Standards

(ISO: Geneva) -- Sustainability claims are everywhere. From recycled plastics and responsibly sourced fibers to renewable fuels and low-carbon materials, companies increasingly promise products with specific environmental or social characteristics.

But in complex global supply…

Nobody would get into a self-driving car simply because the door locks worked and the alarm system was functioning properly. Those security features protect the car from being stolen or tampered with, but they say nothing about whether the car’s AI will stop in time when a child runs into the…

‘This product isn’t approved to be imported into this market,” says a customs official while reviewing the importation documentation.

Local quality and regulatory teams are quickly brought into the conversation and see that the product’s registration has been valid for several…

For decades, the process industries have relied on layers of protection to prevent hazardous events. When risk reduction requirements were high, safety instrumented systems (SIS), governed by standards such as IEC/ISA 61511, provided a clear framework for design, operation, and life-cycle…

Validating AI software makes most quality teams uneasy.

Their unease is not unjustified. The new Annex 22 provides a framework for AI use, but the guidance remains in draft. Most quality teams still have questions, especially around validation.

Why? Quality teams are…

In the medical device industry, compliance isn’t a pop quiz. The U.S. Food and Drug Administration (FDA) has given you all the answers to the test in the form of a regulation: 21 CFR Part 820. That doesn’t mean it’s easy to ace the test. But you now have all the resources you need to pass.