Context of the Organization and ITAR Compliance

Utilizing the context of the organization clause of an ISO 9001:2015 Quality Management System (QMS) can allow for a more resilient ITAR compliance program.    This can be accomplished by integrating export compliance into an existing management system s that includes all the tasks required to ensure that business is conducted in accordance to federal regulations.  These task include top management involvement, risk assessment, training, and auditing.

What is Context of the Organization?

The context of the organization and ITAR Compliance requirement in ISO 9001:2015 uses the internal and external issues that impact its strategic objectives as  inputs for establishing the QMS framework .   This means that you need to define influences of various elements on the organization and how they reflect on the QMS, the company’s culture, objectives and goals, complexity of products, flow of processes and information, size of the organization, markets, customers, etc. It is also a means to detect risks and opportunities regarding the business context.

Assuredly, export compliance is an external factor that effects objectives, goals, and processes.  It also presents a risk to the organization because of the possible penalties that may be faced in the event of violation of any number of federal export violations.

Context of the organization

What is Export Compliance?

The two major set of U.S. export regulations are the International Traffic in Arms Regulations (ITAR) and the Export Administration Regulations  (EAR).   Both are in place to give the government a tool to ensure that restricted technologies do not get into the hands of nation states or parties that threaten U.S. security or impede U.S. foreign policy interests and obligations.

The ITAR was written to control the export of goods and services developed specifically for defense related applications.  These goods are categorized in the United States Munitions List (USML).  The EAR controls items which fall under a dual-use classification under the Commerce Control List (CCL).  An export license may be required for both ITAR and EAR controlled items if the parties involved are non-US citizens or involve non-US charted corporations.

Failure to comply with all parts of these regulations can result in significant fines and even imprisonment.  Additionally, a business can be banned from any future export activities.

Context of the Organization and Export Compliance

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 in the past few years of how U.S. Government Regulatory compliance impacts companies and their operations and they are starting to issue derogatory findings for companies that explicitly ignore the ITAR or EAR in their QMS, when they clearly are 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.  The Context of the Organization and ITAR Compliance is the lens that companies need to view their commitment to ITAR and EAR Compliance.  It allows companies to formalize policies, processes, and procedures to ensure compliance and enact procedures to promptly respond to incidents where violations may have occurred.

Consultants can help you with understanding how to implement this.  We do recommend that your work with a consultant who is fluent in the ITAR and EAR and is experienced in Quality Management Systems such as ISO 9001:2015, ISO 13485:2016 and AS9100D

CVG Strategy Can Help

CVG Strategy consultants are experts in quality management systems and export compliance.  Our team members are Exemplar Global Certified Lead Auditors in these areas as well as certified through ECTI as Export Compliance Professionals.  We have helped business of all sizes in a variety of sectors integrate their export compliance program into their quality management systems.



Kevin Gholston

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