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--- articles:context_of_the_organization [2022/05/15 18:39] – rrandall
+++ articles:context_of_the_organization [2023/03/22 15:45] (current) – [Additional AS 9100:2016 (Rev. D) Requirement] rrandall
@@ Line 9: / Line 9: @@
 <blockquote>**ISO 9001:2015, sec. 4.1** \\
 NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, __cultural, social and economic environments__, whether __international, national, regional or local__. \\
-NOTE 3 Understanding the internal context can be facilitated by considering issues related to __values, culture__, knowledge and performance of the organization. \\
+NOTE 3 Understanding the internal context can be facilitated by considering issues related to __values, culture__, knowledge and performance of the organization.</blockquote>
-</blockquote>
-For example, when reading ISO 9001:2015 & AS 9100:2016, sec. 4.2 “//Understanding the needs and expectations of interested parties//”, the interpretation varies depending upon whether the country is communist, socialist (i.e., closed or restricted economies) or a free society with a free market economy.
+===== The Organization and its Context =====
+The most common way to address this requirement is through the use of a SWOT analysis. A SWOT Analysis provides management with "talking points" to discuss the "//external and internal issues that are relevant to//" the organization's purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.
+The image below provides a general template for how to structure a SWOT to clearly differentiate between external and internal issues. This format also includes the concept of positive risks (opportunities) and negative risks (actual risks). To argue the semantics of these two terms is pointless. I suggest simply including these terms to demonstrate how your SWOT includes "risk-based thinking".
+{{ :articles:swot_analysis_image.png?direct&600 |}}
+A completed SWOT analysis should be either included or referenced in your "Management Review Meeting Minutes" to satisfy ISO 9001 / AS9100, sec. 9.3.2, "Management review inputs", which states:
+<blockquote>The management review shall be planned and carried out taking into consideration: \\
+b) changes in __external and internal issues__ that are relevant to the quality management system;</blockquote>
+===== The Needs and Expectations of Interested Parties =====
+As discussed above, when reading ISO 9001:2015 & AS 9100:2016, sec. 4.2 “//Understanding the needs and expectations of interested parties//”, the interpretation varies depending upon whether the country is communist, socialist (i.e., closed or restricted economies) or a free society with a free market economy.
 In China, where more than a third of all ISO 9001:2015 certifications have been issued, the “//Context of the Organization//” and its relationship with “//Interested Parties / Stakeholders//” has a very different meaning than in the USA!
@@ Line 27: / Line 38: @@
 ISO 9001:2015, Annex A.3 further clarifies this limitation stating:
 <blockquote>“//There is no requirement in this International Standard for the organization to consider interested parties where it has decided that those parties are not relevant to its quality management system. It is for the organization to decide if a particular requirement of a relevant interested party is relevant to its quality management system.//”</blockquote>
-\\
 Consequently, ISO 9001:2015, Annex A.3 makes this "//requirement//" extremely simple for an organization to comply with... because it empowers __the organization__ to decide which requirements from an "//interested party//" are applicable to its quality management system. \\
-\\
 Some U.S. companies have identified their own //employees// and/or //suppliers// as "interested parties"! But do those employees and/or suppliers actually invoke any "//quality-related requirements//" on the business? While the answer is generally no, as per ISO 9001:2015, Annex A.3, the final determination is left to the organization. \\
  \\
@@ Line 40: / Line 51: @@
 person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity \\
  \\
-EXAMPLE **Customers**, owners, people in an organization, providers, bankers, **regulators**, unions, partners or society that can include competitors or opposing pressure groups. </blockquote>
+EXAMPLE **Customers**, owners, people in an organization, providers, bankers, **regulators**, unions, partners or society that can include competitors or opposing pressure groups.</blockquote>
-The only "interested parties" I see listed in the above examples are those I've bolded.
+The only //quality-related// "interested parties" I see listed in the above examples are those I've bolded.
 An example of valid "//Interested Parties//" for a company visiting ports (e.g., performing inspections of, or transferring goods to/from, barges, vessels, shore tanks, etc.) might include:
@@ Line 73: / Line 84: @@
 |  U.S. Department of State  | Defined in the [[https://www.law.cornell.edu/cfr/text/22/chapter-I/subchapter-M|“International Traffic in Arms Regulations” (22 CFR Subchapter M, Parts 120-130)]], when applicable. |
 |  U.S. Department of Defense  | Defined in the “Federal Acquisition Regulations” (FARs) & “Defense Federal Acquisition Regulations” (DFARs), when incorporated into U.S. government solicitations and contracts by reference. |
-|  U.S. Dept. of Commerce, Bureau of Industry and Security (BIS)  | [[https://www.law.cornell.edu/cfr/text/15/subtitle-B/chapter-VII/subchapter-C|15 CFR, Subtitle B, Chapter VII, Subchapter C, “Export Administration Regulations”]] (EAR), when applicable.  |
+|  U.S. Dept. of Commerce, Bureau of Industry and Security (BIS)  | [[https://www.law.cornell.edu/cfr/text/15/subtitle-B/chapter-VII/subchapter-C|15 CFR, Subtitle B, Chapter VII, Subchapter C, “Export Administration Regulations”]] (EAR), when applicable AND/OR \\ [[https://www.bis.doc.gov/index.php/other-areas/strategic-industries-and-economic-security-sies/defense-priorities-a-allocations-system-program-dpas|The Defense Priorities and Allocations System (DPAS)]] regulation ([[https://www.ecfr.gov/current/title-15/subtitle-B/chapter-VII/subchapter-A/part-700|15 CFR Part 700]]), when applicable.  |
 |  U.S. Department of Transportation (DOT)  | [[https://www.law.cornell.edu/cfr/text/49/chapter-I|49 CFR Subtitle B, Chapter I, subchapters A-C, parts 100 thru 185]] & [[https://www.law.cornell.edu/cfr/text/49/subtitle-B|49 CFR Subtitle B, Chapters II thru XII]], as applicable. \\ **Note:** [[https://www.iata.org/en/|IATA (International Air Transport Association)]] is an industry trade organization providing information for the international transportation of dangerous goods by air. The [[https://www.iata.org/en/publications/dgr/|IATA “Dangerous Goods Regulations” (DGR)]] is NOT an official regulatory document but may be referenced for guidance.  |
 |  Certification Body (CB)  | Defined in the specific CB's "Rules of Registration".  |
 \\
+Ignoring ISO 9001:2015, Annex A.3, some AS91xx auditors demand the addition of other interested parties. One of the most common is the "owners". Their logic is that the owners communicate their quality-related requirements through the "Quality Policy". While this is much like claiming that wood is an interested party to the tree, it's easier to add "Owners" as an interested party rather than argue the point.