Standards
A significant change in ISO 9001:2026 involves separate actions to address risks and opportunities. In her article “Brainstorming: The Ultimate Risk Management Tool,” Jenna M Schoettker writes, “Think of risk as two sides of a coin. On one side we have our negative risk, while the other side…
Digital transformation and technologies such as artificial intelligence or the internet of things (IoT) aren’t just changing our society; they’re revolutionizing how we do business.
The speed of innovation can be a challenge. But it also presents an opportunity. As a quality…
Corrective and preventive action (CAPA) is the backbone of any quality management system. It’s where problems get solved, risks get reduced, and processes become more robust. Yet in many organizations, CAPA has become little more than a documentation exercise.
Forms get filled.…
Digital transformation has stopped being a trend and become a condition for competitiveness. In practically every sector, including manufacturing, automotive, food and beverage, healthcare, and logistics, the pace of technological change is redefining what it means to manage quality with…
Growth has a way of outpacing the quality systems built to support it: more products, more sites, more users, more regulatory requirements, and the quality team is expected to absorb all of it.
Document reviews stall waiting for approvals. Training assignments require constant…
The FY 2027 White House budget proposal is not only a fiscal plan but a change in national quality architecture. It lifts total defense funding to about $1.5 trillion while proposing a 10% cut to base nondefense discretionary spending. In quality terms, it shifts the system away from upstream…