People pitch ideas all the time. Most of those pitches never get heard. Why? Because they don’t consider the audience.

Leadership responsibility is included in ISO 9001:2026, Clause 5.1.1,  to promote quality culture and ethical behavior. A strong argument could be made for adding safety as well.

When OpenAI introduced ChatGPT on Nov. 30, 2022, it arrived as a research preview: a conversational system that could answer follow-up questions, draft fluent text, and give millions of people their first direct experience of generative AI.

The real test of a quality system isn’t what happens when everything works. It’s what happens when something doesn’t.

Most organizations are reluctant to spend time and money training their workforce on customer service.

During a recent visit to a brewery in Dublin, I was stopped by one statement displayed on the tour: “The quality of our advertising must be equal to the quality of our beer.”

Teams building software as a medical device (SaMD) tend to think of ISO 14971 as the hardware team’s problem. Risk management files, FMEA tables, severity scores: all quality and regulatory territory, while the engineers close Jira tickets.

A food company spends months and significant budget on consumer research before launching a new product. The survey scores are strong, so the store managers stock it. Six months later, the product is quietly pulled from the shelves.

Three years ago, I’d never heard the term biomedical equipment technician (BMET). I didn’t know the field of healthcare technology management (HTM) existed.

Southern politicians often have a homespun way of making a point. A few years ago, a candidate for a small-town sheriff’s election was overheard saying, “Criticize my drawl, you make me laugh. Criticize my views, you make me listen.