Items Tagged with 'ISO 9001'

ISO14001: 2026 doesn’t require more documented information, but instead expects organizations to better manage their EMS with proof of real performance and effective management.

X-ray Computed Tomography (CT) inspection has become one of the most powerful tools available for diagnosing quality problems that other inspection methods simply cannot reach.

One of the most common misunderstandings is the belief that quality is something checked at the end. But in real operations, quality starts much earlier.

The purpose of this system is simple: to ensure that processes are defined, measurable, and capable of being analyzed.

Although supply chain concerns are sometimes reviewed, their direct impacts on organizations are often overlooked.

Some of the most disruptive quality failures in medical manufacturing are not found on the production floor. They are built into the handoff between the supplier and manufacturer early in the process. 

I have over the past couple of years presented the journey that ISO 10012 has followed to reach the time for release as the latest revision.

Bob Ferrone specializes in integrating industrial design, engineering, quality, manufacturing and environmental management systems for improving environmental and economic performance. 

Previously, I discussed my concerns about organizations not properly managing corrective actions or process variation. While corrective actions were covered before, this piece focuses on variation.

Ever since the announcement that ISO 9001 would be revised, the internet has been alive with speculation about what will change.