-id="elm_X09Gj-KrQW6A8yA8s176qw" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_X09Gj-KrQW6A8yA8s176qw"].zpelem-text { border-radius:1px; margin-block-start:16px; } </style><div class="zptext zptext-align-center " data-editor="true"><div><div><div style="line-height:1.5;"><div style="text-align:left;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;"><div style="color:inherit;line-height:1.5;"><div style="color:inherit;line-height:1.5;"><div style="color:inherit;line-height:1.5;"><p><span style="font-size:16px;">Several reports on <span style="font-weight:bold;">Software as a Medical Device</span> (SWaaMD) market highlights very interesting growth trends. If you take a look at the last one issued by Industry Research you won't be disappointed by the forecasts on 2022-28 global sales you're going to find on it.</span></p><p><span style="font-size:16px;"><br></span></p><span style="font-size:16px;"><span style="font-style:italic;font-size:18px;"><span>The <span style="background-color:rgb(4, 234, 119);"><span style="font-weight:bold;">Global Software as a Medical Device Market Size</span></span> in 2021 valuation was at 1048 million USD and according to this report it <span style="background-color:rgb(234, 234, 4);">will reach 10190 million USD in 2028</span>, with a CAGR of 38.39%.</span></span><span style="font-size:18px;"><span></span></span><br></span><p><span style="font-size:16px;"><br></span></p><p><span style="font-size:16px;"><span>In particular, the <span style="background-color:rgb(4, 234, 119);">European SWaaMD market</span> was about <span style="font-weight:bold;">5,430 USD million in 2019 in 2019</span> and it is expected to reach <span style="background-color:rgb(234, 234, 4);"><span style="font-weight:bold;">24,898 UDS million in 2027</span></span></span>, with a Compound Annual Growth Rate of 21.6% (2020-27).</span></p><p><br></p><p><span style="font-size:16px;">If you think about the reasons why this market shows this promising growing trends you will find probably the memories of the first <span style="background-color:rgb(234, 234, 4);">COVID-19 pandemic</span> wave and the shortage of empty beds in hospital wards worldwide.</span></p><p><br></p><p><span style="font-size:16px;">The public health systems had to strengthen their digitalization to provide therapies to patients in particular due to the overload of the healthcare infrastructure.</span><br></p><span style="color:inherit;"></span></div></div></div></div>
</div></div></div></div></div></div></div></div><div data-element-id="elm_cWdnD-P65F0sYFkdTTrqUQ" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_cWdnD-P65F0sYFkdTTrqUQ"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">The European SWaaMD market and the compliance with EU regulations<br></h2></div>
<div data-element-id="elm_S02qcauVtOkHFl6HgvpBsw" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_S02qcauVtOkHFl6HgvpBsw"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><div style="color:inherit;"><p><span style="font-size:12pt;">Even if to someone it could seems to be useless to remember, we want to remark that <span style="font-weight:bold;">ALL <span style="background-color:rgb(234, 234, 4);">the medical devices</span></span> you plan to sell on the <span style="background-color:rgb(234, 234, 4);"><span style="font-weight:bold;">EU market</span></span> must be <span style="background-color:rgb(234, 234, 4);"><span style="font-weight:bold;">CE marked</span></span>.</span></p><p><span style="font-size:12pt;"><br></span></p><p><span style="font-size:12pt;">Moreover <span style="font-weight:bold;">software</span> can also be classified as <span style="font-weight:bold;">medical devices</span> pursuant to <span style="background-color:rgb(234, 234, 4);"><span style="font-weight:bold;">EU Regulation 745/2017</span></span>. In this case, we usually refer to <span style="color:inherit;font-size:16px;"><span>«</span></span>Software as a Medical Device<span style="color:inherit;"><span style="font-size:12pt;"><span style="font-size:16px;"><span>»</span></span></span></span> (SWaaMD) as outlined by the guidelines <span style="color:inherit;"><span style="font-size:12pt;"><span style="font-size:16px;"><span>«</span></span><span style="font-weight:bold;">MDCG 2019-11</span>: Guidance on Qualification and Classification of Software in Regulation<span><span style="font-size:12pt;"><span style="font-size:16px;"><span> (EU) 2017/745 - MDR and Regulation (EU) 2017/746 - IVDR»</span></span></span></span></span></span></span>.</p><p><br></p><p>The exact evaluation on which are the laws you have to make sure you're compliant with to market your SWaaMD in EU it is critical to grant you the access to a growing market that is also regulated with <span style="background-color:rgb(4, 234, 119);">restrictive privacy regulation</span> (GDPR) in particular with sensitive personal data (e.g. the <span style="background-color:rgb(4, 234, 119);">health condition of people</span>).<br></p></div><p></p></div>
