Most early-stage medical device companies never decide to skip a quality management system (QMS). They just never decide to buy one.

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.

As AI matures, enterprises and customers are rapidly deploying agents seeking to unlock the next level of automation and productivity.

Projects go off the rails all the time. Some statistics I’ve seen say only one in eight projects can truly be declared successful.

Establishing a long-term improvement effort is one of the best investments an organization can make.

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.

They may seem simple, but standard operating procedures (SOPs) are surprisingly tricky. On the surface, they describe how a specific process is carried out at your organization. Pretty straightforward, right?

A quality team’s supplier toolbox is deep. Supplier questionnaires, PPAP, supplier scorecards, incoming inspection, audits, corrective action—the list goes on.

A new Financial Times analysis reports that U.S.

Six weeks after a global manufacturer’s leadership team approved a group of promising new ideas, someone asked for an update. There wasn’t one.