What we’re talking about
Achieving quality objectives is a goal when implementing and maintaining any ISO 9000 family quality management system (QMS). To achieve goals however, an organization must first clearly delineate what those objectives are. Establishing quality objectives is a requirement under the planning clause of ISO 9001:2015. However, to obtain the greatest value, care should be taken
The Food and Drug Administration (FDA) has completed guidance for medical equipment Electromagnetic Compatibility (EMC) information to be submitted before an electrical medical device that is manufactured in the United States is marketed. This guidance updates previous submission recommendations released in 2016. Its intent is to provide clarification of what the FDA will consider in
EMI emission test failures for compliance testing are a major cause of product development delays because most products fail in their first trip to the lab. Radiated Emissions is the most common problem for developmental electronic products and one that is often difficult to mitigate. This holds true for both military and commercial products. Radiated
Internet of Things (IOT) cybersecurity is becoming an issue of increasing concern as these devices continue to secure a larger marketplace presence. This is due to the fact that IoT solutions are a cost effective means of achieving integration of connected devices. IoT include smart home products, wearable technology, health monitoring devices, alarm systems, and
The Bureau of Industry and Security (BIS) is placing controls on marine toxins in a unilateral effort to prevent biological threats to humans and the environment by way of accidental or deliberate release. This control specifically addresses the export, reexport, or transfer of the biotoxins brevetoxin, gonyautoxin, nodularin, and palytoxin. These toxins are generally found
Economic Espionage by China Continues in Every Sector in the United States Economic espionage efforts by China continue to pose a serious threat to the United States in both public and private sectors. In the public sector hacking groups backed by the People’s Republic of China have infiltrated local and federal agencies. These persistent attacks
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
Defining MIL-STD-810 MIL-STD-810H – Environmental Engineering Considerations and Laboratory Tests is a Department of Defense (DoD) test standard to evaluate the effects of environmental stresses on materiel that are likely to occur during all phases of service life. Using MIL-STD-810 effectively in product development is of great importance to developers of military equipment. Over and
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
Understanding CMMC Requirements is critical for businesses of all sizes in the defense industry. This need is becoming more urgent as final release of CMMC 2.0 is expected to occur in 2023. Failure to achieve an appropriate level of Cybersecurity Maturity Model Certification in a timely manner may impede an organization’s ability to participate in
Many users take messaging app security for granted when sending text messages, voice messages, photos, and videos. However, not all apps secure messaging data equally. This is a concern for both organizations and individuals who wish to ensure the confidentiality, integrity, and authenticity of information transferred between authorized users. Elements of Messaging Security Messaging app
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
ISO 13485:2016 Applicability Implementation of ISO 13485:2016 Quality Management System (QMS) is applicable to organizations involved with the any of the steps in a medical devices life cycle, including design, calibration, production, and disposal. This voluntary international standard allows for the variances in regulatory requirements particular to the organization’s region of application. Because ISO
ITAR and EAR- U.S. Export Regulations The ITAR (International Traffic in Arms Regulations) and the EAR (Export Administration Regulations) are export control regulations run by different departments of the U.S. Government. Both are in place to ensure that restricted technologies do not get into the hands of terrorists and countries who are not operating in
AIAA S-121A-2017 is a test standard based on military standards MIL-STD-461 and MIL-STD-464 that addresses EMC for space system requirements. This standard relies heavily upon appropriate tailoring in the development of a test plan. EMC and Space System Applications The burgeoning New Space Economy is providing opportunities for a wide array of product developers to
Infrastructure and the manufacturing sector concerns pose tempting targets for cyberattacks. Widespread effects that can harm vast sectors of society can occur when these systems are compromised. When considering Cyber Security first thoughts usually go to computers and information technology, but industrial devices and processes can fall victims as well. On May of 2021 the