</div><div data-element-id="elm_VZ9nQL45QrO3V6oIdinP-g" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_VZ9nQL45QrO3V6oIdinP-g"].zpelem-heading { border-radius:1px; } </style><h2
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true"><span><span><span><span style="font-size:26px;">Software as a Medical Device and the ISO Management Systems</span><br></span></span></span></h2></div>
<div data-element-id="elm_GFnfX20BavvT3JdeAV7txQ" data-element-type="image" class="zpelement zpelem-image "><style> @media (min-width: 992px) { [data-element-id="elm_GFnfX20BavvT3JdeAV7txQ"] .zpimage-container figure img { width: 703px ; height: 468.48px ; } } @media (max-width: 991px) and (min-width: 768px) { [data-element-id="elm_GFnfX20BavvT3JdeAV7txQ"] .zpimage-container figure img { width:723px ; height:481.81px ; } } @media (max-width: 767px) { [data-element-id="elm_GFnfX20BavvT3JdeAV7txQ"] .zpimage-container figure img { width:415px ; height:276.56px ; } } [data-element-id="elm_GFnfX20BavvT3JdeAV7txQ"].zpelem-image { border-radius:1px; } </style><div data-caption-color="" data-size-tablet="" data-size-mobile="" data-align="center" data-tablet-image-separate="false" data-mobile-image-separate="false" class="zpimage-container zpimage-align-center zpimage-size-fit zpimage-tablet-fallback-fit zpimage-mobile-fallback-fit hb-lightbox " data-lightbox-options="
                type:fullscreen,
                theme:dark"><figure role="none" class="zpimage-data-ref"><span class="zpimage-anchor" role="link" tabindex="0" aria-label="Open Lightbox" style="cursor:pointer;"><picture><img class="zpimage zpimage-style-none zpimage-space-none " src="/software-as-a-medical-device-iso-management-systems-european-market.jpg" width="415" height="276.56" loading="lazy" size="fit" data-lightbox="true"/></picture></span></figure></div>
</div><div data-element-id="elm_9uv5NvaVJDzD_E1Y0MsEeQ" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_9uv5NvaVJDzD_E1Y0MsEeQ"].zpelem-text { border-radius:1px; } </style><div class="zptext zptext-align-left " data-editor="true"><div><div style="color:inherit;"><p style="text-align:justify;"><span style="font-size:16px;">As many other digital solutions, also on the Software as a Medical Device market we find some standards that are useful to define the main references you have to follow to develop <span style="background-color:rgb(234, 234, 4);">products</span> that are going to meet the needs and the expectations of the healthcare industry.</span></p><p style="text-align:justify;"><span style="font-size:16px;"><br></span></p><p style="text-align:justify;"><span style="font-size:16px;">One of the most relevant standard is the <span style="font-weight:bold;">IEC 62304:2006</span> known as a technical international standard about <span style="color:inherit;"><span style="font-size:12pt;"><span style="font-size:16px;"><span>«</span></span><span style="background-color:rgb(234, 234, 4);">Medical device software - software life cycle processes</span><span><span style="font-size:12pt;"><span style="font-size:16px;"><span>». But let focus a little bit more on the relationships you're going to find between ISO management systems and the mandatory requirements.<br></span></span></span></span></span></span></span></p></div></div><p></p></div>
</div><div data-element-id="elm_v7tQejU_8UbZTQaGlv4umg" data-element-type="heading" class="zpelement zpelem-heading "><style> [data-element-id="elm_v7tQejU_8UbZTQaGlv4umg"].zpelem-heading { border-radius:1px; } </style><h3
 class="zpheading zpheading-style-none zpheading-align-left " data-editor="true">The ISO management systems and mandatory requirements<br></h3></div>
