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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
Opportunities for Improvement – Internal Audits and Management Review. Opportunities for improvement can be identified during the performance of a Quality Management System (QMS) Internal Audit. When findings are analyzed with a critical review by management, valuable insights can be gained into increased profit, efficiency, and customer satisfaction. The Benefits of Effective Auditing Often an
The United States Standards Strategy (USSS) supports the development of economic growth through the development of standards. This development is open to participation by U.S. companies in their respective sectors. Originally published in 2000, the USSS was formerly the National Standards Strategy for the United States (NSS). It coordinates the efforts of industry stakeholders in
MIL-STD-810 Shock Methods and Procedures MIL-STD-810 contains numerous shock methods and procedures that provide laboratory simulations of real world events. Mechanical shock can adversely effect the integrity of a component, especially if the resonances of the shock harmonize with natural frequencies of that component. To ensure effective developmental test and evaluation of a product it
Essential Features of an ITAR Compliance Program International Traffic in Arms Regulations (ITAR) compliance is a requirement for companies entering markets with defense related applications. To establish an effective ITAR compliance program all segments of a business must be involved. Important features of an ITAR program include the following: DDTC Registration DDTC registration is a
Preventing Product Damage Due to Shipping Utilizing packaged products methods of evaluation can greatly reduce losses due to shipping damage and increase customer satisfaction. According to Packing Digest, between 2 to 11 percent of packaged products arrive at a distribution with some damage. In many cases this damage could be avoided by ensuring that packaging
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
What is Cybersecurity Maturity Model Certification? The Office of the Under Secretary of Defense for Acquisition & Sustainment has released the Cybersecurity Maturity Model Certification program. The program will be made effective in new programs released by the Department of Defense (DoD) and will be a requirement for product and service providers. This program has
Continuing Changes in Export Compliance Maintaining export compliance programs presents challenges to organizations of all sizes. Given the complexity of the International Traffic in Arms Regulations (ITAR), Export Administration Regulations (EAR), Antiboycott Regulations, and various sanctions, this is not surprising. Additionally, international political events are forcing agencies to continually make changes to these regulations to
What is EMI Susceptibility? EMI/EMC susceptibility is the vulnerability of an electronic device to electromagnetic energy that can result in disruptions to that device’s normal operation. These disruptions can result in physical damage of the device, or unwanted operational events that can lead to property damage, injury, or death. This is of special concern where
Using Your QMS to Enhance Profitability Using your Quality Management System (QMS) to improve processes can enhance customer satisfaction and increase profitability. The key to achieving these goals is for the management team and senior leadership to identify the strategic direction of the organization and align the QMS to achieve those goals. Certification body quality
Cybersecurity Threats by Industry Sector Cybersecurity threats remain a significant concern for organizations in every sector. IBM’s 17th Cost of a Data Breach Report provided insights in to the nature of the threat environment in 2021. This report provides an assessment of risks and strategies for protecting data and responses to data breaches. Among its
