Integrated business management systems provide more effective solutions to the challenges facing organizations today. This approach consolidates business processes and systems across teams and unifies objectives. It can effectively address requirements for quality management, export compliance, information security management, and other concerns, ensuring compliance without gaps, duplication of efforts, or teams working at cross purposes.
Quality Management Systems (QMS)
Quality Management Systems (QMS) are systems that document responsibilities, processes, and procedures of an organization to achieve policies and objectives. These objectives are not limited to maintaining customer satisfaction for an organization’s products or services but extend to any external and internal issues relevant to objectives. As defined in clause 4.3 of ISO 9001:2015, external issues include applicable statutory and regulatory requirements.
To accomplish these objectives, it is critical that leadership demonstrate leadership and commitment by ensuring that these requirements are integrated into business processes and provided adequate resources. Furthermore, leadership must evaluate these requirements using a process approach and risk-based thinking to provide continuous improvement. Leadership is also responsible for review of these inputs to address non-conformities and determine the extent to which objectives have been met.
Export Compliance Management Program Requirements
Export compliance presents challenges for organizations due to its complexity and because regulations are Both the International Traffic in Arms Regulations (ITAR) and the Export Administration Regulations (EAR) have requirements for effective export compliance programs.
ITAR Program Requirements
As with ISO 9001:2015, the Directorate of Defense Trade Controls (DDTC) sites management commitment as an important factor for a successful program. This is essential for promoting a culture of compliance and ensuring that adequate resources to the program are available for its operation. The ITAR also stresses the importance of performing risk assessments and regular program audits.
Training is a requirement for organizations that are subject to ITAR export requirements. This training should be job specific and offered on a recurring basis. Records should be maintained for training activities. Additionally resources should be available for personnel to reference when export questions arise.
EAR Program Requirements
The Bureau of Industry and Security (BIS) places a strong emphasis on the need for commitment from senior management. This top-down approach is to emphasis allocation of sufficient resources, public support of policies and procedures related to the export compliance program, and provision of training.
The BIS strongly advises that regular risk assessments be performed to identify and address preventable risk that could result in release of controlled items or technical data. They also the performance of audits to check for program deficiencies and enable corrective actions to be taken through management processes.
Export Opportunities
Much emphasis is placed on the ramifications of being in violation of export violations, and justifiably so. Export violations can result in costly fines, loss of business reputation, debarment from export activities, and even imprisonment. However, maintaining an awareness of changes in export regulations can also result in new opportunities for business. Examples of this are the AUKUS defense trade integration that has resulted in relaxation of controls of exports between Australia, the United Kingdom, and the United States, and recent developments in the commercial space sector.
Cybersecurity and Information Security Management Systems
Regardless of sector, businesses today are facing increasing pressure to ensure the confidentiality, integrity, availability, and safety of data. This is applicable not only to data directly held by the organization but to data and products vulnerable to unauthorized access in the supply chain. As with quality management and export compliance these security risks must be addressed by an integrated business management approach.
Security breaches must be prevented through implementation of digital controls and physical security. These same physical controls are shared with export compliance requirements. They must also be prevented by management backed policies that are communicated to all personnel and external providers.
Cyber incidents must also be prevented through adequate training because the weakest link in cybersecurity is often the human factor. This training should include security literacy, should inform personnel of changes to policies or procedures, and should stress recognizing and reporting indicators of insider threats or social engineering activities.
NIST SP 800-53, NIST SP 800-161, NIST SP 800171, and ISO 27001 all place requirements for management to define security and privacy risk tolerance to establish a scope for mitigation strategies. This allows for a consistent application of a strategy that is both broad-based and comprehensive.
CVG Strategy Consultants
Quality Management
CVG Strategy quality consultancy team can help your organization implement an integrated business management system effectively and painlessly. Our consulting services will guide you through all phases of QMS, from assessment and development to the certification process.
CVG Strategy also provides the inclusion of statutory requirements for export compliance into your program. Ask our experts how we can provide this feature into your quality management system. Additionally, CVG Strategy can provide you with Quality Management training courses that will empower your team to achieve in a QMS environment.