The Beginning of the End for Fake ISO 13485 Certificates
Many of us have heard horror stories about ISO certificates that were fakes, or of medical-device quality system audits being performed by persons who were not competent.
New Spectrometry Standard for Handheld Chemical Detectors Aids First Responders
When it comes to detectors for dangerous chemicals, toxins, or nefarious germs, smaller and faster is better. But size and speed must still allow for accuracy, especially when measurements by different instruments must give the same result.
Standardize to Improve, Part 1
Taiichi Ohno, the father of the Toyota Production System, once said, “Where there is no standard [process], there can be no kaizen [improvement].”
Building a Practical Risk Management Process into Your QMS
Editor’s note: Tim Lozier will be a guest on Quality Digest Live this Friday, Oct. 18, 2013, at 11 a.m. Pacific
Beethoven’s Fifth and ISO 9001:2015—An Expert’s View
First published Oct. 1, 2013, on the CERM Risk Insights blog. © Umberto Tunesi and CERM Risk Insights.
Who Is the Customer of Your Document?
Arecent call with an old colleague from Europe got me wondering about a question that few are conscious of: Who is the customer of your quality document? Oh boy, did we have an interesting discussion about quality systems.