Items Tagged with 'auditing'

Why do we perform internal audits in the first place, beyond the fact that ISO 9001:2015 requires them?

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.

Andrew Davison is an experienced quality executive with more than 20 years working in the medical device industry. 

Organizations should begin discussions with their registrar now to better understand transition expectations, audit timing, and any additional documentation or review requirements that may be introduced during the transition process.

Policies and procedures are the backbone of traditional quality management. And they have three fundamental problems.

Quality control programs in injection molding are often focused on monitoring production – measuring dimensions, tracking variation, and verifying consistency across runs. 

Gage multiplexers consolidate measurements from multiple instruments into a single output (USB serial, keyboard wedge, or RS-232), simplifying data capture in quality labs and production. 

In aerospace distribution, quality standards are often expressed as requirements.

In laboratories, manufacturing plants, hospitals, testing facilities, and certification bodies around the world, quality systems are quietly losing their soul. 

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.