<div data-element-id="elm_qflNMjXE-9v18hKqJO_F_A" data-element-type="text" class="zpelement zpelem-text "><style> [data-element-id="elm_qflNMjXE-9v18hKqJO_F_A"].zpelem-text { border-radius:1px; margin-block-start:8px; } </style><div class="zptext zptext-align-left " data-editor="true"><div><div><span style="font-size:16px;">If we focus in particular on the correlations between some of the most important <span style="font-weight:bold;">ISO management systems</span> and the <span style="background-color:rgb(4, 234, 119);">mandatory requirements (compliance management)</span>, we can't forget to mention these ones:<br></span></div><div><ul><li>IT Service <span style="background-color:rgb(234, 234, 4);">ISO20000-1</span> about <span style="color:inherit;"><span><span style="font-size:12pt;"><span style="font-size:16px;"><span>«</span></span></span></span></span>Software life cycle<span style="color:inherit;"><span><span style="font-size:12pt;"><span style="font-size:16px;"></span><span><span style="font-size:12pt;"><span style="font-size:16px;"><span>» </span></span></span></span></span></span></span><span style="color:inherit;"><span><span style="font-size:12pt;"><span style="font-size:16px;"></span><span><span style="font-size:12pt;"><span style="font-size:16px;"><span></span></span></span></span></span></span></span></li><li><span style="background-color:rgb(234, 234, 4);">ISO9001 and ISO13485</span><span style="color:inherit;"><span style="font-size:12pt;"><span style="font-size:16px;"><span>about «Quality for SW design and development</span></span><span><span style="font-size:12pt;"><span style="font-size:16px;"><span>» <br></span></span></span></span></span></span></li><li><span style="color:inherit;"><span style="font-size:12pt;"><span><span style="font-size:12pt;"><span style="font-size:16px;"><span><span style="background-color:rgb(234, 234, 4);">ISO/IEC25010:2011</span><span style="color:inherit;"><span><span style="font-size:12pt;"><span style="font-size:16px;"><span>about «Models for SW quality</span></span><span><span style="font-size:12pt;"><span style="font-size:16px;"><span>»</span></span></span></span></span></span></span></span></span></span></span></span></span></li><li><span style="color:inherit;"><span style="font-size:12pt;"><span><span style="font-size:12pt;"><span style="font-size:16px;"><span><span style="color:inherit;"><span><span style="font-size:12pt;"><span><span style="font-size:12pt;"><span style="font-size:16px;"><span><span style="background-color:rgb(234, 234, 4);">ISO27001</span> about <span style="color:inherit;"><span><span style="font-size:12pt;"><span style="font-size:16px;"><span>«Information security for integrity, availability and confidentiality requirements</span></span><span><span style="font-size:12pt;"><span style="font-size:16px;"><span>»</span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></li><li><span style="color:inherit;"><span style="font-size:12pt;"><span><span style="font-size:12pt;"><span style="font-size:16px;"><span><span style="color:inherit;"><span><span style="font-size:12pt;"><span><span style="font-size:12pt;"><span style="font-size:16px;"><span><span style="color:inherit;"><span><span style="font-size:12pt;"><span><span style="font-size:12pt;"><span style="font-size:16px;"><span><span style="background-color:rgb(234, 234, 4);">GDPR</span> (as stated before) and <span style="background-color:rgb(234, 234, 4);">LPD-DSG-LPD</span> (Federal Act on Data Protection) for Switzerland, to be compliant with the privacy requirements refereed to by MDR 745/2017 itself.</span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></li></ul><div><br></div><div>To give you a better view on Software as a Medical Device, ISO Management Systems and Compliance, take a look at our infographic.<br></div></div></div><span style="font-size:16pt;font-weight:normal;"></span><p><strong></strong></p></div>
</div><div data-element-id="elm_6mp3_jyb0InjfIFGxzEC6A" data-element-type="image" class="zpelement zpelem-image "><style> @media (min-width: 992px) { [data-element-id="elm_6mp3_jyb0InjfIFGxzEC6A"] .zpimage-container figure img { width: 703px ; height: 527.25px ; } } @media (max-width: 991px) and (min-width: 768px) { [data-element-id="elm_6mp3_jyb0InjfIFGxzEC6A"] .zpimage-container figure img { width:723px ; height:542.25px ; } } @media (max-width: 767px) { [data-element-id="elm_6mp3_jyb0InjfIFGxzEC6A"] .zpimage-container figure img { width:415px ; height:311.25px ; } } [data-element-id="elm_6mp3_jyb0InjfIFGxzEC6A"].zpelem-image { border-radius:1px; margin-block-start:21px; } </style><div data-caption-color="" data-size-tablet="" data-size-mobile="" data-align="center" data-tablet-image-separate="false" data-mobile-image-separate="false" class="zpimage-container zpimage-align-center zpimage-size-fit zpimage-tablet-fallback-fit zpimage-mobile-fallback-fit hb-lightbox " data-lightbox-options="
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</div></div></div></div></div></div> ]]></content:encoded><pubDate>Wed, 20 Jul 2022 07:00:00 +0200</pubDate></item></channel></rss>