ISO 9001 provides tools for business management beyond the scope of product quality. Incorporating these tools can help an organization effectively and consistently manage specific issues and requirements strategically. Furthermore, because ISO 9001:2015 requires involvement from top management and relevant stakeholders, it ensures that these issues will be addressed comprehensively.
Context of the Organization
“Context of the Organization”, Clause 4 of ISO 9001:2015, provides a means of encompassing wider business planning activities into a Quality Management System (QMS). This clause places requirements to ascertain, monitor and review both internal and external issues that are relevant to an organization’s specific purpose and strategic direction. The importance of these various factors should be assessed through risk management.
External issues can include an array of concerns including legal, financial, social, regulatory and cultural factors. By identifying these issues when creating a quality program by they can be addressed in a process approach that provides continual improvement.
ISO 9001 Business Management Opportunities
Export Compliance
Organizations providing products and services are subject to a number of export regulations. For exporters in the United States these include the Export Administration Regulations (EAR) and the International Traffic in Arms Regulations (ITAR). These laws prevent export of controlled items to hostile entities. With regards to the ITAR, these include the export of defense related materials.
Violation of export compliance can result in fines, imprisonment, and export debarment (organization not allowed to export). Therefore, export compliance is an important external factor that can be addressed through ISO 9001 business management policies, processes, and procedures. Once these have been implemented they can be monitored so that corrective actions can be taken to prevent violations.
Product Design Protocols
Many industries are faced with specific design protocols requirements. These requirements can involve inputs from customers, engineering, government procurement agencies, sales, and upper management. Such is the case for product developers that must meet standard requirements under MIL-STD-810.
MIL-STD-810H establishes distinct processes for conducting a Whole Life Assessment (WLA) of a product under development. This process is to be initiated at the product concept phase.
Proper implementation of these processes allows for identification of relevant environmental stressors likely to be encountered in the product’s life cycle. These include development of a Life Cycle Environmental Profile and an Environmental Issues/Criteria List. Once these assessments have been conducted, design specifications and testing requirements can be created.
These processes can be incorporated into a quality management system to that is initiated at the concept phase of development. These processes should include all stakeholders to ensure that a complete WLA is conducted.
Implementing ISO 9001 for Your Organization
Achieving the highest possible return on investment is important, regardless of which quality management systems standard you organization implements. Taking advantage of all the features of that standard requires an understanding of Quality Management Systems and the growing number of requirements businesses face in their specific sectors.
Effective management of these requirements in a single program can create a more productive and efficient organization that consistently improve its performance and stay in compliance of regulations.
CVG Strategy Quality Management Expertise
Our Exemplar Global and Probitas Certified Quality Experts provide quality consultation in the Quality and Inspection disciplines to customers across North America. Our quality strategy allows clients new to Quality Management Systems to rapidly implement a tailored system.
We have assisted customers in implementing business management opportunities into their quality management systems by coupling our QMS expertise with our extensive experience in export compliance and product test and evaluation. This allows to readily deliver compliant procedures and work instructions.