Risk management has taken center stage in quality management, particularly with recent ISO updates. Organizations must recognize that risk encompasses both negative impacts and potential opportunities. By utilizing diverse analytical tools and effective brainstorming, businesses can navigate risks, minimizing downsides while capitalizing on growth opportunities.
This article discusses the relationship between manufacturing, quality, and metrology in modern industry. Manufacturing creates value, quality ensures it meets requirements, and metrology provides evidence of compliance. It highlights the challenges organizations face in the 21st century.
With the ISO 14001 being scheduled for the next release, even the registrars are beginning to instruct auditors on what to start to look for immediately.
Information about the updates to ISO 9001, ISO 14001, and ISO 45001 is becoming more accessible. Unlike past practices where drafts were kept secret until the FDIS, details are now emerging. Here’s what we know about the new Management System Standards so far.
Configuration management refers to maintaining consistency in a product’s functionality, performance, and physical characteristics by managing its design, operational data, and requirements throughout its lifecycle.
The upcoming revision of ISO 10017: 2017 focuses on "Quality management — Guidelines for configuration management," aimed at maintaining consistency in a product’s functionality and characteristics throughout its lifecycle. The configuration management process includes five steps.
Manufacturers and training providers are overhauling how they prepare nondestructive testing inspectors. New imaging technology, AI, simulation software and changing standards are reshaping training programs, while leaders are expanding their outreach and even changing their organizations’ internal cultures to attract and retain a new generation of inspectors.
Manufacturers and training providers are revamping nondestructive testing training with new technologies and standards, while leaders adapt outreach and culture to attract a new generation of inspectors.
Michael Mills, who writes for isoTracker QMS software, has been involved in quality systems in large and small companies for close to 30 years. He's a member of ASQ and ISO TC 76 and has audited to ISO 9001 since 1996. He's also written several articles for Quality. His latest is "The Seven Quality Management Principles."
Legacy systems in manufacturing lead to inefficiencies and quality risks, prompting companies to upgrade technology for tax savings. Evaluate your limitations, required infrastructure, necessary investments, manageable risks, and strategies for growth.
In the medical device sector, the focus will sharpen on cybersecurity, digital validation, and stronger post-market surveillance, as devices become more connected.
Sai Ranjith Ramakrishnan Kumar (Sai) is a medical device quality engineering expert, Six Sigma Green Belt Certified, and programs chair of ASQ Granite State Section. Quality talked with him about his contributions to advancing quality practices in industry and beyond, focusing on enhancing patient safety, ensuring regulatory compliance, and driving innovation in the profession.
We all talk about the invention of the airplane, the automobile, or other important products, but we rarely talk about the fascinating history of Quality.
It is essential to use relevant external documents—such as industry standards, codes, statutory requirements, and customer specifications—and integrate them into the management system.
This article focuses on preserving product and service integrity throughout its applicable lifecycle stages, which may include design, product realization, inspection, testing, packaging, transportation, installation, commissioning, maintenance, and deactivation.