Why Problem-Solving Skills Are Important For Manufacturing Companies

Problem-solving skills are indispensable for manufacturing companies to navigate the complexities of daily operations, enhance efficiency, and stay competitive. These skills empower companies to handle issues such as equipment failures, supply chain disruptions, and quality control challenges, ensuring smoother processes and improved outcomes.  Below is a comprehensive guide explaining why problem-solving skills are crucial in […]

Why Continuous Improvement Is Important For Manufacturing Companies?

Continuous improvement is a cornerstone of successful manufacturing operations, enabling companies to stay competitive, enhance efficiency, and deliver superior products. By systematically identifying and implementing incremental changes, organizations can optimize processes, reduce waste, and foster a culture of innovation. The Power of Continuous Improvement Key Continuous Improvement Methodologies Overcoming Challenges and Barriers Implementing continuous improvement […]

Integrating Lean Thinking into the Internal Audit Process

Angelo Scangas, QSG CEO and Chief Customer Officer, will be Keynote Speaker at the 2024 30th ASQ Audit Division Conference being held at the Peppermill Resort, Spa & Casino, Reno, Nevada Wednesday, October 9 – 10, 2024  In today’s fast-paced and dynamic business environment, organizations are constantly striving to enhance their operational efficiency and effectiveness. […]

How do Climate Change and Net Zero Guidelines affect your Quality Management System and YOUR BUSINESS?

By Angelo Scangas, CEO and Chief Climate Officer, Quality Support Group, Inc. What is Climate Change? Climate Change refers to long-term shifts in temperatures and weather patterns.  These changes can have drastic impacts on the world with increasing temperatures and more extreme and volatile weather.  We are seeing in real time the effects of climate […]

Auditing the Climate Change Additions to ISO Management System Standards – An Auditor’s Approach

Bob Deysher – Senior Consultant, Quality Systems/Risk Management/Auditing Member Bodies in the London Declaration have amended over 30 of ISO’s Management System Standards, including ISO 9001. As amendments they are not considered revisions; there is no transition period. “[U]pon publication, certification bodies should include the new text in their auditing or the organization and its […]

FDA Final Rule Harmonizes Medical Device Quality System Regulation with International Standard

Angelo Scangas – CEO & Chief Customer Officer The FDA’s Quality Management System Regulation (QMSR) update represents a significant move towards harmonizing the Quality System Regulation (QSR) for medical devices with the international standard ISO 13485:2016. This harmonization aims to streamline regulatory requirements, ease the burden on device manufacturers, and ensure consistent safety and effectiveness […]

Aligning ISO 13485 and FDA QSR 21 CFR 820 for Medical Devices

Introduction: The US Food and Drug Administration (FDA) has proposed a new framework that would harmonize its medical device quality management system (QMS) regulation, 21 CFR Part 820, to the ISO 13485 QMS standard. This draft would align the Quality System Regulation (QSR) with requirements for medical device manufacturers and with quality system requirements in […]

QSG Training & Work Instruction Videos

Studies show that reading blocks of text is one of the least efficient methods of transferring knowledge especially with a diverse workforce. With this in mind, the fact that most quality systems are focused on written procedures is an issue. The existence of modern video tools means that it is easy to create visual work […]