Internal Audit Semantics
‘We call them unscheduled (vs. surprise) audits, in that they are not part of the originally planned, annual first-party audit plan.”
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