Context of the organization is a new requirement in ISO 9001:2015. As the subsequent updates to other ISO Standards are released this will be integral to all new Quality Management Systems. It is about stating how an organization must consider both the internal and external issues that can impact its strategic objectives and the planning of its QMS. It pretty much changes the concept and application of clause 4, and requirements regarding the context of the organization do sound a little bit vague, so what does this clause actually require?
Clause 4 of ISO 9001:2015 Context of the organization requires the organization to evaluate itself and its context. 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.
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 is the lens that companies need to view their commitment to ITAR and EAR Compliance.
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 AS9100:2016. Our experts are Exemplar Global Certified Lead Auditors in these areas as well as certified through ECTI as Export Compliance Professionals.