Context of the Organization and ITAR Compliance

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November 08, 2016

Context of the Organization (Clause 4) is a new requirement in ISO 9001:2015. As subsequent updates to other ISO standards are released, this will be integral to all new quality management systems. It states how an organization must consider both the internal and external issues that can impact its strategic objectives and the planning of its Quality Management System. Essentially, Clause 4 changes the concept and application of requirements regarding the context of the organization. I realize that sounds a little bit vague, so let’s find out what this clause actually requires?


Clause 4 of ISO 9001:2015 Context of the organization requires the Organization to determine influences of various elements on the organization and how they affect its ability to achieve the intended results of the QMS. This determination may include the company’s culture, objectives and goals, complexity of products, flow of processes and information, size of the organization, markets, customers, etc. It can also be used as a method to detect risks and opportunities regarding the business.


If your company manufactures or provides services that are classified as Restricted under the International Traffic in Arms Regulations (ITAR) or Export Administration Regulations (EAR), consideration for compliance must be included. Registrars are becoming more aware of how U.S. Government Regulatory Compliance impacts companies and their operations. Derogatory findings are now being issued to companies that explicitly ignore the ITAR or EAR in their QMS, when they are clearly providing products or services that should be controlled.


Context of the Organization is all about the external and internal factors that will guide the company and its pursuit of risk mitigation through its commitment to continuous improvement. Context of the Organization is the lens that companies need to view their commitment to ITAR and EAR compliance.

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