ISO 14971 2019 Risk Management ISO 14971:2019 is a quality management system that establishes risk management criteria for manufacturers of medical devices. As defined in the standard, risk is the combination of probabilities that harm could occur and the degree of severity of that harm. Harm is defined as injury to the health of persons, … Read more
It wasn’t long ago that EMC Testing and Risk Management wouldn’t have appeared in the same sentence. Electromagnetic Interference (EMI) and Electromagnetic Compatibility (EMC) testing has normally been performed to meet the criterion established for a desired label. Once compliance testing has been passed, it’s off to market. Medical Equipment Safety Concerns A modern medical … Read more
Counterfeit Parts and Quality Management Systems (QMS) AS9100 and associated standards provide a Quality Management System (QMS) approach to the problem of counterfeit parts for the aviation, space, and defense industries. These counterfeit electronics parts avoidance standards were created in response to requirements of the aerospace supply chain where counterfeit parts pose significant performance, reliability, … Read more
Integrated Management Solutions Tailored Programs to Address Risks CVG Strategy’s Quality Management Consulting team can help your organization implement Integrated Management Solutions to address a variety of risks. These risks might include those associated in maintaining customer satisfaction, information security, and regulatory compliance. These risks and requirements vary from organization to organization and therefore require … Read more
Integrating multiple management systems can provide businesses with a more coordinated approach to addressing growing numbers of organizational concerns and responsibilities. This integration can be accomplished prior to implementing a management system or after implementing any number of systems. Once accomplished however, an organization can realize enhanced planning, accountability, and reduction of costs. The International … Read more
ISO 27001 cybersecurity management is an effective Information Security Management System (ISMS) for organizations and businesses of all sizes. It provides a means to ensure confidentiality, integrity, and availability of information in a system that can be harmonized with other management systems. The ISO Advantage There are numerous cyber security solutions for protecting confidential information. … Read more
Collaboration and Quality Management are concepts that should come to mind together. It can, however, be difficult to combine teamwork and quality management in a manufacturing or service process. There are challenges involved in bringing all interested parties to the table and engaging them in working together to continuously improve products and services. These challenges … Read more
Export Compliance Program Management Effective export compliance program management poses challenges for organizations of all sizes and sectors. U.S. export regulations such as the Export Administration Regulations (EAR) and the International Traffic in Arms Regulations (ITAR) are complex and under constant revision. Compliance is further complicated for organizations that have multinational operations and must therefore … Read more
Why Have a Quality Management System for Service Industry Businesses? At first glance a Quality Management System (QMS) might appear inappropriate for service industry businesses. There would appear to be a lack of metrics to serve as inputs, as a large portion of the product is not physical. Customer satisfaction however, is a very tangible … Read more
Risks and Opportunities are Everywhere Businesses evaluate risks and opportunities every time they make a decision. It is all about weighing the probability of a positive outcome versus the impact or cost of a negative outcome from an action taken. Strengths, Weaknesses, Opportunities, and Threats (SWOT) For most organizations ISO 9001:2015 provides a Quality Management … Read more
Having a Cybersecurity Strategy is Essential Having an effective cybersecurity strategy to protect information assets is a necessity in today’s business world. News stories and alerts appear daily, informing us of yet another threat or data breach that has put at risk the valuable data and security of millions of people. This endless pressure can … Read more
What is a Quality Management System? A Quality Management System (QMS) is an assemblage of processes, procedures, and polices for achieving customer requirements and customer satisfaction. These systems, when appropriately applied, can provide an enterprise with increased operational consistency and profitability. Although originally created for manufacturing endeavors, QMS are also applicable for service industries. There … Read more
ISO 9001: 2015 Quality Management System Requirements Proper documentation is the cornerstone of ISO 9001:2015. Creating a system of documentation that is appropriate to your company’s requirements is crucial. This is because the documentation defines the manner in which it will conduct business. Paying attention to the design of your Quality Management System (QMS) at … Read more
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 … Read more
Recent events have illustrated the need for effective supply chain quality management. Industries in any sector are vulnerable to unforeseen changes in global economic and political forces. Indeed, the veracity of supply chains are even subject to microscopic viruses that can render entire companies inoperable. The Role of a Quality Management System in Supply Chain … Read more
Employee cybersecurity negligence is still a major cause of risk for businesses. Despite an increased emphasis on training people, human error and bad habits continue to endanger sensitive information. Data Breaches on the Rise Institutions of all types have seen a dramatic increase in the number of cyber attacks. This has been especially the case … Read more
